Trial Outcomes & Findings for A Study to Evaluate Efficacy and Safety of ALN-AGT01 in Patients With Mild To-Moderate Hypertension (NCT NCT04936035)
NCT ID: NCT04936035
Last Updated: 2025-12-23
Results Overview
24-hour ABPM 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 mean was the average of BP by 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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
394 participants
Primary outcome timeframe
Baseline and Month 3
Results posted on
2025-12-23
Participant Flow
Total of 86 clinical sites across North America \& 25 sites in Europe enrolled 394 participants. 16 participants from Ukraine were unable to continue participation due to geopolitical instability. Due to challenges in data collection \& cleaning, these participants were excluded from all analysis sets. Hence, results are presented for 378 randomized participants. Study has 2 periods: 6-Month Placebo-controlled Double-blind (DB) Period \& Post-6-Month DB Period \[DB (Months 6 to 12)+DB Extension\].
As pre-specified in SAP, data collected for the participant flow after '6-Month Placebo-controlled DB Period' (i.e., Months 6 to 12 DB period + DB Extension Period) was to be reported together as 'Post-6-Month DB Period' per treatment sequence (Pbo/Zil \& Zil/Zil). Before Protocol Amendment 6 (PA6), participants completing 12 months in this study could join a separate open-label extension (OLE) study. With PA6, the OLE study was canceled. Hence, the 24-month extension treatment was also ended.
Participant milestones
| Measure |
Placebo/Zilebesiran 600 mg Q6M
Participants who received placebo 6-month placebo-controlled DB period were re-randomized at Month 6 to 1 of the 4 initial zilebesiran regimens. Participants in this arm received zilebesiran, 600 mg, as SC injection Q6M after re-randomization for the remainder of the study. Participants received placebo at the visit where no zilebesiran dose was planned to maintain blinding between the Q3M and Q6M regimens.
Prior to PA6, participants who completed Months 6 to 12 of blinded treatment and pre-dose assessment at Month 12, before a separate OLE study was available, could continue receiving blinded zilebesiran treatment up to additional 24 months in the DB Extension Period. Following PA6, the DB Extension Period was discontinued. Participants who had not yet completed the Month 12 visit at the time of PA6 implementation received their last dose of study drug at Month 9. For participants already in the DB Extension Period at the time of PA6 implementation, dosing depended on scheduled visits: participants whose next visit was at Month 15, 21, 27, or 33 received their planned study drug, while those whose next visit was at Month 18, 24, 30, or 36 did not receive further study drug in the study.
|
Placebo
Participants received zilebesiran matching placebo, as subcutaneous (SC) injection, once every 3 months (Q3M) during the 6-month placebo-controlled double-blind (DB) period.
|
Zilebesiran 150 Milligrams (mg) Once Every 6 Months (Q6M)
Participants received zilebesiran, 150 mg, as SC injection on Day 1 of the 6-month placebo-controlled DB period. They received placebo at Month 3 of the 6-month placebo-controlled DB period to maintain the blind.
|
Zilebesiran 300 mg Q6M
Participants received zilebesiran, 300 mg, as SC injection on Day 1 of the 6-month placebo-controlled DB period. They received placebo at Month 3 of the 6-month placebo-controlled DB period to maintain the blind.
|
Zilebesiran 300 mg Q3M
Participants received zilebesiran, 300 mg, as SC injection, Q3M, during the 6-month placebo-controlled DB period.
|
Zilebesiran 600 mg Q6M
Participants received zilebesiran, 600 mg, as SC injection, on Day 1 of the 6-month placebo-controlled DB period. They received placebo at Month 3 of the 6-month placebo-controlled DB period to maintain the blind.
|
Placebo/Zilebesiran 150 mg Q6M
Participants who received placebo during the 6-month placebo-controlled DB period were re-randomized at Month 6 to 1 of the 4 initial zilebesiran regimens. Participants in this arm received zilebesiran, 150 mg, as SC injection Q6M after re-randomization for the remainder of the study. Participants received placebo at the visit where no zilebesiran dose was planned to maintain blind between the Q3M and Q6M regimens.
Prior to PA6, participants who completed Months 6 to 12 of blinded treatment and pre-dose assessment at Month 12, before a separate OLE study was available, could continue receiving blinded zilebesiran treatment up to additional 24 months in the DB Extension Period. Following PA6, the DB Extension Period was discontinued. Participants who had not yet completed the Month 12 visit at the time of PA6 implementation received their last dose of study drug at Month 9. For participants already in the DB Extension Period at the time of PA6 implementation, dosing depended on scheduled visits: participants whose next visit was at Month 15, 21, 27, or 33 received their planned study drug, while those whose next visit was at Month 18, 24, 30, or 36 did not receive further study drug in the study.
|
Placebo/Zilebesiran 300 mg Q6M
Participants who received placebo during the 6-month placebo-controlled DB period were re-randomized at Month 6 to 1 of the 4 initial zilebesiran regimens. Participants in this arm received zilebesiran, 300 mg, as SC injection Q6M after re-randomization for the remainder of the study. Participants received placebo at the visit where no zilebesiran dose was planned to maintain blinding between the Q3M and Q6M regimens.
Prior to PA6, participants who completed Months 6 to 12 of blinded treatment and pre-dose assessment at Month 12, before a separate OLE study was available, could continue receiving blinded zilebesiran treatment up to additional 24 months in the DB Extension Period. Following PA6, the DB Extension Period was discontinued. Participants who had not yet completed the Month 12 visit at the time of PA6 implementation received their last dose of study drug at Month 9. For participants already in the DB Extension Period at the time of PA6 implementation, dosing depended on scheduled visits: participants whose next visit was at Month 15, 21, 27, or 33 received their planned study drug, while those whose next visit was at Month 18, 24, 30, or 36 did not receive further study drug in the study.
|
Placebo/Zilebesiran 300 mg Q3M
Participants who received placebo during 6-month placebo-controlled DB period were re-randomized at Month 6 to 1 of the 4 initial zilebesiran regimens. Participants in this arm received zilebesiran, 300 mg, as SC injection Q3M after re-randomization for the remainder of the study.
Prior to PA6, participants who completed Months 6 to 12 of blinded treatment and pre-dose assessment at Month 12, before a separate OLE study was available, could continue receiving blinded zilebesiran treatment up to additional 24 months in the DB Extension Period. Following PA6, the DB Extension Period was discontinued. Participants who had not yet completed the Month 12 visit at the time of PA6 implementation received their last dose of study drug at Month 9. For participants already in the DB Extension Period at the time of PA6 implementation, dosing depended on scheduled visits: participants whose next visit was at Month 15, 21, 27, or 33 received their planned study drug, while those whose next visit was at Month 18, 24, 30, or 36 did not receive further study drug in the study.
|
Zilebesiran/Zilebesiran 150 mg Q6M
Participants who received zilebesiran 150 mg Q6M during the 6-month placebo-controlled DB period remained on the same regimen throughout the study. Participants received placebo at the visit where no zilebesiran dose was planned to maintain blinding between the Q3M and Q6M regimens.
Prior to PA6, participants who completed Months 6 to 12 of blinded treatment and pre-dose assessment at Month 12, before a separate OLE study was available, could continue receiving blinded zilebesiran treatment up to additional 24 months in the DB Extension Period. Following PA6, the DB Extension Period was discontinued. Participants who had not yet completed the Month 12 visit at the time of PA6 implementation received their last dose of study drug at Month 9. For participants already in the DB Extension Period at the time of PA6 implementation, dosing depended on scheduled visits: participants whose next visit was at Month 15, 21, 27, or 33 received their planned study drug, while those whose next visit was at Month 18, 24, 30, or 36 did not receive further study drug in the study.
|
Zilebesiran/Zilebesiran 300 mg Q6M
Participants who received zilebesiran 300 mg Q6M during the 6-month placebo-controlled DB period remained on the same regimen throughout the study. Participants received placebo at the visit where no zilebesiran dose was planned to maintain blinding between the Q3M and Q6M regimens.
