Trial Outcomes & Findings for Zilebesiran as Add-on Therapy in Patients With Hypertension Not Adequately Controlled by a Standard of Care Antihypertensive Medication (KARDIA-2) (NCT NCT05103332)
NCT ID: NCT05103332
Last Updated: 2025-11-03
Results Overview
24-hour ABPM device was programmed to take readings every 20 minutes during day (6 am- 9:59 pm) and every 30 minutes during night (10 pm-5:59 am). ABPM was considered adequate if: 1. the number of successful daytime readings were ≥33; 2. the number of successful nighttime readings were ≥11; 3. no more than 3 hours are not represented (i.e.,3 sections of 60 minutes where 0 valid readings were obtained). To summarize 24-hour ABPM, the hourly adjusted mean was calculated. Hourly adjusted mean was the average BP for each hour of the day. The 24-hour mean was the average of the hourly means. Least squares (LS) mean and standard error (SE) were calculated using a mixed model repeated measures (MMRM) approach. Hypothetical strategy was used for the intercurrent event of using antihypertensive escape medication, i.e., data for SBP assessed using ABPM, while participants were on and within 2 weeks after stopping any escape medication were censored for this endpoint.
COMPLETED
PHASE2
663 participants
Baseline and Month 3
2025-11-03
Participant Flow
A total of 78 clinical sites in North America (66=United States \[US\] \& 12=Canada) \& 24 clinical sites in Europe (10=United Kingdom \[UK\]) enrolled participants in this study. 663 participants who met eligibility criteria after run-in with protocol-assigned background medication (indapamide, amlodipine, olmesartan) were randomized to zilebesiran or placebo in double-blind (DB) period, with the option to receive zilebesiran in open-label extension period (OLE). 1 month=28 days for this study.
Before Protocol Amendment 3 (PA3), participants completing DB period could join a separate zilebesiran OLE study. Those completing DB before OLE study availability entered OLE period in this study to receive zilebesiran until transition. Others ineligible for OLE study/discontinued drug in DB could enter safety follow-up(SFU). With PA3, OLE period was closed \& plans for OLE study canceled. Ongoing DB participants entered SFU at completion; those in OLE stopped treatment \& transitioned to SFU.
Participant milestones
| Measure |
DB Period: Placebo (Add-on to Indapamide)
Participants were randomized to receive placebo matched to zilebesiran, as a subcutaneous (SC) injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to indapamide. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant's protocol-specified background antihypertensive medication per Investigator judgement.
|
DB Period: Zilebesiran (Add-on to Indapamide)
Participants were randomized to receive zilebesiran, 600 milligrams (mg), as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to indapamide. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant's protocol-specified background antihypertensive medication per Investigator judgement.
|
DB Period: Placebo (Add-on to Amlodipine)
Participants were randomized to receive placebo matched to zilebesiran, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to amlodipine. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant's protocol-specified background antihypertensive medication per Investigator judgement.
|
DB Period: Zilebesiran (Add-on to Amlodipine)
Participants were randomized to receive zilebesiran, 600 mg, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to amlodipine. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant's protocol-specified background antihypertensive medication per Investigator judgement.
|
DB Period: Placebo (Add-on to Olmesartan)
Participants were randomized to receive placebo matched to zilebesiran, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to olmesartan. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant's protocol-specified background antihypertensive medication per Investigator judgement.
|
DB Period: Zilebesiran (Add-on to Olmesartan)
Participants were randomized to receive zilebesiran, 600 mg, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to olmesartan. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant's protocol-specified background antihypertensive medication per Investigator judgement.
|
DB (Zilebesiran) to SFU or OLE (Zilebesiran) to SFU [Indapamide Cohort]
Prior to Amendment 3, participants who did not enter OLE period or who discontinued treatment (zilebesiran) during DB period entered SFU period.
Upon implementation of Amendment 3, participants who completed the DB period entered the SFU period directly, and those already in OLE period did not receive any additional study drug in OLE and transitioned to the SFU period.
|
DB (Placebo) to SFU or OLE (Zilebesiran) to SFU [Indapamide Cohort]
Prior to Amendment 3, participants who did not enter OLE period or who discontinued treatment (placebo) during DB period entered SFU period.
Upon implementation of Amendment 3, participants who completed the DB period entered the SFU period directly, and those already in OLE period did not receive any additional study drug in OLE and transitioned to the SFU period.
|
DB Period (Placebo) to OLE Period (Zilebesiran) [Indapamide Cohort]
Prior to Amendment 3, participants who completed the DB period before a separate OLE study was available, entered the OLE period of this study and received treatment with zilebesiran 600 mg SC q6M. Protocol-specified background antihypertensive treatment with indapamide was discontinued at the start of OLE period.
|
DB Period (Zilebesiran) to OLE Period (Zilebesiran) [Indapamide Cohort]
Prior to Amendment 3, participants who completed the DB period before a separate OLE study was available, entered the OLE period of this study and continued treatment with zilebesiran 600 mg SC q6M. Protocol-specified background antihypertensive treatment with indapamide was discontinued at the start of OLE period.
|
DB Period (Placebo) to OLE Period (Zilebesiran) [Amlodipine Cohort]
Prior to Amendment 3, participants who completed the DB period before a separate OLE study was available, entered the OLE period of this study and received treatment with zilebesiran 600 mg SC q6M. Protocol-specified background antihypertensive treatment with amlodipine was discontinued at the start of OLE period.
|
DB Period (Zilebesiran) to OLE Period (Zilebesiran) [Amlodipine Cohort]
Prior to Amendment 3, participants who completed the DB period before a separate OLE study was available, entered the OLE period of this study and continued treatment with zilebesiran 600 mg SC q6M. Protocol-specified background antihypertensive treatment with amlodipine was discontinued at the start of OLE period.
|
DB Period (Placebo) to OLE Period (Zilebesiran) [Olmesartan Cohort]
Prior to Amendment 3, participants who completed the DB period before a separate OLE study was available, entered the OLE period of this study and received treatment with zilebesiran 600 mg SC q6M. Protocol-specified background antihypertensive treatment with olmesartan was discontinued at the start of OLE period.
|
DB Period (Zilebesiran) to OLE Period (Zilebesiran) [Olmesartan Cohort]
Prior to Amendment 3, participants who completed the DB period before a separate OLE study was available, entered the OLE period of this study and continued treatment with zilebesiran 600 mg SC q6M. Protocol-specified background antihypertensive treatment with olmesartan was discontinued at the start of OLE period.
|
DB (Placebo) to SFU or OLE (Zilebesiran) to SFU [Amlodipine Cohort]
Prior to Amendment 3, participants who did not enter OLE period or who discontinued treatment (placebo) during DB period entered SFU period.
Upon implementation of Amendment 3, participants who completed the DB period entered the SFU period directly, and those already in OLE period did not receive any additional study drug in OLE and transitioned to the SFU period.
|
DB (Zilebesiran) to SFU or OLE (Zilebesiran) to SFU [Amlodipine Cohort]
Prior to Amendment 3, participants who did not enter OLE period or who discontinued treatment (zilebesiran) during DB period entered SFU period.
Upon implementation of Amendment 3, participants who completed the DB period entered the SFU period directly, and those already in OLE period did not receive any additional study drug in OLE and transitioned to the SFU period.
|
DB (Placebo) to SFU or OLE (Zilebesiran) to SFU [Olmesartan Cohort]
Prior to Amendment 3, participants who did not enter OLE period or who discontinued treatment (placebo) during DB period entered SFU period.
Upon implementation of Amendment 3, participants who completed the DB period entered the SFU period directly, and those already in OLE period did not receive any additional study drug in OLE and transitioned to the SFU period.
|
DB (Zilebesiran) to SFU or OLE (Zilebesiran) to SFU [Olmesartan Cohort]
Prior to Amendment 3, participants who did not enter OLE period or who discontinued treatment (zilebesiran) during DB period entered SFU period.
Upon implementation of Amendment 3, participants who completed the DB period entered the SFU period directly, and those already in OLE period did not receive any additional study drug in OLE and transitioned to the SFU period.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
DB Period (6 Months=168 Days)
NOT COMPLETED
|
2
|
6
|
6
|
5
|
3
|
8
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
DB Period (6 Months=168 Days)
Modified Full Analysis Set (mFAS)
|
64
|
63
|
120
|
118
|
146
|
147
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
DB Period (6 Months=168 Days)
Modified Safety Analysis Set (mSAS)
|
64
|
63
|
120
|
118
|
145
|
148
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
DB Period (6 Months=168 Days)
STARTED
|
65
|
65
|
120
|
120
|
146
|
147
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
OLE Period (24 Months=672 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
1
|
1
|
2
|
3
|
4
|
0
|
0
|
0
|
0
|
|
OLE Period (24 Months=672 Days)
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
26
|
30
|
48
|
44
|
66
|
60
|
0
|
0
|
0
|
0
|
|
OLE Period (24 Months=672 Days)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
23
|
29
|
47
|
42
|
63
|
56
|
0
|
0
|
0
|
0
|
|
DB Period (6 Months=168 Days)
COMPLETED
|
63
|
59
|
114
|
115
|
143
|
139
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
SFU Period (6 Months=168 Days)
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
59
|
63
|
0
|
0
|
0
|
0
|
0
|
0
|
114
|
115
|
143
|
139
|
|
SFU Period (6 Months=168 Days)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
55
|
57
|
0
|
0
|
0
|
0
|
0
|
0
|
106
|
104
|
133
|
126
|
|
SFU Period (6 Months=168 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
4
|
6
|
0
|
0
|
0
|
0
|
0
|
0
|
8
|
11
|
10
|
13
|
Reasons for withdrawal
| Measure |
DB Period: Placebo (Add-on to Indapamide)
Participants were randomized to receive placebo matched to zilebesiran, as a subcutaneous (SC) injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to indapamide. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant's protocol-specified background antihypertensive medication per Investigator judgement.
|
DB Period: Zilebesiran (Add-on to Indapamide)
Participants were randomized to receive zilebesiran, 600 milligrams (mg), as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to indapamide. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant's protocol-specified background antihypertensive medication per Investigator judgement.
|
DB Period: Placebo (Add-on to Amlodipine)
Participants were randomized to receive placebo matched to zilebesiran, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to amlodipine. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant's protocol-specified background antihypertensive medication per Investigator judgement.
|
DB Period: Zilebesiran (Add-on to Amlodipine)
Participants were randomized to receive zilebesiran, 600 mg, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to amlodipine. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant's protocol-specified background antihypertensive medication per Investigator judgement.
|
DB Period: Placebo (Add-on to Olmesartan)
Participants were randomized to receive placebo matched to zilebesiran, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to olmesartan. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant's protocol-specified background antihypertensive medication per Investigator judgement.
|
DB Period: Zilebesiran (Add-on to Olmesartan)
Participants were randomized to receive zilebesiran, 600 mg, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to olmesartan. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant's protocol-specified background antihypertensive medication per Investigator judgement.
|
DB (Zilebesiran) to SFU or OLE (Zilebesiran) to SFU [Indapamide Cohort]
Prior to Amendment 3, participants who did not enter OLE period or who discontinued treatment (zilebesiran) during DB period entered SFU period.
Upon implementation of Amendment 3, participants who completed the DB period entered the SFU period directly, and those already in OLE period did not receive any additional study drug in OLE and transitioned to the SFU period.
|
DB (Placebo) to SFU or OLE (Zilebesiran) to SFU [Indapamide Cohort]
Prior to Amendment 3, participants who did not enter OLE period or who discontinued treatment (placebo) during DB period entered SFU period.
Upon implementation of Amendment 3, participants who completed the DB period entered the SFU period directly, and those already in OLE period did not receive any additional study drug in OLE and transitioned to the SFU period.
|
DB Period (Placebo) to OLE Period (Zilebesiran) [Indapamide Cohort]
Prior to Amendment 3, participants who completed the DB period before a separate OLE study was available, entered the OLE period of this study and received treatment with zilebesiran 600 mg SC q6M. Protocol-specified background antihypertensive treatment with indapamide was discontinued at the start of OLE period.
|
DB Period (Zilebesiran) to OLE Period (Zilebesiran) [Indapamide Cohort]
Prior to Amendment 3, participants who completed the DB period before a separate OLE study was available, entered the OLE period of this study and continued treatment with zilebesiran 600 mg SC q6M. Protocol-specified background antihypertensive treatment with indapamide was discontinued at the start of OLE period.
|
DB Period (Placebo) to OLE Period (Zilebesiran) [Amlodipine Cohort]
Prior to Amendment 3, participants who completed the DB period before a separate OLE study was available, entered the OLE period of this study and received treatment with zilebesiran 600 mg SC q6M. Protocol-specified background antihypertensive treatment with amlodipine was discontinued at the start of OLE period.
|
DB Period (Zilebesiran) to OLE Period (Zilebesiran) [Amlodipine Cohort]
Prior to Amendment 3, participants who completed the DB period before a separate OLE study was available, entered the OLE period of this study and continued treatment with zilebesiran 600 mg SC q6M. Protocol-specified background antihypertensive treatment with amlodipine was discontinued at the start of OLE period.
|
DB Period (Placebo) to OLE Period (Zilebesiran) [Olmesartan Cohort]
Prior to Amendment 3, participants who completed the DB period before a separate OLE study was available, entered the OLE period of this study and received treatment with zilebesiran 600 mg SC q6M. Protocol-specified background antihypertensive treatment with olmesartan was discontinued at the start of OLE period.
|
DB Period (Zilebesiran) to OLE Period (Zilebesiran) [Olmesartan Cohort]
Prior to Amendment 3, participants who completed the DB period before a separate OLE study was available, entered the OLE period of this study and continued treatment with zilebesiran 600 mg SC q6M. Protocol-specified background antihypertensive treatment with olmesartan was discontinued at the start of OLE period.
|
DB (Placebo) to SFU or OLE (Zilebesiran) to SFU [Amlodipine Cohort]
Prior to Amendment 3, participants who did not enter OLE period or who discontinued treatment (placebo) during DB period entered SFU period.
Upon implementation of Amendment 3, participants who completed the DB period entered the SFU period directly, and those already in OLE period did not receive any additional study drug in OLE and transitioned to the SFU period.
|
DB (Zilebesiran) to SFU or OLE (Zilebesiran) to SFU [Amlodipine Cohort]
Prior to Amendment 3, participants who did not enter OLE period or who discontinued treatment (zilebesiran) during DB period entered SFU period.
Upon implementation of Amendment 3, participants who completed the DB period entered the SFU period directly, and those already in OLE period did not receive any additional study drug in OLE and transitioned to the SFU period.
|
DB (Placebo) to SFU or OLE (Zilebesiran) to SFU [Olmesartan Cohort]
Prior to Amendment 3, participants who did not enter OLE period or who discontinued treatment (placebo) during DB period entered SFU period.
Upon implementation of Amendment 3, participants who completed the DB period entered the SFU period directly, and those already in OLE period did not receive any additional study drug in OLE and transitioned to the SFU period.
|
DB (Zilebesiran) to SFU or OLE (Zilebesiran) to SFU [Olmesartan Cohort]
Prior to Amendment 3, participants who did not enter OLE period or who discontinued treatment (zilebesiran) during DB period entered SFU period.
