Trial Outcomes & Findings for A Study to Evaluate the Efficacy and Safety of Bimekizumab Compared to an Active Comparator in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis (NCT NCT03536884)
NCT ID: NCT03536884
Last Updated: 2025-12-23
Results Overview
The PASI100 response assessments are based on 100% improvement in PASI score from Baseline. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
743 participants
Primary outcome timeframe
Week 16
Results posted on
2025-12-23
Participant Flow
The study started to enroll participants in June 2018 and concluded in August 2023. Study has Screening Period (2-5 weeks (wk)), DB Treatment Period 48 wks (ITP-Wk 0-16 and MTP- Wk 16-Wk 48), an optional OLE Period (96 wks) followed by SFU Visit (20 wks after final dose) and an optional OLE2 Period followed by SFU2 Visit (20 wks after final dose).
Participant flow refers to the Randomized Set (RS), Maintenance Set (MS), Open-Label Set (OLS), and Open-Label Set 2 (OLS2).
Participant milestones
| Measure |
ITP: Bimekizumab (BKZ) 320 Milligrams (mg) Q4W
Participants randomized to this arm received BKZ 320 mg subcutaneously (sc) every 4 weeks (Q4W) for 16 weeks in the Initial Treatment Period (ITP). Placebo was administered at pre-specified time-points to maintain the blinding.
|
ITP: Secukinumab 300 mg Q4W
Participants received secukinumab 300 mg sc at Baseline and Weeks 1, 2, 3, and 4 followed by dosing Q4W until Week 16 in the Initial Treatment Period.
|
MTP: BKZ 320 mg Q4W/Q8W
Participants randomized to this arm received BKZ 320 mg sc Q4W for 16 weeks in the Initial Treatment Period. At Week 16, participants were re-randomized to receive BKZ 320 mg sc Q8W until Week 48 in the Maintenance Treatment Period (MTP). Placebo was administered at pre-specified time-points to maintain the blinding.
|
MTP: BKZ 320 mg Q4W/Q4W
Participants randomized to this arm received BKZ 320 mg sc Q4W for 16 weeks in the Initial Treatment Period. At Week 16, participants continued to receive BKZ 320 mg sc every 4 Weeks (Q4W/Q4W) until Week 48 in the Maintenance Treatment Period.
|
MTP: Secukinumab 300 mg Q4W/Q4W
Participants in secukinumab arm continued to receive secukinumab 300 mg sc Q4W until Week 48 in the Maintenance Treatment Period.
|
OLE Period: BKZ Week 0-48/BKZ Q8W 320 mg
Participants randomized to this arm received BKZ 320 mg sc Q4W for the first 16 weeks and then re-randomized to receive BKZ 320 mg sc Q4W or Q8W until Week 48 of the double-blind Treatment Period. Based on the PASI90 response and the dose the participant was receiving at Week 48, participants were randomized to receive BKZ 320 mg sc Q8W until Week 136 in the Open-Label Extension (OLE) Period.
|
OLE Period: BKZ Week 0-48/ BKZ Q4W 320 mg
Participants randomized to this arm received BKZ 320 mg sc Q4W for the first 16 weeks and then re-randomized to receive BKZ 320 mg sc Q4W or Q8W until Week 48 of the double-blind Treatment Period. Based on the PASI90 response and the dose the participant was receiving at Week 48, participants were randomized to receive BKZ 320 mg sc Q4W starting in OLE Period. The participant's dosing interval was changed from BKZ 320mg Q4W to BKZ 320mg Q8W at Week 64, or at the next scheduled clinic visit if the participant has already completed the Week 64 after protocol amendment 5.
|
OLE Period: Secukinumab Week 0-48/ BKZ Q8W 320 mg
Participants randomized to this arm received Secukinumab 300 mg sc Q4W until Week 48 of the double-blind Treatment Period. Based on the PASI90 response in double-blind Treatment Period, participants randomized to receive BKZ 320 mg sc Q8W until Week 136 of the OLE Period.
|
OLE Period: Secukinumab Week 0-48/ BKZ Q4W 320 mg
Participants randomized to this arm received Secukinumab 300 mg sc Q4W until Week 48 of the double-blind Treatment Period. Based on the PASI90 response in double-blind Treatment Period, participants randomized to receive BKZ 320 mg sc Q4W starting in OLE Period. The participant's dosing interval was changed from BKZ 320mg Q4W to BKZ 320mg Q8W at Week 64, or at the next scheduled clinic visit if the participant has already completed the Week 64 after protocol amendment 5.
|
OLE2 Period - Group A: BKZ 320 mg Q8W
Participants who were still receiving treatment in the OLE Period and attended the Week 144 visit were directly rolled over to the OLE2 Period. In OLE2 Period, participants continued receiving BKZ 320 mg sc Q8W for 40 additional weeks until OLE2 Week 48.
|
OLE2 Period - Group B: BKZ 320 mg Q8W
Participants who completed the Week 144 and were participating in the Safety Follow-Up (SFU) or had completed the SFU visit reinitiated their treatment in the OLE2 Period after having undergone Screening assessments during a 4-week OLE2 Screening Period. Participants with an IGA score less than (\<) 3 at the Week 144/OLE2 Baseline Visit continued receiving BKZ 320 mg sc Q8W for 40 additional weeks until OLE2 Week 48 in OLE2 Period.
|
OLE2 Period -Group B: BKZ 320 mg Q4W/Q8W
Participants who completed the Week 144 visit and were participating in the SFU or had completed the SFU visit reinitiated their treatment in the OLE2 Period after having undergone Screening assessments during a 4-week OLE2 Screening Period. Participants with an IGA score greater than or equal to (\>=) 3 at the Week 144/OLE2 Baseline Visit received BKZ 320 mg sc Q4W for the first 16 weeks, and then switched to BKZ 320 mg sc Q8W for 24 weeks until OLE2 Week 48 in OLE2 Period.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Double-Blind (DB) Period: ITP Wk 0-16
STARTED
|
373
|
370
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Double-Blind (DB) Period: ITP Wk 0-16
COMPLETED
|
362
|
354
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Double-Blind (DB) Period: ITP Wk 0-16
NOT COMPLETED
|
11
|
16
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Double-Blind Period: MTP Wk 16-48
STARTED
|
0
|
0
|
215
|
147
|
354
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Double-Blind Period: MTP Wk 16-48
COMPLETED
|
0
|
0
|
205
|
138
|
325
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Double-Blind Period: MTP Wk 16-48
NOT COMPLETED
|
0
|
0
|
10
|
9
|
29
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
OLE Period: Wk48-Wk144
STARTED
|
0
|
0
|
0
|
0
|
0
|
238
|
98
|
122
|
196
|
0
|
0
|
0
|
|
OLE Period: Wk48-Wk144
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
205
|
80
|
106
|
167
|
0
|
0
|
0
|
|
OLE Period: Wk48-Wk144
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
33
|
18
|
16
|
29
|
0
|
0
|
0
|
|
OLE2 Period: Wk 144/OLE2 BL- OLE2 Wk 48
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
9
|
66
|
59
|
|
OLE2 Period: Wk 144/OLE2 BL- OLE2 Wk 48
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
6
|
61
|
52
|
|
OLE2 Period: Wk 144/OLE2 BL- OLE2 Wk 48
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
5
|
7
|
Reasons for withdrawal
| Measure |
ITP: Bimekizumab (BKZ) 320 Milligrams (mg) Q4W
Participants randomized to this arm received BKZ 320 mg subcutaneously (sc) every 4 weeks (Q4W) for 16 weeks in the Initial Treatment Period (ITP). Placebo was administered at pre-specified time-points to maintain the blinding.
|
ITP: Secukinumab 300 mg Q4W
Participants received secukinumab 300 mg sc at Baseline and Weeks 1, 2, 3, and 4 followed by dosing Q4W until Week 16 in the Initial Treatment Period.
|
MTP: BKZ 320 mg Q4W/Q8W
Participants randomized to this arm received BKZ 320 mg sc Q4W for 16 weeks in the Initial Treatment Period. At Week 16, participants were re-randomized to receive BKZ 320 mg sc Q8W until Week 48 in the Maintenance Treatment Period (MTP). Placebo was administered at pre-specified time-points to maintain the blinding.
|
MTP: BKZ 320 mg Q4W/Q4W
Participants randomized to this arm received BKZ 320 mg sc Q4W for 16 weeks in the Initial Treatment Period. At Week 16, participants continued to receive BKZ 320 mg sc every 4 Weeks (Q4W/Q4W) until Week 48 in the Maintenance Treatment Period.
|
MTP: Secukinumab 300 mg Q4W/Q4W
Participants in secukinumab arm continued to receive secukinumab 300 mg sc Q4W until Week 48 in the Maintenance Treatment Period.
|
OLE Period: BKZ Week 0-48/BKZ Q8W 320 mg
Participants randomized to this arm received BKZ 320 mg sc Q4W for the first 16 weeks and then re-randomized to receive BKZ 320 mg sc Q4W or Q8W until Week 48 of the double-blind Treatment Period. Based on the PASI90 response and the dose the participant was receiving at Week 48, participants were randomized to receive BKZ 320 mg sc Q8W until Week 136 in the Open-Label Extension (OLE) Period.
