Trial Outcomes & Findings for A Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis (NCT NCT03598790)
NCT ID: NCT03598790
Last Updated: 2025-12-23
Results Overview
The number of TEAEs adjusted by duration of exposure to study treatment were scaled such that it provides an incidence rate per 100 patient-years. If a participant had multiple events, the time of exposure was calculated to first occurrence of the AE being considered. If a participant had no events, the total time at risk was used.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1353 participants
Primary outcome timeframe
From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
Results posted on
2025-12-23
Participant Flow
The study started to enroll participants in September 2018 and concluded in November 2023. Participant flow refers to the Cohort A Safety Set, Cohort A OLE2 Period Set and Cohort B Safety Set. Participants who enrolled in PS0014 after completion of Phase 3 feeder studies were included in Cohort A. An additional Cohort B was added in Japan.
Cohort A has Treatment Period (TP) (144 wks) followed by SFU Visit (20 wks after final dose). Cohort B has Screening Period (2 to 5 wks) and TP (144 wks) followed by SFU Visit (20 wks after final dose). After Protocol Amendment 3.3 (US) and 3.4 (Canada), 48-week OLE2 Period followed by SFU2 Visit (20 wks after final dose) was added in Cohort A.
Participant milestones
| Measure |
Cohort A: BKZ 320 mg Q8W
Based on the PASI90 response and the treatment/dose the participant was receiving in the feeder studies (PS0008 \[NCT03412747\], PS0009 \[NCT03370133\], and PS0013 \[NCT03410992\]), participants were randomized to receive BKZ 320 milligrams (mg) subcutaneously (sc) every 8 weeks (Q8W) in this study during the 144-week (wk) Treatment Period. The BKZ 320 mg Q8W group consisted of all participants who received only Q8W during PS0014 study and did not switch dosing regimen at any time point.
|
Cohort A: BKZ 320 mg Q4W/Q8W
Based on the PASI90 response and the treatment/dose the participant was receiving in the feeder study, participants were randomized to receive BKZ 320 mg sc every 4 weeks (Q4W) in this study during the 144-week Treatment Period. The participants switched to BKZ 320 mg Q8W as per protocol. The BKZ 320mg Q4W/Q8W group consisted of all participants who switched from Q4W to Q8W dosing at any of the scheduled switching time points during the study.
|
Cohort A: BKZ 320 mg Q4W
Based on the PASI90 response and the treatment/dose the participant was receiving in the feeder study, participants were randomized to receive BKZ 320 mg sc Q4W in this study during the 144-week Treatment Period. The BKZ 320 mg Q4W group consisted of participants who discontinued prior to the planned change of dosing interval from BKZ 320 mg Q4W to BKZ 320 mg Q8W.
|
Cohort A: Group A BKZ 320 mg Q8W
Participants who completed the Treatment Period (Week 0 to Week 144) were directly rolled over to the Open-Label Extension 2 (OLE2) Period. Participants continued receiving BKZ 320 mg sc Q8W for 40 additional weeks (from Week 144/OLE2 Period Baseline Visit to OLE2 Period Week 48).
|
Cohort A: Group B BKZ 320 mg Q8W
Participants who had completed the Treatment Period Week 144 Visit and who were in the SFU or had completed the SFU at the time of Protocol Amendment 3.3 and 3.4 implementation reinitiated BKZ treatment in the OLE2 Period after 4-week OLE2 Screening Period. Participants in OLE2 Period Group B with an IGA score \<3 upon entry received BKZ 320 mg sc Q8W from the Week 144/OLE2 Period Baseline Visit to OLE2 Period Week 48.
|
Cohort A: Group B BKZ 320 mg Q4W/Q8W
Participants who had completed the Treatment Period Week 144 Visit and who were in the Safety Follow-Up (SFU) or had completed the SFU at the time of Protocol Amendment 3.3 and 3.4 implementation reinitiated BKZ treatment in the OLE2 Period after 4-week OLE2 Screening Period. Participants with an Investigator's Global Assessment (IGA) score greater than equal to (\>=) 3 upon entry in the OLE2 Period received BKZ 320 mg sc Q4W for the first 16 weeks, and then switched to BKZ 320 mg Q8W until OLE2 Period Week 48.
|
Cohort B: PSO BKZ Total
Participants with chronic plaque psoriasis (PSO) in Cohort B received BKZ 320 mg sc Q4W until Week 16 and 320 mg Q8W thereafter through Week 40. At Week 48, Cohort B participants with chronic plaque PSO continued BKZ 320 mg Q8W up to Week 144. If the participant's dosing interval had changed to BKZ 320 mg Q4W under Protocol Amendment 1.2, the participant's dosing interval changed to BKZ 320 mg Q8W at the next scheduled clinic visit after implementation of Protocol Amendment 3.2.
|
Cohort B: EP BKZ Total
Participants with erythrodermic psoriasis (EP) in Cohort B received BKZ 320 mg sc Q4W until Week 16. Based on IGA response, participants received either BKZ 320 mg sc Q4W or BKZ 320 mg sc Q8W up to Week 144.
|
Cohort B: GPP BKZ Total
Participants with generalized pustular psoriasis (GPP) in Cohort B received BKZ 320 mg sc Q4W until Week 16. Based on IGA response, participants received either BKZ 320 mg sc Q4W or BKZ 320 mg sc Q8W up to Week 144.
|
|---|---|---|---|---|---|---|---|---|---|
|
Treatment Period (TP): Wk0-Wk144
STARTED
|
384
|
833
|
70
|
0
|
0
|
0
|
45
|
11
|
10
|
|
Treatment Period (TP): Wk0-Wk144
COMPLETED
|
326
|
746
|
0
|
0
|
0
|
0
|
38
|
10
|
8
|
|
Treatment Period (TP): Wk0-Wk144
NOT COMPLETED
|
58
|
87
|
70
|
0
|
0
|
0
|
7
|
1
|
2
|
|
OLE2 Period: Wk 144/OLE2 BL- OLE2 Wk 48
STARTED
|
0
|
0
|
0
|
226
|
51
|
41
|
0
|
0
|
0
|
|
OLE2 Period: Wk 144/OLE2 BL- OLE2 Wk 48
COMPLETED
|
0
|
0
|
0
|
216
|
49
|
39
|
0
|
0
|
0
|
|
OLE2 Period: Wk 144/OLE2 BL- OLE2 Wk 48
NOT COMPLETED
|
0
|
0
|
0
|
10
|
2
|
2
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Cohort A: BKZ 320 mg Q8W
Based on the PASI90 response and the treatment/dose the participant was receiving in the feeder studies (PS0008 \[NCT03412747\], PS0009 \[NCT03370133\], and PS0013 \[NCT03410992\]), participants were randomized to receive BKZ 320 milligrams (mg) subcutaneously (sc) every 8 weeks (Q8W) in this study during the 144-week (wk) Treatment Period. The BKZ 320 mg Q8W group consisted of all participants who received only Q8W during PS0014 study and did not switch dosing regimen at any time point.
|
Cohort A: BKZ 320 mg Q4W/Q8W
Based on the PASI90 response and the treatment/dose the participant was receiving in the feeder study, participants were randomized to receive BKZ 320 mg sc every 4 weeks (Q4W) in this study during the 144-week Treatment Period. The participants switched to BKZ 320 mg Q8W as per protocol. The BKZ 320mg Q4W/Q8W group consisted of all participants who switched from Q4W to Q8W dosing at any of the scheduled switching time points during the study.
|
Cohort A: BKZ 320 mg Q4W
Based on the PASI90 response and the treatment/dose the participant was receiving in the feeder study, participants were randomized to receive BKZ 320 mg sc Q4W in this study during the 144-week Treatment Period. The BKZ 320 mg Q4W group consisted of participants who discontinued prior to the planned change of dosing interval from BKZ 320 mg Q4W to BKZ 320 mg Q8W.
|
Cohort A: Group A BKZ 320 mg Q8W
Participants who completed the Treatment Period (Week 0 to Week 144) were directly rolled over to the Open-Label Extension 2 (OLE2) Period. Participants continued receiving BKZ 320 mg sc Q8W for 40 additional weeks (from Week 144/OLE2 Period Baseline Visit to OLE2 Period Week 48).
|
Cohort A: Group B BKZ 320 mg Q8W
Participants who had completed the Treatment Period Week 144 Visit and who were in the SFU or had completed the SFU at the time of Protocol Amendment 3.3 and 3.4 implementation reinitiated BKZ treatment in the OLE2 Period after 4-week OLE2 Screening Period. Participants in OLE2 Period Group B with an IGA score \<3 upon entry received BKZ 320 mg sc Q8W from the Week 144/OLE2 Period Baseline Visit to OLE2 Period Week 48.
|
Cohort A: Group B BKZ 320 mg Q4W/Q8W
Participants who had completed the Treatment Period Week 144 Visit and who were in the Safety Follow-Up (SFU) or had completed the SFU at the time of Protocol Amendment 3.3 and 3.4 implementation reinitiated BKZ treatment in the OLE2 Period after 4-week OLE2 Screening Period. Participants with an Investigator's Global Assessment (IGA) score greater than equal to (\>=) 3 upon entry in the OLE2 Period received BKZ 320 mg sc Q4W for the first 16 weeks, and then switched to BKZ 320 mg Q8W until OLE2 Period Week 48.
|
Cohort B: PSO BKZ Total
Participants with chronic plaque psoriasis (PSO) in Cohort B received BKZ 320 mg sc Q4W until Week 16 and 320 mg Q8W thereafter through Week 40. At Week 48, Cohort B participants with chronic plaque PSO continued BKZ 320 mg Q8W up to Week 144. If the participant's dosing interval had changed to BKZ 320 mg Q4W under Protocol Amendment 1.2, the participant's dosing interval changed to BKZ 320 mg Q8W at the next scheduled clinic visit after implementation of Protocol Amendment 3.2.
|
Cohort B: EP BKZ Total
Participants with erythrodermic psoriasis (EP) in Cohort B received BKZ 320 mg sc Q4W until Week 16. Based on IGA response, participants received either BKZ 320 mg sc Q4W or BKZ 320 mg sc Q8W up to Week 144.
|
Cohort B: GPP BKZ Total
Participants with generalized pustular psoriasis (GPP) in Cohort B received BKZ 320 mg sc Q4W until Week 16. Based on IGA response, participants received either BKZ 320 mg sc Q4W or BKZ 320 mg sc Q8W up to Week 144.