Upon implementation of Amendment 3, participants who completed the DB period entered the SFU period directly, and those already in OLE period did not receive any additional study drug in OLE and transitioned to the SFU period.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
DB Period (6 Months=168 Days)
Participant Stopped Participation in the Study
|
2
|
3
|
5
|
3
|
3
|
6
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
DB Period (6 Months=168 Days)
Lost to Follow-up
|
0
|
2
|
1
|
0
|
0
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
DB Period (6 Months=168 Days)
Physician Decision
|
0
|
1
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
DB Period (6 Months=168 Days)
Other
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
OLE Period (24 Months=672 Days)
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
OLE Period (24 Months=672 Days)
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
OLE Period (24 Months=672 Days)
Reason Not Specified
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
1
|
0
|
2
|
2
|
3
|
0
|
0
|
0
|
0
|
|
SFU Period (6 Months=168 Days)
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
5
|
3
|
4
|
4
|
|
OLE Period (24 Months=672 Days)
Physician Decision
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
SFU Period (6 Months=168 Days)
Physician Decision
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
SFU Period (6 Months=168 Days)
Reason Not Specified
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
2
|
|
SFU Period (6 Months=168 Days)
Participant Stopped Participation in the Study
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
4
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
7
|
6
|
5
|
|
SFU Period (6 Months=168 Days)
Death
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
1
|
Baseline Characteristics
Zilebesiran as Add-on Therapy in Patients With Hypertension Not Adequately Controlled by a Standard of Care Antihypertensive Medication (KARDIA-2)
Baseline characteristics by cohort
| Measure |
DB Period: Zilebesiran (Add-on to Indapamide)
n=63 Participants
Participants were randomized to receive zilebesiran, 600 milligrams (mg), as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to indapamide. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant's protocol-specified background antihypertensive medication per Investigator judgement.
|
DB Period: Placebo (Add-on to Indapamide)
n=64 Participants
Participants were randomized to receive placebo matched to zilebesiran, as a subcutaneous (SC) injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to indapamide. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant's protocol-specified background antihypertensive medication per Investigator judgement.
|
DB Period: Placebo (Add-on to Amlodipine)
n=120 Participants
Participants were randomized to receive placebo matched to zilebesiran, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to amlodipine. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant's protocol-specified background antihypertensive medication per Investigator judgement.
|
DB Period: Zilebesiran (Add-on to Amlodipine)
n=118 Participants
Participants were randomized to receive zilebesiran, 600 mg, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to amlodipine. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant's protocol-specified background antihypertensive medication per Investigator judgement.
|
DB Period: Placebo (Add-on to Olmesartan)
n=146 Participants
Participants were randomized to receive placebo matched to zilebesiran, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to olmesartan. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant's protocol-specified background antihypertensive medication per Investigator judgement.
|
DB Period: Zilebesiran (Add-on to Olmesartan)
n=147 Participants
Participants were randomized to receive zilebesiran, 600 mg, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to olmesartan. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant's protocol-specified background antihypertensive medication per Investigator judgement.
|
Total
n=658 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
57.9 years
STANDARD_DEVIATION 10.7 • n=15 Participants
|
60.6 years
STANDARD_DEVIATION 10.2 • n=3 Participants
|
58.4 years
STANDARD_DEVIATION 9.8 • n=18 Participants
|
57.6 years
STANDARD_DEVIATION 10.2 • n=4 Participants
|
57.7 years
STANDARD_DEVIATION 10.6 • n=7 Participants
|
59.3 years
STANDARD_DEVIATION 10.4 • n=8 Participants
|
58.5 years
STANDARD_DEVIATION 10.3 • n=9 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=15 Participants
|
25 Participants
n=3 Participants
|
50 Participants
n=18 Participants
|
53 Participants
n=4 Participants
|
64 Participants
n=7 Participants
|
60 Participants
n=8 Participants
|
282 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=15 Participants
|
39 Participants
n=3 Participants
|
70 Participants
n=18 Participants
|
65 Participants
n=4 Participants
|
82 Participants
n=7 Participants
|
87 Participants
n=8 Participants
|
376 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
27 Participants
n=15 Participants
|
28 Participants
n=3 Participants
|
27 Participants
n=18 Participants
|
37 Participants
n=4 Participants
|
47 Participants
n=7 Participants
|
59 Participants
n=8 Participants
|
225 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
35 Participants
n=15 Participants
|
36 Participants
n=3 Participants
|
93 Participants
n=18 Participants
|
81 Participants
n=4 Participants
|
98 Participants
n=7 Participants
|
88 Participants
n=8 Participants
|
431 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=15 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=9 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=15 Participants
|
1 Participants
n=3 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=9 Participants
|
|
24-hour Mean Systolic Blood Pressure (SBP) Assessed by Ambulatory Blood Pressure Monitoring (ABPM)
|
143.4 millimeter of mercury (mmHg)
STANDARD_DEVIATION 8.5 • n=15 Participants
|
143.2 millimeter of mercury (mmHg)
STANDARD_DEVIATION 8.4 • n=3 Participants
|
142.6 millimeter of mercury (mmHg)
STANDARD_DEVIATION 8.2 • n=18 Participants
|
143.3 millimeter of mercury (mmHg)
STANDARD_DEVIATION 7.8 • n=4 Participants
|
144.2 millimeter of mercury (mmHg)
STANDARD_DEVIATION 8.3 • n=7 Participants
|
143.6 millimeter of mercury (mmHg)
STANDARD_DEVIATION 8.2 • n=8 Participants
|
143.4 millimeter of mercury (mmHg)
STANDARD_DEVIATION 8.2 • n=9 Participants
|
|
Race/Ethnicity, Customized
Asian
|
4 Participants
n=15 Participants
|
0 Participants
n=3 Participants
|
4 Participants
n=18 Participants
|
8 Participants
n=4 Participants
|
13 Participants
n=7 Participants
|
3 Participants
n=8 Participants
|
32 Participants
n=9 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
16 Participants
n=15 Participants
|
14 Participants
n=3 Participants
|
41 Participants
n=18 Participants
|
39 Participants
n=4 Participants
|
39 Participants
n=7 Participants
|
38 Participants
n=8 Participants
|
187 Participants
n=9 Participants
|
|
Race/Ethnicity, Customized
White
|
41 Participants
n=15 Participants
|
48 Participants
n=3 Participants
|
74 Participants
n=18 Participants
|
71 Participants
n=4 Participants
|
93 Participants
n=7 Participants
|
106 Participants
n=8 Participants
|
433 Participants
n=9 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=15 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=9 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
0 Participants
n=15 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=9 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
0 Participants
n=15 Participants
|
1 Participants
n=3 Participants
|
1 Participants
n=18 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=9 Participants
|
PRIMARY outcome
Timeframe: Baseline and Month 3Population: The mFAS included all randomized participants who received any amount of study drug. Analysis was grouped according to the randomized treatment arm. Overall number analyzed is the number of participants with data available for analysis at Month 3.
24-hour ABPM device was programmed to take readings every 20 minutes during day (6 am- 9:59 pm) and every 30 minutes during night (10 pm-5:59 am). ABPM was considered adequate if: 1. the number of successful daytime readings were ≥33; 2. the number of successful nighttime readings were ≥11; 3. no more than 3 hours are not represented (i.e.,3 sections of 60 minutes where 0 valid readings were obtained). To summarize 24-hour ABPM, the hourly adjusted mean was calculated. Hourly adjusted mean was the average BP for each hour of the day. The 24-hour mean was the average of the hourly means. Least squares (LS) mean and standard error (SE) were calculated using a mixed model repeated measures (MMRM) approach. Hypothetical strategy was used for the intercurrent event of using antihypertensive escape medication, i.e., data for SBP assessed using ABPM, while participants were on and within 2 weeks after stopping any escape medication were censored for this endpoint.
Outcome measures
| Measure |
DB Period: Zilebesiran (Add-on to Indapamide)
n=53 Participants
Participants were randomized to receive zilebesiran, 600 milligrams (mg), as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to indapamide. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant's protocol-specified background antihypertensive medication per Investigator judgement.
|
DB Period: Placebo (Add-on to Amlodipine)
n=56 Participants
Participants were randomized to receive placebo matched to zilebesiran, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to amlodipine. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant's protocol-specified background antihypertensive medication per Investigator judgement.
|
|---|---|---|
|
Indapamide: Change From Baseline at Month 3 in 24-hour Mean SBP Assessed by ABPM - Censored Data
|
-15.7 mmHg
Standard Error 1.60
|
-3.7 mmHg
Standard Error 1.56
|
PRIMARY outcome
Timeframe: Baseline and Month 3Population: The mFAS included all randomized participants who received any amount of study drug. Analysis was grouped according to the randomized treatment arm. Overall number analyzed is the number of participants with data available for analysis at Month 3.
24-hour ABPM device was programmed to take readings every 20 minutes during day (6 am- 9:59 pm) and every 30 minutes during night (10 pm-5:59 am). ABPM was considered adequate if: 1. the number of successful daytime readings were ≥33; 2. the number of successful nighttime readings were ≥11; 3. no more than 3 hours are not represented (i.e.,3 sections of 60 minutes where 0 valid readings were obtained). To summarize 24-hour ABPM, the hourly adjusted mean was calculated. Hourly adjusted mean was the average BP for each hour of the day. The 24-hour mean was the average of the hourly means. LS mean and SE were calculated using a MMRM approach. Hypothetical strategy was used for the intercurrent event of using antihypertensive escape medication, i.e., data for SBP assessed using ABPM, while participants were on and within 2 weeks after stopping any escape medication were censored for this endpoint.
Outcome measures
| Measure |
DB Period: Zilebesiran (Add-on to Indapamide)
n=99 Participants
Participants were randomized to receive zilebesiran, 600 milligrams (mg), as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to indapamide. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant's protocol-specified background antihypertensive medication per Investigator judgement.
|
DB Period: Placebo (Add-on to Amlodipine)
n=100 Participants
Participants were randomized to receive placebo matched to zilebesiran, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to amlodipine. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant's protocol-specified background antihypertensive medication per Investigator judgement.
|
|---|---|---|
|
Amlodipine: Change From Baseline at Month 3 in 24-hour Mean SBP Assessed by ABPM - Censored Data
|
-10.5 mmHg
Standard Error 1.15
|
-0.7 mmHg
Standard Error 1.14
|
PRIMARY outcome
Timeframe: Baseline and Month 3Population: The mFAS included all randomized participants who received any amount of study drug. Analysis was grouped according to the randomized treatment arm. Overall number analyzed is the number of participants with data available for analysis at Month 3.
24-hour ABPM device was programmed to take readings every 20 minutes during day (6 am- 9:59 pm) and every 30 minutes during night (10 pm-5:59 am). ABPM was considered adequate if: 1. the number of successful daytime readings were ≥33; 2. the number of successful nighttime readings were ≥11; 3. no more than 3 hours are not represented (i.e.,3 sections of 60 minutes where 0 valid readings were obtained). To summarize 24-hour ABPM, the hourly adjusted mean was calculated. Hourly adjusted mean was the average BP for each hour of the day. The 24-hour mean was average of the hourly means. LS mean and SE were calculated using a MMRM approach. Hypothetical strategy was used for the intercurrent event of using antihypertensive escape medication, i.e., data for SBP assessed using ABPM, while participants were on and within 2 weeks after stopping any escape medication were censored for this endpoint.
Outcome measures
| Measure |
DB Period: Zilebesiran (Add-on to Indapamide)
n=115 Participants
Participants were randomized to receive zilebesiran, 600 milligrams (mg), as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to indapamide. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant's protocol-specified background antihypertensive medication per Investigator judgement.
|
DB Period: Placebo (Add-on to Amlodipine)
n=114 Participants
Participants were randomized to receive placebo matched to zilebesiran, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to amlodipine. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant's protocol-specified background antihypertensive medication per Investigator judgement.
|
|---|---|---|
|
Olmesartan: Change From Baseline at Month 3 in 24-hour Mean SBP Assessed by ABPM - Censored Data
|
-7.7 mmHg
Standard Error 1.33
|
-3.2 mmHg
Standard Error 1.34
|
SECONDARY outcome
Timeframe: Baseline and Month 3Population: The mFAS included all randomized participants who received any amount of study drug. Analysis was grouped according to the randomized treatment arm. Overall number analyzed is the number of participants with data available for analysis at Month 3.
The mean office BP in the sitting position was used for the analysis. Office BP in the sitting position was collected with a set of 4 replicates. The average of the last 3 replicates was calculated and used for analysis. LS mean and SE were calculated using a MMRM approach. Hypothetical strategy was used for the intercurrent event of using antihypertensive escape medication, i.e., data for office SBP assessed while participants were on and within 2 weeks after stopping any escape medication were censored for this endpoint.
Outcome measures
| Measure |
DB Period: Zilebesiran (Add-on to Indapamide)
n=58 Participants
Participants were randomized to receive zilebesiran, 600 milligrams (mg), as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to indapamide. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant's protocol-specified background antihypertensive medication per Investigator judgement.
|
DB Period: Placebo (Add-on to Amlodipine)
n=55 Participants
Participants were randomized to receive placebo matched to zilebesiran, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to amlodipine. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant's protocol-specified background antihypertensive medication per Investigator judgement.
|
|---|---|---|
|
Indapamide: Change From Baseline at Month 3 in Office SBP - Censored Data
|
-19.3 mmHg
Standard Error 1.52
|
-0.8 mmHg
Standard Error 1.55
|
SECONDARY outcome
Timeframe: Baseline through Month 6Population: The mFAS included all randomized participants who received any amount of study drug. Analysis was grouped according to the randomized treatment arm. Overall number analyzed is the number of participants with data available for analysis at Month 6.
Time-adjusted change was defined as the area under the curve (AUC) of BP change from baseline divided by the duration of the time period. LS mean and SE were calculated using a MMRM approach. Treatment policy strategy was used for the intercurrent event of using antihypertensive escape medication, i.e., all collected data for SBP assessed by ABPM, were included in the analysis for this endpoint.
Outcome measures
| Measure |
DB Period: Zilebesiran (Add-on to Indapamide)
n=53 Participants
Participants were randomized to receive zilebesiran, 600 milligrams (mg), as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to indapamide. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant's protocol-specified background antihypertensive medication per Investigator judgement.
|
DB Period: Placebo (Add-on to Amlodipine)
n=57 Participants
Participants were randomized to receive placebo matched to zilebesiran, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to amlodipine. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant's protocol-specified background antihypertensive medication per Investigator judgement.
|
|---|---|---|
|
Indapamide: Time-adjusted Change From Baseline Through Month 6 in 24-hour Mean SBP, Assessed by ABPM - All Collected Data
|
-15.6 mmHg
Standard Error 1.35
|
-4.6 mmHg
Standard Error 1.30
|
SECONDARY outcome
Timeframe: Baseline through Month 6Population: The mFAS included all randomized participants who received any amount of study drug. Analysis was grouped according to the randomized treatment arm. Overall number analyzed is the number of participants with data available for analysis at Month 6.
Time-adjusted change was defined as the AUC of BP change from baseline divided by the duration of the time period. LS mean and SE were calculated using a MMRM approach. Treatment policy strategy was used for the intercurrent event of using antihypertensive escape medication, i.e., all collected data for office SBP were included in the analysis for this endpoint.
Outcome measures
| Measure |
DB Period: Zilebesiran (Add-on to Indapamide)
n=58 Participants
Participants were randomized to receive zilebesiran, 600 milligrams (mg), as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to indapamide. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant's protocol-specified background antihypertensive medication per Investigator judgement.
|
DB Period: Placebo (Add-on to Amlodipine)
n=60 Participants
Participants were randomized to receive placebo matched to zilebesiran, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to amlodipine. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant's protocol-specified background antihypertensive medication per Investigator judgement.
|
|---|---|---|
|
Indapamide: Time-adjusted Change From Baseline Through Month 6 in Office SBP - All Collected Data
|
-18.1 mmHg
Standard Error 1.18
|
-4.5 mmHg
Standard Error 1.16
|
SECONDARY outcome
Timeframe: Month 6Population: The mFAS included all randomized participants who received any amount of study drug. Analysis was grouped according to the randomized treatment arm. Overall number analyzed is the number of participants with data available for analysis at Month 6.
24-hour ABPM device was programmed to take readings every 20 minutes during the day (6 am to 9:59 pm) and every 30 minutes during the night (10 pm to 5:59 am). An ABPM was considered adequate if: 1. the number of successful daytime readings were ≥33; 2. the number of successful nighttime readings were ≥11; 3. no more than 3 hours are not represented (i.e., 3 sections of 60 minutes where 0 valid readings were obtained). To summarize the 24-hour ABPM, the hourly adjusted mean was calculated. Hourly adjusted mean was the average of BP for each hour of the day. The 24-hour mean was average of the hourly means.
Outcome measures
| Measure |
DB Period: Zilebesiran (Add-on to Indapamide)
n=53 Participants
Participants were randomized to receive zilebesiran, 600 milligrams (mg), as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to indapamide. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant's protocol-specified background antihypertensive medication per Investigator judgement.
|
DB Period: Placebo (Add-on to Amlodipine)
n=57 Participants
Participants were randomized to receive placebo matched to zilebesiran, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to amlodipine. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant's protocol-specified background antihypertensive medication per Investigator judgement.
|
|---|---|---|
|
Indapamide: Percentage of Participants With 24-hour Mean SBP <130 mmHg and/or Reduction From Baseline ≥20 mmHg Assessed by ABPM Without Escape Antihypertensive Medications at Month 6
|
64.2 percentage of participants
|
14.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Month 3Population: The mFAS included all randomized participants who received any amount of study drug. Analysis was grouped according to the randomized treatment arm. Overall number analyzed is the number of participants with data available for analysis at Month 3.