|
OLE Period: BKZ Week 0-48/ BKZ Q4W 320 mg
Participants randomized to this arm received BKZ 320 mg sc Q4W for the first 16 weeks and then re-randomized to receive BKZ 320 mg sc Q4W or Q8W until Week 48 of the double-blind Treatment Period. Based on the PASI90 response and the dose the participant was receiving at Week 48, participants were randomized to receive BKZ 320 mg sc Q4W starting in OLE Period. The participant's dosing interval was changed from BKZ 320mg Q4W to BKZ 320mg Q8W at Week 64, or at the next scheduled clinic visit if the participant has already completed the Week 64 after protocol amendment 5.
|
OLE Period: Secukinumab Week 0-48/ BKZ Q8W 320 mg
Participants randomized to this arm received Secukinumab 300 mg sc Q4W until Week 48 of the double-blind Treatment Period. Based on the PASI90 response in double-blind Treatment Period, participants randomized to receive BKZ 320 mg sc Q8W until Week 136 of the OLE Period.
|
OLE Period: Secukinumab Week 0-48/ BKZ Q4W 320 mg
Participants randomized to this arm received Secukinumab 300 mg sc Q4W until Week 48 of the double-blind Treatment Period. Based on the PASI90 response in double-blind Treatment Period, participants randomized to receive BKZ 320 mg sc Q4W starting in OLE Period. The participant's dosing interval was changed from BKZ 320mg Q4W to BKZ 320mg Q8W at Week 64, or at the next scheduled clinic visit if the participant has already completed the Week 64 after protocol amendment 5.
|
OLE2 Period - Group A: BKZ 320 mg Q8W
Participants who were still receiving treatment in the OLE Period and attended the Week 144 visit were directly rolled over to the OLE2 Period. In OLE2 Period, participants continued receiving BKZ 320 mg sc Q8W for 40 additional weeks until OLE2 Week 48.
|
OLE2 Period - Group B: BKZ 320 mg Q8W
Participants who completed the Week 144 and were participating in the Safety Follow-Up (SFU) or had completed the SFU visit reinitiated their treatment in the OLE2 Period after having undergone Screening assessments during a 4-week OLE2 Screening Period. Participants with an IGA score less than (\<) 3 at the Week 144/OLE2 Baseline Visit continued receiving BKZ 320 mg sc Q8W for 40 additional weeks until OLE2 Week 48 in OLE2 Period.
|
OLE2 Period -Group B: BKZ 320 mg Q4W/Q8W
Participants who completed the Week 144 visit and were participating in the SFU or had completed the SFU visit reinitiated their treatment in the OLE2 Period after having undergone Screening assessments during a 4-week OLE2 Screening Period. Participants with an IGA score greater than or equal to (\>=) 3 at the Week 144/OLE2 Baseline Visit received BKZ 320 mg sc Q4W for the first 16 weeks, and then switched to BKZ 320 mg sc Q8W for 24 weeks until OLE2 Week 48 in OLE2 Period.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Double-Blind (DB) Period: ITP Wk 0-16
Adverse Event
|
8
|
6
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Double-Blind (DB) Period: ITP Wk 0-16
Lost to Follow-up
|
0
|
3
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Double-Blind (DB) Period: ITP Wk 0-16
Withdrawal by Subject
|
3
|
4
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Double-Blind (DB) Period: ITP Wk 0-16
Unblinding was reason for dropout
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Double-Blind (DB) Period: ITP Wk 0-16
Withdrawn by Investigator for abnormal lab values
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Double-Blind (DB) Period: ITP Wk 0-16
Unable to attend visits
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Double-Blind Period: MTP Wk 16-48
Death
|
0
|
0
|
1
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Double-Blind Period: MTP Wk 16-48
Adverse Event
|
0
|
0
|
1
|
3
|
3
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Double-Blind Period: MTP Wk 16-48
Lack of Efficacy
|
0
|
0
|
0
|
1
|
4
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Double-Blind Period: MTP Wk 16-48
Lost to Follow-up
|
0
|
0
|
1
|
2
|
9
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Double-Blind Period: MTP Wk 16-48
Withdrawal by Subject
|
0
|
0
|
7
|
3
|
12
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
OLE Period: Wk48-Wk144
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
10
|
8
|
6
|
13
|
0
|
0
|
0
|
|
OLE Period: Wk48-Wk144
Lack of Efficacy
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
1
|
4
|
0
|
0
|
0
|
|
OLE Period: Wk48-Wk144
Protocol Violation
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
2
|
0
|
0
|
0
|
0
|
|
OLE Period: Wk48-Wk144
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
7
|
0
|
1
|
5
|
0
|
0
|
0
|
|
OLE Period: Wk48-Wk144
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
12
|
7
|
6
|
6
|
0
|
0
|
0
|
|
OLE Period: Wk48-Wk144
Not dosing for over 6 Months while out of country
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
OLE Period: Wk48-Wk144
Patient held IP due to pandemic, not restarted
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
OLE Period: Wk48-Wk144
Went to jail, unable to continue study visits
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
OLE Period: Wk48-Wk144
Non-compliance
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
OLE Period: Wk48-Wk144
She wants to be pregnant
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
OLE2 Period: Wk 144/OLE2 BL- OLE2 Wk 48
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
2
|
1
|
|
OLE2 Period: Wk 144/OLE2 BL- OLE2 Wk 48
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
2
|
2
|
|
OLE2 Period: Wk 144/OLE2 BL- OLE2 Wk 48
Site's business is closing on 30 September 2022
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
OLE2 Period: Wk 144/OLE2 BL- OLE2 Wk 48
Site closure
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
|
OLE2 Period: Wk 144/OLE2 BL- OLE2 Wk 48
Subject had threatening behavior to site staff
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
A Study to Evaluate the Efficacy and Safety of Bimekizumab Compared to an Active Comparator in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis
Baseline characteristics by cohort
| Measure |
ITP: Bimekizumab (BKZ) 320 Milligrams (mg) Q4W
n=373 Participants
Participants randomized to this arm received BKZ 320 mg subcutaneously (sc) every 4 weeks (Q4W) for 16 weeks in the Initial Treatment Period (ITP). Placebo was administered at pre-specified time-points to maintain the blinding.
|
ITP: Secukinumab 300 mg Q4W
n=370 Participants
Participants received secukinumab 300 mg sc at Baseline and Weeks 1, 2, 3, and 4 followed by dosing Q4W until Week 16 in the Initial Treatment Period.
|
Total Title
n=743 Participants
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
3 Participants
n=68 Participants
|
7 Participants
n=4 Participants
|
10 Participants
n=219 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
332 Participants
n=68 Participants
|
324 Participants
n=4 Participants
|
656 Participants
n=219 Participants
|
|
Age, Categorical
>=65 years
|
38 Participants
n=68 Participants
|
39 Participants
n=4 Participants
|
77 Participants
n=219 Participants
|
|
Age, Continuous
|
45.9 years
STANDARD_DEVIATION 14.2 • n=68 Participants
|
44.0 years
STANDARD_DEVIATION 14.7 • n=4 Participants
|
45.0 years
STANDARD_DEVIATION 14.5 • n=219 Participants
|
|
Sex: Female, Male
Female
|
122 Participants
n=68 Participants
|
135 Participants
n=4 Participants
|
257 Participants
n=219 Participants
|
|
Sex: Female, Male
Male
|
251 Participants
n=68 Participants
|
235 Participants
n=4 Participants
|
486 Participants
n=219 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=68 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=219 Participants
|
|
Race/Ethnicity, Customized
Asian
|
10 Participants
n=68 Participants
|
9 Participants
n=4 Participants
|
19 Participants
n=219 Participants
|
|
Race/Ethnicity, Customized
Black
|
6 Participants
n=68 Participants
|
4 Participants
n=4 Participants
|
10 Participants
n=219 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=68 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=219 Participants
|
|
Race/Ethnicity, Customized
White
|
347 Participants
n=68 Participants
|
348 Participants
n=4 Participants
|
695 Participants
n=219 Participants
|
|
Race/Ethnicity, Customized
Other or Mixed
|
9 Participants
n=68 Participants
|
6 Participants
n=4 Participants
|
15 Participants
n=219 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
19 Participants
n=68 Participants
|
32 Participants
n=4 Participants
|
51 Participants
n=219 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
354 Participants
n=68 Participants
|
338 Participants
n=4 Participants
|
692 Participants
n=219 Participants
|
PRIMARY outcome
Timeframe: Week 16Population: The Randomized Set (RS) consisted of all randomized study participants.
The PASI100 response assessments are based on 100% improvement in PASI score from Baseline. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.