|
|---|---|---|---|---|---|---|---|---|---|
|
Treatment Period (TP): Wk0-Wk144
Adverse Event
|
24
|
33
|
24
|
0
|
0
|
0
|
3
|
1
|
2
|
|
Treatment Period (TP): Wk0-Wk144
Lack of Efficacy
|
4
|
7
|
5
|
0
|
0
|
0
|
2
|
0
|
0
|
|
Treatment Period (TP): Wk0-Wk144
Protocol Violation
|
1
|
2
|
4
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Treatment Period (TP): Wk0-Wk144
Lost to Follow-up
|
7
|
11
|
14
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Treatment Period (TP): Wk0-Wk144
Consent withdrawn by subject
|
14
|
26
|
17
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Treatment Period (TP): Wk0-Wk144
Pregnancy
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Treatment Period (TP): Wk0-Wk144
Covid-19 Pandemic Circumstances
|
0
|
2
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Treatment Period (TP): Wk0-Wk144
Physician Decision
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Treatment Period (TP): Wk0-Wk144
Long IP pause; Investigator decided termination
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Treatment Period (TP): Wk0-Wk144
Withdrawn By Sponsor
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Treatment Period (TP): Wk0-Wk144
Patient Did Not Comply With Safety Precautions
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Treatment Period (TP): Wk0-Wk144
Sponsor's Decision
|
1
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Treatment Period (TP): Wk0-Wk144
Unplanned Elective Surgery
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Treatment Period (TP): Wk0-Wk144
Non-Compliance
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Treatment Period (TP): Wk0-Wk144
Site Closure; Subject did not want to transfer
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Treatment Period (TP): Wk0-Wk144
COVID-19 restrictions; Subject unable to return
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Treatment Period (TP): Wk0-Wk144
Subject Withdraw Consent (Fear Of Another Ae)
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Treatment Period (TP): Wk0-Wk144
The Subject Can't Visit the Hospital Anymore
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Treatment Period (TP): Wk0-Wk144
Completed treatment but missed Week 144 visit
|
3
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Treatment Period (TP): Wk0-Wk144
Non-Compliance-PI early terminated the subject
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
OLE2 Period: Wk 144/OLE2 BL- OLE2 Wk 48
Adverse Event
|
0
|
0
|
0
|
2
|
1
|
2
|
0
|
0
|
0
|
|
OLE2 Period: Wk 144/OLE2 BL- OLE2 Wk 48
Lack of Efficacy
|
0
|
0
|
0
|
2
|
0
|
0
|
0
|
0
|
0
|
|
OLE2 Period: Wk 144/OLE2 BL- OLE2 Wk 48
Lost to Follow-up
|
0
|
0
|
0
|
4
|
0
|
0
|
0
|
0
|
0
|
|
OLE2 Period: Wk 144/OLE2 BL- OLE2 Wk 48
Consent withdrawn
|
0
|
0
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
|
OLE2 Period: Wk 144/OLE2 BL- OLE2 Wk 48
Pt Cannot Commit To Study Schedule
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
A Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis
Baseline characteristics by cohort
| Measure |
Cohort A: BKZ 320 mg Q8W
n=384 Participants
Based on the PASI90 response and the treatment/dose the participant was receiving in the feeder studies (PS0008 \[NCT03412747\], PS0009 \[NCT03370133\], and PS0013 \[NCT03410992\]), participants were randomized to receive BKZ 320 milligrams (mg) subcutaneously (sc) every 8 weeks (Q8W) in this study during the 144-week (wk) Treatment Period. The BKZ 320 mg Q8W group consisted of all participants who received only Q8W during PS0014 study and did not switch dosing regimen at any time point.
|
Cohort A: BKZ 320 mg Q4W/Q8W
n=833 Participants
Based on the PASI90 response and the treatment/dose the participant was receiving in the feeder study, participants were randomized to receive BKZ 320 mg sc every 4 weeks (Q4W) in this study during the 144-week Treatment Period. The participants switched to BKZ 320 mg Q8W as per protocol. The BKZ 320mg Q4W/Q8W group consisted of all participants who switched from Q4W to Q8W dosing at any of the scheduled switching time points during the study.
|
Cohort A: BKZ 320 mg Q4W
n=70 Participants
Based on the PASI90 response and the treatment/dose the participant was receiving in the feeder study, participants were randomized to receive BKZ 320 mg sc Q4W in this study during the 144-week Treatment Period. The BKZ 320 mg Q4W group consisted of participants who discontinued prior to the planned change of dosing interval from BKZ 320 mg Q4W to BKZ 320 mg Q8W.
|
Cohort B: PSO BKZ Total
n=45 Participants
Participants with chronic plaque psoriasis (PSO) in Cohort B received BKZ 320 mg sc Q4W until Week 16 and 320 mg Q8W thereafter through Week 40. At Week 48, Cohort B participants with chronic plaque PSO continued BKZ 320 mg Q8W up to Week 144. If the participant's dosing interval had changed to BKZ 320 mg Q4W under Protocol Amendment 1.2, the participant's dosing interval changed to BKZ 320 mg Q8W at the next scheduled clinic visit after implementation of Protocol Amendment 3.2.
|
Cohort B: EP BKZ Total
n=11 Participants
Participants with erythrodermic psoriasis (EP) in Cohort B received BKZ 320 mg sc Q4W until Week 16. Based on IGA response, participants received either BKZ 320 mg sc Q4W or BKZ 320 mg sc Q8W up to Week 144.
|
Cohort B: GPP BKZ Total
n=10 Participants
Participants with generalized pustular psoriasis (GPP) in Cohort B received BKZ 320 mg sc Q4W until Week 16. Based on IGA response, participants received either BKZ 320 mg sc Q4W or BKZ 320 mg sc Q8W up to Week 144.
|
Total
n=1353 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
45.3 years
STANDARD_DEVIATION 13.7 • n=68 Participants
|
45.5 years
STANDARD_DEVIATION 13.2 • n=4 Participants
|
45.4 years
STANDARD_DEVIATION 13.4 • n=219 Participants
|
48.8 years
STANDARD_DEVIATION 11.5 • n=219 Participants
|
55.3 years
STANDARD_DEVIATION 11.9 • n=880 Participants
|
46.0 years
STANDARD_DEVIATION 12.5 • n=6 Participants
|
45.6 years
STANDARD_DEVIATION 13.3 • n=23 Participants
|
|
Age, Customized
18 - <65 years
|
349 Participants
n=68 Participants
|
757 Participants
n=4 Participants
|
68 Participants
n=219 Participants
|
42 Participants
n=219 Participants
|
10 Participants
n=880 Participants
|
10 Participants
n=6 Participants
|
1236 Participants
n=23 Participants
|
|
Age, Customized
65 - <85 years
|
35 Participants
n=68 Participants
|
76 Participants
n=4 Participants
|
2 Participants
n=219 Participants
|
3 Participants
n=219 Participants
|
1 Participants
n=880 Participants
|
0 Participants
n=6 Participants
|
117 Participants
n=23 Participants
|
|
Age, Customized
>= 85 years
|
0 Participants
n=68 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=219 Participants
|
0 Participants
n=219 Participants
|
0 Participants
n=880 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=23 Participants
|
|
Sex: Female, Male
Female
|
118 Participants
n=68 Participants
|
221 Participants
n=4 Participants
|
24 Participants
n=219 Participants
|
9 Participants
n=219 Participants
|
0 Participants
n=880 Participants
|
4 Participants
n=6 Participants
|
376 Participants
n=23 Participants
|
|
Sex: Female, Male
Male
|
266 Participants
n=68 Participants
|
612 Participants
n=4 Participants
|
46 Participants
n=219 Participants
|
36 Participants
n=219 Participants
|
11 Participants
n=880 Participants
|
6 Participants
n=6 Participants
|
977 Participants
n=23 Participants
|
|
Race/Ethnicity, Customized
American Indian/Alaskan Native
|
1 Participants
n=68 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=219 Participants
|
0 Participants
n=219 Participants
|
0 Participants
n=880 Participants
|
0 Participants
n=6 Participants
|
2 Participants
n=23 Participants
|
|
Race/Ethnicity, Customized
Asian
|
31 Participants
n=68 Participants
|
107 Participants
n=4 Participants
|
8 Participants
n=219 Participants
|
45 Participants
n=219 Participants
|
11 Participants
n=880 Participants
|
10 Participants
n=6 Participants
|
212 Participants
n=23 Participants
|
|
Race/Ethnicity, Customized
Black
|
1 Participants
n=68 Participants
|
14 Participants
n=4 Participants
|
2 Participants
n=219 Participants
|
0 Participants
n=219 Participants
|
0 Participants
n=880 Participants
|
0 Participants
n=6 Participants
|
17 Participants
n=23 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=68 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=219 Participants
|
0 Participants
n=219 Participants
|
0 Participants
n=880 Participants
|
0 Participants
n=6 Participants
|
4 Participants
n=23 Participants
|
|
Race/Ethnicity, Customized
White
|
344 Participants
n=68 Participants
|
695 Participants
n=4 Participants
|
58 Participants
n=219 Participants
|
0 Participants
n=219 Participants
|
0 Participants
n=880 Participants
|
0 Participants
n=6 Participants
|
1097 Participants
n=23 Participants
|
|
Race/Ethnicity, Customized
Other/mixed
|
5 Participants
n=68 Participants
|
14 Participants
n=4 Participants
|
2 Participants
n=219 Participants
|
0 Participants
n=219 Participants
|
0 Participants
n=880 Participants
|
0 Participants
n=6 Participants
|
21 Participants
n=23 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
20 Participants
n=68 Participants
|
40 Participants
n=4 Participants
|
11 Participants
n=219 Participants
|
0 Participants
n=219 Participants
|
0 Participants
n=880 Participants
|
0 Participants
n=6 Participants
|
71 Participants
n=23 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
364 Participants
n=68 Participants
|
793 Participants
n=4 Participants
|
59 Participants
n=219 Participants
|
45 Participants
n=219 Participants
|
11 Participants
n=880 Participants
|
10 Participants
n=6 Participants
|
1282 Participants
n=23 Participants
|
PRIMARY outcome
Timeframe: From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 PeriodPopulation: CA-SS -All Cohort A participants who received at least 1 dose of the IMP in this study. Cohort A OLE2 Period Set (CA-OL2S)-All participants who received at least 1 dose of BKZ in the OLE2 Period. Cohort B PSO SS-All participants with a diagnosis of PSO disease at Baseline. Cohort B EP-SS-All participants with a diagnosis of EP disease at Baseline. Cohort B GPP-SS-All participants with a diagnosis of GPP disease at Baseline.
The number of TEAEs adjusted by duration of exposure to study treatment were scaled such that it provides an incidence rate per 100 patient-years. If a participant had multiple events, the time of exposure was calculated to first occurrence of the AE being considered. If a participant had no events, the total time at risk was used.
Outcome measures
| Measure |
Cohort A: BKZ 320 mg Q8W
n=1217 Participants
Participants who received BKZ 320 mg Q8W and who switched from Q4W to Q8W dosing at any of the scheduled time points during the 144-week Treatment Period. The participants who switched from BKZ 320 mg Q4W to Q8W during the study were included in both the BKZ 320 mg Q4W group and the BKZ 320 mg Q8W group.
|
Cohort A: BKZ 320 mg Q4W
n=903 Participants
Participants who received BKZ 320 mg Q4W during the 144-week Treatment Period. The participants who switched from BKZ 320 mg Q4W to Q8W during the study were included in both the BKZ 320 mg Q4W group and the BKZ 320 mg Q8W group.
|
Cohort A: Group A BKZ 320 mg Q8W
n=226 Participants
Participants who completed the Treatment Period (Week 0 to Week 144) were directly rolled over to the Open-Label Extension 2 (OLE2) Period. Participants continued receiving BKZ 320 mg sc Q8W for 40 additional weeks (from Week 144/OLE2 Period Baseline Visit to OLE2 Period Week 48).
|
Cohort A: Group B BKZ 320 mg Q8W
n=51 Participants
Participants who had completed the Treatment Period Week 144 Visit and who were in the SFU or had completed the SFU at the time of Protocol Amendment 3.3 and 3.4 implementation reinitiated BKZ treatment in the OLE2 Period after 4-week OLE2 Screening Period. Participants in OLE2 Period Group B with an IGA score \<3 upon entry received BKZ 320 mg sc Q8W from the Week 144/OLE2 Period Baseline Visit to OLE2 Period Week 48.
|
Cohort A: Group B BKZ 320 mg Q4W/Q8W
n=41 Participants
Participants who had completed the Treatment Period Week 144 Visit and who were in the Safety Follow-Up (SFU) or had completed the SFU at the time of Protocol Amendment 3.3 and 3.4 implementation reinitiated BKZ treatment in the OLE2 Period after 4-week OLE2 Screening Period. Participants with an Investigator's Global Assessment (IGA) score greater than equal to (\>=) 3 upon entry in the OLE2 Period received BKZ 320 mg sc Q4W for the first 16 weeks, and then switched to BKZ 320 mg Q8W until OLE2 Period Week 48.
|
Cohort B: PSO BKZ Total
n=45 Participants
Participants with chronic plaque psoriasis (PSO) in Cohort B received BKZ 320 mg sc Q4W until Week 16 and 320 mg Q8W thereafter through Week 40. At Week 48, Cohort B participants with chronic plaque PSO continued BKZ 320 mg Q8W up to Week 144. If the participant's dosing interval had changed to BKZ 320 mg Q4W under Protocol Amendment 1.2, the participant's dosing interval changed to BKZ 320 mg Q8W at the next scheduled clinic visit after implementation of Protocol Amendment 3.2.