Prior to PA6, participants who completed Months 6 to 12 of blinded treatment and pre-dose assessment at Month 12, before a separate OLE study was available, could continue receiving blinded zilebesiran treatment up to additional 24 months in the DB Extension Period. Following PA6, the DB Extension Period was discontinued. Participants who had not yet completed the Month 12 visit at the time of PA6 implementation received their last dose of study drug at Month 9. For participants already in the DB Extension Period at the time of PA6 implementation, dosing depended on scheduled visits: participants whose next visit was at Month 15, 21, 27, or 33 received their planned study drug, while those whose next visit was at Month 18, 24, 30, or 36 did not receive further study drug in the study.
|
Zilebesiran/Zilebesiran 300 mg Q3M
Participants who received zilebesiran 300 mg Q3M during the 6-month placebo-controlled DB period remained on the same regimen throughout the study.
Prior to PA6, participants who completed Months 6 to 12 of blinded treatment and pre-dose assessment at Month 12, before a separate OLE study was available, could continue receiving blinded zilebesiran treatment up to additional 24 months in the DB Extension Period. Following PA6, the DB Extension Period was discontinued. Participants who had not yet completed the Month 12 visit at the time of PA6 implementation received their last dose of study drug at Month 9. For participants already in the DB Extension Period at the time of PA6 implementation, dosing depended on scheduled visits: participants whose next visit was at Month 15, 21, 27, or 33 received their planned study drug, while those whose next visit was at Month 18, 24, 30, or 36 did not receive further study drug in the study.
|
Zilebesiran/Zilebesiran 600 mg Q6M
Participants who received zilebesiran 600 mg Q6M during the 6-month placebo-controlled DB period remained on the same regimen throughout the study. Participants received placebo at the visit where no zilebesiran dose was planned to maintain blinding between the Q3M and Q6M regimens.
Prior to PA6, participants who completed Months 6 to 12 of blinded treatment and pre-dose assessment at Month 12, before a separate OLE study was available, could continue receiving blinded zilebesiran treatment up to additional 24 months in the DB Extension Period. Following PA6, the DB Extension Period was discontinued. Participants who had not yet completed the Month 12 visit at the time of PA6 implementation received their last dose of study drug at Month 9. For participants already in the DB Extension Period at the time of PA6 implementation, dosing depended on scheduled visits: participants whose next visit was at Month 15, 21, 27, or 33 received their planned study drug, while those whose next visit was at Month 18, 24, 30, or 36 did not receive further study drug in the study.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
6-Month Placebo-controlled DB Period
STARTED
|
0
|
76
|
78
|
73
|
75
|
76
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
6-Month Placebo-controlled DB Period
COMPLETED
|
0
|
70
|
70
|
70
|
70
|
71
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
6-Month Placebo-controlled DB Period
NOT COMPLETED
|
0
|
6
|
8
|
3
|
5
|
5
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Post-6-Month DB Period (30months)
STARTED
|
18
|
0
|
0
|
0
|
0
|
0
|
17
|
17
|
16
|
69
|
67
|
66
|
65
|
|
Post-6-Month DB Period (30months)
Completed Month 12 Visit
|
18
|
0
|
0
|
0
|
0
|
0
|
13
|
16
|
16
|
65
|
62
|
65
|
61
|
|
Post-6-Month DB Period (30months)
COMPLETED
|
18
|
0
|
0
|
0
|
0
|
0
|
12
|
15
|
15
|
60
|
57
|
59
|
58
|
|
Post-6-Month DB Period (30months)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
5
|
2
|
1
|
9
|
10
|
7
|
7
|
Reasons for withdrawal
| Measure |
Placebo/Zilebesiran 600 mg Q6M
Participants who received placebo 6-month placebo-controlled DB period were re-randomized at Month 6 to 1 of the 4 initial zilebesiran regimens. Participants in this arm received zilebesiran, 600 mg, as SC injection Q6M after re-randomization for the remainder of the study. Participants received placebo at the visit where no zilebesiran dose was planned to maintain blinding between the Q3M and Q6M regimens.
Prior to PA6, participants who completed Months 6 to 12 of blinded treatment and pre-dose assessment at Month 12, before a separate OLE study was available, could continue receiving blinded zilebesiran treatment up to additional 24 months in the DB Extension Period. Following PA6, the DB Extension Period was discontinued. Participants who had not yet completed the Month 12 visit at the time of PA6 implementation received their last dose of study drug at Month 9. For participants already in the DB Extension Period at the time of PA6 implementation, dosing depended on scheduled visits: participants whose next visit was at Month 15, 21, 27, or 33 received their planned study drug, while those whose next visit was at Month 18, 24, 30, or 36 did not receive further study drug in the study.
|
Placebo
Participants received zilebesiran matching placebo, as subcutaneous (SC) injection, once every 3 months (Q3M) during the 6-month placebo-controlled double-blind (DB) period.
|
Zilebesiran 150 Milligrams (mg) Once Every 6 Months (Q6M)
Participants received zilebesiran, 150 mg, as SC injection on Day 1 of the 6-month placebo-controlled DB period. They received placebo at Month 3 of the 6-month placebo-controlled DB period to maintain the blind.
|
Zilebesiran 300 mg Q6M
Participants received zilebesiran, 300 mg, as SC injection on Day 1 of the 6-month placebo-controlled DB period. They received placebo at Month 3 of the 6-month placebo-controlled DB period to maintain the blind.
|
Zilebesiran 300 mg Q3M
Participants received zilebesiran, 300 mg, as SC injection, Q3M, during the 6-month placebo-controlled DB period.
|
Zilebesiran 600 mg Q6M
Participants received zilebesiran, 600 mg, as SC injection, on Day 1 of the 6-month placebo-controlled DB period. They received placebo at Month 3 of the 6-month placebo-controlled DB period to maintain the blind.
|
Placebo/Zilebesiran 150 mg Q6M
Participants who received placebo during the 6-month placebo-controlled DB period were re-randomized at Month 6 to 1 of the 4 initial zilebesiran regimens. Participants in this arm received zilebesiran, 150 mg, as SC injection Q6M after re-randomization for the remainder of the study. Participants received placebo at the visit where no zilebesiran dose was planned to maintain blind between the Q3M and Q6M regimens.
Prior to PA6, participants who completed Months 6 to 12 of blinded treatment and pre-dose assessment at Month 12, before a separate OLE study was available, could continue receiving blinded zilebesiran treatment up to additional 24 months in the DB Extension Period. Following PA6, the DB Extension Period was discontinued. Participants who had not yet completed the Month 12 visit at the time of PA6 implementation received their last dose of study drug at Month 9. For participants already in the DB Extension Period at the time of PA6 implementation, dosing depended on scheduled visits: participants whose next visit was at Month 15, 21, 27, or 33 received their planned study drug, while those whose next visit was at Month 18, 24, 30, or 36 did not receive further study drug in the study.
|
Placebo/Zilebesiran 300 mg Q6M
Participants who received placebo during the 6-month placebo-controlled DB period were re-randomized at Month 6 to 1 of the 4 initial zilebesiran regimens. Participants in this arm received zilebesiran, 300 mg, as SC injection Q6M after re-randomization for the remainder of the study. Participants received placebo at the visit where no zilebesiran dose was planned to maintain blinding between the Q3M and Q6M regimens.