24-hour ABPM device was programmed to take readings every 20 minutes during the day (6 am to 9:59 pm) and every 30 minutes during the night (10 pm to 5:59 am). An ABPM was considered adequate if: 1. the number of successful daytime readings were ≥33; 2. the number of successful nighttime readings were ≥11; 3. no more than 3 hours are not represented (i.e., 3 sections of 60 minutes where 0 valid readings were obtained). To summarize the 24-hour ABPM, the hourly adjusted mean was calculated. Hourly adjusted mean was the average BP for each hour of the day. The 24-hour mean was average of the hourly means. LS mean and SE were calculated using a MMRM approach. Hypothetical strategy was used for the intercurrent event of using antihypertensive escape medication, i.e., data for DBP assessed using ABPM, while participants were on and within 2 weeks after stopping any escape medication were censored for this endpoint.
Outcome measures
| Measure |
DB Period: Zilebesiran (Add-on to Indapamide)
n=53 Participants
Participants were randomized to receive zilebesiran, 600 milligrams (mg), as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to indapamide. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant's protocol-specified background antihypertensive medication per Investigator judgement.
|
DB Period: Placebo (Add-on to Amlodipine)
n=56 Participants
Participants were randomized to receive placebo matched to zilebesiran, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to amlodipine. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant's protocol-specified background antihypertensive medication per Investigator judgement.
|
|---|---|---|
|
Indapamide: Change From Baseline at Month 3 in 24-hour Mean Diastolic Blood Pressure (DBP), Assessed by ABPM - Censored Data
|
-9.1 mmHg
Standard Error 0.89
|
-1.3 mmHg
Standard Error 0.87
|
SECONDARY outcome
Timeframe: Baseline and Month 3Population: The mFAS included all randomized participants who received any amount of study drug. Analysis was grouped according to the randomized treatment arm. Overall number analyzed is the number of participants with data available for analysis at Month 3.
The mean office BP in the sitting position was used for the analysis. Office BP in the sitting position was collected with a set of 4 replicates. The average of the last 3 replicates was calculated and used for analysis. LS mean and SE were calculated using a MMRM approach. Hypothetical strategy was used for the intercurrent event of using antihypertensive escape medication, i.e., data for office DBP assessed while participants were on and within 2 weeks after stopping any escape medication was censored for this endpoint.
Outcome measures
| Measure |
DB Period: Zilebesiran (Add-on to Indapamide)
n=58 Participants
Participants were randomized to receive zilebesiran, 600 milligrams (mg), as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to indapamide. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant's protocol-specified background antihypertensive medication per Investigator judgement.
|
DB Period: Placebo (Add-on to Amlodipine)
n=55 Participants
Participants were randomized to receive placebo matched to zilebesiran, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to amlodipine. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant's protocol-specified background antihypertensive medication per Investigator judgement.
|
|---|---|---|
|
Indapamide: Change From Baseline at Month 3 in Office DBP - Censored Data
|
-10.5 mmHg
Standard Error 1.01
|
-0.2 mmHg
Standard Error 1.03
|
SECONDARY outcome
Timeframe: Baseline through Month 3Population: The mFAS included all randomized participants who received any amount of study drug. Analysis was grouped according to the randomized treatment arm. Overall number analyzed is the number of participants with data available for analysis at Month 3.
Time-adjusted change was defined as the AUC of BP change from baseline divided by the duration of the time period. LS mean and SE were calculated using a MMRM approach. Hypothetical strategy was used for the intercurrent event of using antihypertensive escape medication, i.e., data for SBP and DBP, assessed using ABPM, while participants were on and within 2 weeks after stopping any escape medication were censored for this endpoint.
Outcome measures
| Measure |
DB Period: Zilebesiran (Add-on to Indapamide)
n=53 Participants
Participants were randomized to receive zilebesiran, 600 milligrams (mg), as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to indapamide. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant's protocol-specified background antihypertensive medication per Investigator judgement.
|
DB Period: Placebo (Add-on to Amlodipine)
n=56 Participants
Participants were randomized to receive placebo matched to zilebesiran, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to amlodipine. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant's protocol-specified background antihypertensive medication per Investigator judgement.
|
|---|---|---|
|
Indapamide: Time-adjusted Change From Baseline Through Month 3 in 24-hour Mean SBP and DBP, Assessed by ABPM - Censored Data
24-hour Mean SBP
|
-15.4 mmHg
Standard Error 1.26
|
-2.5 mmHg
Standard Error 1.22
|
|
Indapamide: Time-adjusted Change From Baseline Through Month 3 in 24-hour Mean SBP and DBP, Assessed by ABPM - Censored Data
24-hour Mean DBP
|
-8.7 mmHg
Standard Error 0.78
|
-0.9 mmHg
Standard Error 0.76
|
SECONDARY outcome
Timeframe: Baseline through Month 3Population: The mFAS included all randomized participants who received any amount of study drug. Analysis was grouped according to the randomized treatment arm. Overall number analyzed is the number of participants with data available for analysis at Month 3.
Time-adjusted change was defined as the AUC of BP change from baseline divided by the duration of the time period. LS mean and SE were calculated using a MMRM approach. Hypothetical strategy was used for the intercurrent event of using antihypertensive escape medication, i.e., data for office SBP and DBP, while participants were on and within 2 weeks after stopping any escape medication were censored for this endpoint.
Outcome measures
| Measure |
DB Period: Zilebesiran (Add-on to Indapamide)
n=58 Participants
Participants were randomized to receive zilebesiran, 600 milligrams (mg), as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to indapamide. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant's protocol-specified background antihypertensive medication per Investigator judgement.
|
DB Period: Placebo (Add-on to Amlodipine)
n=55 Participants
Participants were randomized to receive placebo matched to zilebesiran, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to amlodipine. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant's protocol-specified background antihypertensive medication per Investigator judgement.
|
|---|---|---|
|
Indapamide: Time-adjusted Change From Baseline in Office SBP and DBP Through Month 3 - Censored Data
Office SBP
|
-17.2 mmHg
Standard Error 1.34
|
-2.5 mmHg
Standard Error 1.35
|
|
Indapamide: Time-adjusted Change From Baseline in Office SBP and DBP Through Month 3 - Censored Data
Office DBP
|
-9.2 mmHg
Standard Error 0.77
|
-0.7 mmHg
Standard Error 0.78
|
SECONDARY outcome
Timeframe: Baseline and Month 6Population: The mFAS included all randomized participants who received any amount of study drug. Analysis was grouped according to the randomized treatment arm. Overall number analyzed is the number of participants with data available for analysis at Month 6.
24-hour ABPM device was programmed to take readings every 20 minutes during the day (6 am to 9:59 pm) and every 30 minutes during the night (10 pm to 5:59 am). An ABPM was considered adequate if: 1. the number of successful daytime readings were ≥33; 2. the number of successful nighttime readings were ≥11; 3. no more than 3 hours are not represented (i.e., 3 sections of 60 minutes where 0 valid readings were obtained). To summarize the 24-hour ABPM, the hourly adjusted mean was calculated. Hourly adjusted mean was the average BP for each hour of the day. The 24-hour mean was average of the hourly means. LS mean and SE were calculated using a MMRM approach. Treatment policy strategy was used for the intercurrent event of using antihypertensive escape medication, i.e., all collected data for SBP and DBP assessed by ABPM are included in the analysis for this endpoint.
Outcome measures
| Measure |
DB Period: Zilebesiran (Add-on to Indapamide)
n=53 Participants
Participants were randomized to receive zilebesiran, 600 milligrams (mg), as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to indapamide. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant's protocol-specified background antihypertensive medication per Investigator judgement.
|
DB Period: Placebo (Add-on to Amlodipine)
n=57 Participants
Participants were randomized to receive placebo matched to zilebesiran, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to amlodipine. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant's protocol-specified background antihypertensive medication per Investigator judgement.
|
|---|---|---|
|
Indapamide: Change From Baseline at Month 6 in 24-hour Mean SBP and DBP, Assessed by ABPM - All Collected Data
24-hour Mean SBP
|
-16.1 mmHg
Standard Error 1.74
|
-5.8 mmHg
Standard Error 1.68
|
|
Indapamide: Change From Baseline at Month 6 in 24-hour Mean SBP and DBP, Assessed by ABPM - All Collected Data
24-hour Mean DBP
|
-8.0 mmHg
Standard Error 1.11
|
-3.2 mmHg
Standard Error 1.07
|
SECONDARY outcome
Timeframe: Baseline and Month 6Population: The mFAS included all randomized participants who received any amount of study drug. Analysis was grouped according to the randomized treatment arm. Overall number analyzed is the number of participants with data available for analysis at Month 6.
The mean office BP in the sitting position was used for the analysis. Office BP in the sitting position was collected with a set of 4 replicates. The average of the last 3 replicates was calculated and used for analysis. LS mean and SE were calculated using a MMRM approach. Treatment policy strategy was used for the intercurrent event of using antihypertensive escape medication, i.e., all collected data for office SBP and DBP, were included in the analysis for this endpoint.
Outcome measures
| Measure |
DB Period: Zilebesiran (Add-on to Indapamide)
n=58 Participants
Participants were randomized to receive zilebesiran, 600 milligrams (mg), as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to indapamide. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant's protocol-specified background antihypertensive medication per Investigator judgement.
|
DB Period: Placebo (Add-on to Amlodipine)
n=60 Participants
Participants were randomized to receive placebo matched to zilebesiran, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to amlodipine. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant's protocol-specified background antihypertensive medication per Investigator judgement.
|
|---|---|---|
|
Indapamide: Change From Baseline at Month 6 in Office SBP and DBP - All Collected Data
Office DBP
|
-7.8 mmHg
Standard Error 1.15
|
-3.6 mmHg
Standard Error 1.13
|
|
Indapamide: Change From Baseline at Month 6 in Office SBP and DBP - All Collected Data
Office SBP
|
-15.5 mmHg
Standard Error 1.84
|
-7.2 mmHg
Standard Error 1.82
|
SECONDARY outcome
Timeframe: Baseline through Month 6Population: The mFAS included all randomized participants who received any amount of study drug. Analysis was grouped according to the randomized treatment arm. Overall number analyzed is the number of participants with data available for analysis at Month 6.
Time-adjusted change was defined as the AUC of BP change from baseline divided by the duration of the time period. LS mean and SE were calculated using a MMRM approach. Treatment policy strategy was used for the intercurrent event of using antihypertensive escape medication, i.e., all collected data for DBP assessed by ABPM were included in the analysis for this endpoint.
Outcome measures
| Measure |
DB Period: Zilebesiran (Add-on to Indapamide)
n=53 Participants
Participants were randomized to receive zilebesiran, 600 milligrams (mg), as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to indapamide. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant's protocol-specified background antihypertensive medication per Investigator judgement.
|
DB Period: Placebo (Add-on to Amlodipine)
n=57 Participants
Participants were randomized to receive placebo matched to zilebesiran, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to amlodipine. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant's protocol-specified background antihypertensive medication per Investigator judgement.
|
|---|---|---|
|
Indapamide: Time-adjusted Change From Baseline Through Month 6 in 24-hour Mean DBP, Assessed by ABPM - All Collected Data
|
-8.5 mmHg
Standard Error 0.80
|
-2.3 mmHg
Standard Error 0.77
|
SECONDARY outcome
Timeframe: Baseline through Month 6Population: The mFAS included all randomized participants who received any amount of study drug. Analysis was grouped according to the randomized treatment arm. Overall number analyzed is the number of participants with data available for analysis at Month 6.
Time-adjusted change was defined as the AUC of BP change from baseline divided by the duration of the time period. LS mean and SE were calculated using a MMRM approach. Treatment policy strategy was used for the intercurrent event of using antihypertensive escape medication, i.e., all collected data for office DBP were included in the analysis for this endpoint.
Outcome measures
| Measure |
DB Period: Zilebesiran (Add-on to Indapamide)
n=58 Participants
Participants were randomized to receive zilebesiran, 600 milligrams (mg), as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to indapamide. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant's protocol-specified background antihypertensive medication per Investigator judgement.
|
DB Period: Placebo (Add-on to Amlodipine)
n=60 Participants
Participants were randomized to receive placebo matched to zilebesiran, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to amlodipine. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant's protocol-specified background antihypertensive medication per Investigator judgement.
|
|---|---|---|
|
Indapamide: Time-adjusted Change From Baseline Through Month 6 in Office DBP - All Collected Data
|
-9.5 mmHg
Standard Error 0.67
|
-2.0 mmHg
Standard Error 0.67
|
SECONDARY outcome
Timeframe: Baseline, and Month 2, 3 and 6Population: The mFAS included all randomized participants who received any amount of study drug. Analysis was grouped according to the randomized treatment arm. Number analyzed are unique number of participants out of all the assessed participants who were evaluable for the specified category. Different participants may have contributed data for each category.
ABPM device was programmed to take readings every 20 minutes during the day (6 am to 9:59 pm) and every 30 minutes during the night (10 pm to 5:59 am). An ABPM was considered adequate if: 1. the number of successful daytime readings were ≥33; 2. the number of successful nighttime readings were ≥11; and 3. no more than 3 hours are not represented (i.e., 3 sections of 60 minutes where 0 valid readings were obtained). LS mean and SE were calculated using a MMRM approach. Treatment policy strategy was used for the intercurrent event of using antihypertensive escape medication, i.e., all collected data for daytime and nighttime SBP and DBP, assessed by ABPM, were included in the analysis for this endpoint.
Outcome measures
| Measure |
DB Period: Zilebesiran (Add-on to Indapamide)
n=63 Participants
Participants were randomized to receive zilebesiran, 600 milligrams (mg), as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to indapamide. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant's protocol-specified background antihypertensive medication per Investigator judgement.
|
DB Period: Placebo (Add-on to Amlodipine)
n=64 Participants
Participants were randomized to receive placebo matched to zilebesiran, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to amlodipine. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant's protocol-specified background antihypertensive medication per Investigator judgement.
|
|---|---|---|
|
Indapamide: Change From Baseline in Daytime and Nighttime SBP and DBP by ABPM at Each Visit - All Collected Data
Change in Daytime Mean SBP at Month 2
|
-15.9 mmHg
Standard Error 1.63
|
-1.8 mmHg
Standard Error 1.54
|
|
Indapamide: Change From Baseline in Daytime and Nighttime SBP and DBP by ABPM at Each Visit - All Collected Data
Change in Daytime Mean SBP at Month 3
|
-15.9 mmHg
Standard Error 1.68
|
-5.3 mmHg
Standard Error 1.59
|
|
Indapamide: Change From Baseline in Daytime and Nighttime SBP and DBP by ABPM at Each Visit - All Collected Data
Change in Daytime Mean SBP at Month 6
|
-16.4 mmHg
Standard Error 1.69
|
-6.5 mmHg
Standard Error 1.64
|
|
Indapamide: Change From Baseline in Daytime and Nighttime SBP and DBP by ABPM at Each Visit - All Collected Data
Change in Nighttime Mean SBP at Month 2
|
-13.5 mmHg
Standard Error 1.53
|
-0.5 mmHg
Standard Error 1.44
|
|
Indapamide: Change From Baseline in Daytime and Nighttime SBP and DBP by ABPM at Each Visit - All Collected Data
Change in Nighttime Mean SBP at Month 3
|
-14.2 mmHg
Standard Error 2.05
|
-2.9 mmHg
Standard Error 1.94
|
|
Indapamide: Change From Baseline in Daytime and Nighttime SBP and DBP by ABPM at Each Visit - All Collected Data
Change in Nighttime Mean SBP at Month 6
|
-15.2 mmHg
Standard Error 2.14
|
-4.3 mmHg
Standard Error 2.07
|
|
Indapamide: Change From Baseline in Daytime and Nighttime SBP and DBP by ABPM at Each Visit - All Collected Data
Change in Daytime Mean DBP at Month 2
|
-8.6 mmHg
Standard Error 1.01
|
-0.6 mmHg
Standard Error 0.95
|
|
Indapamide: Change From Baseline in Daytime and Nighttime SBP and DBP by ABPM at Each Visit - All Collected Data
Change in Daytime Mean DBP at Month 3
|
-8.7 mmHg
Standard Error 0.96
|
-2.6 mmHg
Standard Error 0.91
|
|
Indapamide: Change From Baseline in Daytime and Nighttime SBP and DBP by ABPM at Each Visit - All Collected Data
Change in Daytime Mean DBP at Month 6
|
-7.7 mmHg
Standard Error 1.13
|
-3.7 mmHg
Standard Error 1.09
|
|
Indapamide: Change From Baseline in Daytime and Nighttime SBP and DBP by ABPM at Each Visit - All Collected Data
Change in Nighttime Mean DBP at Month 2
|
-8.1 mmHg
Standard Error 1.10
|
-0.4 mmHg
Standard Error 1.03
|
|
Indapamide: Change From Baseline in Daytime and Nighttime SBP and DBP by ABPM at Each Visit - All Collected Data
Change in Nighttime Mean DBP at Month 3
|
-8.6 mmHg
Standard Error 1.18
|
-0.9 mmHg
Standard Error 1.12
|
|
Indapamide: Change From Baseline in Daytime and Nighttime SBP and DBP by ABPM at Each Visit - All Collected Data
Change in Nighttime Mean DBP at Month 6
|
-8.7 mmHg
Standard Error 1.28
|
-1.8 mmHg
Standard Error 1.24
|
SECONDARY outcome
Timeframe: Baseline, Week 2 and Months 1, 2, 3, 4, 5 and 6Population: Modified Pharmacodynamic (PD) Analysis Set included all participants who received at least 1 full dose of study drug. All by-treatment analyses based on the Modified PD Analysis Set were grouped according to the treatment actually received. Number analyzed are unique number of participants out of all the assessed participants who were evaluable for the specified category. Different participants may have contributed data for each category.