|
Cohort B: EP BKZ Total
n=11 Participants
Participants with erythrodermic psoriasis (EP) in Cohort B received BKZ 320 mg sc Q4W until Week 16. Based on IGA response, participants received either BKZ 320 mg sc Q4W or BKZ 320 mg sc Q8W up to Week 144.
|
Cohort B: GPP BKZ Total
n=10 Participants
Participants with generalized pustular psoriasis (GPP) in Cohort B received BKZ 320 mg sc Q4W until Week 16. Based on IGA response, participants received either BKZ 320 mg sc Q4W or BKZ 320 mg sc Q8W up to Week 144.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Treatment Emergent Adverse Events (TEAEs) Adjusted by Duration of Subject Exposure to Investigational Medicinal Product (IMP)
|
97.83 no. of new events per 100 subject-years
Interval 91.73 to 104.22
|
179.68 no. of new events per 100 subject-years
Interval 166.62 to 193.49
|
79.02 no. of new events per 100 subject-years
Interval 65.97 to 93.89
|
77.11 no. of new events per 100 subject-years
Interval 51.64 to 110.74
|
73.78 no. of new events per 100 subject-years
Interval 47.75 to 108.92
|
244.08 no. of new events per 100 subject-years
Interval 178.03 to 326.6
|
328.25 no. of new events per 100 subject-years
Interval 163.86 to 587.33
|
188.71 no. of new events per 100 subject-years
Interval 86.29 to 358.22
|
SECONDARY outcome
Timeframe: From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 PeriodPopulation: CA-SS -All Cohort A participants who received at least 1 dose of the IMP in this study. CA-OL2S-All participants who received at least 1 dose of BKZ in the OLE2 Period. Cohort B PSO SS-All participants with a diagnosis of PSO disease at Baseline. Cohort B EP-SS-All participants with a diagnosis of EP disease at Baseline. Cohort B GPP-SS-All participants with a diagnosis of GPP disease at Baseline.
The number of SAEs adjusted by duration of exposure to study treatment were scaled such that it provides 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 is used.
Outcome measures
| Measure |
Cohort A: BKZ 320 mg Q8W
n=1217 Participants
Participants who received BKZ 320 mg Q8W and who switched from Q4W to Q8W dosing at any of the scheduled time points during the 144-week Treatment Period. The participants who switched from BKZ 320 mg Q4W to Q8W during the study were included in both the BKZ 320 mg Q4W group and the BKZ 320 mg Q8W group.
|
Cohort A: BKZ 320 mg Q4W
n=903 Participants
Participants who received BKZ 320 mg Q4W during the 144-week Treatment Period. The participants who switched from BKZ 320 mg Q4W to Q8W during the study were included in both the BKZ 320 mg Q4W group and the BKZ 320 mg Q8W group.
|
Cohort A: Group A BKZ 320 mg Q8W
n=226 Participants
Participants who completed the Treatment Period (Week 0 to Week 144) were directly rolled over to the Open-Label Extension 2 (OLE2) Period. Participants continued receiving BKZ 320 mg sc Q8W for 40 additional weeks (from Week 144/OLE2 Period Baseline Visit to OLE2 Period Week 48).
|
Cohort A: Group B BKZ 320 mg Q8W
n=51 Participants
Participants who had completed the Treatment Period Week 144 Visit and who were in the SFU or had completed the SFU at the time of Protocol Amendment 3.3 and 3.4 implementation reinitiated BKZ treatment in the OLE2 Period after 4-week OLE2 Screening Period. Participants in OLE2 Period Group B with an IGA score \<3 upon entry received BKZ 320 mg sc Q8W from the Week 144/OLE2 Period Baseline Visit to OLE2 Period Week 48.
|
Cohort A: Group B BKZ 320 mg Q4W/Q8W
n=41 Participants
Participants who had completed the Treatment Period Week 144 Visit and who were in the Safety Follow-Up (SFU) or had completed the SFU at the time of Protocol Amendment 3.3 and 3.4 implementation reinitiated BKZ treatment in the OLE2 Period after 4-week OLE2 Screening Period. Participants with an Investigator's Global Assessment (IGA) score greater than equal to (\>=) 3 upon entry in the OLE2 Period received BKZ 320 mg sc Q4W for the first 16 weeks, and then switched to BKZ 320 mg Q8W until OLE2 Period Week 48.
|
Cohort B: PSO BKZ Total
n=45 Participants
Participants with chronic plaque psoriasis (PSO) in Cohort B received BKZ 320 mg sc Q4W until Week 16 and 320 mg Q8W thereafter through Week 40. At Week 48, Cohort B participants with chronic plaque PSO continued BKZ 320 mg Q8W up to Week 144. If the participant's dosing interval had changed to BKZ 320 mg Q4W under Protocol Amendment 1.2, the participant's dosing interval changed to BKZ 320 mg Q8W at the next scheduled clinic visit after implementation of Protocol Amendment 3.2.
|
Cohort B: EP BKZ Total
n=11 Participants
Participants with erythrodermic psoriasis (EP) in Cohort B received BKZ 320 mg sc Q4W until Week 16. Based on IGA response, participants received either BKZ 320 mg sc Q4W or BKZ 320 mg sc Q8W up to Week 144.
|
Cohort B: GPP BKZ Total
n=10 Participants
Participants with generalized pustular psoriasis (GPP) in Cohort B received BKZ 320 mg sc Q4W until Week 16. Based on IGA response, participants received either BKZ 320 mg sc Q4W or BKZ 320 mg sc Q8W up to Week 144.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Serious Adverse Events (SAEs) Adjusted by Duration of Subject Exposure to IMP
|
5.24 no. of new events per 100 subject-years
Interval 4.36 to 6.25
|
6.72 no. of new events per 100 subject-years
Interval 5.19 to 8.56
|
4.44 no. of new events per 100 subject-years
Interval 2.22 to 7.95
|
9.05 no. of new events per 100 subject-years
Interval 2.94 to 21.13
|
8.93 no. of new events per 100 subject-years
Interval 2.43 to 22.86
|
5.86 no. of new events per 100 subject-years
Interval 2.36 to 12.08
|
19.51 no. of new events per 100 subject-years
Interval 6.34 to 45.54
|
7.56 no. of new events per 100 subject-years
Interval 0.92 to 27.32
|
SECONDARY outcome
Timeframe: From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 PeriodPopulation: CA-SS -All Cohort A participants who received at least 1 dose of the IMP in this study. CA-OL2S-All participants who received at least 1 dose of BKZ in the OLE2 Period. Cohort B PSO SS-All participants with a diagnosis of PSO disease at Baseline. Cohort B EP-SS-All participants with a diagnosis of EP disease at Baseline. Cohort B GPP-SS-All participants with a diagnosis of GPP disease at Baseline.
The number of TEAEs leading to withdrawal adjusted by duration of exposure to study treatment were 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 |
Cohort A: BKZ 320 mg Q8W
n=1217 Participants
Participants who received BKZ 320 mg Q8W and who switched from Q4W to Q8W dosing at any of the scheduled time points during the 144-week Treatment Period. The participants who switched from BKZ 320 mg Q4W to Q8W during the study were included in both the BKZ 320 mg Q4W group and the BKZ 320 mg Q8W group.
|
Cohort A: BKZ 320 mg Q4W
n=903 Participants
Participants who received BKZ 320 mg Q4W during the 144-week Treatment Period. The participants who switched from BKZ 320 mg Q4W to Q8W during the study were included in both the BKZ 320 mg Q4W group and the BKZ 320 mg Q8W group.
|
Cohort A: Group A BKZ 320 mg Q8W
n=226 Participants
Participants who completed the Treatment Period (Week 0 to Week 144) were directly rolled over to the Open-Label Extension 2 (OLE2) Period. Participants continued receiving BKZ 320 mg sc Q8W for 40 additional weeks (from Week 144/OLE2 Period Baseline Visit to OLE2 Period Week 48).
|
Cohort A: Group B BKZ 320 mg Q8W
n=51 Participants
Participants who had completed the Treatment Period Week 144 Visit and who were in the SFU or had completed the SFU at the time of Protocol Amendment 3.3 and 3.4 implementation reinitiated BKZ treatment in the OLE2 Period after 4-week OLE2 Screening Period. Participants in OLE2 Period Group B with an IGA score \<3 upon entry received BKZ 320 mg sc Q8W from the Week 144/OLE2 Period Baseline Visit to OLE2 Period Week 48.
|
Cohort A: Group B BKZ 320 mg Q4W/Q8W
n=41 Participants
Participants who had completed the Treatment Period Week 144 Visit and who were in the Safety Follow-Up (SFU) or had completed the SFU at the time of Protocol Amendment 3.3 and 3.4 implementation reinitiated BKZ treatment in the OLE2 Period after 4-week OLE2 Screening Period. Participants with an Investigator's Global Assessment (IGA) score greater than equal to (\>=) 3 upon entry in the OLE2 Period received BKZ 320 mg sc Q4W for the first 16 weeks, and then switched to BKZ 320 mg Q8W until OLE2 Period Week 48.
|
Cohort B: PSO BKZ Total
n=45 Participants
Participants with chronic plaque psoriasis (PSO) in Cohort B received BKZ 320 mg sc Q4W until Week 16 and 320 mg Q8W thereafter through Week 40. At Week 48, Cohort B participants with chronic plaque PSO continued BKZ 320 mg Q8W up to Week 144. If the participant's dosing interval had changed to BKZ 320 mg Q4W under Protocol Amendment 1.2, the participant's dosing interval changed to BKZ 320 mg Q8W at the next scheduled clinic visit after implementation of Protocol Amendment 3.2.
|
Cohort B: EP BKZ Total
n=11 Participants
Participants with erythrodermic psoriasis (EP) in Cohort B received BKZ 320 mg sc Q4W until Week 16. Based on IGA response, participants received either BKZ 320 mg sc Q4W or BKZ 320 mg sc Q8W up to Week 144.
|
Cohort B: GPP BKZ Total
n=10 Participants
Participants with generalized pustular psoriasis (GPP) in Cohort B received BKZ 320 mg sc Q4W until Week 16. Based on IGA response, participants received either BKZ 320 mg sc Q4W or BKZ 320 mg sc Q8W up to Week 144.
|
|---|---|---|---|---|---|---|---|---|
|
Number of TEAEs Leading to Withdrawal Adjusted by Duration of Subject Exposure to IMP
|
2.11 no. of new events per 100 subject-years
Interval 1.57 to 2.76
|
2.59 no. of new events per 100 subject-years
Interval 1.69 to 3.8
|
0.79 no. of new events per 100 subject-years
Interval 0.1 to 2.86
|
1.77 no. of new events per 100 subject-years
Interval 0.04 to 9.86
|
4.37 no. of new events per 100 subject-years
Interval 0.53 to 15.79
|
2.42 no. of new events per 100 subject-years
Interval 0.5 to 7.08
|
3.27 no. of new events per 100 subject-years
Interval 0.08 to 18.19
|
7.68 no. of new events per 100 subject-years
Interval 0.93 to 27.74
|
SECONDARY outcome
Timeframe: Week 144 compared to Baseline of Feeder study for Cohort A and Baseline of PS0014 for Cohort BPopulation: Cohort A FAS included all Cohort A enrolled study participants who received at least 1 dose of IMP and had a valid efficacy measurement for PASI at Baseline of the feeder study and at Baseline of this study. Cohort B Psoriasis FAS included study participants with chronic plaque PSO at Baseline. Study participants who had missing data at the Week 144 were treated as though they did not respond to the treatment using Non-responder imputation (NRI) method.