Prior to PA6, participants who completed Months 6 to 12 of blinded treatment and pre-dose assessment at Month 12, before a separate OLE study was available, could continue receiving blinded zilebesiran treatment up to additional 24 months in the DB Extension Period. Following PA6, the DB Extension Period was discontinued. Participants who had not yet completed the Month 12 visit at the time of PA6 implementation received their last dose of study drug at Month 9. For participants already in the DB Extension Period at the time of PA6 implementation, dosing depended on scheduled visits: participants whose next visit was at Month 15, 21, 27, or 33 received their planned study drug, while those whose next visit was at Month 18, 24, 30, or 36 did not receive further study drug in the study.
|
Placebo/Zilebesiran 300 mg Q3M
Participants who received placebo during 6-month placebo-controlled DB period were re-randomized at Month 6 to 1 of the 4 initial zilebesiran regimens. Participants in this arm received zilebesiran, 300 mg, as SC injection Q3M after re-randomization for the remainder of the study.
Prior to PA6, participants who completed Months 6 to 12 of blinded treatment and pre-dose assessment at Month 12, before a separate OLE study was available, could continue receiving blinded zilebesiran treatment up to additional 24 months in the DB Extension Period. Following PA6, the DB Extension Period was discontinued. Participants who had not yet completed the Month 12 visit at the time of PA6 implementation received their last dose of study drug at Month 9. For participants already in the DB Extension Period at the time of PA6 implementation, dosing depended on scheduled visits: participants whose next visit was at Month 15, 21, 27, or 33 received their planned study drug, while those whose next visit was at Month 18, 24, 30, or 36 did not receive further study drug in the study.
|
Zilebesiran/Zilebesiran 150 mg Q6M
Participants who received zilebesiran 150 mg Q6M during the 6-month placebo-controlled DB period remained on the same regimen throughout the study. Participants received placebo at the visit where no zilebesiran dose was planned to maintain blinding between the Q3M and Q6M regimens.
Prior to PA6, participants who completed Months 6 to 12 of blinded treatment and pre-dose assessment at Month 12, before a separate OLE study was available, could continue receiving blinded zilebesiran treatment up to additional 24 months in the DB Extension Period. Following PA6, the DB Extension Period was discontinued. Participants who had not yet completed the Month 12 visit at the time of PA6 implementation received their last dose of study drug at Month 9. For participants already in the DB Extension Period at the time of PA6 implementation, dosing depended on scheduled visits: participants whose next visit was at Month 15, 21, 27, or 33 received their planned study drug, while those whose next visit was at Month 18, 24, 30, or 36 did not receive further study drug in the study.
|
Zilebesiran/Zilebesiran 300 mg Q6M
Participants who received zilebesiran 300 mg Q6M during the 6-month placebo-controlled DB period remained on the same regimen throughout the study. Participants received placebo at the visit where no zilebesiran dose was planned to maintain blinding between the Q3M and Q6M regimens.
Prior to PA6, participants who completed Months 6 to 12 of blinded treatment and pre-dose assessment at Month 12, before a separate OLE study was available, could continue receiving blinded zilebesiran treatment up to additional 24 months in the DB Extension Period. Following PA6, the DB Extension Period was discontinued. Participants who had not yet completed the Month 12 visit at the time of PA6 implementation received their last dose of study drug at Month 9. For participants already in the DB Extension Period at the time of PA6 implementation, dosing depended on scheduled visits: participants whose next visit was at Month 15, 21, 27, or 33 received their planned study drug, while those whose next visit was at Month 18, 24, 30, or 36 did not receive further study drug in the study.
|
Zilebesiran/Zilebesiran 300 mg Q3M
Participants who received zilebesiran 300 mg Q3M during the 6-month placebo-controlled DB period remained on the same regimen throughout the study.
Prior to PA6, participants who completed Months 6 to 12 of blinded treatment and pre-dose assessment at Month 12, before a separate OLE study was available, could continue receiving blinded zilebesiran treatment up to additional 24 months in the DB Extension Period. Following PA6, the DB Extension Period was discontinued. Participants who had not yet completed the Month 12 visit at the time of PA6 implementation received their last dose of study drug at Month 9. For participants already in the DB Extension Period at the time of PA6 implementation, dosing depended on scheduled visits: participants whose next visit was at Month 15, 21, 27, or 33 received their planned study drug, while those whose next visit was at Month 18, 24, 30, or 36 did not receive further study drug in the study.
|
Zilebesiran/Zilebesiran 600 mg Q6M
Participants who received zilebesiran 600 mg Q6M during the 6-month placebo-controlled DB period remained on the same regimen throughout the study. Participants received placebo at the visit where no zilebesiran dose was planned to maintain blinding between the Q3M and Q6M regimens.
Prior to PA6, participants who completed Months 6 to 12 of blinded treatment and pre-dose assessment at Month 12, before a separate OLE study was available, could continue receiving blinded zilebesiran treatment up to additional 24 months in the DB Extension Period. Following PA6, the DB Extension Period was discontinued. Participants who had not yet completed the Month 12 visit at the time of PA6 implementation received their last dose of study drug at Month 9. For participants already in the DB Extension Period at the time of PA6 implementation, dosing depended on scheduled visits: participants whose next visit was at Month 15, 21, 27, or 33 received their planned study drug, while those whose next visit was at Month 18, 24, 30, or 36 did not receive further study drug in the study.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
6-Month Placebo-controlled DB Period
Adverse Event
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
6-Month Placebo-controlled DB Period
Death
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
6-Month Placebo-controlled DB Period
Lost to Follow-up
|
0
|
0
|
1
|
1
|
2
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
6-Month Placebo-controlled DB Period
Physician Decision
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
6-Month Placebo-controlled DB Period
Protocol Deviation
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
6-Month Placebo-controlled DB Period
Subject Stopped Participation in the Study
|
0
|
5
|
5
|
1
|
2
|
3
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
6-Month Placebo-controlled DB Period
Reason Unknown
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
6-Month Placebo-controlled DB Period
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Post-6-Month DB Period (30months)
Participant Stopped Participation in the Study
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
1
|
0
|
2
|
7
|
5
|
3
|
|
Post-6-Month DB Period (30months)
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
3
|
1
|
1
|
4
|
|
Post-6-Month DB Period (30months)
Physician Decision
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
1
|
0
|
|
Post-6-Month DB Period (30months)
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Post-6-Month DB Period (30months)
Death
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Post-6-Month DB Period (30months)
Reason Not Specified
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
1
|
2
|
0
|
0
|
Baseline Characteristics
A Study to Evaluate Efficacy and Safety of ALN-AGT01 in Patients With Mild To-Moderate Hypertension
Baseline characteristics by cohort
| Measure |
Placebo
n=75 Participants
Participants received zilebesiran matching placebo, as SC injection, Q3M during the 6-month placebo-controlled DB period.
|
Zilebesiran 150 mg Q6M
n=78 Participants
Participants received zilebesiran, 150 mg, as SC injection on Day 1 of the 6-month placebo-controlled DB period. They received placebo at Month 3 of the 6-month placebo-controlled DB period to maintain the blind.
|
Zilebesiran 300 mg Q6M
n=73 Participants
Participants received zilebesiran, 300 mg, as SC injection on Day 1 of the 6-month placebo-controlled DB period. They received placebo at Month 3 of the 6-month placebo-controlled DB period to maintain the blind.
|
Zilebesiran 300 mg Q3M
n=75 Participants
Participants received zilebesiran, 300 mg, as SC injection, Q3M, during the 6-month placebo-controlled DB period.
|
Zilebesiran 600 mg Q6M
n=76 Participants
Participants received zilebesiran, 600 mg, as SC injection, on Day 1 of the 6-month placebo-controlled DB period. They received placebo at Month 3 of the 6-month placebo-controlled DB period to maintain the blind.