Outcome measures
| Measure |
ITP: Bimekizumab (BKZ) 320 mg Q4W
n=373 Participants
Participants randomized to this arm received BKZ 320 mg sc Q4W for 16 weeks in the Initial Treatment Period (ITP). Placebo was administered at pre-specified time-points to maintain the blinding.
|
ITP: Secukinumab 300 mg Q4W
n=370 Participants
Participants received secukinumab 300 mg sc at Baseline and Weeks 1, 2, 3, and 4 followed by dosing Q4W until Week 16 in the Initial Treatment Period.
|
MTP: BKZ 320 mg Q4W/Q8W
Participants randomized to this arm received BKZ 320 mg sc Q4W for 16 weeks in the Initial Treatment Period. At Week 16, participants were re-randomized to receive BKZ 320 mg sc Q8W until Week 48 in the Maintenance Treatment Period (MTP). Placebo was administered at pre-specified time-points to maintain the blinding.
|
MTP: BKZ 320 mg Q4W/Q4W
Participants randomized to this arm received BKZ 320 mg sc Q4W for 16 weeks in the Initial Treatment Period. At Week 16, participants continued to receive BKZ 320 mg sc every 4 Weeks (Q4W/Q4W) until Week 48 in the Maintenance Treatment Period.
|
MTP: Secukinumab 300 mg Q4W/Q4W
Participants in secukinumab arm continued to receive secukinumab 300 mg sc Q4W until Week 48 in the Maintenance Treatment Period.
|
OLE2 Period - Group A: BKZ 320 mg Q8W
Participants who were still receiving treatment in the OLE Period and attended the Week 144 visit were directly rolled over to the OLE2 Period. In OLE2 Period, participants continued receiving BKZ 320 mg sc Q8W for 40 additional weeks until OLE2 Week 48.
|
OLE2 Period - Group B: BKZ 320 mg Q8W
Participants who completed the Week 144 and were participating in the Safety Follow-Up (SFU) or had completed the SFU visit reinitiated their treatment in the OLE2 Period after having undergone Screening assessments during a 4-week OLE2 Screening Period. Participants with an IGA score less than (\<) 3 at the Week 144/OLE2 Baseline Visit continued receiving BKZ 320 mg sc Q8W for 40 additional weeks until OLE2 Week 48 in OLE2 Period.
|
OLE2 Period -Group B: BKZ 320 mg Q4W/Q8W
Participants who completed the Week 144 visit and were participating in the SFU or had completed the SFU visit reinitiated their treatment in the OLE2 Period after having undergone Screening assessments during a 4-week OLE2 Screening Period. Participants with an IGA score greater than or equal to (\>=) 3 at the Week 144/OLE2 Baseline Visit received BKZ 320 mg sc Q4W for the first 16 weeks, and then switched to BKZ 320 mg sc Q8W for 24 weeks until OLE2 Week 48 in OLE2 Period.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With a Psoriasis Area and Severity Index 100 (PASI100) Response at Week 16
|
61.7 percentage of participants
|
48.9 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 4Population: The Randomized Set (RS) consisted of all randomized study participants.
The PASI75 response assessments are based on at least 75% improvement in PASI score from Baseline. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for redness, thickness, and scaling for each of the 4 body areas with score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of body areas and converting to 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.
Outcome measures
| Measure |
ITP: Bimekizumab (BKZ) 320 mg Q4W
n=373 Participants
Participants randomized to this arm received BKZ 320 mg sc Q4W for 16 weeks in the Initial Treatment Period (ITP). Placebo was administered at pre-specified time-points to maintain the blinding.
|
ITP: Secukinumab 300 mg Q4W
n=370 Participants
Participants received secukinumab 300 mg sc at Baseline and Weeks 1, 2, 3, and 4 followed by dosing Q4W until Week 16 in the Initial Treatment Period.
|
MTP: BKZ 320 mg Q4W/Q8W
Participants randomized to this arm received BKZ 320 mg sc Q4W for 16 weeks in the Initial Treatment Period. At Week 16, participants were re-randomized to receive BKZ 320 mg sc Q8W until Week 48 in the Maintenance Treatment Period (MTP). Placebo was administered at pre-specified time-points to maintain the blinding.
|
MTP: BKZ 320 mg Q4W/Q4W
Participants randomized to this arm received BKZ 320 mg sc Q4W for 16 weeks in the Initial Treatment Period. At Week 16, participants continued to receive BKZ 320 mg sc every 4 Weeks (Q4W/Q4W) until Week 48 in the Maintenance Treatment Period.
|
MTP: Secukinumab 300 mg Q4W/Q4W
Participants in secukinumab arm continued to receive secukinumab 300 mg sc Q4W until Week 48 in the Maintenance Treatment Period.
|
OLE2 Period - Group A: BKZ 320 mg Q8W
Participants who were still receiving treatment in the OLE Period and attended the Week 144 visit were directly rolled over to the OLE2 Period. In OLE2 Period, participants continued receiving BKZ 320 mg sc Q8W for 40 additional weeks until OLE2 Week 48.
|
OLE2 Period - Group B: BKZ 320 mg Q8W
Participants who completed the Week 144 and were participating in the Safety Follow-Up (SFU) or had completed the SFU visit reinitiated their treatment in the OLE2 Period after having undergone Screening assessments during a 4-week OLE2 Screening Period. Participants with an IGA score less than (\<) 3 at the Week 144/OLE2 Baseline Visit continued receiving BKZ 320 mg sc Q8W for 40 additional weeks until OLE2 Week 48 in OLE2 Period.
|
OLE2 Period -Group B: BKZ 320 mg Q4W/Q8W
Participants who completed the Week 144 visit and were participating in the SFU or had completed the SFU visit reinitiated their treatment in the OLE2 Period after having undergone Screening assessments during a 4-week OLE2 Screening Period. Participants with an IGA score greater than or equal to (\>=) 3 at the Week 144/OLE2 Baseline Visit received BKZ 320 mg sc Q4W for the first 16 weeks, and then switched to BKZ 320 mg sc Q8W for 24 weeks until OLE2 Week 48 in OLE2 Period.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With a PASI75 Response at Week 4
|
71.0 percentage of participants
|
47.3 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 16Population: The Randomized Set (RS) consisted of all randomized study participants.
The PASI90 response assessments are based on at least 90% improvement in PASI score from Baseline. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for redness, thickness, and scaling for each of the 4 body areas with score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI=average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.
Outcome measures
| Measure |
ITP: Bimekizumab (BKZ) 320 mg Q4W
n=373 Participants
Participants randomized to this arm received BKZ 320 mg sc Q4W for 16 weeks in the Initial Treatment Period (ITP). Placebo was administered at pre-specified time-points to maintain the blinding.
|
ITP: Secukinumab 300 mg Q4W
n=370 Participants
Participants received secukinumab 300 mg sc at Baseline and Weeks 1, 2, 3, and 4 followed by dosing Q4W until Week 16 in the Initial Treatment Period.
|
MTP: BKZ 320 mg Q4W/Q8W
Participants randomized to this arm received BKZ 320 mg sc Q4W for 16 weeks in the Initial Treatment Period. At Week 16, participants were re-randomized to receive BKZ 320 mg sc Q8W until Week 48 in the Maintenance Treatment Period (MTP). Placebo was administered at pre-specified time-points to maintain the blinding.
|
MTP: BKZ 320 mg Q4W/Q4W
Participants randomized to this arm received BKZ 320 mg sc Q4W for 16 weeks in the Initial Treatment Period. At Week 16, participants continued to receive BKZ 320 mg sc every 4 Weeks (Q4W/Q4W) until Week 48 in the Maintenance Treatment Period.
|
MTP: Secukinumab 300 mg Q4W/Q4W
Participants in secukinumab arm continued to receive secukinumab 300 mg sc Q4W until Week 48 in the Maintenance Treatment Period.
|
OLE2 Period - Group A: BKZ 320 mg Q8W
Participants who were still receiving treatment in the OLE Period and attended the Week 144 visit were directly rolled over to the OLE2 Period. In OLE2 Period, participants continued receiving BKZ 320 mg sc Q8W for 40 additional weeks until OLE2 Week 48.
|
OLE2 Period - Group B: BKZ 320 mg Q8W
Participants who completed the Week 144 and were participating in the Safety Follow-Up (SFU) or had completed the SFU visit reinitiated their treatment in the OLE2 Period after having undergone Screening assessments during a 4-week OLE2 Screening Period. Participants with an IGA score less than (\<) 3 at the Week 144/OLE2 Baseline Visit continued receiving BKZ 320 mg sc Q8W for 40 additional weeks until OLE2 Week 48 in OLE2 Period.
|
OLE2 Period -Group B: BKZ 320 mg Q4W/Q8W
Participants who completed the Week 144 visit and were participating in the SFU or had completed the SFU visit reinitiated their treatment in the OLE2 Period after having undergone Screening assessments during a 4-week OLE2 Screening Period. Participants with an IGA score greater than or equal to (\>=) 3 at the Week 144/OLE2 Baseline Visit received BKZ 320 mg sc Q4W for the first 16 weeks, and then switched to BKZ 320 mg sc Q8W for 24 weeks until OLE2 Week 48 in OLE2 Period.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With a PASI90 Response at Week 16
|
85.5 percentage of participants
|
74.3 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 48Population: The Randomized Set (RS) consisted of all randomized study participants. The Maintenance Set (MS) consisted of all study participants that received at least 1 dose of IMP at Week 16 or later in the Double-Blind Treatment Period (including the Week 16 dose).
The PASI100 response assessments are based on 100% improvement in PASI score from Baseline. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.