Outcome measures
| Measure |
DB Period: Zilebesiran (Add-on to Indapamide)
n=63 Participants
Participants were randomized to receive zilebesiran, 600 milligrams (mg), as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to indapamide. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant's protocol-specified background antihypertensive medication per Investigator judgement.
|
DB Period: Placebo (Add-on to Amlodipine)
n=64 Participants
Participants were randomized to receive placebo matched to zilebesiran, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to amlodipine. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant's protocol-specified background antihypertensive medication per Investigator judgement.
|
|---|---|---|
|
Indapamide: Percent Change From Baseline in Serum Angiotensinogen (AGT)
Percent Change from Baseline at Week 2
|
-91.99 percent change
Standard Deviation 17.89
|
6.37 percent change
Standard Deviation 29.27
|
|
Indapamide: Percent Change From Baseline in Serum Angiotensinogen (AGT)
Percent Change from Baseline at Month 1
|
-92.48 percent change
Standard Deviation 28.49
|
1.90 percent change
Standard Deviation 26.11
|
|
Indapamide: Percent Change From Baseline in Serum Angiotensinogen (AGT)
Percent Change from Baseline at Month 2
|
-95.50 percent change
Standard Deviation 15.91
|
4.34 percent change
Standard Deviation 32.24
|
|
Indapamide: Percent Change From Baseline in Serum Angiotensinogen (AGT)
Percent Change from Baseline at Month 3
|
-94.80 percent change
Standard Deviation 17.89
|
4.86 percent change
Standard Deviation 28.19
|
|
Indapamide: Percent Change From Baseline in Serum Angiotensinogen (AGT)
Percent Change from Baseline at Month 4
|
-92.28 percent change
Standard Deviation 21.64
|
1.81 percent change
Standard Deviation 30.86
|
|
Indapamide: Percent Change From Baseline in Serum Angiotensinogen (AGT)
Percent Change from Baseline at Month 5
|
-93.08 percent change
Standard Deviation 17.07
|
1.23 percent change
Standard Deviation 26.19
|
|
Indapamide: Percent Change From Baseline in Serum Angiotensinogen (AGT)
Percent Change from Baseline at Month 6
|
-91.92 percent change
Standard Deviation 16.23
|
4.81 percent change
Standard Deviation 26.12
|
SECONDARY outcome
Timeframe: Baseline and Month 3Population: The mFAS included all randomized participants who received any amount of study drug. Analysis was grouped according to the randomized treatment arm. Overall number analyzed is the number of participants with data available for analysis at Month 3.
The mean office BP in the sitting position was used for the analysis. Office BP in the sitting position was collected with a set of 4 replicates. The average of the last 3 replicates was calculated and used for analysis. LS mean and SE were calculated using a MMRM approach. Hypothetical strategy was used for the intercurrent event of using antihypertensive escape medication, i.e., data for office SBP assessed while participants were on and within 2 weeks after stopping any escape medication were censored for this endpoint.
Outcome measures
| Measure |
DB Period: Zilebesiran (Add-on to Indapamide)
n=112 Participants
Participants were randomized to receive zilebesiran, 600 milligrams (mg), as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to indapamide. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant's protocol-specified background antihypertensive medication per Investigator judgement.
|
DB Period: Placebo (Add-on to Amlodipine)
n=103 Participants
Participants were randomized to receive placebo matched to zilebesiran, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to amlodipine. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant's protocol-specified background antihypertensive medication per Investigator judgement.
|
|---|---|---|
|
Amlodipine: Change From Baseline at Month 3 in Office SBP - Censored Data
|
-11.5 mmHg
Standard Error 1.16
|
-1.4 mmHg
Standard Error 1.20
|
SECONDARY outcome
Timeframe: Baseline through Month 6Population: The mFAS included all randomized participants who received any amount of study drug. Analysis was grouped according to the randomized treatment arm. Overall number analyzed is the number of participants with data available for analysis at Month 6.
Time-adjusted change was defined as the AUC of BP change from baseline divided by the duration of the time period. LS mean and SE were calculated using a MMRM approach. Treatment policy strategy was used for the intercurrent event of using antihypertensive escape medication, i.e., all collected data for SBP assessed by ABPM, were included in the analysis for this endpoint.
Outcome measures
| Measure |
DB Period: Zilebesiran (Add-on to Indapamide)
n=103 Participants
Participants were randomized to receive zilebesiran, 600 milligrams (mg), as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to indapamide. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant's protocol-specified background antihypertensive medication per Investigator judgement.
|
DB Period: Placebo (Add-on to Amlodipine)
n=102 Participants
Participants were randomized to receive placebo matched to zilebesiran, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to amlodipine. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant's protocol-specified background antihypertensive medication per Investigator judgement.
|
|---|---|---|
|
Amlodipine: Time-adjusted Change From Baseline Through Month 6 in 24-hour Mean SBP, Assessed by ABPM - All Collected Data
|
-9.7 mmHg
Standard Deviation 0.97
|
-1.8 mmHg
Standard Deviation 0.95
|
SECONDARY outcome
Timeframe: Baseline through Month 6Population: The mFAS included all randomized participants who received any amount of study drug. Analysis was grouped according to the randomized treatment arm. Overall number analyzed is the number of participants with data available for analysis at Month 6.
Time-adjusted change was defined as the AUC of BP change from baseline divided by the duration of the time period. LS mean and SE were calculated using a MMRM approach. Treatment policy strategy was used for the intercurrent event of using antihypertensive escape medication, i.e., all collected data for office SBP were included in the analysis for this endpoint.
Outcome measures
| Measure |
DB Period: Zilebesiran (Add-on to Indapamide)
n=111 Participants
Participants were randomized to receive zilebesiran, 600 milligrams (mg), as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to indapamide. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant's protocol-specified background antihypertensive medication per Investigator judgement.
|
DB Period: Placebo (Add-on to Amlodipine)
n=113 Participants
Participants were randomized to receive placebo matched to zilebesiran, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to amlodipine. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant's protocol-specified background antihypertensive medication per Investigator judgement.
|
|---|---|---|
|
Amlodipine: Time-adjusted Change From Baseline Through Month 6 in Office SBP - All Collected Data
|
-11.5 mmHg
Standard Error 0.82
|
-2.9 mmHg
Standard Error 0.82
|
SECONDARY outcome
Timeframe: Month 6Population: The mFAS included all randomized participants who received any amount of study drug. Analysis was grouped according to the randomized treatment arm. Overall number analyzed is the number of participants with data available for analysis at Month 6.
24-hour ABPM device was programmed to take readings every 20 minutes during the day (6 am to 9:59 pm) and every 30 minutes during the night (10 pm to 5:59 am). An ABPM was considered adequate if: 1. the number of successful daytime readings were ≥33; 2. the number of successful nighttime readings were ≥11; 3. no more than 3 hours are not represented (i.e., 3 sections of 60 minutes where 0 valid readings were obtained). To summarize the 24-hour ABPM, the hourly adjusted mean was calculated. Hourly adjusted mean was the average of BP for each hour of the day. The 24-hour mean was average of the hourly means.
Outcome measures
| Measure |
DB Period: Zilebesiran (Add-on to Indapamide)
n=103 Participants
Participants were randomized to receive zilebesiran, 600 milligrams (mg), as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to indapamide. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant's protocol-specified background antihypertensive medication per Investigator judgement.
|
DB Period: Placebo (Add-on to Amlodipine)
n=102 Participants
Participants were randomized to receive placebo matched to zilebesiran, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to amlodipine. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant's protocol-specified background antihypertensive medication per Investigator judgement.
|
|---|---|---|
|
Amlodipine: Percentage of Participants With 24-hour Mean SBP <130 mmHg and/or Reduction From Baseline ≥20 mmHg Assessed by ABPM Without Escape Antihypertensive Medications at Month 6
|
39.8 percentage of participants
|
13.7 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Month 3Population: The mFAS included all randomized participants who received any amount of study drug. Analysis was grouped according to the randomized treatment arm. Overall number analyzed is the number of participants with data available for analysis at Month 3.
24-hour ABPM device was programmed to take readings every 20 minutes during the day (6 am to 9:59 pm) and every 30 minutes during the night (10 pm to 5:59 am). An ABPM was considered adequate if: 1. the number of successful daytime readings were ≥33; 2. the number of successful nighttime readings were ≥11; 3. no more than 3 hours are not represented (i.e., 3 sections of 60 minutes where 0 valid readings were obtained). To summarize the 24-hour ABPM, the hourly adjusted mean was calculated. Hourly adjusted mean was the average BP for each hour of the day. The 24-hour mean was average of the hourly means. LS mean and SE were calculated using a MMRM approach. Hypothetical strategy was used for the intercurrent event of using antihypertensive escape medication, i.e., data for DBP assessed using ABPM, while participants were on and within 2 weeks after stopping any escape medication were censored for this endpoint.
Outcome measures
| Measure |
DB Period: Zilebesiran (Add-on to Indapamide)
n=99 Participants
Participants were randomized to receive zilebesiran, 600 milligrams (mg), as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to indapamide. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant's protocol-specified background antihypertensive medication per Investigator judgement.
|
DB Period: Placebo (Add-on to Amlodipine)
n=100 Participants
Participants were randomized to receive placebo matched to zilebesiran, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to amlodipine. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant's protocol-specified background antihypertensive medication per Investigator judgement.
|
|---|---|---|
|
Amlodipine: Change From Baseline at Month 3 in 24-hour Mean DBP, Assessed by ABPM - Censored Data
|
-6.6 mmHg
Standard Error 0.64
|
-0.8 mmHg
Standard Error 0.63
|
SECONDARY outcome
Timeframe: Baseline and Month 3Population: The mFAS included all randomized participants who received any amount of study drug. Analysis was grouped according to the randomized treatment arm. Overall number analyzed is the number of participants with data available for analysis at Month 3.
The mean office BP in the sitting position was used for the analysis. Office BP in the sitting position was collected with a set of 4 replicates. The average of the last 3 replicates was calculated and used for analysis. LS mean and SE were calculated using a MMRM approach. Hypothetical strategy was used for the intercurrent event of using antihypertensive escape medication, i.e., data for office DBP assessed while participants were on and within 2 weeks after stopping any escape medication was censored for this endpoint.
Outcome measures
| Measure |
DB Period: Zilebesiran (Add-on to Indapamide)
n=112 Participants
Participants were randomized to receive zilebesiran, 600 milligrams (mg), as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to indapamide. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant's protocol-specified background antihypertensive medication per Investigator judgement.
|
DB Period: Placebo (Add-on to Amlodipine)
n=103 Participants
Participants were randomized to receive placebo matched to zilebesiran, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to amlodipine. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant's protocol-specified background antihypertensive medication per Investigator judgement.
|
|---|---|---|
|
Amlodipine: Change From Baseline at Month 3 in Office DBP - Censored Data
|
-6.2 mmHg
Standard Error 0.81
|
-1.2 mmHg
Standard Error 0.84
|
SECONDARY outcome
Timeframe: Baseline through Month 3Population: The mFAS included all randomized participants who received any amount of study drug. Analysis was grouped according to the randomized treatment arm. Overall number analyzed is the number of participants with data available for analysis at Month 3.
Time-adjusted change was defined as the AUC of BP change from baseline divided by the duration of the time period. LS mean and SE were calculated using a MMRM approach. Hypothetical strategy was used for the intercurrent event of using antihypertensive escape medication, i.e., data for SBP and DBP, assessed using ABPM, while participants were on and within 2 weeks after stopping any escape medication were censored for this endpoint.
Outcome measures
| Measure |
DB Period: Zilebesiran (Add-on to Indapamide)
n=99 Participants
Participants were randomized to receive zilebesiran, 600 milligrams (mg), as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to indapamide. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant's protocol-specified background antihypertensive medication per Investigator judgement.
|
DB Period: Placebo (Add-on to Amlodipine)
n=100 Participants
Participants were randomized to receive placebo matched to zilebesiran, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to amlodipine. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant's protocol-specified background antihypertensive medication per Investigator judgement.
|
|---|---|---|
|
Amlodipine: Time-adjusted Change From Baseline Through Month 3 in 24-hour Mean SBP and DBP, Assessed by ABPM - Censored Data
24-hour Mean SBP
|
-9.9 mmHg
Standard Error 1.00
|
-0.9 mmHg
Standard Error 0.99
|
|
Amlodipine: Time-adjusted Change From Baseline Through Month 3 in 24-hour Mean SBP and DBP, Assessed by ABPM - Censored Data
24-hour Mean DBP
|
-6.4 mmHg
Standard Error 0.57
|
-0.7 mmHg
Standard Error 0.56
|
SECONDARY outcome
Timeframe: Baseline through Month 3Population: The mFAS included all randomized participants who received any amount of study drug. Analysis was grouped according to the randomized treatment arm. Overall number analyzed is the number of participants with data available for analysis at Month 3.
Time-adjusted change was defined as the AUC of BP change from baseline divided by the duration of the time period. LS mean and SE were calculated using a MMRM approach. Hypothetical strategy was used for the intercurrent event of using antihypertensive escape medication, i.e., data for office SBP and DBP, while participants were on and within 2 weeks after stopping any escape medication were censored for this endpoint.
Outcome measures
| Measure |
DB Period: Zilebesiran (Add-on to Indapamide)
n=112 Participants
Participants were randomized to receive zilebesiran, 600 milligrams (mg), as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to indapamide. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant's protocol-specified background antihypertensive medication per Investigator judgement.
|
DB Period: Placebo (Add-on to Amlodipine)
n=103 Participants
Participants were randomized to receive placebo matched to zilebesiran, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to amlodipine. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant's protocol-specified background antihypertensive medication per Investigator judgement.
|
|---|---|---|
|
Amlodipine: Time-adjusted Change From Baseline in Office SBP and DBP Through Month 3 - Censored Data
Office DBP
|
-6.1 mmHg
Standard Error 0.61
|
-0.6 mmHg
Standard Error 0.60
|
|
Amlodipine: Time-adjusted Change From Baseline in Office SBP and DBP Through Month 3 - Censored Data
Office SBP
|
-11.3 mmHg
Standard Error 0.96
|
-1.4 mmHg
Standard Error 0.95
|
SECONDARY outcome
Timeframe: Baseline and Month 6Population: The mFAS included all randomized participants who received any amount of study drug. Analysis was grouped according to the randomized treatment arm. Overall number analyzed is the number of participants with data available for analysis at Month 6.
24-hour ABPM device was programmed to take readings every 20 minutes during the day (6 am to 9:59 pm) and every 30 minutes during the night (10 pm to 5:59 am). An ABPM was considered adequate if: 1. the number of successful daytime readings were ≥33; 2. the number of successful nighttime readings were ≥11; 3. no more than 3 hours are not represented (i.e., 3 sections of 60 minutes where 0 valid readings were obtained). To summarize the 24-hour ABPM, the hourly adjusted mean was calculated. Hourly adjusted mean was the average BP for each hour of the day. The 24-hour mean was average of the hourly means. LS mean and SE were calculated using a MMRM approach. Treatment policy strategy was used for the intercurrent event of using antihypertensive escape medication, i.e., all collected data for SBP and DBP assessed by ABPM are included in the analysis for this endpoint.