|
Total
n=377 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
56.8 years
STANDARD_DEVIATION 11.2 • n=68 Participants
|
55.5 years
STANDARD_DEVIATION 10.6 • n=4 Participants
|
56.4 years
STANDARD_DEVIATION 10.3 • n=219 Participants
|
57.7 years
STANDARD_DEVIATION 10.6 • n=219 Participants
|
57.4 years
STANDARD_DEVIATION 10.2 • n=880 Participants
|
56.8 years
STANDARD_DEVIATION 10.6 • n=6 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=68 Participants
|
39 Participants
n=4 Participants
|
29 Participants
n=219 Participants
|
30 Participants
n=219 Participants
|
31 Participants
n=880 Participants
|
167 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=68 Participants
|
39 Participants
n=4 Participants
|
44 Participants
n=219 Participants
|
45 Participants
n=219 Participants
|
45 Participants
n=880 Participants
|
210 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=68 Participants
|
19 Participants
n=4 Participants
|
16 Participants
n=219 Participants
|
10 Participants
n=219 Participants
|
20 Participants
n=880 Participants
|
74 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
66 Participants
n=68 Participants
|
59 Participants
n=4 Participants
|
57 Participants
n=219 Participants
|
65 Participants
n=219 Participants
|
56 Participants
n=880 Participants
|
303 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=68 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=219 Participants
|
0 Participants
n=219 Participants
|
0 Participants
n=880 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=68 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=219 Participants
|
0 Participants
n=219 Participants
|
0 Participants
n=880 Participants
|
1 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=68 Participants
|
4 Participants
n=4 Participants
|
2 Participants
n=219 Participants
|
7 Participants
n=219 Participants
|
5 Participants
n=880 Participants
|
23 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=68 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=219 Participants
|
1 Participants
n=219 Participants
|
0 Participants
n=880 Participants
|
1 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Black or African American
|
18 Participants
n=68 Participants
|
20 Participants
n=4 Participants
|
17 Participants
n=219 Participants
|
19 Participants
n=219 Participants
|
19 Participants
n=880 Participants
|
93 Participants
n=6 Participants
|
|
Race (NIH/OMB)
White
|
52 Participants
n=68 Participants
|
53 Participants
n=4 Participants
|
54 Participants
n=219 Participants
|
48 Participants
n=219 Participants
|
52 Participants
n=880 Participants
|
259 Participants
n=6 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=68 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=219 Participants
|
0 Participants
n=219 Participants
|
0 Participants
n=880 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=68 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=219 Participants
|
0 Participants
n=219 Participants
|
0 Participants
n=880 Participants
|
0 Participants
n=6 Participants
|
|
24-hour Mean Systolic Blood Pressure (SBP) Assessed by Ambulatory Blood Pressure Monitoring (ABPM)
|
141.1 millimeter of mercury (mmHg)
STANDARD_DEVIATION 7.9 • n=68 Participants
|
140.6 millimeter of mercury (mmHg)
STANDARD_DEVIATION 8.5 • n=4 Participants
|
142.5 millimeter of mercury (mmHg)
STANDARD_DEVIATION 8.8 • n=219 Participants
|
141.6 millimeter of mercury (mmHg)
STANDARD_DEVIATION 7.7 • n=219 Participants
|
143.1 millimeter of mercury (mmHg)
STANDARD_DEVIATION 9.0 • n=880 Participants
|
141.8 millimeter of mercury (mmHg)
STANDARD_DEVIATION 8.4 • n=6 Participants
|
PRIMARY outcome
Timeframe: Baseline and Month 3Population: The Full Analysis Set included all randomized participants who received any amount of the study drug. Overall number analyzed is the number of participants with data available for analyses. As pre-specified in the SAP, for assessment of Month 3 outcome measures, zilebesiran 300mg Q3M and 300mg Q6M were pooled together.
24-hour ABPM 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 mean was the average of BP by 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.
Outcome measures
| Measure |
Zilebesiran 150 mg Q6M
n=68 Participants
Participants received zilebesiran, 150 mg, as SC injection on Day 1 of the 6-month placebo-controlled DB period. They received placebo at Month 3 of the 6-month placebo-controlled DB period to maintain the blind.
|
Zilebesiran 300 mg Q6M
n=137 Participants
Participants received zilebesiran, 300 mg, as SC injection on Day 1 of the 6-month placebo-controlled DB period. They received placebo at Month 3 of the 6-month placebo-controlled DB period to maintain the blind.
|
Zilebesiran 300 mg Q3M
n=65 Participants
Participants received zilebesiran, 300 mg, as SC injection, Q3M, during the 6-month placebo-controlled DB period.
|
Zilebesiran 600 mg Q6M
Participants received zilebesiran, 600 mg, as SC injection, on Day 1 of the 6-month placebo-controlled DB period. They received placebo at Month 3 of the 6-month placebo-controlled DB period to maintain the blind.
|
Placebo
n=60 Participants
Participants received zilebesiran matching placebo, as SC injection, Q3M during the 6-month placebo-controlled DB period.
|
|---|---|---|---|---|---|
|
Change From Baseline at Month 3 in 24-hour Mean SBP Assessed by ABPM
|
-7.3 millimeters of mercury (mmHg)
Standard Error 1.49
|
-10.0 millimeters of mercury (mmHg)
Standard Error 1.05
|
-8.9 millimeters of mercury (mmHg)
Standard Error 1.52
|
—
|
6.8 millimeters of mercury (mmHg)
Standard Error 1.58
|
SECONDARY outcome
Timeframe: Baseline and Month 3Population: The Full Analysis Set included all randomized participants who received any amount of the study drug. Overall number analyzed is the number of participants with data available for analyses. As pre-specified in the SAP, for assessment of Month 3 outcome measures, zilebesiran 300mg Q3M and 300mg Q6M were pooled together.
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.
Outcome measures
| Measure |
Zilebesiran 150 mg Q6M
n=68 Participants
Participants received zilebesiran, 150 mg, as SC injection on Day 1 of the 6-month placebo-controlled DB period. They received placebo at Month 3 of the 6-month placebo-controlled DB period to maintain the blind.
|
Zilebesiran 300 mg Q6M
n=133 Participants
Participants received zilebesiran, 300 mg, as SC injection on Day 1 of the 6-month placebo-controlled DB period. They received placebo at Month 3 of the 6-month placebo-controlled DB period to maintain the blind.
|
Zilebesiran 300 mg Q3M
n=64 Participants
Participants received zilebesiran, 300 mg, as SC injection, Q3M, during the 6-month placebo-controlled DB period.
|
Zilebesiran 600 mg Q6M
Participants received zilebesiran, 600 mg, as SC injection, on Day 1 of the 6-month placebo-controlled DB period. They received placebo at Month 3 of the 6-month placebo-controlled DB period to maintain the blind.
|
Placebo
n=60 Participants
Participants received zilebesiran matching placebo, as SC injection, Q3M during the 6-month placebo-controlled DB period.
|
|---|---|---|---|---|---|
|
Change From Baseline at Month 3 in Mean Sitting Office SBP
|
-9.7 mmHg
Standard Error 1.49
|
-12.1 mmHg
Standard Error 1.06
|
-9.2 mmHg
Standard Error 1.52
|
—
|
-0.1 mmHg
Standard Error 1.57
|
SECONDARY outcome
Timeframe: Baseline and Month 6Population: The Full Analysis Set included all randomized participants who received any amount of the study drug. Overall number analyzed is the number of participants with data available for analyses.
24-hour ABPM 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 mean was the average of blood pressure (BP) by 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.