Outcome measures
| Measure |
ITP: Bimekizumab (BKZ) 320 mg Q4W
n=373 Participants
Participants randomized to this arm received BKZ 320 mg sc Q4W for 16 weeks in the Initial Treatment Period (ITP). Placebo was administered at pre-specified time-points to maintain the blinding.
|
ITP: Secukinumab 300 mg Q4W
n=370 Participants
Participants received secukinumab 300 mg sc at Baseline and Weeks 1, 2, 3, and 4 followed by dosing Q4W until Week 16 in the Initial Treatment Period.
|
MTP: BKZ 320 mg Q4W/Q8W
n=215 Participants
Participants randomized to this arm received BKZ 320 mg sc Q4W for 16 weeks in the Initial Treatment Period. At Week 16, participants were re-randomized to receive BKZ 320 mg sc Q8W until Week 48 in the Maintenance Treatment Period (MTP). Placebo was administered at pre-specified time-points to maintain the blinding.
|
MTP: BKZ 320 mg Q4W/Q4W
n=147 Participants
Participants randomized to this arm received BKZ 320 mg sc Q4W for 16 weeks in the Initial Treatment Period. At Week 16, participants continued to receive BKZ 320 mg sc every 4 Weeks (Q4W/Q4W) until Week 48 in the Maintenance Treatment Period.
|
MTP: Secukinumab 300 mg Q4W/Q4W
n=354 Participants
Participants in secukinumab arm continued to receive secukinumab 300 mg sc Q4W until Week 48 in the Maintenance Treatment Period.
|
OLE2 Period - Group A: BKZ 320 mg Q8W
Participants who were still receiving treatment in the OLE Period and attended the Week 144 visit were directly rolled over to the OLE2 Period. In OLE2 Period, participants continued receiving BKZ 320 mg sc Q8W for 40 additional weeks until OLE2 Week 48.
|
OLE2 Period - Group B: BKZ 320 mg Q8W
Participants who completed the Week 144 and were participating in the Safety Follow-Up (SFU) or had completed the SFU visit reinitiated their treatment in the OLE2 Period after having undergone Screening assessments during a 4-week OLE2 Screening Period. Participants with an IGA score less than (\<) 3 at the Week 144/OLE2 Baseline Visit continued receiving BKZ 320 mg sc Q8W for 40 additional weeks until OLE2 Week 48 in OLE2 Period.
|
OLE2 Period -Group B: BKZ 320 mg Q4W/Q8W
Participants who completed the Week 144 visit and were participating in the SFU or had completed the SFU visit reinitiated their treatment in the OLE2 Period after having undergone Screening assessments during a 4-week OLE2 Screening Period. Participants with an IGA score greater than or equal to (\>=) 3 at the Week 144/OLE2 Baseline Visit received BKZ 320 mg sc Q4W for the first 16 weeks, and then switched to BKZ 320 mg sc Q8W for 24 weeks until OLE2 Week 48 in OLE2 Period.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With a PASI100 Response at Week 48
|
67.3 percentage of participants
|
46.2 percentage of participants
|
66.5 percentage of participants
|
73.5 percentage of participants
|
48.3 percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 16Population: The Randomized Set (RS) consisted of all randomized study participants.
The IGA measures the overall psoriasis severity following a 5-point scale (0-4), where scale 0= clear, no signs of psoriasis; presence of post-inflammatory hyperpigmentation, scale 1= almost clear, no thickening; normal to pink coloration; no to minimal focal scaling, scale 2= mild thickening, pink to light red coloration and predominately fine scaling, 3= moderate, clearly distinguishable to moderate thickening; dull to bright red, clearly distinguishable to moderate thickening; moderate scaling and 4= severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions. IGA response was defined as Clear (0) or Almost Clear (1) with at least a two-category improvement from Baseline at Week 16.
Outcome measures
| Measure |
ITP: Bimekizumab (BKZ) 320 mg Q4W
n=373 Participants
Participants randomized to this arm received BKZ 320 mg sc Q4W for 16 weeks in the Initial Treatment Period (ITP). Placebo was administered at pre-specified time-points to maintain the blinding.
|
ITP: Secukinumab 300 mg Q4W
n=370 Participants
Participants received secukinumab 300 mg sc at Baseline and Weeks 1, 2, 3, and 4 followed by dosing Q4W until Week 16 in the Initial Treatment Period.
|
MTP: BKZ 320 mg Q4W/Q8W
Participants randomized to this arm received BKZ 320 mg sc Q4W for 16 weeks in the Initial Treatment Period. At Week 16, participants were re-randomized to receive BKZ 320 mg sc Q8W until Week 48 in the Maintenance Treatment Period (MTP). Placebo was administered at pre-specified time-points to maintain the blinding.
|
MTP: BKZ 320 mg Q4W/Q4W
Participants randomized to this arm received BKZ 320 mg sc Q4W for 16 weeks in the Initial Treatment Period. At Week 16, participants continued to receive BKZ 320 mg sc every 4 Weeks (Q4W/Q4W) until Week 48 in the Maintenance Treatment Period.
|
MTP: Secukinumab 300 mg Q4W/Q4W
Participants in secukinumab arm continued to receive secukinumab 300 mg sc Q4W until Week 48 in the Maintenance Treatment Period.
|
OLE2 Period - Group A: BKZ 320 mg Q8W
Participants who were still receiving treatment in the OLE Period and attended the Week 144 visit were directly rolled over to the OLE2 Period. In OLE2 Period, participants continued receiving BKZ 320 mg sc Q8W for 40 additional weeks until OLE2 Week 48.
|
OLE2 Period - Group B: BKZ 320 mg Q8W
Participants who completed the Week 144 and were participating in the Safety Follow-Up (SFU) or had completed the SFU visit reinitiated their treatment in the OLE2 Period after having undergone Screening assessments during a 4-week OLE2 Screening Period. Participants with an IGA score less than (\<) 3 at the Week 144/OLE2 Baseline Visit continued receiving BKZ 320 mg sc Q8W for 40 additional weeks until OLE2 Week 48 in OLE2 Period.
|
OLE2 Period -Group B: BKZ 320 mg Q4W/Q8W
Participants who completed the Week 144 visit and were participating in the SFU or had completed the SFU visit reinitiated their treatment in the OLE2 Period after having undergone Screening assessments during a 4-week OLE2 Screening Period. Participants with an IGA score greater than or equal to (\>=) 3 at the Week 144/OLE2 Baseline Visit received BKZ 320 mg sc Q4W for the first 16 weeks, and then switched to BKZ 320 mg sc Q8W for 24 weeks until OLE2 Week 48 in OLE2 Period.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With a Investigator´s Global Assessment (IGA) Response (0/1) at Week 16
|
85.5 percentage of participants
|
78.6 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Baseline up to Week 225Population: The Safety Set (SS) consisted of all study participants that received at least 1 dose of IMP. The Open-Label Set (OLS) consisted of all study participants who received at least 1 dose of BKZ at Week 48 or later in the OLE Period (including the Week 48 dose). The Open-Label Set 2 (OLS2) consisted of all study participants who received at least 1 dose of BKZ at the Week 144/OLE2 Baseline Visit or later in the OLE2 Period (including the Week 144/OLE2 Baseline dose).
The number of TEAEs adjusted by duration of exposure to study treatment was scaled such that provided an incidence rate per 100 patient-years. If a participant had multiple events, the time of exposure was calculated to the first occurrence of the AE being considered. If a participant had no events, the total time at risk was used.
Outcome measures
| Measure |
ITP: Bimekizumab (BKZ) 320 mg Q4W
n=215 Participants
Participants randomized to this arm received BKZ 320 mg sc Q4W for 16 weeks in the Initial Treatment Period (ITP). Placebo was administered at pre-specified time-points to maintain the blinding.
|
ITP: Secukinumab 300 mg Q4W
n=373 Participants
Participants received secukinumab 300 mg sc at Baseline and Weeks 1, 2, 3, and 4 followed by dosing Q4W until Week 16 in the Initial Treatment Period.
|
MTP: BKZ 320 mg Q4W/Q8W
n=370 Participants
Participants randomized to this arm received BKZ 320 mg sc Q4W for 16 weeks in the Initial Treatment Period. At Week 16, participants were re-randomized to receive BKZ 320 mg sc Q8W until Week 48 in the Maintenance Treatment Period (MTP). Placebo was administered at pre-specified time-points to maintain the blinding.
|
MTP: BKZ 320 mg Q4W/Q4W
n=626 Participants
Participants randomized to this arm received BKZ 320 mg sc Q4W for 16 weeks in the Initial Treatment Period. At Week 16, participants continued to receive BKZ 320 mg sc every 4 Weeks (Q4W/Q4W) until Week 48 in the Maintenance Treatment Period.
|
MTP: Secukinumab 300 mg Q4W/Q4W
n=294 Participants
Participants in secukinumab arm continued to receive secukinumab 300 mg sc Q4W until Week 48 in the Maintenance Treatment Period.
|
OLE2 Period - Group A: BKZ 320 mg Q8W
n=9 Participants
Participants who were still receiving treatment in the OLE Period and attended the Week 144 visit were directly rolled over to the OLE2 Period. In OLE2 Period, participants continued receiving BKZ 320 mg sc Q8W for 40 additional weeks until OLE2 Week 48.
|
OLE2 Period - Group B: BKZ 320 mg Q8W
n=66 Participants
Participants who completed the Week 144 and were participating in the Safety Follow-Up (SFU) or had completed the SFU visit reinitiated their treatment in the OLE2 Period after having undergone Screening assessments during a 4-week OLE2 Screening Period. Participants with an IGA score less than (\<) 3 at the Week 144/OLE2 Baseline Visit continued receiving BKZ 320 mg sc Q8W for 40 additional weeks until OLE2 Week 48 in OLE2 Period.