Outcome measures
| Measure |
DB Period: Zilebesiran (Add-on to Indapamide)
n=103 Participants
Participants were randomized to receive zilebesiran, 600 milligrams (mg), as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to indapamide. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant's protocol-specified background antihypertensive medication per Investigator judgement.
|
DB Period: Placebo (Add-on to Amlodipine)
n=102 Participants
Participants were randomized to receive placebo matched to zilebesiran, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to amlodipine. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant's protocol-specified background antihypertensive medication per Investigator judgement.
|
|---|---|---|
|
Amlodipine: Change From Baseline at Month 6 in 24-hour Mean SBP and DBP, Assessed by ABPM - All Collected Data
24-hour Mean SBP
|
-9.0 mmHg
Standard Error 1.26
|
-3.0 mmHg
Standard Error 1.26
|
|
Amlodipine: Change From Baseline at Month 6 in 24-hour Mean SBP and DBP, Assessed by ABPM - All Collected Data
24-hour Mean DBP
|
-5.7 mmHg
Standard Error 0.68
|
-1.6 mmHg
Standard Error 0.68
|
SECONDARY outcome
Timeframe: Baseline and Month 6Population: The mFAS included all randomized participants who received any amount of study drug. Analysis was grouped according to the randomized treatment arm. Overall number analyzed is the number of participants with data available for analysis at Month 6.
The mean office BP in the sitting position was used for the analysis. Office BP in the sitting position was collected with a set of 4 replicates. The average of the last 3 replicates was calculated and used for analysis. LS mean and SE were calculated using a MMRM approach. Treatment policy strategy was used for the intercurrent event of using antihypertensive escape medication, i.e., all collected data for office SBP and DBP, were included in the analysis for this endpoint.
Outcome measures
| Measure |
DB Period: Zilebesiran (Add-on to Indapamide)
n=111 Participants
Participants were randomized to receive zilebesiran, 600 milligrams (mg), as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to indapamide. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant's protocol-specified background antihypertensive medication per Investigator judgement.
|
DB Period: Placebo (Add-on to Amlodipine)
n=113 Participants
Participants were randomized to receive placebo matched to zilebesiran, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to amlodipine. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant's protocol-specified background antihypertensive medication per Investigator judgement.
|
|---|---|---|
|
Amlodipine: Change From Baseline at Month 6 in Office SBP and DBP - All Collected Data
Office SBP
|
-12.6 mmHg
Standard Error 1.13
|
-5.8 mmHg
Standard Error 1.12
|
|
Amlodipine: Change From Baseline at Month 6 in Office SBP and DBP - All Collected Data
Office DBP
|
-6.7 mmHg
Standard Error 0.75
|
-3.5 mmHg
Standard Error 0.74
|
SECONDARY outcome
Timeframe: Baseline through Month 6Population: The mFAS included all randomized participants who received any amount of study drug. Analysis was grouped according to the randomized treatment arm. Overall number analyzed is the number of participants with data available for analysis at Month 6.
Time-adjusted change was defined as the AUC of BP change from baseline divided by the duration of the time period. LS mean and SE were calculated using a MMRM approach. Treatment policy strategy was used for the intercurrent event of using antihypertensive escape medication, i.e., all collected data for DBP assessed by ABPM were included in the analysis for this endpoint.
Outcome measures
| Measure |
DB Period: Zilebesiran (Add-on to Indapamide)
n=103 Participants
Participants were randomized to receive zilebesiran, 600 milligrams (mg), as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to indapamide. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant's protocol-specified background antihypertensive medication per Investigator judgement.
|
DB Period: Placebo (Add-on to Amlodipine)
n=102 Participants
Participants were randomized to receive placebo matched to zilebesiran, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to amlodipine. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant's protocol-specified background antihypertensive medication per Investigator judgement.
|
|---|---|---|
|
Amlodipine: Time-adjusted Change From Baseline Through Month 6 in 24-hour Mean DBP, Assessed by ABPM - All Collected Data
|
-6.2 mmHg
Standard Error 0.54
|
-1.1 mmHg
Standard Error 0.53
|
SECONDARY outcome
Timeframe: Baseline through Month 6Population: The mFAS included all randomized participants who received any amount of study drug. Analysis was grouped according to the randomized treatment arm. Overall number analyzed is the number of participants with data available for analysis at Month 6.
Time-adjusted change was defined as the AUC of BP change from baseline divided by the duration of the time period. LS mean and SE were calculated using a MMRM approach. Treatment policy strategy was used for the intercurrent event of using antihypertensive escape medication, i.e., all collected data for office DBP were included in the analysis for this endpoint.
Outcome measures
| Measure |
DB Period: Zilebesiran (Add-on to Indapamide)
n=111 Participants
Participants were randomized to receive zilebesiran, 600 milligrams (mg), as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to indapamide. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant's protocol-specified background antihypertensive medication per Investigator judgement.
|
DB Period: Placebo (Add-on to Amlodipine)
n=113 Participants
Participants were randomized to receive placebo matched to zilebesiran, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to amlodipine. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant's protocol-specified background antihypertensive medication per Investigator judgement.
|
|---|---|---|
|
Amlodipine: Time-adjusted Change From Baseline Through Month 6 in Office DBP - All Collected Data
|
-6.2 mmHg
Standard Error 0.53
|
-1.4 mmHg
Standard Error 0.52
|
SECONDARY outcome
Timeframe: Baseline, and Month 2, 3 and 6Population: The mFAS included all randomized participants who received any amount of study drug. Analysis was grouped according to the randomized treatment arm. Number analyzed are unique number of participants out of all the assessed participants who were evaluable for the specified category. Different participants may have contributed data for each category.
ABPM device was programmed to take readings every 20 minutes during the day (6 am to 9:59 pm) and every 30 minutes during the night (10 pm to 5:59 am). An ABPM was considered adequate if: 1. the number of successful daytime readings were ≥33; 2. the number of successful nighttime readings were ≥11; and 3. no more than 3 hours are not represented (i.e., 3 sections of 60 minutes where 0 valid readings were obtained). LS mean and SE were calculated using a MMRM approach. Treatment policy strategy was used for the intercurrent event of using antihypertensive escape medication, i.e., all collected data for daytime and nighttime SBP and DBP, assessed by ABPM, were included in the analysis for this endpoint.
Outcome measures
| Measure |
DB Period: Zilebesiran (Add-on to Indapamide)
n=118 Participants
Participants were randomized to receive zilebesiran, 600 milligrams (mg), as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to indapamide. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant's protocol-specified background antihypertensive medication per Investigator judgement.
|
DB Period: Placebo (Add-on to Amlodipine)
n=120 Participants
Participants were randomized to receive placebo matched to zilebesiran, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to amlodipine. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant's protocol-specified background antihypertensive medication per Investigator judgement.
|
|---|---|---|
|
Amlodipine: Change From Baseline in Daytime and Nighttime SBP and DBP by ABPM at Each Visit - All Collected Data
Change in Daytime Mean SBP at Month 2
|
-9.3 mmHg
Standard Error 1.26
|
-2.2 mmHg
Standard Error 1.24
|
|
Amlodipine: Change From Baseline in Daytime and Nighttime SBP and DBP by ABPM at Each Visit - All Collected Data
Change in Daytime Mean SBP at Month 3
|
-11.0 mmHg
Standard Error 1.18
|
-1.3 mmHg
Standard Error 1.14
|
|
Amlodipine: Change From Baseline in Daytime and Nighttime SBP and DBP by ABPM at Each Visit - All Collected Data
Change in Daytime Mean SBP at Month 6
|
-9.1 mmHg
Standard Error 1.31
|
-3.3 mmHg
Standard Error 1.31
|
|
Amlodipine: Change From Baseline in Daytime and Nighttime SBP and DBP by ABPM at Each Visit - All Collected Data
Change in Nighttime Mean SBP at Month 2
|
-7.3 mmHg
Standard Error 1.34
|
0.1 mmHg
Standard Error 1.31
|
|
Amlodipine: Change From Baseline in Daytime and Nighttime SBP and DBP by ABPM at Each Visit - All Collected Data
Change in Nighttime Mean SBP at Month 3
|
-8.9 mmHg
Standard Error 1.39
|
0.1 mmHg
Standard Error 1.34
|
|
Amlodipine: Change From Baseline in Daytime and Nighttime SBP and DBP by ABPM at Each Visit - All Collected Data
Change in Nighttime Mean SBP at Month 6
|
-8.8 mmHg
Standard Error 1.48
|
-2.6 mmHg
Standard Error 1.48
|
|
Amlodipine: Change From Baseline in Daytime and Nighttime SBP and DBP by ABPM at Each Visit - All Collected Data
Change in Daytime Mean DBP at Month 2
|
-6.4 mmHg
Standard Error 0.72
|
-0.8 mmHg
Standard Error 0.70
|
|
Amlodipine: Change From Baseline in Daytime and Nighttime SBP and DBP by ABPM at Each Visit - All Collected Data
Change in Daytime Mean DBP at Month 3
|
-7.2 mmHg
Standard Error 0.69
|
-0.8 mmHg
Standard Error 0.66
|
|
Amlodipine: Change From Baseline in Daytime and Nighttime SBP and DBP by ABPM at Each Visit - All Collected Data
Change in Daytime Mean DBP at Month 6
|
-5.8 mmHg
Standard Error 0.74
|
-1.5 mmHg
Standard Error 0.74
|
|
Amlodipine: Change From Baseline in Daytime and Nighttime SBP and DBP by ABPM at Each Visit - All Collected Data
Change in Nighttime Mean DBP at Month 2
|
-5.2 mmHg
Standard Error 0.77
|
-0.4 mmHg
Standard Error 0.76
|
|
Amlodipine: Change From Baseline in Daytime and Nighttime SBP and DBP by ABPM at Each Visit - All Collected Data
Change in Nighttime Mean DBP at Month 3
|
-5.6 mmHg
Standard Error 0.79
|
-0.4 mmHg
Standard Error 0.76
|
|
Amlodipine: Change From Baseline in Daytime and Nighttime SBP and DBP by ABPM at Each Visit - All Collected Data
Change in Nighttime Mean DBP at Month 6
|
-5.8 mmHg
Standard Error 0.84
|
-1.4 mmHg
Standard Error 0.84
|
SECONDARY outcome
Timeframe: Baseline, Week 2 and Months 1, 2, 3, 4, 5 and 6Population: Modified PD Analysis Set included all participants who received at least 1 full dose of study drug. All by-treatment analyses based on the Modified PD Analysis Set were grouped according to the treatment actually received. Number analyzed are unique number of participants out of all the assessed participants who were evaluable for the specified category. Different participants may have contributed data for each category.
Outcome measures
| Measure |
DB Period: Zilebesiran (Add-on to Indapamide)
n=118 Participants
Participants were randomized to receive zilebesiran, 600 milligrams (mg), as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to indapamide. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant's protocol-specified background antihypertensive medication per Investigator judgement.
|
DB Period: Placebo (Add-on to Amlodipine)
n=120 Participants
Participants were randomized to receive placebo matched to zilebesiran, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to amlodipine. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant's protocol-specified background antihypertensive medication per Investigator judgement.
|
|---|---|---|
|
Amlodipine: Percent Change From Baseline in Serum AGT
Percent Change from Baseline at Month 1
|
-95.35 percent change
Standard Deviation 21.36
|
9.62 percent change
Standard Deviation 35.83
|
|
Amlodipine: Percent Change From Baseline in Serum AGT
Percent Change from Baseline at Month 2
|
-97.45 percent change
Standard Deviation 8.59
|
11.23 percent change
Standard Deviation 35.17
|
|
Amlodipine: Percent Change From Baseline in Serum AGT
Percent Change from Baseline at Month 3
|
-96.37 percent change
Standard Deviation 11.24
|
12.78 percent change
Standard Deviation 34.90
|
|
Amlodipine: Percent Change From Baseline in Serum AGT
Percent Change from Baseline at Month 4
|
-96.52 percent change
Standard Deviation 8.41
|
12.42 percent change
Standard Deviation 41.83
|
|
Amlodipine: Percent Change From Baseline in Serum AGT
Percent Change from Baseline at Month 5
|
-93.87 percent change
Standard Deviation 19.20
|
10.81 percent change
Standard Deviation 37.94
|
|
Amlodipine: Percent Change From Baseline in Serum AGT
Percent Change from Baseline at Month 6
|
-94.52 percent change
Standard Deviation 9.37
|
9.51 percent change
Standard Deviation 48.05
|
|
Amlodipine: Percent Change From Baseline in Serum AGT
Percent Change from Baseline at Week 2
|
-92.80 percent change
Standard Deviation 15.99
|
2.67 percent change
Standard Deviation 22.81
|
SECONDARY outcome
Timeframe: Baseline and Month 3Population: The mFAS included all randomized participants who received any amount of study drug. Analysis was grouped according to the randomized treatment arm. Overall number analyzed is the number of participants with data available for analysis at Month 3.
The mean office BP in the sitting position was used for the analysis. Office BP in the sitting position was collected with a set of 4 replicates. The average of the last 3 replicates was calculated and used for analysis. LS mean and SE were calculated using a MMRM approach. Hypothetical strategy was used for the intercurrent event of using antihypertensive escape medication, i.e., data for office SBP assessed while participants were on and within 2 weeks after stopping any escape medication were censored for this endpoint.
Outcome measures
| Measure |
DB Period: Zilebesiran (Add-on to Indapamide)
n=121 Participants
Participants were randomized to receive zilebesiran, 600 milligrams (mg), as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to indapamide. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant's protocol-specified background antihypertensive medication per Investigator judgement.
|
DB Period: Placebo (Add-on to Amlodipine)
n=117 Participants
Participants were randomized to receive placebo matched to zilebesiran, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to amlodipine. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant's protocol-specified background antihypertensive medication per Investigator judgement.
|
|---|---|---|
|
Olmesartan: Change From Baseline at Month 3 in Office SBP - Censored Data
|
-9.3 mmHg
Standard Error 1.23
|
-2.6 mmHg
Standard Error 1.25
|
SECONDARY outcome
Timeframe: Baseline through Month 6Population: The mFAS included all randomized participants who received any amount of study drug. Analysis was grouped according to the randomized treatment arm. Overall number analyzed is the number of participants with data available for analysis at Month 6.
Time-adjusted change was defined as the AUC of BP change from baseline divided by the duration of the time period. LS mean and SE were calculated using a MMRM approach. Treatment policy strategy was used for the intercurrent event of using antihypertensive escape medication, i.e., all collected data for SBP assessed by ABPM, were included in the analysis for this endpoint.
Outcome measures
| Measure |
DB Period: Zilebesiran (Add-on to Indapamide)
n=116 Participants
Participants were randomized to receive zilebesiran, 600 milligrams (mg), as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to indapamide. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant's protocol-specified background antihypertensive medication per Investigator judgement.
|
DB Period: Placebo (Add-on to Amlodipine)
n=128 Participants
Participants were randomized to receive placebo matched to zilebesiran, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to amlodipine. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant's protocol-specified background antihypertensive medication per Investigator judgement.
|
|---|---|---|
|
Olmesartan: Time-adjusted Change From Baseline Through Month 6 in 24-hour Mean SBP, Assessed by ABPM - All Collected Data
|
-7.6 mmHg
Standard Error 1.01
|
-5.8 mmHg
Standard Error 0.99
|
SECONDARY outcome
Timeframe: Baseline through Month 6Population: The mFAS included all randomized participants who received any amount of study drug. Analysis was grouped according to the randomized treatment arm. Overall number analyzed is the number of participants with data available for analysis at Month 6.
Time-adjusted change was defined as the AUC of BP change from baseline divided by the duration of the time period. LS mean and SE were calculated using a MMRM approach. Treatment policy strategy was used for the intercurrent event of using antihypertensive escape medication, i.e., all collected data for office SBP were included in the analysis for this endpoint.