Outcome measures
| Measure |
Zilebesiran 150 mg Q6M
n=62 Participants
Participants received zilebesiran, 150 mg, as SC injection on Day 1 of the 6-month placebo-controlled DB period. They received placebo at Month 3 of the 6-month placebo-controlled DB period to maintain the blind.
|
Zilebesiran 300 mg Q6M
n=68 Participants
Participants received zilebesiran, 300 mg, as SC injection on Day 1 of the 6-month placebo-controlled DB period. They received placebo at Month 3 of the 6-month placebo-controlled DB period to maintain the blind.
|
Zilebesiran 300 mg Q3M
n=60 Participants
Participants received zilebesiran, 300 mg, as SC injection, Q3M, during the 6-month placebo-controlled DB period.
|
Zilebesiran 600 mg Q6M
n=63 Participants
Participants received zilebesiran, 600 mg, as SC injection, on Day 1 of the 6-month placebo-controlled DB period. They received placebo at Month 3 of the 6-month placebo-controlled DB period to maintain the blind.
|
Placebo
n=54 Participants
Participants received zilebesiran matching placebo, as SC injection, Q3M during the 6-month placebo-controlled DB period.
|
|---|---|---|---|---|---|
|
Change From Baseline at Month 6 in 24-hour Mean SBP Assessed by ABPM
|
-6.5 mmHg
Standard Error 1.63
|
-9.9 mmHg
Standard Error 1.58
|
-9.5 mmHg
Standard Error 1.65
|
-9.6 mmHg
Standard Error 1.62
|
4.6 mmHg
Standard Error 1.73
|
SECONDARY outcome
Timeframe: Baseline and Month 6Population: The Full Analysis Set included all randomized participants who received any amount of the study drug. Overall number analyzed is the number of participants with data available for analyses.
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.
Outcome measures
| Measure |
Zilebesiran 150 mg Q6M
n=65 Participants
Participants received zilebesiran, 150 mg, as SC injection on Day 1 of the 6-month placebo-controlled DB period. They received placebo at Month 3 of the 6-month placebo-controlled DB period to maintain the blind.
|
Zilebesiran 300 mg Q6M
n=68 Participants
Participants received zilebesiran, 300 mg, as SC injection on Day 1 of the 6-month placebo-controlled DB period. They received placebo at Month 3 of the 6-month placebo-controlled DB period to maintain the blind.
|
Zilebesiran 300 mg Q3M
n=57 Participants
Participants received zilebesiran, 300 mg, as SC injection, Q3M, during the 6-month placebo-controlled DB period.
|
Zilebesiran 600 mg Q6M
n=62 Participants
Participants received zilebesiran, 600 mg, as SC injection, on Day 1 of the 6-month placebo-controlled DB period. They received placebo at Month 3 of the 6-month placebo-controlled DB period to maintain the blind.
|
Placebo
n=57 Participants
Participants received zilebesiran matching placebo, as SC injection, Q3M during the 6-month placebo-controlled DB period.
|
|---|---|---|---|---|---|
|
Change From Baseline at Month 6 in Mean Sitting Office SBP
|
-8.2 mmHg
Standard Error 1.70
|
-11.1 mmHg
Standard Error 1.67
|
-12.8 mmHg
Standard Error 1.80
|
-10.8 mmHg
Standard Error 1.73
|
-0.6 mmHg
Standard Error 1.80
|
SECONDARY outcome
Timeframe: Month 6Population: The Full Analysis Set included all randomized participants who received any amount of the study drug.
24-hour ABPM 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 mean was the average of blood pressure (BP) by each hour of the day. The 24-hour mean was the average of the hourly means.
Outcome measures
| Measure |
Zilebesiran 150 mg Q6M
n=78 Participants
Participants received zilebesiran, 150 mg, as SC injection on Day 1 of the 6-month placebo-controlled DB period. They received placebo at Month 3 of the 6-month placebo-controlled DB period to maintain the blind.
|
Zilebesiran 300 mg Q6M
n=73 Participants
Participants received zilebesiran, 300 mg, as SC injection on Day 1 of the 6-month placebo-controlled DB period. They received placebo at Month 3 of the 6-month placebo-controlled DB period to maintain the blind.
|
Zilebesiran 300 mg Q3M
n=75 Participants
Participants received zilebesiran, 300 mg, as SC injection, Q3M, during the 6-month placebo-controlled DB period.
|
Zilebesiran 600 mg Q6M
n=76 Participants
Participants received zilebesiran, 600 mg, as SC injection, on Day 1 of the 6-month placebo-controlled DB period. They received placebo at Month 3 of the 6-month placebo-controlled DB period to maintain the blind.
|
Placebo
n=75 Participants
Participants received zilebesiran matching placebo, as SC injection, Q3M during the 6-month placebo-controlled DB period.
|
|---|---|---|---|---|---|
|
Percentage of Participants With 24-hour Mean SBP Assessed by ABPM <130 mmHg and/or Reduction of ≥20 mmHg From Baseline Without Additional Antihypertensive Medications at Month 6
|
30.8 percentage of participants
|
50.7 percentage of participants
|
38.7 percentage of participants
|
47.4 percentage of participants
|
6.7 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Month 3Population: The Full Analysis Set included all randomized participants who received any amount of the study drug. Overall number analyzed is the number of participants with data available for analyses. As pre-specified in the SAP, for assessment of Month 3 outcome measures, zilebesiran 300mg Q3M and 300mg Q6M were pooled together.
24-hour ABPM 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 mean was the average of blood pressure (BP) by 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.
Outcome measures
| Measure |
Zilebesiran 150 mg Q6M
n=68 Participants
Participants received zilebesiran, 150 mg, as SC injection on Day 1 of the 6-month placebo-controlled DB period. They received placebo at Month 3 of the 6-month placebo-controlled DB period to maintain the blind.
|
Zilebesiran 300 mg Q6M
n=137 Participants
Participants received zilebesiran, 300 mg, as SC injection on Day 1 of the 6-month placebo-controlled DB period. They received placebo at Month 3 of the 6-month placebo-controlled DB period to maintain the blind.
|
Zilebesiran 300 mg Q3M
n=65 Participants
Participants received zilebesiran, 300 mg, as SC injection, Q3M, during the 6-month placebo-controlled DB period.
|
Zilebesiran 600 mg Q6M
Participants received zilebesiran, 600 mg, as SC injection, on Day 1 of the 6-month placebo-controlled DB period. They received placebo at Month 3 of the 6-month placebo-controlled DB period to maintain the blind.
|
Placebo
n=60 Participants
Participants received zilebesiran matching placebo, as SC injection, Q3M during the 6-month placebo-controlled DB period.
|
|---|---|---|---|---|---|
|
Change From Baseline at Month 3 in 24-hour Mean DBP Assessed by ABPM
|
-4.5 mmHg
Standard Error 0.82
|
-5.7 mmHg
Standard Error 0.58
|
-5.8 mmHg
Standard Error 0.84
|
—
|
3.5 mmHg
Standard Error 0.87
|
SECONDARY outcome
Timeframe: Baseline and Month 6Population: The Full Analysis Set included all randomized participants who received any amount of the study drug. Overall number analyzed is the number of participants with data available for analyses.