The PASI90 response assessments were based on improvement (reduction) of at least 90% in the PASI score compared to 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 |
Cohort A: BKZ 320 mg Q8W
n=384 Participants
Participants who received BKZ 320 mg Q8W and who switched from Q4W to Q8W dosing at any of the scheduled time points during the 144-week Treatment Period. The participants who switched from BKZ 320 mg Q4W to Q8W during the study were included in both the BKZ 320 mg Q4W group and the BKZ 320 mg Q8W group.
|
Cohort A: BKZ 320 mg Q4W
n=832 Participants
Participants who received BKZ 320 mg Q4W during the 144-week Treatment Period. The participants who switched from BKZ 320 mg Q4W to Q8W during the study were included in both the BKZ 320 mg Q4W group and the BKZ 320 mg Q8W group.
|
Cohort A: Group A BKZ 320 mg Q8W
n=70 Participants
Participants who completed the Treatment Period (Week 0 to Week 144) were directly rolled over to the Open-Label Extension 2 (OLE2) Period. Participants continued receiving BKZ 320 mg sc Q8W for 40 additional weeks (from Week 144/OLE2 Period Baseline Visit to OLE2 Period Week 48).
|
Cohort A: Group B BKZ 320 mg Q8W
n=45 Participants
Participants who had completed the Treatment Period Week 144 Visit and who were in the SFU or had completed the SFU at the time of Protocol Amendment 3.3 and 3.4 implementation reinitiated BKZ treatment in the OLE2 Period after 4-week OLE2 Screening Period. Participants in OLE2 Period Group B with an IGA score \<3 upon entry received BKZ 320 mg sc Q8W from the Week 144/OLE2 Period Baseline Visit to OLE2 Period Week 48.
|
Cohort A: Group B BKZ 320 mg Q4W/Q8W
Participants who had completed the Treatment Period Week 144 Visit and who were in the Safety Follow-Up (SFU) or had completed the SFU at the time of Protocol Amendment 3.3 and 3.4 implementation reinitiated BKZ treatment in the OLE2 Period after 4-week OLE2 Screening Period. Participants with an Investigator's Global Assessment (IGA) score greater than equal to (\>=) 3 upon entry in the OLE2 Period received BKZ 320 mg sc Q4W for the first 16 weeks, and then switched to BKZ 320 mg Q8W until OLE2 Period Week 48.
|
Cohort B: PSO BKZ Total
Participants with chronic plaque psoriasis (PSO) in Cohort B received BKZ 320 mg sc Q4W until Week 16 and 320 mg Q8W thereafter through Week 40. At Week 48, Cohort B participants with chronic plaque PSO continued BKZ 320 mg Q8W up to Week 144. If the participant's dosing interval had changed to BKZ 320 mg Q4W under Protocol Amendment 1.2, the participant's dosing interval changed to BKZ 320 mg Q8W at the next scheduled clinic visit after implementation of Protocol Amendment 3.2.
|
Cohort B: EP BKZ Total
Participants with erythrodermic psoriasis (EP) in Cohort B received BKZ 320 mg sc Q4W until Week 16. Based on IGA response, participants received either BKZ 320 mg sc Q4W or BKZ 320 mg sc Q8W up to Week 144.
|
Cohort B: GPP BKZ Total
Participants with generalized pustular psoriasis (GPP) in Cohort B received BKZ 320 mg sc Q4W until Week 16. Based on IGA response, participants received either BKZ 320 mg sc Q4W or BKZ 320 mg sc Q8W up to Week 144.
|
|---|---|---|---|---|---|---|---|---|
|
Psoriasis Area Severity Index 90 (PASI90) Response at Week 144 (Non-responder Imputation)
|
77.6 percentage of participants
|
80.2 percentage of participants
|
0 percentage of participants
|
73.3 percentage of participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 144 compared to Baseline of PS0014 for Cohort BPopulation: Cohort B GPP FAS included study participants with GPP at Baseline. Cohort B EP FAS included study participants with EP at Baseline. Only study participants with available data who had not discontinued study treatment at Week 144 were considered for the analysis.
PASI90 response assessments were based on improvement (reduction) of at least 90% in the PASI score compared to 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 involved psoriasis area score of respective section, and weighted by percentage of person's affected skin for respective section. Minimum score is 0= no disease, maximum score is 72= maximal disease.
Outcome measures
| Measure |
Cohort A: BKZ 320 mg Q8W
n=11 Participants
Participants who received BKZ 320 mg Q8W and who switched from Q4W to Q8W dosing at any of the scheduled time points during the 144-week Treatment Period. The participants who switched from BKZ 320 mg Q4W to Q8W during the study were included in both the BKZ 320 mg Q4W group and the BKZ 320 mg Q8W group.
|
Cohort A: BKZ 320 mg Q4W
n=10 Participants
Participants who received BKZ 320 mg Q4W during the 144-week Treatment Period. The participants who switched from BKZ 320 mg Q4W to Q8W during the study were included in both the BKZ 320 mg Q4W group and the BKZ 320 mg Q8W group.
|
Cohort A: Group A BKZ 320 mg Q8W
Participants who completed the Treatment Period (Week 0 to Week 144) were directly rolled over to the Open-Label Extension 2 (OLE2) Period. Participants continued receiving BKZ 320 mg sc Q8W for 40 additional weeks (from Week 144/OLE2 Period Baseline Visit to OLE2 Period Week 48).
|
Cohort A: Group B BKZ 320 mg Q8W
Participants who had completed the Treatment Period Week 144 Visit and who were in the SFU or had completed the SFU at the time of Protocol Amendment 3.3 and 3.4 implementation reinitiated BKZ treatment in the OLE2 Period after 4-week OLE2 Screening Period. Participants in OLE2 Period Group B with an IGA score \<3 upon entry received BKZ 320 mg sc Q8W from the Week 144/OLE2 Period Baseline Visit to OLE2 Period Week 48.
|
Cohort A: Group B BKZ 320 mg Q4W/Q8W
Participants who had completed the Treatment Period Week 144 Visit and who were in the Safety Follow-Up (SFU) or had completed the SFU at the time of Protocol Amendment 3.3 and 3.4 implementation reinitiated BKZ treatment in the OLE2 Period after 4-week OLE2 Screening Period. Participants with an Investigator's Global Assessment (IGA) score greater than equal to (\>=) 3 upon entry in the OLE2 Period received BKZ 320 mg sc Q4W for the first 16 weeks, and then switched to BKZ 320 mg Q8W until OLE2 Period Week 48.
|
Cohort B: PSO BKZ Total
Participants with chronic plaque psoriasis (PSO) in Cohort B received BKZ 320 mg sc Q4W until Week 16 and 320 mg Q8W thereafter through Week 40. At Week 48, Cohort B participants with chronic plaque PSO continued BKZ 320 mg Q8W up to Week 144. If the participant's dosing interval had changed to BKZ 320 mg Q4W under Protocol Amendment 1.2, the participant's dosing interval changed to BKZ 320 mg Q8W at the next scheduled clinic visit after implementation of Protocol Amendment 3.2.
|
Cohort B: EP BKZ Total
Participants with erythrodermic psoriasis (EP) in Cohort B received BKZ 320 mg sc Q4W until Week 16. Based on IGA response, participants received either BKZ 320 mg sc Q4W or BKZ 320 mg sc Q8W up to Week 144.
|
Cohort B: GPP BKZ Total
Participants with generalized pustular psoriasis (GPP) in Cohort B received BKZ 320 mg sc Q4W until Week 16. Based on IGA response, participants received either BKZ 320 mg sc Q4W or BKZ 320 mg sc Q8W up to Week 144.
|
|---|---|---|---|---|---|---|---|---|
|
Psoriasis Area Severity Index 90 (PASI90) Response at Week 144 (Observed Case)
|
90.0 percentage of participants
|
85.7 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 144 compared to Baseline of Feeder study for Cohort A and Baseline of PS0014 for Cohort BPopulation: Cohort A FAS included all Cohort A enrolled study participants who received at least 1 dose of IMP and had a valid efficacy measurement for PASI at Baseline of the feeder study and at Baseline of this study. Cohort B Psoriasis FAS included study participants with chronic plaque PSO at Baseline. Study participants who had missing data at the Week 144 were treated as though they did not respond to the treatment using NRI.
The Investigator assessed the overall severity of psoriasis using the following 5-point scale: 0 = Clear (no signs of psoriasis; post-inflammatory hyperpigmentation may be present); 1= Almost clear (no thickening; normal to pink coloration; no to minimal focal scaling); 2= Mild (just detectable to mild thickening; pink to light red coloration; predominately fine scaling); 3= Moderate (clearly distinguishable to moderate thickening; dull to bright red coloration; moderate scaling); 4= Severe (Severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions). IGA response -IGA score of clear \[0\] or almost clear \[1\] with at least two category improvement from Baseline at visit timepoint.
Outcome measures
| Measure |
Cohort A: BKZ 320 mg Q8W
n=384 Participants
Participants who received BKZ 320 mg Q8W and who switched from Q4W to Q8W dosing at any of the scheduled time points during the 144-week Treatment Period. The participants who switched from BKZ 320 mg Q4W to Q8W during the study were included in both the BKZ 320 mg Q4W group and the BKZ 320 mg Q8W group.
|
Cohort A: BKZ 320 mg Q4W
n=832 Participants
Participants who received BKZ 320 mg Q4W during the 144-week Treatment Period. The participants who switched from BKZ 320 mg Q4W to Q8W during the study were included in both the BKZ 320 mg Q4W group and the BKZ 320 mg Q8W group.
|
Cohort A: Group A BKZ 320 mg Q8W
n=70 Participants
Participants who completed the Treatment Period (Week 0 to Week 144) were directly rolled over to the Open-Label Extension 2 (OLE2) Period. Participants continued receiving BKZ 320 mg sc Q8W for 40 additional weeks (from Week 144/OLE2 Period Baseline Visit to OLE2 Period Week 48).
|
Cohort A: Group B BKZ 320 mg Q8W
n=45 Participants
Participants who had completed the Treatment Period Week 144 Visit and who were in the SFU or had completed the SFU at the time of Protocol Amendment 3.3 and 3.4 implementation reinitiated BKZ treatment in the OLE2 Period after 4-week OLE2 Screening Period. Participants in OLE2 Period Group B with an IGA score \<3 upon entry received BKZ 320 mg sc Q8W from the Week 144/OLE2 Period Baseline Visit to OLE2 Period Week 48.
|
Cohort A: Group B BKZ 320 mg Q4W/Q8W
Participants who had completed the Treatment Period Week 144 Visit and who were in the Safety Follow-Up (SFU) or had completed the SFU at the time of Protocol Amendment 3.3 and 3.4 implementation reinitiated BKZ treatment in the OLE2 Period after 4-week OLE2 Screening Period. Participants with an Investigator's Global Assessment (IGA) score greater than equal to (\>=) 3 upon entry in the OLE2 Period received BKZ 320 mg sc Q4W for the first 16 weeks, and then switched to BKZ 320 mg Q8W until OLE2 Period Week 48.
|
Cohort B: PSO BKZ Total
Participants with chronic plaque psoriasis (PSO) in Cohort B received BKZ 320 mg sc Q4W until Week 16 and 320 mg Q8W thereafter through Week 40. At Week 48, Cohort B participants with chronic plaque PSO continued BKZ 320 mg Q8W up to Week 144. If the participant's dosing interval had changed to BKZ 320 mg Q4W under Protocol Amendment 1.2, the participant's dosing interval changed to BKZ 320 mg Q8W at the next scheduled clinic visit after implementation of Protocol Amendment 3.2.
|
Cohort B: EP BKZ Total
Participants with erythrodermic psoriasis (EP) in Cohort B received BKZ 320 mg sc Q4W until Week 16. Based on IGA response, participants received either BKZ 320 mg sc Q4W or BKZ 320 mg sc Q8W up to Week 144.
|
Cohort B: GPP BKZ Total
Participants with generalized pustular psoriasis (GPP) in Cohort B received BKZ 320 mg sc Q4W until Week 16. Based on IGA response, participants received either BKZ 320 mg sc Q4W or BKZ 320 mg sc Q8W up to Week 144.
|
|---|---|---|---|---|---|---|---|---|
|
Investigator´s Global Assessment (IGA) 0/1 Response at Week 144 (Non-responder Imputation)
|
76.8 percentage of participants
|
79.0 percentage of participants
|
0 percentage of participants
|
60.0 percentage of participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 144 for Cohort B EP and GPP groupsPopulation: Cohort B GPP FAS included study participants with GPP at Baseline. Cohort B EP FAS included study participants with EP at Baseline. Only study participants with available data who had not discontinued study treatment at Week 144 were considered for the analysis.