Outcome measures
| Measure |
DB Period: Zilebesiran (Add-on to Indapamide)
n=134 Participants
Participants were randomized to receive zilebesiran, 600 milligrams (mg), as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to indapamide. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant's protocol-specified background antihypertensive medication per Investigator judgement.
|
DB Period: Placebo (Add-on to Amlodipine)
n=137 Participants
Participants were randomized to receive placebo matched to zilebesiran, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to amlodipine. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant's protocol-specified background antihypertensive medication per Investigator judgement.
|
|---|---|---|
|
Olmesartan: Time-adjusted Change From Baseline Through Month 6 in Office SBP - All Collected Data
|
-10.8 mmHg
Standard Error 0.81
|
-6.3 mmHg
Standard Error 0.81
|
SECONDARY outcome
Timeframe: Month 6Population: The mFAS included all randomized participants who received any amount of study drug. Analysis was grouped according to the randomized treatment arm. Overall number analyzed is the number of participants with data available for analysis at Month 6.
24-hour ABPM device was programmed to take readings every 20 minutes during the day (6 am to 9:59 pm) and every 30 minutes during the night (10 pm to 5:59 am). An ABPM was considered adequate if: 1. the number of successful daytime readings were ≥33; 2. the number of successful nighttime readings were ≥11; 3. no more than 3 hours are not represented (i.e., 3 sections of 60 minutes where 0 valid readings were obtained). To summarize the 24-hour ABPM, the hourly adjusted mean was calculated. Hourly adjusted mean was the average of BP for each hour of the day. The 24-hour mean was average of the hourly means.
Outcome measures
| Measure |
DB Period: Zilebesiran (Add-on to Indapamide)
n=116 Participants
Participants were randomized to receive zilebesiran, 600 milligrams (mg), as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to indapamide. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant's protocol-specified background antihypertensive medication per Investigator judgement.
|
DB Period: Placebo (Add-on to Amlodipine)
n=128 Participants
Participants were randomized to receive placebo matched to zilebesiran, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to amlodipine. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant's protocol-specified background antihypertensive medication per Investigator judgement.
|
|---|---|---|
|
Olmesartan: Percentage of Participants With 24-hour Mean SBP <130 mmHg and/or Reduction From Baseline ≥20 mmHg Assessed by ABPM Without Escape Antihypertensive Medications at Month 6
|
25.9 percentage of participants
|
17.2 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Month 3Population: The mFAS included all randomized participants who received any amount of study drug. Analysis was grouped according to the randomized treatment arm. Overall number analyzed is the number of participants with data available for analysis at Month 3.
24-hour ABPM device was programmed to take readings every 20 minutes during the day (6 am to 9:59 pm) and every 30 minutes during the night (10 pm to 5:59 am). An ABPM was considered adequate if: 1. the number of successful daytime readings were ≥33; 2. the number of successful nighttime readings were ≥11; 3. no more than 3 hours are not represented (i.e., 3 sections of 60 minutes where 0 valid readings were obtained). To summarize the 24-hour ABPM, the hourly adjusted mean was calculated. Hourly adjusted mean was the average BP for each hour of the day. The 24-hour mean was average of the hourly means. LS mean and SE were calculated using a MMRM approach. Hypothetical strategy was used for the intercurrent event of using antihypertensive escape medication, i.e., data for DBP assessed using ABPM, while participants were on and within 2 weeks after stopping any escape medication were censored for this endpoint.
Outcome measures
| Measure |
DB Period: Zilebesiran (Add-on to Indapamide)
n=115 Participants
Participants were randomized to receive zilebesiran, 600 milligrams (mg), as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to indapamide. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant's protocol-specified background antihypertensive medication per Investigator judgement.
|
DB Period: Placebo (Add-on to Amlodipine)
n=114 Participants
Participants were randomized to receive placebo matched to zilebesiran, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to amlodipine. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant's protocol-specified background antihypertensive medication per Investigator judgement.
|
|---|---|---|
|
Olmesartan: Change From Baseline at Month 3 in 24-hour Mean DBP, Assessed by ABPM - Censored Data
|
-3.4 mmHg
Standard Error 0.78
|
-1.4 mmHg
Standard Error 0.78
|
SECONDARY outcome
Timeframe: Baseline and Month 3Population: The mFAS included all randomized participants who received any amount of study drug. Analysis was grouped according to the randomized treatment arm. Overall number analyzed is the number of participants with data available for analysis at Month 3.
The mean office BP in the sitting position was used for the analysis. Office BP in the sitting position was collected with a set of 4 replicates. The average of the last 3 replicates was calculated and used for analysis. LS mean and SE were calculated using a MMRM approach. Hypothetical strategy was used for the intercurrent event of using antihypertensive escape medication, i.e., data for office DBP assessed while participants were on and within 2 weeks after stopping any escape medication was censored for this endpoint.
Outcome measures
| Measure |
DB Period: Zilebesiran (Add-on to Indapamide)
n=121 Participants
Participants were randomized to receive zilebesiran, 600 milligrams (mg), as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to indapamide. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant's protocol-specified background antihypertensive medication per Investigator judgement.
|
DB Period: Placebo (Add-on to Amlodipine)
n=117 Participants
Participants were randomized to receive placebo matched to zilebesiran, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to amlodipine. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant's protocol-specified background antihypertensive medication per Investigator judgement.
|
|---|---|---|
|
Olmesartan: Change From Baseline at Month 3 in Office DBP - Censored Data
|
-5.3 mmHg
Standard Error 0.85
|
-2.0 mmHg
Standard Error 0.86
|
SECONDARY outcome
Timeframe: Baseline through Month 3Population: The mFAS included all randomized participants who received any amount of study drug. Analysis was grouped according to the randomized treatment arm. Overall number analyzed is the number of participants with data available for analysis at Month 3.
Time-adjusted change was defined as the AUC of BP change from baseline divided by the duration of the time period. LS mean and SE were calculated using a MMRM approach. Hypothetical strategy was used for the intercurrent event of using antihypertensive escape medication, i.e., data for SBP and DBP, assessed using ABPM, while participants were on and within 2 weeks after stopping any escape medication were censored for this endpoint.
Outcome measures
| Measure |
DB Period: Zilebesiran (Add-on to Indapamide)
n=115 Participants
Participants were randomized to receive zilebesiran, 600 milligrams (mg), as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to indapamide. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant's protocol-specified background antihypertensive medication per Investigator judgement.
|
DB Period: Placebo (Add-on to Amlodipine)
n=114 Participants
Participants were randomized to receive placebo matched to zilebesiran, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to amlodipine. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant's protocol-specified background antihypertensive medication per Investigator judgement.
|
|---|---|---|
|
Olmesartan: Time-adjusted Change From Baseline Through Month 3 in 24-hour Mean SBP and DBP, Assessed by ABPM - Censored Data
24-hour Mean SBP
|
-5.3 mmHg
Standard Error 1.13
|
-2.2 mmHg
Standard Error 1.12
|
|
Olmesartan: Time-adjusted Change From Baseline Through Month 3 in 24-hour Mean SBP and DBP, Assessed by ABPM - Censored Data
24-hour Mean DBP
|
-2.3 mmHg
Standard Error 0.64
|
-1.1 mmHg
Standard Error 0.63
|
SECONDARY outcome
Timeframe: Baseline through Month 3Population: The mFAS included all randomized participants who received any amount of study drug. Analysis was grouped according to the randomized treatment arm. Overall number analyzed is the number of participants with data available for analysis at Month 3.
Time-adjusted change was defined as the AUC of BP change from baseline divided by the duration of the time period. LS mean and SE were calculated using a MMRM approach. Hypothetical strategy was used for the intercurrent event of using antihypertensive escape medication, i.e., data for office SBP and DBP, while participants were on and within 2 weeks after stopping any escape medication was censored for this endpoint.
Outcome measures
| Measure |
DB Period: Zilebesiran (Add-on to Indapamide)
n=121 Participants
Participants were randomized to receive zilebesiran, 600 milligrams (mg), as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to indapamide. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant's protocol-specified background antihypertensive medication per Investigator judgement.
|
DB Period: Placebo (Add-on to Amlodipine)
n=117 Participants
Participants were randomized to receive placebo matched to zilebesiran, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to amlodipine. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant's protocol-specified background antihypertensive medication per Investigator judgement.
|
|---|---|---|
|
Olmesartan: Time-adjusted Change From Baseline in Office SBP and DBP Through Month 3 - Censored Data
Office SBP
|
-7.9 mmHg
Standard Error 0.97
|
-2.4 mmHg
Standard Error 0.99
|
|
Olmesartan: Time-adjusted Change From Baseline in Office SBP and DBP Through Month 3 - Censored Data
Office DBP
|
-3.8 mmHg
Standard Error 0.64
|
-1.2 mmHg
Standard Error 0.65
|
SECONDARY outcome
Timeframe: Baseline and Month 6Population: The mFAS included all randomized participants who received any amount of study drug. Analysis was grouped according to the randomized treatment arm. Overall number analyzed is the number of participants with data available for analysis at Month 6.
24-hour ABPM device was programmed to take readings every 20 minutes during the day (6 am to 9:59 pm) and every 30 minutes during the night (10 pm to 5:59 am). An ABPM was considered adequate if: 1. the number of successful daytime readings were ≥33; 2. the number of successful nighttime readings were ≥11; 3. no more than 3 hours are not represented (i.e., 3 sections of 60 minutes where 0 valid readings were obtained). To summarize the 24-hour ABPM, the hourly adjusted mean was calculated. Hourly adjusted mean was the average BP for each hour of the day. The 24-hour mean was average of the hourly means. LS mean and SE were calculated using a MMRM approach. Treatment policy strategy was used for the intercurrent event of using antihypertensive escape medication, i.e., all collected data for SBP and DBP assessed by ABPM are included in the analysis for this endpoint.
Outcome measures
| Measure |
DB Period: Zilebesiran (Add-on to Indapamide)
n=116 Participants
Participants were randomized to receive zilebesiran, 600 milligrams (mg), as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to indapamide. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant's protocol-specified background antihypertensive medication per Investigator judgement.
|
DB Period: Placebo (Add-on to Amlodipine)
n=128 Participants
Participants were randomized to receive placebo matched to zilebesiran, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to amlodipine. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant's protocol-specified background antihypertensive medication per Investigator judgement.
|
|---|---|---|
|
Olmesartan: Change From Baseline at Month 6 in 24-hour Mean SBP and DBP, Assessed by ABPM - All Collected Data
24-hour Mean SBP
|
-8.3 mmHg
Standard Error 1.29
|
-9.2 mmHg
Standard Error 1.24
|
|
Olmesartan: Change From Baseline at Month 6 in 24-hour Mean SBP and DBP, Assessed by ABPM - All Collected Data
24-hour Mean DBP
|
-4.3 mmHg
Standard Error 0.76
|
-5.2 mmHg
Standard Error 0.73
|
SECONDARY outcome
Timeframe: Baseline and Month 6Population: The mFAS included all randomized participants who received any amount of study drug. Analysis was grouped according to the randomized treatment arm. Overall number analyzed is the number of participants with data available for analysis at Month 6.
The mean office BP in the sitting position was used for the analysis. Office BP in the sitting position was collected with a set of 4 replicates. The average of the last 3 replicates was calculated and used for analysis. LS mean and SE were calculated using a MMRM approach. Treatment policy strategy was used for the intercurrent event of using antihypertensive escape medication, i.e., all collected data for office SBP and DBP, were included in the analysis for this endpoint.
Outcome measures
| Measure |
DB Period: Zilebesiran (Add-on to Indapamide)
n=134 Participants
Participants were randomized to receive zilebesiran, 600 milligrams (mg), as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to indapamide. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant's protocol-specified background antihypertensive medication per Investigator judgement.
|
DB Period: Placebo (Add-on to Amlodipine)
n=137 Participants
Participants were randomized to receive placebo matched to zilebesiran, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to amlodipine. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant's protocol-specified background antihypertensive medication per Investigator judgement.
|
|---|---|---|
|
Olmesartan: Change From Baseline at Month 6 in Office SBP and DBP - All Collected Data
Office SBP
|
-12.4 mmHg
Standard Error 1.34
|
-11.9 mmHg
Standard Error 1.33
|
|
Olmesartan: Change From Baseline at Month 6 in Office SBP and DBP - All Collected Data
Office DBP
|
-7.1 mmHg
Standard Error 0.76
|
-7.0 mmHg
Standard Error 0.76
|
SECONDARY outcome
Timeframe: Baseline through Month 6Population: The mFAS included all randomized participants who received any amount of study drug. Analysis was grouped according to the randomized treatment arm. Overall number analyzed is the number of participants with data available for analysis at Month 6.
Time-adjusted change was defined as the AUC of BP change from baseline divided by the duration of the time period. LS mean and SE were calculated using a MMRM approach. Treatment policy strategy was used for the intercurrent event of using antihypertensive escape medication, i.e., all collected data for DBP assessed by ABPM were included in the analysis for this endpoint.
Outcome measures
| Measure |
DB Period: Zilebesiran (Add-on to Indapamide)
n=116 Participants
Participants were randomized to receive zilebesiran, 600 milligrams (mg), as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to indapamide. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant's protocol-specified background antihypertensive medication per Investigator judgement.
|
DB Period: Placebo (Add-on to Amlodipine)
n=128 Participants
Participants were randomized to receive placebo matched to zilebesiran, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to amlodipine. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant's protocol-specified background antihypertensive medication per Investigator judgement.
|
|---|---|---|
|
Olmesartan: Time-adjusted Change From Baseline Through Month 6 in 24-hour Mean DBP, Assessed by ABPM - All Collected Data
|
-3.5 mmHg
Standard Error 0.59
|
-3.1 mmHg
Standard Error 0.58
|
SECONDARY outcome
Timeframe: Baseline through Month 6Population: The mFAS included all randomized participants who received any amount of study drug. Analysis was grouped according to the randomized treatment arm. Overall number analyzed is the number of participants with data available for analysis at Month 6.
Time-adjusted change was defined as the AUC of BP change from baseline divided by the duration of the time period. LS mean and SE were calculated using a MMRM approach. Treatment policy strategy was used for the intercurrent event of using antihypertensive escape medication, i.e., all collected data for office DBP were included in the analysis for this endpoint.
Outcome measures
| Measure |
DB Period: Zilebesiran (Add-on to Indapamide)
n=134 Participants
Participants were randomized to receive zilebesiran, 600 milligrams (mg), as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to indapamide. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant's protocol-specified background antihypertensive medication per Investigator judgement.
|
DB Period: Placebo (Add-on to Amlodipine)
n=137 Participants
Participants were randomized to receive placebo matched to zilebesiran, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to amlodipine. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant's protocol-specified background antihypertensive medication per Investigator judgement.
|
|---|---|---|
|
Olmesartan: Time-adjusted Change From Baseline Through Month 6 in Office DBP - All Collected Data
|
-5.8 mmHg
Standard Error 0.52
|
-3.5 mmHg
Standard Error 0.53
|
SECONDARY outcome
Timeframe: Baseline, and Month 2, 3 and 6Population: The mFAS included all randomized participants who received any amount of study drug. Analysis was grouped according to the randomized treatment arm. Number analyzed are unique number of participants out of all the assessed participants who were evaluable for the specified category. Different participants may have contributed data for each category.
ABPM device was programmed to take readings every 20 minutes during the day (6 am to 9:59 pm) and every 30 minutes during the night (10 pm to 5:59 am). An ABPM was considered adequate if: 1. the number of successful daytime readings were ≥33; 2. the number of successful nighttime readings were ≥11; and 3. no more than 3 hours are not represented (i.e., 3 sections of 60 minutes where 0 valid readings were obtained). LS mean and SE were calculated using a MMRM approach. Treatment policy strategy was used for the intercurrent event of using antihypertensive escape medication, i.e., all collected data for daytime and nighttime SBP and DBP, assessed by ABPM, were included in the analysis for this endpoint.