24-hour ABPM 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 mean was the average of blood pressure (BP) by 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
Outcome measures
| Measure |
Zilebesiran 150 mg Q6M
n=62 Participants
Participants received zilebesiran, 150 mg, as SC injection on Day 1 of the 6-month placebo-controlled DB period. They received placebo at Month 3 of the 6-month placebo-controlled DB period to maintain the blind.
|
Zilebesiran 300 mg Q6M
n=68 Participants
Participants received zilebesiran, 300 mg, as SC injection on Day 1 of the 6-month placebo-controlled DB period. They received placebo at Month 3 of the 6-month placebo-controlled DB period to maintain the blind.
|
Zilebesiran 300 mg Q3M
n=60 Participants
Participants received zilebesiran, 300 mg, as SC injection, Q3M, during the 6-month placebo-controlled DB period.
|
Zilebesiran 600 mg Q6M
n=63 Participants
Participants received zilebesiran, 600 mg, as SC injection, on Day 1 of the 6-month placebo-controlled DB period. They received placebo at Month 3 of the 6-month placebo-controlled DB period to maintain the blind.
|
Placebo
n=54 Participants
Participants received zilebesiran matching placebo, as SC injection, Q3M during the 6-month placebo-controlled DB period.
|
|---|---|---|---|---|---|
|
Change From Baseline at Month 6 in 24-hour Mean DBP Assessed by ABPM
|
-4.8 mmHg
Standard Error 0.91
|
-6.1 mmHg
Standard Error 0.89
|
-6.3 mmHg
Standard Error 0.93
|
-6.3 mmHg
Standard Error 0.91
|
2.2 mmHg
Standard Error 0.97
|
SECONDARY outcome
Timeframe: Baseline and Month 3Population: The Full Analysis Set included all randomized participants who received any amount of the study drug. Overall number analyzed is the number of participants with data available for analyses. As pre-specified in the SAP, for assessment of Month 3 outcome measures, zilebesiran 300mg Q3M and 300mg Q6M were pooled together.
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.
Outcome measures
| Measure |
Zilebesiran 150 mg Q6M
n=68 Participants
Participants received zilebesiran, 150 mg, as SC injection on Day 1 of the 6-month placebo-controlled DB period. They received placebo at Month 3 of the 6-month placebo-controlled DB period to maintain the blind.
|
Zilebesiran 300 mg Q6M
n=133 Participants
Participants received zilebesiran, 300 mg, as SC injection on Day 1 of the 6-month placebo-controlled DB period. They received placebo at Month 3 of the 6-month placebo-controlled DB period to maintain the blind.
|
Zilebesiran 300 mg Q3M
n=64 Participants
Participants received zilebesiran, 300 mg, as SC injection, Q3M, during the 6-month placebo-controlled DB period.
|
Zilebesiran 600 mg Q6M
Participants received zilebesiran, 600 mg, as SC injection, on Day 1 of the 6-month placebo-controlled DB period. They received placebo at Month 3 of the 6-month placebo-controlled DB period to maintain the blind.
|
Placebo
n=60 Participants
Participants received zilebesiran matching placebo, as SC injection, Q3M during the 6-month placebo-controlled DB period.
|
|---|---|---|---|---|---|
|
Change From Baseline at Month 3 in Mean Sitting Office DBP
|
-5.3 mmHg
Standard Error 0.94
|
-7.0 mmHg
Standard Error 0.67
|
-5.4 mmHg
Standard Error 0.97
|
—
|
-0.6 mmHg
Standard Error 1.00
|
SECONDARY outcome
Timeframe: Baseline and Month 3Population: The Full Analysis Set included all randomized participants who received any amount of the study drug. Overall number analyzed is the number of participants with data available for analyses. As pre-specified in the SAP, for assessment of Month 3 outcome measures, zilebesiran 300mg Q3M and 300mg Q6M were pooled together.
Time adjusted change from baseline in mean sitting office SBP and DBP was the area under the curve (AUC) between Month 1 and 3 visits divided by the duration of time period.
Outcome measures
| Measure |
Zilebesiran 150 mg Q6M
n=68 Participants
Participants received zilebesiran, 150 mg, as SC injection on Day 1 of the 6-month placebo-controlled DB period. They received placebo at Month 3 of the 6-month placebo-controlled DB period to maintain the blind.
|
Zilebesiran 300 mg Q6M
n=133 Participants
Participants received zilebesiran, 300 mg, as SC injection on Day 1 of the 6-month placebo-controlled DB period. They received placebo at Month 3 of the 6-month placebo-controlled DB period to maintain the blind.
|
Zilebesiran 300 mg Q3M
n=64 Participants
Participants received zilebesiran, 300 mg, as SC injection, Q3M, during the 6-month placebo-controlled DB period.
|
Zilebesiran 600 mg Q6M
Participants received zilebesiran, 600 mg, as SC injection, on Day 1 of the 6-month placebo-controlled DB period. They received placebo at Month 3 of the 6-month placebo-controlled DB period to maintain the blind.
|
Placebo
n=60 Participants
Participants received zilebesiran matching placebo, as SC injection, Q3M during the 6-month placebo-controlled DB period.
|
|---|---|---|---|---|---|
|
Time Adjusted Change From Baseline Through Month 3 in Mean Sitting Office SBP and DBP
Office SBP
|
-9.1 mmHg
Standard Error 1.24
|
-10.9 mmHg
Standard Error 0.89
|
-10.1 mmHg
Standard Error 1.26
|
—
|
-0.6 mmHg
Standard Error 1.29
|
|
Time Adjusted Change From Baseline Through Month 3 in Mean Sitting Office SBP and DBP
Office DBP
|
-4.8 mmHg
Standard Error 0.77
|
-6.5 mmHg
Standard Error 0.55
|
-6.0 mmHg
Standard Error 0.78
|
—
|
-0.0 mmHg
Standard Error 0.80
|
SECONDARY outcome
Timeframe: Baseline and Month 6Population: The Full Analysis Set included all randomized participants who received any amount of the study drug. Overall number analyzed is the number of participants with data available for analyses.
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.
Outcome measures
| Measure |
Zilebesiran 150 mg Q6M
n=65 Participants
Participants received zilebesiran, 150 mg, as SC injection on Day 1 of the 6-month placebo-controlled DB period. They received placebo at Month 3 of the 6-month placebo-controlled DB period to maintain the blind.
|
Zilebesiran 300 mg Q6M
n=68 Participants
Participants received zilebesiran, 300 mg, as SC injection on Day 1 of the 6-month placebo-controlled DB period. They received placebo at Month 3 of the 6-month placebo-controlled DB period to maintain the blind.
|
Zilebesiran 300 mg Q3M
n=57 Participants
Participants received zilebesiran, 300 mg, as SC injection, Q3M, during the 6-month placebo-controlled DB period.
|
Zilebesiran 600 mg Q6M
n=62 Participants
Participants received zilebesiran, 600 mg, as SC injection, on Day 1 of the 6-month placebo-controlled DB period. They received placebo at Month 3 of the 6-month placebo-controlled DB period to maintain the blind.
|
Placebo
n=57 Participants
Participants received zilebesiran matching placebo, as SC injection, Q3M during the 6-month placebo-controlled DB period.
|
|---|---|---|---|---|---|
|
Change From Baseline at Month 6 in Mean Sitting Office DBP
|
-4.1 mmHg
Standard Error 1.13
|
-6.8 mmHg
Standard Error 1.12
|
-8.2 mmHg
Standard Error 1.20
|
-5.0 mmHg
Standard Error 1.16
|
-1.2 mmHg
Standard Error 1.20
|
SECONDARY outcome
Timeframe: Baseline and Month 6Population: The Full Analysis Set included all randomized participants who received any amount of the study drug. Overall number analyzed is the number of participants with data available for analyses.
Time adjusted change from baseline through Month 6 in 24-hour mean SBP and DBP was determined as the AUC between Month 1 and 6 visits divided by the duration of the time period.