The Investigator assessed the overall severity of psoriasis using the following 5-point scale: 0 = Clear (no signs of psoriasis; post-inflammatory hyperpigmentation may be present); 1= Almost clear (no thickening; normal to pink coloration; no to minimal focal scaling); 2= Mild (just detectable to mild thickening; pink to light red coloration; predominately fine scaling); 3= Moderate (clearly distinguishable to moderate thickening; dull to bright red coloration; moderate scaling); 4= Severe (Severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions). IGA response -IGA score of 0 or 1 at Week 144.
Outcome measures
| Measure |
Cohort A: BKZ 320 mg Q8W
n=11 Participants
Participants who received BKZ 320 mg Q8W and who switched from Q4W to Q8W dosing at any of the scheduled time points during the 144-week Treatment Period. The participants who switched from BKZ 320 mg Q4W to Q8W during the study were included in both the BKZ 320 mg Q4W group and the BKZ 320 mg Q8W group.
|
Cohort A: BKZ 320 mg Q4W
n=10 Participants
Participants who received BKZ 320 mg Q4W during the 144-week Treatment Period. The participants who switched from BKZ 320 mg Q4W to Q8W during the study were included in both the BKZ 320 mg Q4W group and the BKZ 320 mg Q8W group.
|
Cohort A: Group A BKZ 320 mg Q8W
Participants who completed the Treatment Period (Week 0 to Week 144) were directly rolled over to the Open-Label Extension 2 (OLE2) Period. Participants continued receiving BKZ 320 mg sc Q8W for 40 additional weeks (from Week 144/OLE2 Period Baseline Visit to OLE2 Period Week 48).
|
Cohort A: Group B BKZ 320 mg Q8W
Participants who had completed the Treatment Period Week 144 Visit and who were in the SFU or had completed the SFU at the time of Protocol Amendment 3.3 and 3.4 implementation reinitiated BKZ treatment in the OLE2 Period after 4-week OLE2 Screening Period. Participants in OLE2 Period Group B with an IGA score \<3 upon entry received BKZ 320 mg sc Q8W from the Week 144/OLE2 Period Baseline Visit to OLE2 Period Week 48.
|
Cohort A: Group B BKZ 320 mg Q4W/Q8W
Participants who had completed the Treatment Period Week 144 Visit and who were in the Safety Follow-Up (SFU) or had completed the SFU at the time of Protocol Amendment 3.3 and 3.4 implementation reinitiated BKZ treatment in the OLE2 Period after 4-week OLE2 Screening Period. Participants with an Investigator's Global Assessment (IGA) score greater than equal to (\>=) 3 upon entry in the OLE2 Period received BKZ 320 mg sc Q4W for the first 16 weeks, and then switched to BKZ 320 mg Q8W until OLE2 Period Week 48.
|
Cohort B: PSO BKZ Total
Participants with chronic plaque psoriasis (PSO) in Cohort B received BKZ 320 mg sc Q4W until Week 16 and 320 mg Q8W thereafter through Week 40. At Week 48, Cohort B participants with chronic plaque PSO continued BKZ 320 mg Q8W up to Week 144. If the participant's dosing interval had changed to BKZ 320 mg Q4W under Protocol Amendment 1.2, the participant's dosing interval changed to BKZ 320 mg Q8W at the next scheduled clinic visit after implementation of Protocol Amendment 3.2.
|
Cohort B: EP BKZ Total
Participants with erythrodermic psoriasis (EP) in Cohort B received BKZ 320 mg sc Q4W until Week 16. Based on IGA response, participants received either BKZ 320 mg sc Q4W or BKZ 320 mg sc Q8W up to Week 144.
|
Cohort B: GPP BKZ Total
Participants with generalized pustular psoriasis (GPP) in Cohort B received BKZ 320 mg sc Q4W until Week 16. Based on IGA response, participants received either BKZ 320 mg sc Q4W or BKZ 320 mg sc Q8W up to Week 144.
|
|---|---|---|---|---|---|---|---|---|
|
Investigator´s Global Assessment (IGA) 0/1 Response at Week 144 (Observed Case)
|
80.0 percentage of participants
|
85.7 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Cohort A: BKZ 320 mg Q8W
Serious events: 124 serious events
Other events: 771 other events
Deaths: 9 deaths
Cohort A: BKZ 320 mg Q4W
Serious events: 65 serious events
Other events: 566 other events
Deaths: 6 deaths
Cohort A: Group A BKZ 320 mg Q8W
Serious events: 11 serious events
Other events: 97 other events
Deaths: 0 deaths
Cohort A: Group B BKZ 320 mg Q8W
Serious events: 5 serious events
Other events: 16 other events
Deaths: 0 deaths
Cohort A: Group B BKZ 320 mg Q4W/Q8W
Serious events: 4 serious events
Other events: 21 other events
Deaths: 0 deaths
Cohort B: PSO BKZ Total
Serious events: 7 serious events
Other events: 43 other events
Deaths: 0 deaths
Cohort B: EP BKZ Total
Serious events: 5 serious events
Other events: 11 other events
Deaths: 0 deaths
Cohort B: GPP BKZ Total
Serious events: 2 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort A: BKZ 320 mg Q8W
n=1217 participants at risk
Participants who received BKZ 320 mg Q8W and who switched from Q4W to Q8W dosing at any of the scheduled time points during the 144-week Treatment Period. The participants who switched from BKZ 320 mg Q4W to Q8W during the study were included in both the BKZ 320 mg Q4W group and the BKZ 320 mg Q8W group. All the adverse events occurred during the BKZ 320 mg Q8W treatment at any timepoint of the study were included in this arm.
|
Cohort A: BKZ 320 mg Q4W
n=903 participants at risk
Participants who received BKZ 320 mg Q4W during the 144-week Treatment Period. The participants who switched from BKZ 320 mg Q4W to Q8W during the study were included in both the BKZ 320 mg Q4W group and the BKZ 320 mg Q8W group. All the adverse events occurred during the BKZ 320 mg Q4W treatment at any timepoint of the study were included in this arm.
|
Cohort A: Group A BKZ 320 mg Q8W
n=226 participants at risk
Participants who completed the Treatment Period (Week 0 to Week 144) were directly rolled over to the Open-Label Extension 2 (OLE2) Period. Participants continued receiving BKZ 320 mg sc Q8W for 40 additional weeks (from Week 144/OLE2 Period Baseline Visit to OLE2 Period Week 48).
|
Cohort A: Group B BKZ 320 mg Q8W
n=51 participants at risk
Participants who had completed the Treatment Period Week 144 Visit and who were in the SFU or had completed the SFU at the time of Protocol Amendment 3.3 and 3.4 implementation reinitiated BKZ treatment in the OLE2 Period after 4-week OLE2 Screening Period. Participants in OLE2 Period Group B with an IGA score \<3 upon entry received BKZ 320 mg sc Q8W from the Week 144/OLE2 Period Baseline Visit to OLE2 Period Week 48.
|
Cohort A: Group B BKZ 320 mg Q4W/Q8W
n=41 participants at risk
Participants who had completed the Treatment Period Week 144 Visit and who were in the Safety Follow-Up (SFU) or had completed the SFU at the time of Protocol Amendment 3.3 and 3.4 implementation reinitiated BKZ treatment in the OLE2 Period after 4-week OLE2 Screening Period. Participants with an Investigator's Global Assessment (IGA) score greater than equal to (\>=) 3 upon entry in the OLE2 Period received BKZ 320 mg sc Q4W for the first 16 weeks, and then switched to BKZ 320 mg Q8W until OLE2 Period Week 48.
|
Cohort B: PSO BKZ Total
n=45 participants at risk
Participants with chronic plaque psoriasis (PSO) in Cohort B received BKZ 320 mg sc Q4W until Week 16 and 320 mg Q8W thereafter through Week 40. At Week 48, Cohort B participants with chronic plaque PSO continued BKZ 320 mg Q8W up to Week 144. If the participant's dosing interval had changed to BKZ 320 mg Q4W under Protocol Amendment 1.2, the participant's dosing interval changed to BKZ 320 mg Q8W at the next scheduled clinic visit after implementation of Protocol Amendment 3.2.
|
Cohort B: EP BKZ Total
n=11 participants at risk
Participants with erythrodermic psoriasis (EP) in Cohort B received BKZ 320 mg sc Q4W until Week 16. Based on IGA response, participants received either BKZ 320 mg sc Q4W or BKZ 320 mg sc Q8W up to Week 144.
|
Cohort B: GPP BKZ Total
n=10 participants at risk
Participants with generalized pustular psoriasis (GPP) in Cohort B received BKZ 320 mg sc Q4W until Week 16. Based on IGA response, participants received either BKZ 320 mg sc Q4W or BKZ 320 mg sc Q8W up to Week 144.