|
OLE2 Period -Group B: BKZ 320 mg Q4W/Q8W
n=59 Participants
Participants who completed the Week 144 visit and were participating in the SFU or had completed the SFU visit reinitiated their treatment in the OLE2 Period after having undergone Screening assessments during a 4-week OLE2 Screening Period. Participants with an IGA score greater than or equal to (\>=) 3 at the Week 144/OLE2 Baseline Visit received BKZ 320 mg sc Q4W for the first 16 weeks, and then switched to BKZ 320 mg sc Q8W for 24 weeks until OLE2 Week 48 in OLE2 Period.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Treatment-emergent Adverse Events (TEAEs) Adjusted by Duration of Participant Exposure to Investigational Medicinal Product (IMP) From Baseline up to Week 225
|
250.13 no. of new events per 100 subject-years
Interval 213.09 to 291.75
|
331.26 no. of new events per 100 subject-years
Interval 293.4 to 372.66
|
234.88 no. of new events per 100 subject-years
Interval 209.22 to 262.83
|
115.35 no. of new events per 100 subject-years
Interval 105.27 to 126.14
|
165.22 no. of new events per 100 subject-years
Interval 143.73 to 189.02
|
164.95 no. of new events per 100 subject-years
Interval 66.32 to 339.86
|
74.25 no. of new events per 100 subject-years
Interval 51.72 to 103.26
|
94.18 no. of new events per 100 subject-years
Interval 65.97 to 130.39
|
SECONDARY outcome
Timeframe: From Baseline up to Week 225Population: The SS consisted of all study participants that received at least 1 dose of IMP. The OLS consisted of all study participants who received at least 1 dose of BKZ at Week 48 or later in the OLE Period (including the Week 48 dose). The OLS2 consisted of all study participants who received at least 1 dose of BKZ at the Week 144/OLE2 Baseline Visit or later in the OLE2 Period (including the Week 144/OLE2 Baseline dose).
The number of SAEs adjusted by duration of exposure to study treatment was scaled such that it provided an incidence rate per 100 patient-years. If a participant had multiple events, the time of exposure was calculated to the first occurrence of the AE being considered. If a participant had no events, the total time at risk was used.
Outcome measures
| Measure |
ITP: Bimekizumab (BKZ) 320 mg Q4W
n=215 Participants
Participants randomized to this arm received BKZ 320 mg sc Q4W for 16 weeks in the Initial Treatment Period (ITP). Placebo was administered at pre-specified time-points to maintain the blinding.
|
ITP: Secukinumab 300 mg Q4W
n=373 Participants
Participants received secukinumab 300 mg sc at Baseline and Weeks 1, 2, 3, and 4 followed by dosing Q4W until Week 16 in the Initial Treatment Period.
|
MTP: BKZ 320 mg Q4W/Q8W
n=370 Participants
Participants randomized to this arm received BKZ 320 mg sc Q4W for 16 weeks in the Initial Treatment Period. At Week 16, participants were re-randomized to receive BKZ 320 mg sc Q8W until Week 48 in the Maintenance Treatment Period (MTP). Placebo was administered at pre-specified time-points to maintain the blinding.
|
MTP: BKZ 320 mg Q4W/Q4W
n=626 Participants
Participants randomized to this arm received BKZ 320 mg sc Q4W for 16 weeks in the Initial Treatment Period. At Week 16, participants continued to receive BKZ 320 mg sc every 4 Weeks (Q4W/Q4W) until Week 48 in the Maintenance Treatment Period.
|
MTP: Secukinumab 300 mg Q4W/Q4W
n=294 Participants
Participants in secukinumab arm continued to receive secukinumab 300 mg sc Q4W until Week 48 in the Maintenance Treatment Period.
|
OLE2 Period - Group A: BKZ 320 mg Q8W
n=9 Participants
Participants who were still receiving treatment in the OLE Period and attended the Week 144 visit were directly rolled over to the OLE2 Period. In OLE2 Period, participants continued receiving BKZ 320 mg sc Q8W for 40 additional weeks until OLE2 Week 48.
|
OLE2 Period - Group B: BKZ 320 mg Q8W
n=66 Participants
Participants who completed the Week 144 and were participating in the Safety Follow-Up (SFU) or had completed the SFU visit reinitiated their treatment in the OLE2 Period after having undergone Screening assessments during a 4-week OLE2 Screening Period. Participants with an IGA score less than (\<) 3 at the Week 144/OLE2 Baseline Visit continued receiving BKZ 320 mg sc Q8W for 40 additional weeks until OLE2 Week 48 in OLE2 Period.
|
OLE2 Period -Group B: BKZ 320 mg Q4W/Q8W
n=59 Participants
Participants who completed the Week 144 visit and were participating in the SFU or had completed the SFU visit reinitiated their treatment in the OLE2 Period after having undergone Screening assessments during a 4-week OLE2 Screening Period. Participants with an IGA score greater than or equal to (\>=) 3 at the Week 144/OLE2 Baseline Visit received BKZ 320 mg sc Q4W for the first 16 weeks, and then switched to BKZ 320 mg sc Q8W for 24 weeks until OLE2 Week 48 in OLE2 Period.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Serious Adverse Events (SAEs) Adjusted by Duration of Participant Exposure to IMP From Baseline up to Week 225
|
6.94 no. of new events per 100 subject-years
Interval 3.17 to 13.17
|
7.33 no. of new events per 100 subject-years
Interval 4.1 to 12.09
|
6.75 no. of new events per 100 subject-years
Interval 4.23 to 10.22
|
5.93 no. of new events per 100 subject-years
Interval 4.48 to 7.7
|
4.34 no. of new events per 100 subject-years
Interval 2.16 to 7.76
|
12.28 no. of new events per 100 subject-years
Interval 0.31 to 68.43
|
1.38 no. of new events per 100 subject-years
Interval 0.03 to 7.66
|
6.39 no. of new events per 100 subject-years
Interval 1.74 to 16.37
|
SECONDARY outcome
Timeframe: From Baseline up to Week 225Population: The SS consisted of all study participants that received at least 1 dose of IMP. The OLS consisted of all study participants who received at least 1 dose of BKZ at Week 48 or later in the OLE Period (including the Week 48 dose). The OLS2 consisted of all study participants who received at least 1 dose of BKZ at the Week 144/OLE2 Baseline Visit or later in the OLE2 Period (including the Week 144/OLE2 Baseline dose).
The number of TEAEs leading to discontinuation adjusted by duration of exposure to study treatment was scaled such that it provided an incidence rate per 100 patient-years. If a participant had multiple events, the time of exposure was calculated to the first occurrence of the AE being considered. If a participant had no events, the total time at risk was used.
Outcome measures
| Measure |
ITP: Bimekizumab (BKZ) 320 mg Q4W
n=215 Participants
Participants randomized to this arm received BKZ 320 mg sc Q4W for 16 weeks in the Initial Treatment Period (ITP). Placebo was administered at pre-specified time-points to maintain the blinding.
|
ITP: Secukinumab 300 mg Q4W
n=373 Participants
Participants received secukinumab 300 mg sc at Baseline and Weeks 1, 2, 3, and 4 followed by dosing Q4W until Week 16 in the Initial Treatment Period.
|
MTP: BKZ 320 mg Q4W/Q8W
n=370 Participants
Participants randomized to this arm received BKZ 320 mg sc Q4W for 16 weeks in the Initial Treatment Period. At Week 16, participants were re-randomized to receive BKZ 320 mg sc Q8W until Week 48 in the Maintenance Treatment Period (MTP). Placebo was administered at pre-specified time-points to maintain the blinding.
|
MTP: BKZ 320 mg Q4W/Q4W
n=626 Participants
Participants randomized to this arm received BKZ 320 mg sc Q4W for 16 weeks in the Initial Treatment Period. At Week 16, participants continued to receive BKZ 320 mg sc every 4 Weeks (Q4W/Q4W) until Week 48 in the Maintenance Treatment Period.
|
MTP: Secukinumab 300 mg Q4W/Q4W
n=294 Participants
Participants in secukinumab arm continued to receive secukinumab 300 mg sc Q4W until Week 48 in the Maintenance Treatment Period.
|
OLE2 Period - Group A: BKZ 320 mg Q8W
n=9 Participants
Participants who were still receiving treatment in the OLE Period and attended the Week 144 visit were directly rolled over to the OLE2 Period. In OLE2 Period, participants continued receiving BKZ 320 mg sc Q8W for 40 additional weeks until OLE2 Week 48.
|
OLE2 Period - Group B: BKZ 320 mg Q8W
n=66 Participants
Participants who completed the Week 144 and were participating in the Safety Follow-Up (SFU) or had completed the SFU visit reinitiated their treatment in the OLE2 Period after having undergone Screening assessments during a 4-week OLE2 Screening Period. Participants with an IGA score less than (\<) 3 at the Week 144/OLE2 Baseline Visit continued receiving BKZ 320 mg sc Q8W for 40 additional weeks until OLE2 Week 48 in OLE2 Period.