Outcome measures
| Measure |
Zilebesiran 150 mg Q6M
n=62 Participants
Participants received zilebesiran, 150 mg, as SC injection on Day 1 of the 6-month placebo-controlled DB period. They received placebo at Month 3 of the 6-month placebo-controlled DB period to maintain the blind.
|
Zilebesiran 300 mg Q6M
n=68 Participants
Participants received zilebesiran, 300 mg, as SC injection on Day 1 of the 6-month placebo-controlled DB period. They received placebo at Month 3 of the 6-month placebo-controlled DB period to maintain the blind.
|
Zilebesiran 300 mg Q3M
n=60 Participants
Participants received zilebesiran, 300 mg, as SC injection, Q3M, during the 6-month placebo-controlled DB period.
|
Zilebesiran 600 mg Q6M
n=63 Participants
Participants received zilebesiran, 600 mg, as SC injection, on Day 1 of the 6-month placebo-controlled DB period. They received placebo at Month 3 of the 6-month placebo-controlled DB period to maintain the blind.
|
Placebo
n=54 Participants
Participants received zilebesiran matching placebo, as SC injection, Q3M during the 6-month placebo-controlled DB period.
|
|---|---|---|---|---|---|
|
Time Adjusted Change From Baseline Through Month 6 in 24-hour Mean SBP and DBP Assessed by ABPM
24-hour Mean SBP
|
-6.3 mmHg
Standard Error 1.20
|
-9.2 mmHg
Standard Error 1.20
|
-9.6 mmHg
Standard Error 1.22
|
-9.1 mmHg
Standard Error 1.22
|
5.8 mmHg
Standard Error 1.26
|
|
Time Adjusted Change From Baseline Through Month 6 in 24-hour Mean SBP and DBP Assessed by ABPM
24-hour Mean DBP
|
-4.2 mmHg
Standard Error 0.69
|
-5.5 mmHg
Standard Error 0.69
|
-5.8 mmHg
Standard Error 0.70
|
-5.9 mmHg
Standard Error 0.70
|
3.1 mmHg
Standard Error 0.72
|
SECONDARY outcome
Timeframe: Baseline and Month 6Population: The Full Analysis Set included all randomized participants who received any amount of the study drug. Overall number analyzed is the number of participants with data available for analyses.
Time adjusted change is the AUC between Month 1 and 6 visits divided by the duration of time period.
Outcome measures
| Measure |
Zilebesiran 150 mg Q6M
n=65 Participants
Participants received zilebesiran, 150 mg, as SC injection on Day 1 of the 6-month placebo-controlled DB period. They received placebo at Month 3 of the 6-month placebo-controlled DB period to maintain the blind.
|
Zilebesiran 300 mg Q6M
n=68 Participants
Participants received zilebesiran, 300 mg, as SC injection on Day 1 of the 6-month placebo-controlled DB period. They received placebo at Month 3 of the 6-month placebo-controlled DB period to maintain the blind.
|
Zilebesiran 300 mg Q3M
n=57 Participants
Participants received zilebesiran, 300 mg, as SC injection, Q3M, during the 6-month placebo-controlled DB period.
|
Zilebesiran 600 mg Q6M
n=62 Participants
Participants received zilebesiran, 600 mg, as SC injection, on Day 1 of the 6-month placebo-controlled DB period. They received placebo at Month 3 of the 6-month placebo-controlled DB period to maintain the blind.
|
Placebo
n=57 Participants
Participants received zilebesiran matching placebo, as SC injection, Q3M during the 6-month placebo-controlled DB period.
|
|---|---|---|---|---|---|
|
Time Adjusted Change From Baseline Through Month 6 in Mean Sitting Office SBP and DBP
Office SBP
|
-9.0 mmHg
Standard Error 1.20
|
-12.1 mmHg
Standard Error 1.21
|
-11.0 mmHg
Standard Error 1.24
|
-10.0 mmHg
Standard Error 1.22
|
-0.5 mmHg
Standard Error 1.25
|
|
Time Adjusted Change From Baseline Through Month 6 in Mean Sitting Office SBP and DBP
Office DBP
|
-4.7 mmHg
Standard Error 0.76
|
-7.2 mmHg
Standard Error 0.77
|
-6.7 mmHg
Standard Error 0.79
|
-5.5 mmHg
Standard Error 0.78
|
-0.6 mmHg
Standard Error 0.80
|
SECONDARY outcome
Timeframe: Baseline, and Months 1, 3 and 6Population: The Full Analysis Set included all randomized participants who received any amount of the study drug. Overall number analyzed is the number of participants with data available for analyses. Number analyzed is the number of participants with data available for analyses at specified timepoints.
ABPM 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). Baseline was defined as the last assessment prior to receiving the first dose of study drug. LS mean and SE were calculated using a MMRM approach.
Outcome measures
| Measure |
Zilebesiran 150 mg Q6M
n=72 Participants
Participants received zilebesiran, 150 mg, as SC injection on Day 1 of the 6-month placebo-controlled DB period. They received placebo at Month 3 of the 6-month placebo-controlled DB period to maintain the blind.
|
Zilebesiran 300 mg Q6M
n=70 Participants
Participants received zilebesiran, 300 mg, as SC injection on Day 1 of the 6-month placebo-controlled DB period. They received placebo at Month 3 of the 6-month placebo-controlled DB period to maintain the blind.
|
Zilebesiran 300 mg Q3M
n=71 Participants
Participants received zilebesiran, 300 mg, as SC injection, Q3M, during the 6-month placebo-controlled DB period.
|
Zilebesiran 600 mg Q6M
n=69 Participants
Participants received zilebesiran, 600 mg, as SC injection, on Day 1 of the 6-month placebo-controlled DB period. They received placebo at Month 3 of the 6-month placebo-controlled DB period to maintain the blind.
|
Placebo
n=67 Participants
Participants received zilebesiran matching placebo, as SC injection, Q3M during the 6-month placebo-controlled DB period.
|
|---|---|---|---|---|---|
|
Change From Baseline in Daytime/Nighttime Mean SBP and DBP Assessed by ABPM at Each Visit
Change in Daytime Mean SBP at Month 1
|
-3.6 mmHg
Standard Error 1.45
|
-6.4 mmHg
Standard Error 1.51
|
-9.6 mmHg
Standard Error 1.46
|
-9.1 mmHg
Standard Error 1.48
|
4.3 mmHg
Standard Error 1.50
|
|
Change From Baseline in Daytime/Nighttime Mean SBP and DBP Assessed by ABPM at Each Visit
Change in Daytime Mean SBP at Month 3
|
-7.6 mmHg
Standard Error 1.53
|
-10.7 mmHg
Standard Error 1.52
|
-9.8 mmHg
Standard Error 1.54
|
-8.9 mmHg
Standard Error 1.56
|
6.7 mmHg
Standard Error 1.62
|
|
Change From Baseline in Daytime/Nighttime Mean SBP and DBP Assessed by ABPM at Each Visit
Change in Nighttime Mean SBP at Month 3
|
-6.4 mmHg
Standard Error 1.76
|
-8.2 mmHg
Standard Error 1.74
|
-9.7 mmHg
Standard Error 1.77
|
-8.5 mmHg
Standard Error 1.79
|
7.0 mmHg
Standard Error 1.85
|
|
Change From Baseline in Daytime/Nighttime Mean SBP and DBP Assessed by ABPM at Each Visit
Change in Nighttime Mean SBP at Month 6
|
-5.8 mmHg
Standard Error 1.75
|
-8.9 mmHg
Standard Error 1.69
|
-10.2 mmHg
Standard Error 1.78
|
-11.1 mmHg
Standard Error 1.74
|
4.7 mmHg
Standard Error 1.86
|
|
Change From Baseline in Daytime/Nighttime Mean SBP and DBP Assessed by ABPM at Each Visit
Change in Daytime Mean DBP at Month 1
|
-2.7 mmHg
Standard Error 0.88
|
-4.0 mmHg
Standard Error 0.91
|
-5.9 mmHg