Outcome measures
| Measure |
DB Period: Zilebesiran (Add-on to Indapamide)
n=147 Participants
Participants were randomized to receive zilebesiran, 600 milligrams (mg), as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to indapamide. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant's protocol-specified background antihypertensive medication per Investigator judgement.
|
DB Period: Placebo (Add-on to Amlodipine)
n=146 Participants
Participants were randomized to receive placebo matched to zilebesiran, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to amlodipine. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant's protocol-specified background antihypertensive medication per Investigator judgement.
|
|---|---|---|
|
Olmesartan: Change From Baseline in Daytime and Nighttime SBP and DBP by ABPM at Each Visit - All Collected Data
Change in Daytime Mean SBP at Month 2
|
-3.3 mmHg
Standard Error 1.41
|
-1.0 mmHg
Standard Error 1.39
|
|
Olmesartan: Change From Baseline in Daytime and Nighttime SBP and DBP by ABPM at Each Visit - All Collected Data
Change in Daytime Mean SBP at Month 3
|
-8.5 mmHg
Standard Error 1.31
|
-3.7 mmHg
Standard Error 1.29
|
|
Olmesartan: Change From Baseline in Daytime and Nighttime SBP and DBP by ABPM at Each Visit - All Collected Data
Change in Daytime Mean SBP at Month 6
|
-8.3 mmHg
Standard Error 1.34
|
-8.8 mmHg
Standard Error 1.29
|
|
Olmesartan: Change From Baseline in Daytime and Nighttime SBP and DBP by ABPM at Each Visit - All Collected Data
Change in Nighttime Mean SBP at Month 2
|
-2.7 mmHg
Standard Error 1.56
|
-2.4 mmHg
Standard Error 1.53
|
|
Olmesartan: Change From Baseline in Daytime and Nighttime SBP and DBP by ABPM at Each Visit - All Collected Data
Change in Nighttime Mean SBP at Month 3
|
-7.4 mmHg
Standard Error 1.37
|
-5.3 mmHg
Standard Error 1.35
|
|
Olmesartan: Change From Baseline in Daytime and Nighttime SBP and DBP by ABPM at Each Visit - All Collected Data
Change in Nighttime Mean SBP at Month 6
|
-8.4 mmHg
Standard Error 1.41
|
-9.7 mmHg
Standard Error 1.35
|
|
Olmesartan: Change From Baseline in Daytime and Nighttime SBP and DBP by ABPM at Each Visit - All Collected Data
Change in Daytime Mean DBP at Month 2
|
-1.2 mmHg
Standard Error 0.77
|
-0.5 mmHg
Standard Error 0.76
|
|
Olmesartan: Change From Baseline in Daytime and Nighttime SBP and DBP by ABPM at Each Visit - All Collected Data
Change in Daytime Mean DBP at Month 3
|
-3.9 mmHg
Standard Error 0.78
|
-1.7 mmHg
Standard Error 0.76
|
|
Olmesartan: Change From Baseline in Daytime and Nighttime SBP and DBP by ABPM at Each Visit - All Collected Data
Change in Daytime Mean DBP at Month 6
|
-4.3 mmHg
Standard Error 0.79
|
-5.0 mmHg
Standard Error 0.76
|
|
Olmesartan: Change From Baseline in Daytime and Nighttime SBP and DBP by ABPM at Each Visit - All Collected Data
Change in Nighttime Mean DBP at Month 2
|
-1.4 mmHg
Standard Error 0.87
|
-1.3 mmHg
Standard Error 0.86
|
|
Olmesartan: Change From Baseline in Daytime and Nighttime SBP and DBP by ABPM at Each Visit - All Collected Data
Change in Nighttime Mean DBP at Month 3
|
-3.2 mmHg
Standard Error 0.87
|
-2.6 mmHg
Standard Error 0.86
|
|
Olmesartan: Change From Baseline in Daytime and Nighttime SBP and DBP by ABPM at Each Visit - All Collected Data
Change in Nighttime Mean DBP at Month 6
|
-4.2 mmHg
Standard Error 0.88
|
-5.5 mmHg
Standard Error 0.85
|
SECONDARY outcome
Timeframe: Baseline, Week 2 and Months 1, 2, 3, 4, 5 and 6Population: Modified PD Analysis Set included all participants who received at least 1 full dose of study drug. All by-treatment analyses based on the Modified PD Analysis Set were grouped according to the treatment actually received. Number analyzed are unique number of participants out of all the assessed participants who were evaluable for the specified category. Different participants may have contributed data for each category.
Outcome measures
| Measure |
DB Period: Zilebesiran (Add-on to Indapamide)
n=148 Participants
Participants were randomized to receive zilebesiran, 600 milligrams (mg), as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to indapamide. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant's protocol-specified background antihypertensive medication per Investigator judgement.
|
DB Period: Placebo (Add-on to Amlodipine)
n=144 Participants
Participants were randomized to receive placebo matched to zilebesiran, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to amlodipine. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant's protocol-specified background antihypertensive medication per Investigator judgement.
|
|---|---|---|
|
Olmesartan: Percent Change From Baseline in Serum AGT
Percent Change from Baseline at Week 2
|
-87.83 percent change
Standard Deviation 35.99
|
8.08 percent change
Standard Deviation 86.70
|
|
Olmesartan: Percent Change From Baseline in Serum AGT
Percent Change from Baseline at Month 1
|
-92.61 percent change
Standard Deviation 25.21
|
4.64 percent change
Standard Deviation 28.05
|
|
Olmesartan: Percent Change From Baseline in Serum AGT
Percent Change from Baseline at Month 2
|
-92.58 percent change
Standard Deviation 29.50
|
4.87 percent change
Standard Deviation 29.58
|
|
Olmesartan: Percent Change From Baseline in Serum AGT
Percent Change from Baseline at Month 3
|
-92.98 percent change
Standard Deviation 23.98
|
6.45 percent change
Standard Deviation 28.36
|
|
Olmesartan: Percent Change From Baseline in Serum AGT
Percent Change from Baseline at Month 5
|
-91.14 percent change
Standard Deviation 24.14
|
5.82 percent change
Standard Deviation 31.65
|
|
Olmesartan: Percent Change From Baseline in Serum AGT
Percent Change from Baseline at Month 6
|
-88.22 percent change
Standard Deviation 41.42
|
1.93 percent change
Standard Deviation 26.66
|
|
Olmesartan: Percent Change From Baseline in Serum AGT
Percent Change from Baseline at Month 4
|
-91.66 percent change
Standard Deviation 25.44
|
4.62 percent change
Standard Deviation 27.62
|
Adverse Events
Run-in: Indapamide
Run-in: Amlodipine
Run-in: Olmesartan
DB Period: Placebo (Add-on to Olmesartan)
DB Period: Placebo (Add-on to Indapamide)
DB Period: Zilebesiran (Add-on to Indapamide)
DB Period: Placebo (Add-on to Amlodipine)
DB Period: Zilebesiran (Add-on to Amlodipine)
DB (Zilebesiran) to SFU or OLE to SFU [Olmesartan Cohort]
DB (Zilebesiran) to SFU or OLE to SFU [Amlodipine Cohort]
DB (Placebo) to SFU [Olmesartan Cohort]
DB Period: Zilebesiran (Add-on to Olmesartan)
DB Period (Placebo) to OLE Period (Zilebesiran) [Indapamide Cohort]
DB Period (Zilebesiran) to OLE Period (Zilebesiran) [Indapamide Cohort]
DB Period (Placebo) to OLE Period (Zilebesiran) [Amlodipine Cohort]
DB Period (Zilebesiran) to OLE Period (Zilebesiran) [Amlodipine Cohort]
DB Period (Placebo) to OLE Period (Zilebesiran) [Olmesartan Cohort]
DB Period (Zilebesiran) to OLE Period (Zilebesiran) [Olmesartan Cohort]
DB (Placebo) to SFU [Indapamide Cohort]
DB (Zilebesiran) to SFU or OLE to SFU [Indapamide Cohort]
DB (Placebo) to SFU [Amlodipine Cohort]
Serious adverse events
| Measure |
Run-in: Indapamide
n=127 participants at risk
Participants who cleared screening received open-label therapy with indapamide 2.5 mg orally once daily (QD) as their protocol-specified background antihypertensive medication during a Run-in period of at least 4 weeks.
|
Run-in: Amlodipine
n=238 participants at risk
Participants who cleared screening received open-label therapy with amlodipine 5 mg orally QD as their protocol-specified background antihypertensive medication during a Run-in period of at least 4 weeks.
|
Run-in: Olmesartan
n=293 participants at risk
Participants who cleared screening received open-label therapy with olmesartan 40 mg orally QD \[or 20 mg orally QD for participants with creatinine clearance ≤ 60 mL/min at screening enrolled at sites outside of the US\] as their protocol-specified background antihypertensive medication during a Run-in period of at least 4 weeks.
|
DB Period: Placebo (Add-on to Olmesartan)
n=145 participants at risk
Participants received placebo matched to zilebesiran, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to olmesartan. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant's protocol-specified background antihypertensive medication per Investigator judgement.
|
DB Period: Placebo (Add-on to Indapamide)
n=64 participants at risk
Participants received placebo matched to zilebesiran, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to indapamide. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant's protocol-specified background antihypertensive medication per Investigator judgement.
|
DB Period: Zilebesiran (Add-on to Indapamide)
n=63 participants at risk
Participants received zilebesiran, 600 mg, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to indapamide. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant's protocol-specified background antihypertensive medication per Investigator judgement.
|
DB Period: Placebo (Add-on to Amlodipine)
n=120 participants at risk
Participants received placebo matched to zilebesiran, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to amlodipine. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant's protocol-specified background antihypertensive medication per Investigator judgement.
|
DB Period: Zilebesiran (Add-on to Amlodipine)
n=118 participants at risk
Participants received zilebesiran, 600 mg, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to amlodipine. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant's protocol-specified background antihypertensive medication per Investigator judgement.
|
DB (Zilebesiran) to SFU or OLE to SFU [Olmesartan Cohort]
n=214 participants at risk
Prior to Amendment 3, participants treated with zilebesiran who did not enter the OLE Period or who discontinued treatment (zilebesiran) during the DB period entered the SFU period for safety monitoring.
Upon implementation of Amendment 3, participants who completed the DB period entered the SFU period directly. Participants who were already in OLE period (after completing treatment with zilebesiran/placebo in DB period) did not receive any additional study drug in OLE and transitioned to the SFU period for safety monitoring.
No treatment was administered in SFU.
|
DB (Zilebesiran) to SFU or OLE to SFU [Amlodipine Cohort]
n=166 participants at risk
Prior to Amendment 3, participants treated with zilebesiran who did not enter the OLE Period or who discontinued treatment (zilebesiran) during the DB period entered the SFU period for safety monitoring.
Upon implementation of Amendment 3, participants who completed the DB period entered the SFU period directly. Participants who were already in OLE period (after completing treatment with zilebesiran/placebo in DB period) did not receive any additional study drug in OLE and transitioned to the SFU period for safety monitoring.
No treatment was administered in SFU.
|
DB (Placebo) to SFU [Olmesartan Cohort]
n=79 participants at risk
Participants treated with placebo during DB period who did not enter the OLE period (prior to Amendment 3) or who discontinued treatment during the DB period entered the SFU period for safety monitoring.
No treatment was administered in SFU.
|
DB Period: Zilebesiran (Add-on to Olmesartan)
n=148 participants at risk
Participants received zilebesiran, 600 mg, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to olmesartan. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant's protocol-specified background antihypertensive medication per Investigator judgement.
|
DB Period (Placebo) to OLE Period (Zilebesiran) [Indapamide Cohort]
n=26 participants at risk
Prior to Amendment 3, participants who completed the DB period before a separate OLE study was available, entered the OLE period of this study and received treatment with zilebesiran 600 mg SC q6M. Protocol-specified background antihypertensive treatment with indapamide was discontinued at the start of OLE period.
|
DB Period (Zilebesiran) to OLE Period (Zilebesiran) [Indapamide Cohort]
n=63 participants at risk
Prior to Amendment 3, participants who completed the DB period before a separate OLE study was available, entered the OLE period of this study and continued treatment with zilebesiran 600 mg SC q6M. Protocol-specified background antihypertensive treatment with indapamide was discontinued at the start of OLE period.
|
DB Period (Placebo) to OLE Period (Zilebesiran) [Amlodipine Cohort]
n=48 participants at risk
Prior to Amendment 3, participants who completed the DB period before a separate OLE study was available, entered the OLE period of this study and received treatment with zilebesiran 600 mg SC q6M. Protocol-specified background antihypertensive treatment with amlodipine was discontinued at the start of OLE period.
|
DB Period (Zilebesiran) to OLE Period (Zilebesiran) [Amlodipine Cohort]
n=118 participants at risk
Prior to Amendment 3, participants who completed the DB period before a separate OLE study was available, entered the OLE period of this study and continued treatment with zilebesiran 600 mg SC q6M. Protocol-specified background antihypertensive treatment with amlodipine was discontinued at the start of OLE period.
|
DB Period (Placebo) to OLE Period (Zilebesiran) [Olmesartan Cohort]
n=66 participants at risk
Prior to Amendment 3, participants who completed the DB period before a separate OLE study was available, entered the OLE period of this study and received treatment with zilebesiran 600 mg SC q6M. Protocol-specified background antihypertensive treatment with olmesartan was discontinued at the start of OLE period.
|
DB Period (Zilebesiran) to OLE Period (Zilebesiran) [Olmesartan Cohort]
n=148 participants at risk
Prior to Amendment 3, participants who completed the DB period before a separate OLE study was available, entered the OLE period of this study and continued treatment with zilebesiran 600 mg SC q6M. Protocol-specified background antihypertensive treatment with olmesartan was discontinued at the start of OLE period.
|
DB (Placebo) to SFU [Indapamide Cohort]
n=38 participants at risk
Participants treated with placebo during DB period who did not enter the OLE period (prior to Amendment 3) or who discontinued treatment during the DB period entered the SFU period for safety monitoring.
No treatment was administered in SFU.
|
DB (Zilebesiran) to SFU or OLE to SFU [Indapamide Cohort]
n=89 participants at risk
Prior to Amendment 3, participants treated with zilebesiran who did not enter the OLE Period or who discontinued treatment (zilebesiran) during the DB period entered the SFU period for safety monitoring.
Upon implementation of Amendment 3, participants who completed the DB period entered the SFU period directly. Participants who were already in OLE period (after completing treatment with zilebesiran/placebo in DB period) did not receive any additional study drug in OLE and transitioned to the SFU period for safety monitoring.
No treatment was administered in SFU.
|
DB (Placebo) to SFU [Amlodipine Cohort]
n=72 participants at risk
Participants treated with placebo during DB period who did not enter the OLE period (prior to Amendment 3) or who discontinued treatment during the DB period entered the SFU period for safety monitoring.