|
|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
0.08%
1/1217 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Blood and lymphatic system disorders
Microcytic anaemia
|
0.00%
0/1217 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.11%
1/903 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Blood and lymphatic system disorders
Haemorrhagic diathesis
|
0.00%
0/1217 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.11%
1/903 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Cardiac disorders
Wolff-Parkinson-White syndrome
|
0.08%
1/1217 • Number of events 2 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Cardiac disorders
Hypertensive cardiomyopathy
|
0.08%
1/1217 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Cardiac disorders
Coronary artery disease
|
0.16%
2/1217 • Number of events 2 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.08%
1/1217 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.11%
1/903 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.44%
1/226 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
9.1%
1/11 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.00%
0/1217 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.11%
1/903 • Number of events 2 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.33%
4/1217 • Number of events 4 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.11%
1/903 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
2.0%
1/51 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
2.4%
1/41 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Cardiac disorders
Myocardial infarction
|
0.25%
3/1217 • Number of events 3 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.11%
1/903 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
1.3%
3/226 • Number of events 3 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.25%
3/1217 • Number of events 3 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Cardiac disorders
Angina pectoris
|
0.08%
1/1217 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.33%
3/903 • Number of events 3 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.08%
1/1217 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Cardiac disorders
Systolic dysfunction
|
0.00%
0/1217 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.11%
1/903 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Cardiac disorders
Pericarditis
|
0.08%
1/1217 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Cardiac disorders
Tachycardia
|
0.08%
1/1217 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Cardiac disorders
Atrial fibrillation
|
0.08%
1/1217 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.11%
1/903 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Cardiac disorders
Atrial flutter
|
0.08%
1/1217 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Cardiac disorders
Cardiac arrest
|
0.08%
1/1217 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.22%
2/903 • Number of events 2 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Endocrine disorders
Hyperparathyroidism primary
|
0.08%
1/1217 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Endocrine disorders
Inappropriate antidiuretic hormone secretion
|
0.08%
1/1217 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Eye disorders
Cataract
|
0.08%
1/1217 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.11%
1/903 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
2.2%
1/45 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Eye disorders
Retinal detachment
|
0.08%
1/1217 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.08%
1/1217 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.08%
1/1217 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Gastrointestinal disorders
Anal prolapse
|
0.08%
1/1217 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.08%
1/1217 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Gastrointestinal disorders
Crohn's disease
|
0.08%
1/1217 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.11%
1/903 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/1217 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.11%
1/903 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Gastrointestinal disorders
Diverticulum intestinal haemorrhagic
|
0.08%
1/1217 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.11%
1/903 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.08%
1/1217 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.08%
1/1217 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Gastrointestinal disorders
Oesophageal varices haemorrhage
|
0.08%
1/1217 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Gastrointestinal disorders
Chronic gastritis
|
0.08%
1/1217 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.08%
1/1217 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.08%
1/1217 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
—
0/0 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
—
0/0 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Gastrointestinal disorders
Oroantral fistula
|
0.08%
1/1217 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/1217 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.11%
1/903 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.44%
1/226 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Gastrointestinal disorders
Diverticular perforation
|
0.16%
2/1217 • Number of events 2 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.44%
1/226 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.08%
1/1217 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.08%
1/1217 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/1217 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.11%
1/903 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/1217 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.11%
1/903 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
General disorders
Death
|
0.08%
1/1217 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
General disorders
Pain
|
0.00%
0/1217 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.11%
1/903 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
General disorders
Stent-graft endoleak
|
0.08%
1/1217 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Hepatobiliary disorders
Cholecystocholangitis
|
0.00%
0/1217 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.11%
1/903 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/1217 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.11%
1/903 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.08%
1/1217 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.44%
1/226 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.08%
1/1217 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.08%
1/1217 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Immune system disorders
Anaphylactic shock
|
0.00%
0/1217 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.11%
1/903 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Infections and infestations
Diverticulitis
|
0.16%
2/1217 • Number of events 2 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.11%
1/903 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Infections and infestations
Abdominal wall abscess
|
0.08%
1/1217 • Number of events 2 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/1217 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.11%
1/903 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Infections and infestations
Colonic abscess
|
0.08%
1/1217 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/1217 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.22%
2/903 • Number of events 2 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Infections and infestations
Bursitis infective
|
0.08%
1/1217 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Infections and infestations
Ophthalmic herpes zoster
|
0.00%
0/1217 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.11%
1/903 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Infections and infestations
Abscess limb
|
0.00%
0/1217 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.22%
2/903 • Number of events 2 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Infections and infestations
Pneumonia
|
0.08%
1/1217 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.11%
1/903 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.44%
1/226 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Infections and infestations
Psoas abscess
|
0.08%
1/1217 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Infections and infestations
Sepsis
|
0.08%
1/1217 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.88%
2/226 • Number of events 2 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Infections and infestations
Subcutaneous abscess
|
0.08%
1/1217 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Infections and infestations
Staphylococcal abscess
|
0.08%
1/1217 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Infections and infestations
Staphylococcal skin infection
|
0.00%
0/1217 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.11%
1/903 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Infections and infestations
Erysipelas
|
0.08%
1/1217 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.11%
1/903 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
2.2%
1/45 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Infections and infestations
Streptococcal abscess
|
0.00%
0/1217 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.11%
1/903 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Infections and infestations
Chronic sinusitis
|
0.08%
1/1217 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/1217 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.11%
1/903 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Infections and infestations
Urinary tract infection
|
0.16%
2/1217 • Number of events 2 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Infections and infestations
Corona virus infection
|
1.1%
13/1217 • Number of events 13 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.16%
2/1217 • Number of events 2 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.08%
1/1217 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Injury, poisoning and procedural complications
Pneumothorax traumatic
|
0.08%
1/1217 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.16%
2/1217 • Number of events 2 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.08%
1/1217 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.11%
1/903 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/1217 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.11%
1/903 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/1217 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.11%
1/903 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.08%
1/1217 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.08%
1/1217 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.00%
0/1217 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.11%
1/903 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/1217 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.11%
1/903 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.25%
3/1217 • Number of events 3 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Injury, poisoning and procedural complications
Post lumbar puncture syndrome
|
0.00%
0/1217 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.11%
1/903 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Injury, poisoning and procedural complications
Fall
|
0.08%
1/1217 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.08%
1/1217 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.08%
1/1217 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.08%
1/1217 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.11%
1/903 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/1217 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.11%
1/903 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Injury, poisoning and procedural complications
Spinal column injury
|
0.00%
0/1217 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.11%
1/903 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.16%
2/1217 • Number of events 2 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.08%
1/1217 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.08%
1/1217 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.08%
1/1217 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.11%
1/903 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
2.2%
1/45 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Metabolism and nutrition disorders
Obesity
|
0.08%
1/1217 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Metabolism and nutrition disorders
Ketoacidosis
|
0.00%
0/1217 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.11%
1/903 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.08%
1/1217 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
0.00%
0/1217 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.11%
1/903 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
0.08%
1/1217 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Musculoskeletal and connective tissue disorders
Osteitis
|
0.00%
0/1217 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.11%
1/903 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/1217 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.11%
1/903 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.08%
1/1217 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Musculoskeletal and connective tissue disorders
Inclusion body myositis
|
0.00%
0/1217 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.11%
1/903 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Musculoskeletal and connective tissue disorders
Fibromyalgia
|
0.00%
0/1217 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.11%
1/903 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.08%
1/1217 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.16%
2/1217 • Number of events 3 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.11%
1/903 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
9.1%
1/11 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/1217 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.11%
1/903 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.08%
1/1217 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.11%
1/903 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Musculoskeletal and connective tissue disorders
Kyphosis
|
0.08%
1/1217 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/1217 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.11%
1/903 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma
|
0.00%
0/1217 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.11%
1/903 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.08%
1/1217 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer stage I
|
0.08%
1/1217 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive breast carcinoma
|
0.08%
1/1217 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.08%
1/1217 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.11%
1/903 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.08%
1/1217 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer metastatic
|
0.08%
1/1217 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal adenocarcinoma
|
0.08%
1/1217 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal cancer metastatic
|
0.08%
1/1217 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid neoplasm
|
0.08%
1/1217 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tongue neoplasm benign
|
0.08%
1/1217 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lip and/or oral cavity cancer
|
0.08%
1/1217 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm
|
0.00%
0/1217 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.11%
1/903 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of lung
|
0.00%
0/1217 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.11%
1/903 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma pancreas
|
0.08%
1/1217 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostatic adenoma
|
0.08%
1/1217 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.08%
1/1217 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer stage I
|
0.08%
1/1217 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Clear cell renal cell carcinoma
|
0.08%
1/1217 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic bronchial carcinoma
|
0.08%
1/1217 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer metastatic
|
0.08%
1/1217 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Nervous system disorders
Cerebral artery embolism
|
0.08%
1/1217 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma in situ
|
0.08%
1/1217 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/1217 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.11%
1/903 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.08%
1/1217 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary thyroid cancer
|
0.16%
2/1217 • Number of events 2 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.08%
1/1217 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.08%
1/1217 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.11%
1/903 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/1217 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.11%
1/903 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.00%
0/1217 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.11%
1/903 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Nervous system disorders
Cerebrovascular disorder
|
0.00%
0/1217 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.11%
1/903 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Nervous system disorders
Loss of consciousness
|
0.16%
2/1217 • Number of events 2 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Nervous system disorders
Syncope
|
0.08%
1/1217 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Nervous system disorders
Seizure
|
0.08%
1/1217 • Number of events 2 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.11%
1/903 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Nervous system disorders
Toxic encephalopathy
|
0.08%
1/1217 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Nervous system disorders
Intracranial pressure increased
|
0.00%
0/1217 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.11%
1/903 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Nervous system disorders
Hemiplegic migraine
|
0.00%
0/1217 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.11%
1/903 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Nervous system disorders
Migraine
|
0.00%
0/1217 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.11%
1/903 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Nervous system disorders
Relapsing-remitting multiple sclerosis
|
0.08%
1/1217 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Nervous system disorders
Intercostal neuralgia
|
0.08%
1/1217 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Nervous system disorders
Spondylitic myelopathy
|
0.00%
0/1217 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.11%
1/903 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.08%
1/1217 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.11%
1/903 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
2.0%
1/51 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/1217 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.11%
1/903 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy on oral contraceptive
|
0.00%
0/1217 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.11%
1/903 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Psychiatric disorders
Bipolar I disorder
|
0.00%
0/1217 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.11%
1/903 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Psychiatric disorders
Alcohol withdrawal syndrome
|
0.00%
0/1217 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.11%
1/903 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Psychiatric disorders
Drug dependence
|
0.00%
0/1217 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.11%
1/903 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Psychiatric disorders
Completed suicide
|
0.00%
0/1217 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.11%
1/903 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Psychiatric disorders
Suicidal ideation
|
0.08%
1/1217 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/1217 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.22%
2/903 • Number of events 2 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/1217 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.11%
1/903 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.08%
1/1217 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Renal and urinary disorders
Renal cyst
|
0.08%
1/1217 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Renal and urinary disorders
Renal colic
|
0.08%
1/1217 • Number of events 2 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Reproductive system and breast disorders
Cervical dysplasia
|
0.08%
1/1217 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.08%
1/1217 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Reproductive system and breast disorders
Uterine prolapse
|
0.00%
0/1217 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.11%
1/903 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Reproductive system and breast disorders
Genital haemorrhage
|
0.08%
1/1217 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.00%
0/1217 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.11%
1/903 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.08%
1/1217 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.33%
4/1217 • Number of events 4 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.11%
1/903 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.08%
1/1217 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.08%
1/1217 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal ulceration
|
0.00%
0/1217 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.11%
1/903 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal ulceration
|
0.00%
0/1217 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.11%
1/903 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.08%
1/1217 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
9.1%
1/11 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.08%
1/1217 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.22%
2/903 • Number of events 2 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.08%
1/1217 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.11%
1/903 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
2.0%
1/51 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.08%
1/1217 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/1217 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.11%
1/903 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.00%
0/1217 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.11%
1/903 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.08%
1/1217 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.11%
1/903 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.08%
1/1217 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.11%
1/903 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Vascular disorders
Aortic aneurysm
|
0.08%
1/1217 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.11%
1/903 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Vascular disorders
Aortic aneurysm rupture
|
0.08%
1/1217 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Vascular disorders
Circulatory collapse
|
0.08%
1/1217 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Vascular disorders
Hypovolaemic shock
|
0.00%
0/1217 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.11%
1/903 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Vascular disorders
Deep vein thrombosis
|
0.08%
1/1217 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.11%
1/903 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Vascular disorders
Femoral artery embolism
|
0.00%
0/1217 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.11%
1/903 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Vascular disorders
Hypertension
|
0.00%
0/1217 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.11%
1/903 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/1217 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.44%
1/226 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Cardiac disorders
Pulseless electrical activity
|
0.00%
0/1217 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.44%
1/226 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.00%
0/1217 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
2.4%
1/41 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Gastrointestinal disorders
Haemorrhoids thrombosed
|
0.00%
0/1217 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
2.0%
1/51 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/1217 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.44%
1/226 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Infections and infestations
Pulmonary sepsis
|
0.00%
0/1217 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.44%
1/226 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/1217 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.44%
1/226 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/1217 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
2.0%
1/51 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.00%
0/1217 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
2.4%
1/41 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Injury, poisoning and procedural complications
Jaw fracture
|
0.00%
0/1217 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
2.4%
1/41 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma
|
0.00%
0/1217 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
2.0%
1/51 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/1217 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
2.4%
1/41 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/1217 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
2.0%
1/51 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
2.2%
1/45 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/1217 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.44%
1/226 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Surgical and medical procedures
Hip arthroplasty
|
0.00%
0/1217 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
2.0%
1/51 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/1217 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
2.2%
1/45 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.00%
0/1217 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
2.2%
1/45 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
10.0%
1/10 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/1217 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
2.2%
1/45 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal tract adenoma
|
0.00%
0/1217 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
2.2%
1/45 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer
|
0.00%
0/1217 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
2.2%
1/45 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/1217 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
9.1%
1/11 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
General disorders
Oedema peripheral
|
0.00%
0/1217 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
9.1%
1/11 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/1217 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
9.1%
1/11 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/1217 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
9.1%
1/11 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Skin and subcutaneous tissue disorders
Erythrodermic psoriasis
|
0.00%
0/1217 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
9.1%
1/11 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Hepatobiliary disorders
Autoimmune hepatitis
|
0.00%
0/1217 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
10.0%
1/10 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Skin and subcutaneous tissue disorders
Pustular psoriasis
|
0.00%
0/1217 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
10.0%
1/10 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
Other adverse events
| Measure |
Cohort A: BKZ 320 mg Q8W
n=1217 participants at risk
Participants who received BKZ 320 mg Q8W and who switched from Q4W to Q8W dosing at any of the scheduled time points during the 144-week Treatment Period. The participants who switched from BKZ 320 mg Q4W to Q8W during the study were included in both the BKZ 320 mg Q4W group and the BKZ 320 mg Q8W group. All the adverse events occurred during the BKZ 320 mg Q8W treatment at any timepoint of the study were included in this arm.