|
OLE2 Period -Group B: BKZ 320 mg Q4W/Q8W
n=59 Participants
Participants who completed the Week 144 visit and were participating in the SFU or had completed the SFU visit reinitiated their treatment in the OLE2 Period after having undergone Screening assessments during a 4-week OLE2 Screening Period. Participants with an IGA score greater than or equal to (\>=) 3 at the Week 144/OLE2 Baseline Visit received BKZ 320 mg sc Q4W for the first 16 weeks, and then switched to BKZ 320 mg sc Q8W for 24 weeks until OLE2 Week 48 in OLE2 Period.
|
|---|---|---|---|---|---|---|---|---|
|
Number of TEAEs Leading to Withdrawal Adjusted by Duration of Participant Exposure to IMP From Baseline up to Week 225
|
1.51 no. of new events per 100 subject-years
Interval 0.18 to 5.45
|
5.85 no. of new events per 100 subject-years
Interval 3.02 to 10.22
|
3.33 no. of new events per 100 subject-years
Interval 1.66 to 5.96
|
2.56 no. of new events per 100 subject-years
Interval 1.65 to 3.77
|
3.52 no. of new events per 100 subject-years
Interval 1.61 to 6.69
|
11.33 no. of new events per 100 subject-years
Interval 0.29 to 63.1
|
2.76 no. of new events per 100 subject-years
Interval 0.33 to 9.99
|
0 no. of new events per 100 subject-years
Interval 0.0 to 0.0
|
Adverse Events
ITP: BKZ 320 mg Q4W (up to Week 16)
Serious events: 10 serious events
Other events: 107 other events
Deaths: 0 deaths
ITP: Secukinumab 300 mg Q4W (up to Week 16)
Serious events: 6 serious events
Other events: 88 other events
Deaths: 0 deaths
MTP: BKZ 320 mg Q8W (Week 16 to Week 48)
Serious events: 9 serious events
Other events: 87 other events
Deaths: 1 deaths
ITP+MTP: BKZ 320 mg Q4W (up to Week 48)
Serious events: 15 serious events
Other events: 140 other events
Deaths: 0 deaths
ITP+MTP: Secukinumab 300 mg Q4W (up to Week 48)
Serious events: 22 serious events
Other events: 166 other events
Deaths: 2 deaths
OLE Period: BKZ 320 mg Q8W (Week 48 to Week 144)
Serious events: 56 serious events
Other events: 233 other events
Deaths: 3 deaths
OLE Period: BKZ 320 mg Q4W (Week 48 to Week 144)
Serious events: 11 serious events
Other events: 103 other events
Deaths: 1 deaths
OLE2 Period - Group A: BKZ 320 mg Q8W
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
OLE2 Period - Group B: BKZ 320 mg Q8W
Serious events: 1 serious events
Other events: 18 other events
Deaths: 0 deaths
OLE2 Period -Group B: BKZ 320 mg Q4W/Q8W
Serious events: 4 serious events
Other events: 19 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
ITP: BKZ 320 mg Q4W (up to Week 16)
n=373 participants at risk
Participants randomized to this arm received BKZ 320 mg sc Q4W for 16 weeks in the Initial Treatment Period. Placebo was administered at pre-specified time-points to maintain the blinding.
|
ITP: Secukinumab 300 mg Q4W (up to Week 16)
n=370 participants at risk
Participants received secukinumab 300 mg sc at Baseline and Weeks 1, 2, 3, and 4 followed by dosing Q4W until Week 16 in the Initial Treatment Period.
|
MTP: BKZ 320 mg Q8W (Week 16 to Week 48)
n=215 participants at risk
Participants who received at least one dose of BKZ 320 mg sc Q8W from Week 16 until Week 48.
|
ITP+MTP: BKZ 320 mg Q4W (up to Week 48)
n=373 participants at risk
Participants who received at least one dose of BKZ 320 mg sc Q4W until Week 48.
|
ITP+MTP: Secukinumab 300 mg Q4W (up to Week 48)
n=370 participants at risk
Participants received secukinumab 300 mg sc at Baseline and Weeks 1, 2, 3, and 4 followed by dosing Q4W until Week 48.
|
OLE Period: BKZ 320 mg Q8W (Week 48 to Week 144)
n=626 participants at risk
Participants received BKZ 320 mg sc Q8W from Week 48 until Week 136 during OLE Period. For participants that received both BKZ 320 mg Q4W and Q8W, events are counted in the dose group most recently received prior to the date of the event or assessment.
|
OLE Period: BKZ 320 mg Q4W (Week 48 to Week 144)
n=294 participants at risk
Participants received BKZ 320 mg sc Q4W from Week 48 until Week 136 during OLE Period. The participant's dosing interval was changed from BKZ 320 mg Q4W to BKZ 320 mg Q8W at Week 64, or at the next scheduled clinic visit if the participant has already completed the Week 64.
|
OLE2 Period - Group A: BKZ 320 mg Q8W
n=9 participants at risk
Participants who were still receiving treatment in the OLE Period and attended the Week 144 visit were directly rolled over to the OLE2 Period. In OLE2 Period, participants continued receiving BKZ 320 mg sc Q8W for 40 additional weeks until OLE2 Week 48. Due to small number of participants, each event met the 5% threshold frequency criteria.
|
OLE2 Period - Group B: BKZ 320 mg Q8W
n=66 participants at risk
Participants who completed the Week 144 and were participating in the Safety Follow-Up (SFU) or had completed the SFU visit reinitiated their treatment in the OLE2 Period after having undergone Screening assessments during a 4-week OLE2 Screening Period. Participants with an IGA score less than (\<) 3 at the Week 144/OLE2 Baseline Visit continued receiving BKZ 320 mg sc Q8W for 40 additional weeks until OLE2 Week 48 in OLE2 Period.
|
OLE2 Period -Group B: BKZ 320 mg Q4W/Q8W
n=59 participants at risk
Participants who completed the Week 144 visit and were participating in the SFU or had completed the SFU visit reinitiated their treatment in the OLE2 Period after having undergone Screening assessments during a 4-week OLE2 Screening Period. Participants with an IGA score greater than or equal to (\>=) 3 at the Week 144/OLE2 Baseline Visit received BKZ 320 mg sc Q4W for the first 16 weeks, and then switched to BKZ 320 mg sc Q8W for 24 weeks until OLE2 Week 48 in OLE2 Period.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.27%
1/373 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/215 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.27%
1/373 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.16%
1/626 • Number of events 3 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/294 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/9 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/66 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/59 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.27%
1/373 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/215 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.27%
1/373 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/626 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/294 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/9 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/66 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/59 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
|
Infections and infestations
Dengue fever
|
0.27%
1/373 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/215 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.27%
1/373 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/626 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/294 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/9 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/66 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/59 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
|
Infections and infestations
Atypical pneumonia
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.27%
1/370 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/215 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.27%
1/370 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/626 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/294 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/9 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/66 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/59 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.27%
1/373 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.47%
1/215 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.27%
1/373 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.16%
1/626 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/294 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/9 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/66 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/59 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.27%
1/373 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/215 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.27%
1/373 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/626 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/294 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/9 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/66 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/59 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.27%
1/373 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/215 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.27%
1/373 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/626 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/294 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/9 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/66 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/59 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.27%
1/373 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/215 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.27%
1/373 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/626 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/294 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/9 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/66 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/59 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.27%
1/370 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/215 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.27%
1/370 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.16%
1/626 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/294 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/9 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/66 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/59 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.27%
1/373 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.27%
1/370 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/215 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.27%
1/373 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.27%
1/370 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.64%
4/626 • Number of events 4 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/294 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/9 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/66 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/59 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma in situ
|
0.27%
1/373 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/215 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.27%
1/373 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/626 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.34%
1/294 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/9 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/66 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/59 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/215 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.27%
1/370 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.32%
2/626 • Number of events 2 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/294 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/9 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/66 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/59 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.27%
1/370 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/215 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.27%
1/370 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/626 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/294 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/9 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/66 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/59 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy on oral contraceptive
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.27%
1/370 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/215 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.27%
1/370 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/626 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/294 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/9 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/66 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/59 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
|
Psychiatric disorders
Suicide attempt
|
0.27%
1/373 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/215 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.27%
1/373 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.16%
1/626 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/294 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/9 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/66 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/59 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.27%
1/373 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/215 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.27%
1/373 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.16%
1/626 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/294 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/9 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/66 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/59 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
|
Respiratory, thoracic and mediastinal disorders
Idiopathic pulmonary fibrosis
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.27%
1/370 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/215 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.27%
1/370 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/626 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/294 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/9 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/66 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/59 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.27%
1/373 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/215 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.27%
1/373 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/626 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/294 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/9 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/66 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/59 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/215 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.27%
1/370 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/626 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.34%
1/294 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/9 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/66 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/59 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/215 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.27%
1/370 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/626 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/294 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/9 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/66 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/59 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.47%
1/215 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.54%
2/370 • Number of events 2 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.16%
1/626 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.68%
2/294 • Number of events 2 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/9 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/66 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/59 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/215 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.27%
1/373 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/626 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/294 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/9 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/66 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/59 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/215 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.27%
1/370 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/626 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/294 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/9 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/66 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/59 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/215 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.27%
1/370 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/626 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/294 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/9 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/66 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/59 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
|
Gastrointestinal disorders
Diverticulum oesophageal
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/215 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.27%
1/373 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/626 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/294 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/9 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/66 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/59 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/215 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.27%
1/370 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/626 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/294 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/9 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/66 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/59 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
|
Gastrointestinal disorders
Pancreatic fistula
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/215 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.27%
1/370 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/626 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/294 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/9 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/66 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/59 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.47%
1/215 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.27%
1/370 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/626 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/294 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/9 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/66 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/59 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/215 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.27%
1/370 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.16%
1/626 • Number of events 2 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/294 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/9 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/66 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/59 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.93%
2/215 • Number of events 2 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/626 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/294 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/9 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/66 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/59 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/215 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.27%
1/370 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/626 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/294 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/9 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/66 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/59 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
|
Infections and infestations
Peritoneal abscess
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/215 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.27%
1/370 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/626 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/294 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/9 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/66 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/59 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
|
Infections and infestations
Extradural abscess
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.47%
1/215 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/626 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/294 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/9 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/66 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/59 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.47%
1/215 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.27%
1/370 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/626 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/294 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/9 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/66 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/59 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
|
Infections and infestations
Localised infection
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.47%
1/215 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/626 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/294 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/9 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/66 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/59 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/215 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.27%
1/370 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/626 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/294 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/9 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/66 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/59 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/215 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.27%
1/370 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.16%
1/626 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/294 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/9 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/66 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
1.7%
1/59 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/215 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.27%
1/370 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/626 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.34%
1/294 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/9 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/66 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/59 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/215 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.27%
1/370 • Number of events 2 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/626 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/294 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/9 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/66 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/59 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
|
Infections and infestations
Latent tuberculosis
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.47%
1/215 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/626 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/294 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/9 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/66 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/59 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/215 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.27%
1/373 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/626 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.34%
1/294 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/9 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/66 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/59 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
|
Nervous system disorders
IIIrd nerve paralysis
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.47%
1/215 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/626 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/294 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/9 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/66 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/59 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/215 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.27%
1/373 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/626 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/294 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/9 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/66 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/59 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
|
Respiratory, thoracic and mediastinal disorders
Asphyxia
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/215 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.27%
1/370 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/626 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/294 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/9 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/66 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/59 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/215 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.16%
1/626 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/294 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/9 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/66 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/59 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/215 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.27%
1/373 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/626 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/294 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/9 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/66 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/59 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/215 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.27%
1/370 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/626 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/294 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/9 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/66 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/59 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/215 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.27%
1/370 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/626 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/294 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/9 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/66 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/59 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/215 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.32%