No treatment was administered in SFU.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
General disorders
Chills
|
0.00%
0/127 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/238 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/293 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/145 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/64 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/63 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/120 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/118 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/214 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/166 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/79 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/148 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/26 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/63 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/48 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/118 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
1.5%
1/66 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/148 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/38 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/89 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/72 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/127 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/238 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/293 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/145 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/64 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/63 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/120 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/118 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/214 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/166 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/79 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.68%
1/148 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/26 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/63 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/48 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/118 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/66 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.68%
1/148 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/38 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/89 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/72 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/127 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/238 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/293 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.69%
1/145 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/64 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/63 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/120 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/118 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/214 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/166 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/79 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/148 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/26 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/63 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/48 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/118 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/66 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/148 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/38 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/89 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/72 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
|
Cardiac disorders
Cardiac failure chronic
|
0.00%
0/127 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/238 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/293 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/145 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/64 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/63 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/120 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/118 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/214 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/166 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/79 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.68%
1/148 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/26 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/63 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/48 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/118 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/66 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.68%
1/148 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/38 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/89 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/72 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/127 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/238 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/293 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/145 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/64 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/63 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/120 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/118 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/214 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/166 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/79 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.68%
1/148 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/26 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/63 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/48 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/118 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/66 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.68%
1/148 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/38 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/89 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/72 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/127 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/238 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/293 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/145 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/64 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/63 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/120 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/118 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.47%
1/214 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/166 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/79 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/148 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/26 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/63 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/48 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/118 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/66 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/148 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/38 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/89 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/72 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.00%
0/127 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/238 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/293 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/145 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
1.6%
1/64 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/63 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/120 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/118 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/214 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/166 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/79 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/148 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/26 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/63 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/48 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/118 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/66 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/148 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/38 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/89 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/72 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
|
Gastrointestinal disorders
Incarcerated umbilical hernia
|
0.00%
0/127 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/238 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/293 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/145 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/64 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/63 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/120 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/118 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/214 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/166 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/79 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/148 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/26 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/63 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/48 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/118 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/66 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.68%
1/148 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/38 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/89 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/72 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
|
Gastrointestinal disorders
Proctitis
|
0.00%
0/127 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/238 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/293 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/145 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/64 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/63 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/120 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/118 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/214 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/166 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/79 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/148 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/26 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
1.6%
1/63 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/48 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/118 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/66 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/148 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/38 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/89 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/72 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/127 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/238 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/293 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/145 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/64 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/63 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/120 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/118 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/214 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/166 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/79 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/148 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/26 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/63 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/48 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.85%
1/118 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/66 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/148 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/38 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/89 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/72 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/127 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/238 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/293 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/145 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/64 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/63 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/120 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/118 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/214 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/166 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/79 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.68%
1/148 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/26 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/63 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/48 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/118 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/66 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.68%
1/148 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/38 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/89 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/72 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
|
General disorders
Oedema peripheral
|
0.00%
0/127 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/238 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/293 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/145 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/64 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/63 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/120 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/118 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/214 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/166 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/79 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/148 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/26 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/63 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/48 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/118 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/66 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.68%
1/148 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/38 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/89 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/72 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/127 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/238 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/293 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/145 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/64 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/63 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/120 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/118 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/214 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/166 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/79 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/148 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/26 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/63 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/48 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/118 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/66 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.68%
1/148 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/38 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/89 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/72 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/127 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/238 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/293 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/145 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/64 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/63 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/120 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.85%
1/118 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/214 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/166 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/79 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
1.4%
2/148 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/26 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/63 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/48 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.85%
1/118 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/66 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
1.4%
2/148 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/38 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/89 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/72 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/127 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/238 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/293 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.69%
1/145 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/64 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/63 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/120 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/118 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/214 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/166 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/79 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/148 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/26 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/63 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/48 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/118 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/66 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/148 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/38 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/89 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/72 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/127 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/238 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/293 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/145 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/64 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/63 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/120 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/118 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/214 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/166 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/79 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/148 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/26 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/63 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/48 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/118 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
1.5%
1/66 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/148 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/38 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/89 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/72 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
|
Infections and infestations
Helicobacter gastritis
|
0.00%
0/127 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/238 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/293 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/145 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/64 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/63 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/120 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/118 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/214 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/166 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/79 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.68%
1/148 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/26 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/63 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/48 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/118 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/66 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.68%
1/148 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/38 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/89 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/72 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
|
Infections and infestations
Tracheobronchitis
|
0.00%
0/127 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/238 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.34%
1/293 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/145 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/64 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/63 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/120 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/118 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/214 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/166 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/79 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/148 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/26 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/63 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/48 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/118 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/66 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/148 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/38 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/89 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/72 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/127 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/238 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/293 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/145 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/64 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/63 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/120 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/118 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/214 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/166 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/79 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.68%
1/148 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/26 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/63 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/48 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/118 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/66 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.68%
1/148 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/38 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/89 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/72 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/127 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/238 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/293 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/145 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/64 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/63 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/120 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/118 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/214 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/166 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/79 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/148 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/26 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/63 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/48 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/118 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
1.5%
1/66 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/148 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/38 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/89 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/72 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/127 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/238 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/293 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/145 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/64 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/63 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/120 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/118 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/214 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/166 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/79 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/148 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
3.8%
1/26 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/63 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/48 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/118 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/66 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/148 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/38 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/89 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/72 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/127 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/238 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/293 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/145 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/64 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/63 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/120 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/118 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/214 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/166 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/79 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/148 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
3.8%
1/26 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/63 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/48 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/118 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/66 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/148 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/38 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/89 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/72 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/127 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/238 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/293 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/145 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/64 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/63 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/120 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/118 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/214 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/166 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/79 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/148 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/26 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/63 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
2.1%
1/48 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/118 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/66 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/148 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/38 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/89 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/72 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/127 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/238 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/293 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/145 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/64 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/63 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/120 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/118 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/214 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/166 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/79 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/148 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/26 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/63 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
2.1%
1/48 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/118 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/66 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/148 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/38 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/89 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/72 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/127 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/238 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/293 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.69%
1/145 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/64 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/63 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/120 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/118 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/214 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/166 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/79 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/148 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/26 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/63 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/48 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/118 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/66 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/148 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/38 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/89 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/72 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/127 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/238 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/293 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/145 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/64 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/63 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/120 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.85%
1/118 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/214 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/166 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/79 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/148 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/26 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/63 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/48 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.85%
1/118 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/66 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/148 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/38 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/89 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/72 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.00%
0/127 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/238 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/293 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/145 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/64 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/63 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/120 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/118 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/214 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/166 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/79 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/148 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/26 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/63 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/48 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/118 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/66 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.68%
1/148 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/38 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/89 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/72 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/127 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/238 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/293 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/145 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/64 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/63 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/120 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.85%
1/118 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/214 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/166 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/79 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/148 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/26 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/63 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/48 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.85%
1/118 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/66 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/148 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/38 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/89 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/72 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/127 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/238 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/293 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/145 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
1.6%
1/64 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/63 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/120 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/118 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/214 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/166 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/79 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/148 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/26 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/63 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/48 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/118 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/66 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/148 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/38 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/89 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/72 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/127 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/238 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/293 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.69%
1/145 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/64 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/63 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/120 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/118 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/214 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/166 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/79 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/148 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/26 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/63 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/48 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/118 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/66 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/148 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/38 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/89 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/72 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/127 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/238 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/293 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/145 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/64 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/63 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/120 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/118 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/214 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/166 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/79 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/148 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/26 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/63 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/48 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/118 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/66 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.68%
1/148 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/38 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/89 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/72 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/127 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/238 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/293 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/145 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/64 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/63 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/120 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/118 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/214 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/166 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/79 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/148 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/26 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/63 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/48 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/118 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
1.5%
1/66 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/148 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/38 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/89 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/72 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/127 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/238 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/293 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/145 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
1.6%
1/64 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/63 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/120 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/118 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/214 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/166 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/79 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/148 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/26 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/63 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/48 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/118 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/66 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/148 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/38 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/89 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/72 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
|
Vascular disorders
Hypertension
|
0.00%
0/127 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/238 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/293 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/145 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/64 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/63 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.83%
1/120 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/118 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/214 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/166 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/79 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/148 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/26 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/63 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/48 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/118 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/66 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/148 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/38 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/89 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/72 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
|
Vascular disorders
Hypotension
|
0.00%
0/127 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/238 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/293 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/145 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/64 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/63 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/120 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/118 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/214 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/166 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/79 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/148 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/26 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/63 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/48 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/118 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/66 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.68%
1/148 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/38 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/89 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/72 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/127 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/238 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/293 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/145 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/64 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/63 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/120 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/118 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/214 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/166 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/79 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/148 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/26 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/63 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/48 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/118 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/66 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/148 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/38 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
1.1%
1/89 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/72 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
|
Surgical and medical procedures
Hospitalisation
|
0.00%
0/127 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/238 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/293 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/145 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/64 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/63 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/120 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/118 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/214 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/166 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/79 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/148 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/26 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/63 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/48 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/118 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/66 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/148 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/38 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
1.1%
1/89 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/72 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
Other adverse events
| Measure |
Run-in: Indapamide
n=127 participants at risk
Participants who cleared screening received open-label therapy with indapamide 2.5 mg orally once daily (QD) as their protocol-specified background antihypertensive medication during a Run-in period of at least 4 weeks.
|
Run-in: Amlodipine
n=238 participants at risk
Participants who cleared screening received open-label therapy with amlodipine 5 mg orally QD as their protocol-specified background antihypertensive medication during a Run-in period of at least 4 weeks.
|
Run-in: Olmesartan
n=293 participants at risk
Participants who cleared screening received open-label therapy with olmesartan 40 mg orally QD \[or 20 mg orally QD for participants with creatinine clearance ≤ 60 mL/min at screening enrolled at sites outside of the US\] as their protocol-specified background antihypertensive medication during a Run-in period of at least 4 weeks.
|
DB Period: Placebo (Add-on to Olmesartan)
n=145 participants at risk
Participants received placebo matched to zilebesiran, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to olmesartan. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant's protocol-specified background antihypertensive medication per Investigator judgement.
|
DB Period: Placebo (Add-on to Indapamide)
n=64 participants at risk
Participants received placebo matched to zilebesiran, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to indapamide. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant's protocol-specified background antihypertensive medication per Investigator judgement.
|
DB Period: Zilebesiran (Add-on to Indapamide)
n=63 participants at risk
Participants received zilebesiran, 600 mg, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to indapamide. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant's protocol-specified background antihypertensive medication per Investigator judgement.
|
DB Period: Placebo (Add-on to Amlodipine)
n=120 participants at risk
Participants received placebo matched to zilebesiran, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to amlodipine. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant's protocol-specified background antihypertensive medication per Investigator judgement.
|
DB Period: Zilebesiran (Add-on to Amlodipine)
n=118 participants at risk
Participants received zilebesiran, 600 mg, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to amlodipine. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant's protocol-specified background antihypertensive medication per Investigator judgement.
|
DB (Zilebesiran) to SFU or OLE to SFU [Olmesartan Cohort]
n=214 participants at risk
Prior to Amendment 3, participants treated with zilebesiran who did not enter the OLE Period or who discontinued treatment (zilebesiran) during the DB period entered the SFU period for safety monitoring.
Upon implementation of Amendment 3, participants who completed the DB period entered the SFU period directly. Participants who were already in OLE period (after completing treatment with zilebesiran/placebo in DB period) did not receive any additional study drug in OLE and transitioned to the SFU period for safety monitoring.
No treatment was administered in SFU.
|
DB (Zilebesiran) to SFU or OLE to SFU [Amlodipine Cohort]
n=166 participants at risk
Prior to Amendment 3, participants treated with zilebesiran who did not enter the OLE Period or who discontinued treatment (zilebesiran) during the DB period entered the SFU period for safety monitoring.
Upon implementation of Amendment 3, participants who completed the DB period entered the SFU period directly. Participants who were already in OLE period (after completing treatment with zilebesiran/placebo in DB period) did not receive any additional study drug in OLE and transitioned to the SFU period for safety monitoring.
No treatment was administered in SFU.
|
DB (Placebo) to SFU [Olmesartan Cohort]
n=79 participants at risk
Participants treated with placebo during DB period who did not enter the OLE period (prior to Amendment 3) or who discontinued treatment during the DB period entered the SFU period for safety monitoring.
No treatment was administered in SFU.
|
DB Period: Zilebesiran (Add-on to Olmesartan)
n=148 participants at risk
Participants received zilebesiran, 600 mg, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to olmesartan. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant's protocol-specified background antihypertensive medication per Investigator judgement.
|
DB Period (Placebo) to OLE Period (Zilebesiran) [Indapamide Cohort]
n=26 participants at risk
Prior to Amendment 3, participants who completed the DB period before a separate OLE study was available, entered the OLE period of this study and received treatment with zilebesiran 600 mg SC q6M. Protocol-specified background antihypertensive treatment with indapamide was discontinued at the start of OLE period.
|
DB Period (Zilebesiran) to OLE Period (Zilebesiran) [Indapamide Cohort]
n=63 participants at risk
Prior to Amendment 3, participants who completed the DB period before a separate OLE study was available, entered the OLE period of this study and continued treatment with zilebesiran 600 mg SC q6M. Protocol-specified background antihypertensive treatment with indapamide was discontinued at the start of OLE period.
|
DB Period (Placebo) to OLE Period (Zilebesiran) [Amlodipine Cohort]
n=48 participants at risk
Prior to Amendment 3, participants who completed the DB period before a separate OLE study was available, entered the OLE period of this study and received treatment with zilebesiran 600 mg SC q6M. Protocol-specified background antihypertensive treatment with amlodipine was discontinued at the start of OLE period.
|
DB Period (Zilebesiran) to OLE Period (Zilebesiran) [Amlodipine Cohort]
n=118 participants at risk
Prior to Amendment 3, participants who completed the DB period before a separate OLE study was available, entered the OLE period of this study and continued treatment with zilebesiran 600 mg SC q6M. Protocol-specified background antihypertensive treatment with amlodipine was discontinued at the start of OLE period.
|
DB Period (Placebo) to OLE Period (Zilebesiran) [Olmesartan Cohort]
n=66 participants at risk
Prior to Amendment 3, participants who completed the DB period before a separate OLE study was available, entered the OLE period of this study and received treatment with zilebesiran 600 mg SC q6M. Protocol-specified background antihypertensive treatment with olmesartan was discontinued at the start of OLE period.
|
DB Period (Zilebesiran) to OLE Period (Zilebesiran) [Olmesartan Cohort]
n=148 participants at risk
Prior to Amendment 3, participants who completed the DB period before a separate OLE study was available, entered the OLE period of this study and continued treatment with zilebesiran 600 mg SC q6M. Protocol-specified background antihypertensive treatment with olmesartan was discontinued at the start of OLE period.
|
DB (Placebo) to SFU [Indapamide Cohort]
n=38 participants at risk
Participants treated with placebo during DB period who did not enter the OLE period (prior to Amendment 3) or who discontinued treatment during the DB period entered the SFU period for safety monitoring.
No treatment was administered in SFU.
|
DB (Zilebesiran) to SFU or OLE to SFU [Indapamide Cohort]
n=89 participants at risk
Prior to Amendment 3, participants treated with zilebesiran who did not enter the OLE Period or who discontinued treatment (zilebesiran) during the DB period entered the SFU period for safety monitoring.
Upon implementation of Amendment 3, participants who completed the DB period entered the SFU period directly. Participants who were already in OLE period (after completing treatment with zilebesiran/placebo in DB period) did not receive any additional study drug in OLE and transitioned to the SFU period for safety monitoring.
No treatment was administered in SFU.
|
DB (Placebo) to SFU [Amlodipine Cohort]
n=72 participants at risk
Participants treated with placebo during DB period who did not enter the OLE period (prior to Amendment 3) or who discontinued treatment during the DB period entered the SFU period for safety monitoring.
No treatment was administered in SFU.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
General disorders
Injection site reaction
|
0.00%
0/127 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/238 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/293 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.69%
1/145 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/64 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
6.3%
4/63 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/120 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
1.7%
2/118 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/214 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/166 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/79 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
2.7%
4/148 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/26 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
7.9%
5/63 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/48 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
2.5%
3/118 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
4.5%
3/66 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
4.7%
7/148 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/38 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/89 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/72 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
|
Infections and infestations
COVID-19
|
0.00%
0/127 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/238 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/293 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
2.1%
3/145 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
1.6%
1/64 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
3.2%
2/63 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
1.7%
2/120 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
5.1%
6/118 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/214 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/166 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/79 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
3.4%
5/148 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
3.8%
1/26 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
4.8%
3/63 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
6.2%
3/48 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
7.6%
9/118 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
3.0%
2/66 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
5.4%
8/148 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/38 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/89 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/72 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/127 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/238 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/293 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/145 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/64 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/63 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/120 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/118 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/214 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/166 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/79 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/148 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/26 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
1.6%
1/63 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
2.1%
1/48 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.85%
1/118 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
6.1%
4/66 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
3.4%
5/148 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/38 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/89 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/72 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/127 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/238 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/293 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
2.1%
3/145 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/64 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
3.2%
2/63 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.83%
1/120 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
3.4%
4/118 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/214 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/166 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/79 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
5.4%
8/148 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/26 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
4.8%
3/63 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
2.1%
1/48 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
4.2%
5/118 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
6.1%
4/66 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
6.8%
10/148 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/38 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/89 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/72 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/127 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/238 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/293 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
2.1%
3/145 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
1.6%
1/64 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
1.6%
1/63 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/120 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
5.1%
6/118 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/214 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/166 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/79 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
7.4%
11/148 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/26 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
4.8%
3/63 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/48 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
6.8%
8/118 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
4.5%
3/66 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
8.1%
12/148 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/38 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/89 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/72 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
|
Nervous system disorders
Headache
|
0.00%
0/127 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/238 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/293 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
3.4%
5/145 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
1.6%
1/64 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
6.3%
4/63 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
3.3%
4/120 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
4.2%
5/118 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/214 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/166 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/79 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
2.7%
4/148 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/26 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
9.5%
6/63 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/48 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
5.1%
6/118 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
7.6%
5/66 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
4.7%
7/148 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/38 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/89 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/72 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
|
Vascular disorders
Hypertension
|
0.00%
0/127 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/238 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/293 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
11.7%
17/145 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
12.5%
8/64 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
6.3%
4/63 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
13.3%
16/120 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
5.1%
6/118 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/214 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/166 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/79 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
9.5%
14/148 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/26 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
11.1%
7/63 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
6.2%
3/48 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
6.8%
8/118 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
9.1%
6/66 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
9.5%
14/148 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/38 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/89 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
0.00%
0/72 • Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place