|
Cohort A: BKZ 320 mg Q4W
n=903 participants at risk
Participants who received BKZ 320 mg Q4W during the 144-week Treatment Period. The participants who switched from BKZ 320 mg Q4W to Q8W during the study were included in both the BKZ 320 mg Q4W group and the BKZ 320 mg Q8W group. All the adverse events occurred during the BKZ 320 mg Q4W treatment at any timepoint of the study were included in this arm.
|
Cohort A: Group A BKZ 320 mg Q8W
n=226 participants at risk
Participants who completed the Treatment Period (Week 0 to Week 144) were directly rolled over to the Open-Label Extension 2 (OLE2) Period. Participants continued receiving BKZ 320 mg sc Q8W for 40 additional weeks (from Week 144/OLE2 Period Baseline Visit to OLE2 Period Week 48).
|
Cohort A: Group B BKZ 320 mg Q8W
n=51 participants at risk
Participants who had completed the Treatment Period Week 144 Visit and who were in the SFU or had completed the SFU at the time of Protocol Amendment 3.3 and 3.4 implementation reinitiated BKZ treatment in the OLE2 Period after 4-week OLE2 Screening Period. Participants in OLE2 Period Group B with an IGA score \<3 upon entry received BKZ 320 mg sc Q8W from the Week 144/OLE2 Period Baseline Visit to OLE2 Period Week 48.
|
Cohort A: Group B BKZ 320 mg Q4W/Q8W
n=41 participants at risk
Participants who had completed the Treatment Period Week 144 Visit and who were in the Safety Follow-Up (SFU) or had completed the SFU at the time of Protocol Amendment 3.3 and 3.4 implementation reinitiated BKZ treatment in the OLE2 Period after 4-week OLE2 Screening Period. Participants with an Investigator's Global Assessment (IGA) score greater than equal to (\>=) 3 upon entry in the OLE2 Period received BKZ 320 mg sc Q4W for the first 16 weeks, and then switched to BKZ 320 mg Q8W until OLE2 Period Week 48.
|
Cohort B: PSO BKZ Total
n=45 participants at risk
Participants with chronic plaque psoriasis (PSO) in Cohort B received BKZ 320 mg sc Q4W until Week 16 and 320 mg Q8W thereafter through Week 40. At Week 48, Cohort B participants with chronic plaque PSO continued BKZ 320 mg Q8W up to Week 144. If the participant's dosing interval had changed to BKZ 320 mg Q4W under Protocol Amendment 1.2, the participant's dosing interval changed to BKZ 320 mg Q8W at the next scheduled clinic visit after implementation of Protocol Amendment 3.2.
|
Cohort B: EP BKZ Total
n=11 participants at risk
Participants with erythrodermic psoriasis (EP) in Cohort B received BKZ 320 mg sc Q4W until Week 16. Based on IGA response, participants received either BKZ 320 mg sc Q4W or BKZ 320 mg sc Q8W up to Week 144.
|
Cohort B: GPP BKZ Total
n=10 participants at risk
Participants with generalized pustular psoriasis (GPP) in Cohort B received BKZ 320 mg sc Q4W until Week 16. Based on IGA response, participants received either BKZ 320 mg sc Q4W or BKZ 320 mg sc Q8W up to Week 144.
|
|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Leukopenia
|
0.08%
1/1217 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.22%
2/903 • Number of events 2 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
4.4%
2/45 • Number of events 3 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
10.0%
1/10 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Cardiac disorders
Cardiac failure chronic
|
0.08%
1/1217 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
9.1%
1/11 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Cardiac disorders
Cardiac hypertrophy
|
0.00%
0/1217 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
9.1%
1/11 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Ear and labyrinth disorders
Vertigo
|
0.41%
5/1217 • Number of events 5 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.78%
7/903 • Number of events 7 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
18.2%
2/11 • Number of events 2 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/1217 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
9.1%
1/11 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Eye disorders
Cataract
|
0.99%
12/1217 • Number of events 14 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.66%
6/903 • Number of events 6 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.88%
2/226 • Number of events 3 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
4.4%
2/45 • Number of events 2 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
10.0%
1/10 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Eye disorders
Conjunctivitis allergic
|
0.66%
8/1217 • Number of events 8 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.55%
5/903 • Number of events 5 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.44%
1/226 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
4.4%
2/45 • Number of events 2 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
9.1%
1/11 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
10.0%
1/10 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Eye disorders
Dry eye
|
0.33%
4/1217 • Number of events 4 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.44%
4/903 • Number of events 5 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
10.0%
1/10 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Eye disorders
Conjunctival haemorrhage
|
0.08%
1/1217 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
9.1%
1/11 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.0%
24/1217 • Number of events 27 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
2.1%
19/903 • Number of events 20 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.88%
2/226 • Number of events 2 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
15.6%
7/45 • Number of events 8 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
20.0%
2/10 • Number of events 2 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
1.2%
14/1217 • Number of events 15 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
1.9%
17/903 • Number of events 17 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.88%
2/226 • Number of events 2 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
4.9%
2/41 • Number of events 2 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
2.2%
1/45 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
10.0%
1/10 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Gastrointestinal disorders
Dental caries
|
1.2%
14/1217 • Number of events 14 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.78%
7/903 • Number of events 7 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.88%
2/226 • Number of events 3 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
2.4%
1/41 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
15.6%
7/45 • Number of events 8 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
10.0%
1/10 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.90%
11/1217 • Number of events 12 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.55%
5/903 • Number of events 5 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
2.2%
1/45 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
10.0%
1/10 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Gastrointestinal disorders
Nausea
|
0.90%
11/1217 • Number of events 13 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.44%
4/903 • Number of events 4 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.44%
1/226 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
10.0%
1/10 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.66%
8/1217 • Number of events 8 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.55%
5/903 • Number of events 7 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
2.2%
1/45 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
9.1%
1/11 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Gastrointestinal disorders
Constipation
|
0.49%
6/1217 • Number of events 6 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.44%
4/903 • Number of events 4 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.44%
1/226 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
6.7%
3/45 • Number of events 3 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Gastrointestinal disorders
Gastritis
|
0.41%
5/1217 • Number of events 5 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.55%
5/903 • Number of events 5 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.44%
1/226 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
9.1%
1/11 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.33%
4/1217 • Number of events 4 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.33%
3/903 • Number of events 3 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
10.0%
1/10 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.16%
2/1217 • Number of events 2 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.55%
5/903 • Number of events 5 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
10.0%
1/10 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Gastrointestinal disorders
Stomatitis
|
0.25%
3/1217 • Number of events 3 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.33%
3/903 • Number of events 3 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
6.7%
3/45 • Number of events 7 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
9.1%
1/11 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
10.0%
1/10 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Gastrointestinal disorders
Chronic gastritis
|
0.16%
2/1217 • Number of events 2 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.33%
3/903 • Number of events 3 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
4.4%
2/45 • Number of events 2 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
20.0%
2/10 • Number of events 2 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Gastrointestinal disorders
Glossitis
|
0.16%
2/1217 • Number of events 2 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.22%
2/903 • Number of events 2 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
6.7%
3/45 • Number of events 5 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Gastrointestinal disorders
Coating in mouth
|
0.00%
0/1217 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.11%
1/903 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
9.1%
1/11 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/1217 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
2.2%
1/45 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
10.0%
1/10 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
General disorders
Pyrexia
|
2.1%
25/1217 • Number of events 30 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.89%
8/903 • Number of events 9 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
1.3%
3/226 • Number of events 3 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
22.2%
10/45 • Number of events 11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
9.1%
1/11 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
30.0%
3/10 • Number of events 4 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
General disorders
Peripheral swelling
|
0.66%
8/1217 • Number of events 9 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.11%
1/903 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
2.0%
1/51 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
9.1%
1/11 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
General disorders
Oedema peripheral
|
0.41%
5/1217 • Number of events 5 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
1.8%
4/226 • Number of events 4 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
4.4%
2/45 • Number of events 2 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
9.1%
1/11 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
General disorders
Malaise
|
0.08%
1/1217 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.33%
3/903 • Number of events 3 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
9.1%
1/11 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.82%
10/1217 • Number of events 10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.44%
4/903 • Number of events 4 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.44%
1/226 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
9.1%
1/11 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.08%
1/1217 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
9.1%
1/11 • Number of events 2 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.00%
0/1217 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
10.0%
1/10 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Infections and infestations
Nasopharyngitis
|
12.5%
152/1217 • Number of events 223 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
19.3%
174/903 • Number of events 230 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
6.2%
14/226 • Number of events 15 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
2.0%
1/51 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
2.4%
1/41 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
42.2%
19/45 • Number of events 25 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
63.6%
7/11 • Number of events 9 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
20.0%
2/10 • Number of events 2 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Infections and infestations
Oral candidiasis
|
10.4%
127/1217 • Number of events 238 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
16.1%
145/903 • Number of events 234 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
5.8%
13/226 • Number of events 18 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
5.9%
3/51 • Number of events 5 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
14.6%
6/41 • Number of events 6 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
24.4%
11/45 • Number of events 18 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
36.4%
4/11 • Number of events 4 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
20.0%
2/10 • Number of events 2 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Infections and infestations
Corona virus infection
|
14.3%
174/1217 • Number of events 187 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
2.0%
18/903 • Number of events 18 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
15.0%
34/226 • Number of events 35 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
5.9%
3/51 • Number of events 3 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
19.5%
8/41 • Number of events 8 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Infections and infestations
Upper respiratory tract infection
|
8.0%
97/1217 • Number of events 127 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
8.2%
74/903 • Number of events 85 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
5.3%
12/226 • Number of events 14 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
2.0%
1/51 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
4.4%
2/45 • Number of events 2 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Infections and infestations
Urinary tract infection
|
4.8%
58/1217 • Number of events 79 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
5.4%
49/903 • Number of events 72 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
2.7%
6/226 • Number of events 8 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
3.9%
2/51 • Number of events 2 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
9.1%
1/11 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Infections and infestations
Folliculitis
|
2.0%
24/1217 • Number of events 30 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
3.9%
35/903 • Number of events 43 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.44%
1/226 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
2.0%
1/51 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
2.4%
1/41 • Number of events 2 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
15.6%
7/45 • Number of events 11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
9.1%
1/11 • Number of events 2 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
10.0%
1/10 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Infections and infestations
Pharyngitis
|
2.2%
27/1217 • Number of events 28 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
2.1%
19/903 • Number of events 22 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
2.4%
1/41 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
6.7%
3/45 • Number of events 3 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
10.0%
1/10 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Infections and infestations
Conjunctivitis
|
1.6%
20/1217 • Number of events 22 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
2.8%
25/903 • Number of events 30 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.44%
1/226 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
2.4%
1/41 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
2.2%
1/45 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
9.1%
1/11 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Infections and infestations
Otitis externa
|
1.4%
17/1217 • Number of events 19 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
1.4%
13/903 • Number of events 15 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.44%
1/226 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
2.0%
1/51 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
2.4%
1/41 • Number of events 3 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
11.1%
5/45 • Number of events 7 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
9.1%
1/11 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
10.0%
1/10 • Number of events 2 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Infections and infestations
Oral herpes
|
1.2%
15/1217 • Number of events 19 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
1.8%
16/903 • Number of events 18 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
2.0%
1/51 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
2.2%
1/45 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
9.1%
1/11 • Number of events 2 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
10.0%
1/10 • Number of events 3 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Infections and infestations
Angular cheilitis
|
1.2%
14/1217 • Number of events 15 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
1.6%
14/903 • Number of events 18 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
6.7%
3/45 • Number of events 3 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Infections and infestations
Tinea pedis
|
1.3%
16/1217 • Number of events 16 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
1.3%
12/903 • Number of events 13 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
11.1%
5/45 • Number of events 5 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
9.1%
1/11 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Infections and infestations
Influenza
|
0.99%
12/1217 • Number of events 13 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
1.00%
9/903 • Number of events 11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.44%
1/226 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
2.4%
1/41 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
8.9%
4/45 • Number of events 4 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
9.1%
1/11 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
10.0%
1/10 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Infections and infestations
Cellulitis
|
0.82%
10/1217 • Number of events 11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.78%
7/903 • Number of events 8 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
2.4%
1/41 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
4.4%
2/45 • Number of events 2 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
18.2%
2/11 • Number of events 2 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Infections and infestations
Cystitis
|
0.74%
9/1217 • Number of events 11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.44%
4/903 • Number of events 5 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.88%
2/226 • Number of events 2 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
4.4%
2/45 • Number of events 3 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
9.1%
1/11 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Infections and infestations
Skin bacterial infection
|
0.25%
3/1217 • Number of events 3 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.55%