2/626 • Number of events 2 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/294 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/9 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/66 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/59 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/215 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/626 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.34%
1/294 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/9 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/66 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/59 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/215 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.16%
1/626 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/294 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/9 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/66 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/59 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/215 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.16%
1/626 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/294 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/9 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/66 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/59 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/215 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.16%
1/626 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/294 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/9 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/66 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/59 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/215 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.16%
1/626 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/294 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/9 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/66 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/59 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
|
Ear and labyrinth disorders
Otosclerosis
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/215 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.16%
1/626 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/294 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/9 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/66 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/59 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
|
Endocrine disorders
Endocrine disorder
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/215 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.16%
1/626 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/294 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/9 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/66 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/59 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/215 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.16%
1/626 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/294 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/9 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/66 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/59 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/215 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/626 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.34%
1/294 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/9 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/66 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/59 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/215 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.16%
1/626 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/294 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/9 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/66 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/59 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/215 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.16%
1/626 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/294 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/9 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/66 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/59 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/215 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.16%
1/626 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/294 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/9 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/66 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/59 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
|
Hepatobiliary disorders
Hepatic pain
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/215 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/626 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.34%
1/294 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/9 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/66 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/59 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
|
Infections and infestations
Anal abscess
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/215 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.16%
1/626 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.34%
1/294 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/9 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/66 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/59 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
|
Infections and infestations
Rectal abscess
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/215 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.16%
1/626 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/294 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/9 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/66 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/59 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
|
Infections and infestations
Candida sepsis
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/215 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/626 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.34%
1/294 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/9 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/66 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/59 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
|
Infections and infestations
Otitis externa
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/215 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/626 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.34%
1/294 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/9 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/66 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/59 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
|
Infections and infestations
Postoperative abscess
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/215 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.16%
1/626 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/294 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/9 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/66 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/59 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/215 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.16%
1/626 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/294 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/9 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/66 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/59 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/215 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.16%
1/626 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/294 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/9 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/66 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/59 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
|
Infections and infestations
Staphylococcal skin infection
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/215 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.16%
1/626 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/294 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/9 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/66 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/59 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
|
Infections and infestations
Erysipelas
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/215 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.32%
2/626 • Number of events 2 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/294 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/9 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/66 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/59 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/215 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.16%
1/626 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/294 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/9 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/66 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/59 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/215 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.16%
1/626 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.34%
1/294 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/9 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/66 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/59 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/215 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.16%
1/626 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/294 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/9 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/66 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/59 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
|
Infections and infestations
Corona virus infection
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/215 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.80%
5/626 • Number of events 5 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/294 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/9 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/66 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
1.7%
1/59 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/215 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.16%
1/626 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/294 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/9 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/66 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/59 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
|
Injury, poisoning and procedural complications
Pneumothorax traumatic
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/215 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.16%
1/626 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/294 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/9 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/66 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/59 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/215 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.16%
1/626 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/294 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/9 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/66 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/59 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
|
Injury, poisoning and procedural complications
Multiple fractures
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/215 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.16%
1/626 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/294 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/9 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/66 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/59 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/215 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.16%
1/626 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/294 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/9 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/66 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/59 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/215 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.16%
1/626 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/294 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/9 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/66 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/59 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/215 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.16%
1/626 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/294 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/9 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/66 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/59 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/215 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.16%
1/626 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/294 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/9 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/66 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/59 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/215 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.16%
1/626 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/294 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/9 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/66 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/59 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/215 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.16%
1/626 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/294 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/9 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/66 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/59 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis of jaw
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/215 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.16%
1/626 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/294 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/9 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/66 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/59 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
|
Musculoskeletal and connective tissue disorders
Chondropathy
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/215 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.16%
1/626 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/294 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/9 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/66 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/59 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/215 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.16%
1/626 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/294 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/9 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/66 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/59 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/215 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.16%
1/626 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/294 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/9 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/66 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/59 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/215 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.32%
2/626 • Number of events 2 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/294 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/9 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/66 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/59 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer stage III
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/215 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.16%
1/626 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/294 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/9 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/66 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/59 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hodgkin's disease nodular sclerosis
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/215 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.16%
1/626 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/294 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/9 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/66 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/59 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Angiofibroma
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/215 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.16%
1/626 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/294 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/9 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/66 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/59 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/215 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.16%
1/626 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/294 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/9 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/66 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/59 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lentigo maligna
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/215 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.16%
1/626 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/294 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/9 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
1.5%
1/66 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/59 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/215 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.16%
1/626 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/294 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/9 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/66 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/59 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/215 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.16%
1/626 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/294 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/9 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/66 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/59 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/215 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.16%
1/626 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/294 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/9 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/66 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/59 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
|
Nervous system disorders
Relapsing-remitting multiple sclerosis
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/215 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.16%
1/626 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/294 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/9 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/66 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/59 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy on contraceptive
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/215 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.16%
1/626 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/294 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/9 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/66 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/59 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
|
Renal and urinary disorders
Obstructive nephropathy
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/215 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/626 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.34%
1/294 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/9 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/66 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/59 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/215 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/626 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.34%
1/294 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/9 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/66 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/59 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/215 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.32%
2/626 • Number of events 2 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.34%
1/294 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/9 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/66 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/59 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
|
Reproductive system and breast disorders
Endometriosis
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/215 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.16%
1/626 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/294 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/9 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/66 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/59 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/215 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.16%
1/626 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/294 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/9 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/66 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/59 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/215 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.16%
1/626 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/294 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/9 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/66 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/59 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/215 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.16%
1/626 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/294 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/9 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/66 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/59 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/215 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.16%
1/626 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/294 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/9 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/66 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/59 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
|
Skin and subcutaneous tissue disorders
Erythrodermic psoriasis
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/215 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.16%
1/626 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/294 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/9 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/66 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/59 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
|
Surgical and medical procedures
Abortion induced
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/215 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.16%
1/626 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/294 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/9 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/66 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/59 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
|
Vascular disorders
Aortic aneurysm
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/215 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.16%
1/626 • Number of events 2 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/294 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/9 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/66 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/59 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/215 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/626 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/294 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/9 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/66 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
1.7%
1/59 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Parathyroid tumour benign
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/215 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/626 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/294 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
11.1%
1/9 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/66 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/59 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/215 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/626 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/294 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/9 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/66 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
1.7%
1/59 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
|
Nervous system disorders
Seizure
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/215 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/626 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/294 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/9 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/66 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
1.7%
1/59 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/215 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.27%
1/373 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/626 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/294 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/9 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/66 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/59 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
|
Vascular disorders
Thromboangiitis obliterans
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/215 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.27%
1/370 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/626 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/294 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/9 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/66 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/59 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic neoplasm
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/215 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.16%
1/626 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/294 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/9 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/66 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/59 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
Other adverse events
| Measure |
ITP: BKZ 320 mg Q4W (up to Week 16)
n=373 participants at risk
Participants randomized to this arm received BKZ 320 mg sc Q4W for 16 weeks in the Initial Treatment Period. Placebo was administered at pre-specified time-points to maintain the blinding.