5/903 • Number of events 5 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
2.2%
1/45 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
10.0%
1/10 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Infections and infestations
Erysipelas
|
0.25%
3/1217 • Number of events 4 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.44%
4/903 • Number of events 5 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.44%
1/226 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
10.0%
1/10 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Infections and infestations
Paronychia
|
0.41%
5/1217 • Number of events 7 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.22%
2/903 • Number of events 3 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.44%
1/226 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
2.4%
1/41 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
4.4%
2/45 • Number of events 3 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
9.1%
1/11 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Infections and infestations
Tinea cruris
|
0.41%
5/1217 • Number of events 5 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.11%
1/903 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
2.0%
1/51 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
2.2%
1/45 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
10.0%
1/10 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Infections and infestations
Genital candidiasis
|
0.08%
1/1217 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.11%
1/903 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
10.0%
1/10 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Infections and infestations
Wound infection staphylococcal
|
0.00%
0/1217 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
9.1%
1/11 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.82%
10/1217 • Number of events 10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.89%
8/903 • Number of events 8 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.88%
2/226 • Number of events 2 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
10.0%
1/10 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.74%
9/1217 • Number of events 12 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.55%
5/903 • Number of events 5 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.44%
1/226 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
6.7%
3/45 • Number of events 3 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
9.1%
1/11 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.58%
7/1217 • Number of events 7 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.66%
6/903 • Number of events 6 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
2.2%
1/45 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
9.1%
1/11 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.41%
5/1217 • Number of events 6 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.44%
4/903 • Number of events 4 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
6.7%
3/45 • Number of events 3 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Injury, poisoning and procedural complications
Bone contusion
|
0.16%
2/1217 • Number of events 2 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.22%
2/903 • Number of events 2 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
9.1%
1/11 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Injury, poisoning and procedural complications
Post-traumatic neck syndrome
|
0.00%
0/1217 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.22%
2/903 • Number of events 2 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
9.1%
1/11 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Injury, poisoning and procedural complications
Sternal fracture
|
0.16%
2/1217 • Number of events 2 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
9.1%
1/11 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Injury, poisoning and procedural complications
Eye injury
|
0.00%
0/1217 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
10.0%
1/10 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Investigations
Gamma-glutamyltransferase increased
|
1.6%
19/1217 • Number of events 23 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.66%
6/903 • Number of events 6 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
2.2%
1/45 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
10.0%
1/10 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Investigations
Hepatic enzyme increased
|
1.2%
15/1217 • Number of events 17 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.78%
7/903 • Number of events 7 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
2.2%
1/45 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
9.1%
1/11 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
10.0%
1/10 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Investigations
Aspartate aminotransferase increased
|
0.99%
12/1217 • Number of events 14 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.55%
5/903 • Number of events 6 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
4.4%
2/45 • Number of events 2 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
10.0%
1/10 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Investigations
Alanine aminotransferase increased
|
0.74%
9/1217 • Number of events 9 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.55%
5/903 • Number of events 5 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
2.2%
1/45 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
20.0%
2/10 • Number of events 2 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Investigations
White blood cell count decreased
|
0.16%
2/1217 • Number of events 3 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
9.1%
1/11 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
10.0%
1/10 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
1.1%
13/1217 • Number of events 14 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.89%
8/903 • Number of events 8 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.44%
1/226 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
6.7%
3/45 • Number of events 3 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
9.1%
1/11 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.90%
11/1217 • Number of events 11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
1.00%
9/903 • Number of events 9 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
2.2%
1/45 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
10.0%
1/10 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.99%
12/1217 • Number of events 12 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.66%
6/903 • Number of events 6 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
2.0%
1/51 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
2.2%
1/45 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
9.1%
1/11 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.58%
7/1217 • Number of events 7 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.44%
4/903 • Number of events 4 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
2.0%
1/51 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
2.4%
1/41 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
2.2%
1/45 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
10.0%
1/10 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.41%
5/1217 • Number of events 5 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.11%
1/903 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
4.4%
2/45 • Number of events 2 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
10.0%
1/10 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.9%
48/1217 • Number of events 55 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
2.1%
19/903 • Number of events 22 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
2.4%
1/41 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
8.9%
4/45 • Number of events 6 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
9.1%
1/11 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
10.0%
1/10 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.3%
28/1217 • Number of events 31 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
2.5%
23/903 • Number of events 24 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
1.3%
3/226 • Number of events 3 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
2.0%
1/51 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
4.4%
2/45 • Number of events 2 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
9.1%
1/11 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Musculoskeletal and connective tissue disorders
Psoriatic arthropathy
|
2.1%
26/1217 • Number of events 27 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.55%
5/903 • Number of events 5 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
2.2%
5/226 • Number of events 5 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
2.0%
1/51 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
2.4%
1/41 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
2.2%
1/45 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
9.1%
1/11 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.74%
9/1217 • Number of events 10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
1.00%
9/903 • Number of events 11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
2.2%
1/45 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
9.1%
1/11 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.41%
5/1217 • Number of events 7 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.78%
7/903 • Number of events 8 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
2.2%
1/45 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
9.1%
1/11 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.58%
7/1217 • Number of events 8 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.33%
3/903 • Number of events 3 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
9.1%
1/11 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.58%
7/1217 • Number of events 10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.22%
2/903 • Number of events 2 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
9.1%
1/11 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.16%
2/1217 • Number of events 2 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.22%
2/903 • Number of events 2 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
9.1%
1/11 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Musculoskeletal and connective tissue disorders
Plantar fasciitis
|
0.16%
2/1217 • Number of events 2 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.11%
1/903 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.44%
1/226 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
10.0%
1/10 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/1217 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
9.1%
1/11 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acrochordon
|
0.08%
1/1217 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.22%
2/903 • Number of events 2 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
2.2%
1/45 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
10.0%
1/10 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Nervous system disorders
Headache
|
4.5%
55/1217 • Number of events 61 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
2.2%
20/903 • Number of events 27 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
8.9%
4/45 • Number of events 4 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
9.1%
1/11 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/1217 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.44%
1/226 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
6.7%
3/45 • Number of events 3 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Renal and urinary disorders
Renal impairment
|
0.08%
1/1217 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
10.0%
1/10 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.2%
27/1217 • Number of events 30 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
2.3%
21/903 • Number of events 22 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
2.2%
5/226 • Number of events 5 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
2.2%
1/45 • Number of events 2 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
9.1%
1/11 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
1.3%
16/1217 • Number of events 16 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
1.7%
15/903 • Number of events 15 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
6.7%
3/45 • Number of events 3 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
9.1%
1/11 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
10.0%
1/10 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
1.1%
13/1217 • Number of events 13 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.55%
5/903 • Number of events 5 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.44%
1/226 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
2.4%
1/41 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
6.7%
3/45 • Number of events 3 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.08%
1/1217 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
2.2%
1/45 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
9.1%
1/11 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.08%
1/1217 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
10.0%
1/10 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
3.6%
44/1217 • Number of events 52 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
1.8%
16/903 • Number of events 18 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
1.3%
3/226 • Number of events 4 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
8.9%
4/45 • Number of events 4 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
10.0%
1/10 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
2.8%
34/1217 • Number of events 38 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
2.8%
25/903 • Number of events 32 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.88%
2/226 • Number of events 2 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
3.9%
2/51 • Number of events 2 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
9.8%
4/41 • Number of events 5 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
13.3%
6/45 • Number of events 9 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
10.0%
1/10 • Number of events 2 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
2.5%
30/1217 • Number of events 42 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
1.9%
17/903 • Number of events 21 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.44%
1/226 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
33.3%
15/45 • Number of events 28 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
27.3%
3/11 • Number of events 3 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
1.2%
15/1217 • Number of events 15 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
1.1%
10/903 • Number of events 11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.44%
1/226 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
2.4%
1/41 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
2.2%
1/45 • Number of events 3 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
9.1%
1/11 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
10.0%
1/10 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
1.1%
13/1217 • Number of events 13 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.66%
6/903 • Number of events 7 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
4.4%
2/45 • Number of events 2 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
10.0%
1/10 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Skin and subcutaneous tissue disorders
Eczema asteatotic
|
1.2%
14/1217 • Number of events 14 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.55%
5/903 • Number of events 5 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
11.1%
5/45 • Number of events 5 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
9.1%
1/11 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.74%
9/1217 • Number of events 9 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
1.00%
9/903 • Number of events 9 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
4.4%
2/45 • Number of events 2 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
20.0%
2/10 • Number of events 3 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.25%
3/1217 • Number of events 3 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.66%
6/903 • Number of events 7 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.44%
1/226 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
2.2%
1/45 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
10.0%
1/10 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.49%
6/1217 • Number of events 7 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.33%
3/903 • Number of events 3 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.44%
1/226 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
10.0%
1/10 • Number of events 2 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Skin and subcutaneous tissue disorders
Dyshidrotic eczema
|
0.49%
6/1217 • Number of events 7 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.22%
2/903 • Number of events 2 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.88%
2/226 • Number of events 2 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
2.2%
1/45 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
10.0%
1/10 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.41%
5/1217 • Number of events 5 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.22%
2/903 • Number of events 2 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
2.0%
1/51 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
2.2%
1/45 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
9.1%
1/11 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
10.0%
1/10 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
0.08%
1/1217 • Number of events 2 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.33%
3/903 • Number of events 3 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.44%
1/226 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
6.7%
3/45 • Number of events 3 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
10.0%
1/10 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Skin and subcutaneous tissue disorders
Pustular psoriasis
|
0.08%
1/1217 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.11%
1/903 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
10.0%
1/10 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/1217 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.11%
1/903 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
2.4%
1/41 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
9.1%
1/11 • Number of events 3 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Skin and subcutaneous tissue disorders
Erythrodermic psoriasis
|
0.00%
0/1217 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
18.2%
2/11 • Number of events 2 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/10 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Skin and subcutaneous tissue disorders
Milia
|
0.00%
0/1217 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/903 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/226 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/41 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/45 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/11 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
10.0%
1/10 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
|
Vascular disorders
Hypertension
|
4.5%
55/1217 • Number of events 55 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
3.7%
33/903 • Number of events 34 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.44%
1/226 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
0.00%
0/51 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
2.4%
1/41 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
4.4%
2/45 • Number of events 2 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
9.1%
1/11 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
10.0%
1/10 • Number of events 1 • From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60