|
ITP: Secukinumab 300 mg Q4W (up to Week 16)
n=370 participants at risk
Participants received secukinumab 300 mg sc at Baseline and Weeks 1, 2, 3, and 4 followed by dosing Q4W until Week 16 in the Initial Treatment Period.
|
MTP: BKZ 320 mg Q8W (Week 16 to Week 48)
n=215 participants at risk
Participants who received at least one dose of BKZ 320 mg sc Q8W from Week 16 until Week 48.
|
ITP+MTP: BKZ 320 mg Q4W (up to Week 48)
n=373 participants at risk
Participants who received at least one dose of BKZ 320 mg sc Q4W until Week 48.
|
ITP+MTP: Secukinumab 300 mg Q4W (up to Week 48)
n=370 participants at risk
Participants received secukinumab 300 mg sc at Baseline and Weeks 1, 2, 3, and 4 followed by dosing Q4W until Week 48.
|
OLE Period: BKZ 320 mg Q8W (Week 48 to Week 144)
n=626 participants at risk
Participants received BKZ 320 mg sc Q8W from Week 48 until Week 136 during OLE Period. For participants that received both BKZ 320 mg Q4W and Q8W, events are counted in the dose group most recently received prior to the date of the event or assessment.
|
OLE Period: BKZ 320 mg Q4W (Week 48 to Week 144)
n=294 participants at risk
Participants received BKZ 320 mg sc Q4W from Week 48 until Week 136 during OLE Period. The participant's dosing interval was changed from BKZ 320 mg Q4W to BKZ 320 mg Q8W at Week 64, or at the next scheduled clinic visit if the participant has already completed the Week 64.
|
OLE2 Period - Group A: BKZ 320 mg Q8W
n=9 participants at risk
Participants who were still receiving treatment in the OLE Period and attended the Week 144 visit were directly rolled over to the OLE2 Period. In OLE2 Period, participants continued receiving BKZ 320 mg sc Q8W for 40 additional weeks until OLE2 Week 48. Due to small number of participants, each event met the 5% threshold frequency criteria.
|
OLE2 Period - Group B: BKZ 320 mg Q8W
n=66 participants at risk
Participants who completed the Week 144 and were participating in the Safety Follow-Up (SFU) or had completed the SFU visit reinitiated their treatment in the OLE2 Period after having undergone Screening assessments during a 4-week OLE2 Screening Period. Participants with an IGA score less than (\<) 3 at the Week 144/OLE2 Baseline Visit continued receiving BKZ 320 mg sc Q8W for 40 additional weeks until OLE2 Week 48 in OLE2 Period.
|
OLE2 Period -Group B: BKZ 320 mg Q4W/Q8W
n=59 participants at risk
Participants who completed the Week 144 visit and were participating in the SFU or had completed the SFU visit reinitiated their treatment in the OLE2 Period after having undergone Screening assessments during a 4-week OLE2 Screening Period. Participants with an IGA score greater than or equal to (\>=) 3 at the Week 144/OLE2 Baseline Visit received BKZ 320 mg sc Q4W for the first 16 weeks, and then switched to BKZ 320 mg sc Q8W for 24 weeks until OLE2 Week 48 in OLE2 Period.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Macrocytosis
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/215 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/626 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/294 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
11.1%
1/9 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/66 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/59 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
|
Blood and lymphatic system disorders
Polycythaemia
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/215 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/626 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/294 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
11.1%
1/9 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/66 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/59 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
|
General disorders
Malaise
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.27%
1/370 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/215 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.27%
1/370 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/626 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/294 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
11.1%
1/9 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/66 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/59 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/215 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.32%
2/626 • Number of events 2 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/294 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
11.1%
1/9 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/66 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/59 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
|
Infections and infestations
Corona virus infection
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/215 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
7.8%
49/626 • Number of events 50 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
3.1%
9/294 • Number of events 9 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
22.2%
2/9 • Number of events 2 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
10.6%
7/66 • Number of events 7 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
16.9%
10/59 • Number of events 10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
|
Infections and infestations
Nasopharyngitis
|
12.6%
47/373 • Number of events 54 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
14.6%
54/370 • Number of events 61 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
15.3%
33/215 • Number of events 40 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
16.6%
62/373 • Number of events 76 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
27.6%
102/370 • Number of events 141 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
9.9%
62/626 • Number of events 85 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
11.6%
34/294 • Number of events 41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/9 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
4.5%
3/66 • Number of events 3 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
1.7%
1/59 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
|
Infections and infestations
Oral candidiasis
|
10.5%
39/373 • Number of events 41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
1.1%
4/370 • Number of events 4 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
16.7%
36/215 • Number of events 47 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
13.4%
50/373 • Number of events 64 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
3.0%
11/370 • Number of events 16 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
8.5%
53/626 • Number of events 68 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
13.3%
39/294 • Number of events 51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/9 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
6.1%
4/66 • Number of events 4 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
8.5%
5/59 • Number of events 7 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
|
Infections and infestations
Upper respiratory tract infection
|
4.3%
16/373 • Number of events 16 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
4.6%
17/370 • Number of events 17 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
9.8%
21/215 • Number of events 25 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
6.2%
23/373 • Number of events 26 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
9.7%
36/370 • Number of events 39 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
5.6%
35/626 • Number of events 46 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
4.4%
13/294 • Number of events 13 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/9 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/66 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
3.4%
2/59 • Number of events 2 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
|
Infections and infestations
Urinary tract infection
|
1.6%
6/373 • Number of events 7 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
1.9%
7/370 • Number of events 8 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
4.7%
10/215 • Number of events 14 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
4.0%
15/373 • Number of events 19 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
5.9%
22/370 • Number of events 30 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
4.8%
30/626 • Number of events 40 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
6.5%
19/294 • Number of events 25 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
11.1%
1/9 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
1.5%
1/66 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/59 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.54%
2/373 • Number of events 2 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.27%
1/370 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/215 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.80%
3/373 • Number of events 3 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.54%
2/370 • Number of events 2 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.16%
1/626 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/294 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
11.1%
1/9 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
1.5%
1/66 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/59 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
|
Injury, poisoning and procedural complications
Fall
|
0.80%
3/373 • Number of events 3 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.27%
1/370 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/215 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.80%
3/373 • Number of events 3 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.27%
1/370 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.64%
4/626 • Number of events 4 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/294 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
11.1%
1/9 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
1.5%
1/66 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
3.4%
2/59 • Number of events 2 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
|
Investigations
Blood pressure increased
|
1.3%
5/373 • Number of events 5 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.27%
1/370 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.47%
1/215 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
1.9%
7/373 • Number of events 8 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.81%
3/370 • Number of events 3 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
1.8%
11/626 • Number of events 12 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.68%
2/294 • Number of events 2 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
11.1%
1/9 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
1.5%
1/66 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/59 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
|
Investigations
Psychiatric evaluation abnormal
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.47%
1/215 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.16%
1/626 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/294 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
11.1%
1/9 • Number of events 2 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/66 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/59 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
|
Investigations
White blood cell count increased
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/215 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/370 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/626 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/294 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
11.1%
1/9 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/66 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/59 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.54%
2/373 • Number of events 2 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.27%
1/370 • Number of events 5 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.47%
1/215 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.80%
3/373 • Number of events 3 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.54%
2/370 • Number of events 12 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.48%
3/626 • Number of events 4 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.34%
1/294 • Number of events 2 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
11.1%
1/9 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/66 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
3.4%
2/59 • Number of events 2 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
|
Nervous system disorders
Paraesthesia
|
0.27%
1/373 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.27%
1/370 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.47%
1/215 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.27%
1/373 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.27%
1/370 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/626 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.34%
1/294 • Number of events 2 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
11.1%
1/9 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/66 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/59 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
|
Reproductive system and breast disorders
Prostatomegaly
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.27%
1/370 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/215 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.27%
1/370 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.16%
1/626 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/294 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
11.1%
1/9 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/66 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/59 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.27%
1/370 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.47%
1/215 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/373 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.54%
2/370 • Number of events 2 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.48%
3/626 • Number of events 3 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/294 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
11.1%
1/9 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/66 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/59 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
|
Skin and subcutaneous tissue disorders
Intertrigo
|
0.27%
1/373 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.54%
2/370 • Number of events 2 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.47%
1/215 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.54%
2/373 • Number of events 3 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.81%
3/370 • Number of events 4 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
1.3%
8/626 • Number of events 9 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.34%
1/294 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
11.1%
1/9 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
1.5%
1/66 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/59 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
1.1%
4/373 • Number of events 4 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.54%
2/370 • Number of events 3 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.47%
1/215 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
1.3%
5/373 • Number of events 6 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
4.3%
16/370 • Number of events 17 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
6.1%
38/626 • Number of events 40 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
1.7%
5/294 • Number of events 7 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
0.00%
0/9 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
1.5%
1/66 • Number of events 2 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
1.7%
1/59 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 225 weeks for participants entering OLE2 Period
TEAEs were defined as those AEs that have a start date on or following the first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in Q4W group and events after switch are counted in Q8W group.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60