Standard Error 0.89
|
-5.8 mmHg
Standard Error 0.89
|
2.9 mmHg
Standard Error 0.91
|
|
Change From Baseline in Daytime/Nighttime Mean SBP and DBP Assessed by ABPM at Each Visit
Change in Nighttime Mean DBP at Month 1
|
-2.4 mmHg
Standard Error 0.98
|
-3.5 mmHg
Standard Error 1.02
|
-5.9 mmHg
Standard Error 0.99
|
-5.4 mmHg
Standard Error 1.00
|
3.2 mmHg
Standard Error 1.01
|
|
Change From Baseline in Daytime/Nighttime Mean SBP and DBP Assessed by ABPM at Each Visit
Change in Daytime Mean SBP at Month 6
|
-6.9 mmHg
Standard Error 1.72
|
-10.4 mmHg
Standard Error 1.66
|
-9.3 mmHg
Standard Error 1.74
|
-8.8 mmHg
Standard Error 1.71
|
4.5 mmHg
Standard Error 1.83
|
|
Change From Baseline in Daytime/Nighttime Mean SBP and DBP Assessed by ABPM at Each Visit
Change in Nighttime Mean SBP at Month 1
|
-3.4 mmHg
Standard Error 1.59
|
-5.1 mmHg
Standard Error 1.64
|
-9.5 mmHg
Standard Error 1.60
|
-8.0 mmHg
Standard Error 1.62
|
4.7 mmHg
Standard Error 1.64
|
|
Change From Baseline in Daytime/Nighttime Mean SBP and DBP Assessed by ABPM at Each Visit
Change in Daytime Mean DBP at Month 3
|
-4.8 mmHg
Standard Error 0.89
|
-6.1 mmHg
Standard Error 0.88
|
-5.7 mmHg
Standard Error 0.90
|
-5.6 mmHg
Standard Error 0.90
|
3.5 mmHg
Standard Error 0.94
|
|
Change From Baseline in Daytime/Nighttime Mean SBP and DBP Assessed by ABPM at Each Visit
Change in Daytime Mean DBP at Month 6
|
-4.8 mmHg
Standard Error 1.01
|
-6.2 mmHg
Standard Error 0.98
|
-6.1 mmHg
Standard Error 1.02
|
-5.7 mmHg
Standard Error 1.00
|
2.1 mmHg
Standard Error 1.07
|
|
Change From Baseline in Daytime/Nighttime Mean SBP and DBP Assessed by ABPM at Each Visit
Change in Nighttime Mean DBP at Month 3
|
-3.6 mmHg
Standard Error 1.02
|
-5.1 mmHg
Standard Error 1.01
|
-4.8 mmHg
Standard Error 1.03
|
-5.8 mmHg
Standard Error 1.04
|
3.7 mmHg
Standard Error 1.08
|
|
Change From Baseline in Daytime/Nighttime Mean SBP and DBP Assessed by ABPM at Each Visit
Change in Nighttime Mean DBP at Month 6
|
-4.3 mmHg
Standard Error 1.03
|
-5.9 mmHg
Standard Error 1.00
|
-6.7 mmHg
Standard Error 1.05
|
-7.6 mmHg
Standard Error 1.03
|
2.2 mmHg
Standard Error 1.09
|
SECONDARY outcome
Timeframe: Baseline, Week 2 and Months 1, 2, 3, 4, 5 and 6Population: Pharmacodynamic (PD) Analysis Set included all participants who received at least 1 full dose of study drug. All by-treatment analyses based on the PD Analysis Set were grouped according to the treatment actually received. Overall number analyzed is the number of participants with data available for analyses. Number analyzed is the number of participants with data available for analyses at specified timepoints.
Outcome measures
| Measure |
Zilebesiran 150 mg Q6M
n=78 Participants
Participants received zilebesiran, 150 mg, as SC injection on Day 1 of the 6-month placebo-controlled DB period. They received placebo at Month 3 of the 6-month placebo-controlled DB period to maintain the blind.
|
Zilebesiran 300 mg Q6M
n=73 Participants
Participants received zilebesiran, 300 mg, as SC injection on Day 1 of the 6-month placebo-controlled DB period. They received placebo at Month 3 of the 6-month placebo-controlled DB period to maintain the blind.
|
Zilebesiran 300 mg Q3M
n=75 Participants
Participants received zilebesiran, 300 mg, as SC injection, Q3M, during the 6-month placebo-controlled DB period.
|
Zilebesiran 600 mg Q6M
n=76 Participants
Participants received zilebesiran, 600 mg, as SC injection, on Day 1 of the 6-month placebo-controlled DB period. They received placebo at Month 3 of the 6-month placebo-controlled DB period to maintain the blind.
|
Placebo
n=74 Participants
Participants received zilebesiran matching placebo, as SC injection, Q3M during the 6-month placebo-controlled DB period.
|
|---|---|---|---|---|---|
|
Percentage Change From Baseline in Serum Angiotensinogen (AGT) Through Month 6
Percent Change from Baseline at Month 5
|
-90.10 percent change
Standard Deviation 12.48
|
-94.85 percent change
Standard Deviation 6.58
|
-98.23 percent change
Standard Deviation 1.13
|
-97.38 percent change
Standard Deviation 2.41
|
-2.27 percent change
Standard Deviation 21.18
|
|
Percentage Change From Baseline in Serum Angiotensinogen (AGT) Through Month 6
Percent Change from Baseline at Month 6
|
-87.84 percent change
Standard Deviation 13.82
|
-93.13 percent change
Standard Deviation 8.29
|
-97.71 percent change
Standard Deviation 1.91
|
-96.41 percent change
Standard Deviation 4.04
|
-4.97 percent change
Standard Deviation 24.90
|
|
Percentage Change From Baseline in Serum Angiotensinogen (AGT) Through Month 6
Percent Change from Baseline at Month 4
|
-91.89 percent change
Standard Deviation 11.61
|
-95.94 percent change
Standard Deviation 5.23
|
-98.38 percent change
Standard Deviation 1.08
|
-97.98 percent change
Standard Deviation 1.74
|
1.39 percent change
Standard Deviation 26.06
|
|
Percentage Change From Baseline in Serum Angiotensinogen (AGT) Through Month 6
Percent Change from Baseline at Month 1
|
-94.48 percent change
Standard Deviation 9.04
|
-97.38 percent change
Standard Deviation 1.72
|
-97.20 percent change
Standard Deviation 2.30
|
-98.22 percent change
Standard Deviation 2.69
|
1.61 percent change
Standard Deviation 22.96
|
|
Percentage Change From Baseline in Serum Angiotensinogen (AGT) Through Month 6
Percent Change from Baseline at Month 2
|
-94.47 percent change
Standard Deviation 12.38
|
-97.74 percent change
Standard Deviation 2.04
|
-97.64 percent change
Standard Deviation 2.15
|
-98.70 percent change
Standard Deviation 0.74
|
-2.06 percent change
Standard Deviation 21.87
|
|
Percentage Change From Baseline in Serum Angiotensinogen (AGT) Through Month 6
Percent Change from Baseline at Month 3
|
-93.31 percent change
Standard Deviation 9.94
|
-97.26 percent change
Standard Deviation 2.78
|
-97.00 percent change
Standard Deviation 2.61
|
-98.25 percent change
Standard Deviation 1.60
|
-2.19 percent change
Standard Deviation 22.86
|
|
Percentage Change From Baseline in Serum Angiotensinogen (AGT) Through Month 6
Percent Change from Baseline at Week 2
|
-88.34 percent change
Standard Deviation 9.96
|
-92.68 percent change
Standard Deviation 4.40
|
-92.77 percent change
Standard Deviation 4.03
|
-94.49 percent change
Standard Deviation 5.52
|
-0.05 percent change
Standard Deviation 23.99
|
Adverse Events
Placebo/Zilebesiran 600 mg Q6M
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Placebo
Serious events: 5 serious events
Other events: 18 other events
Deaths: 0 deaths
Zilebesiran 150 mg Q6M
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
Zilebesiran 300 mg Q6M
Serious events: 1 serious events
Other events: 24 other events
Deaths: 0 deaths
Zilebesiran 300 mg Q3M
Serious events: 4 serious events
Other events: 23 other events
Deaths: 1 deaths
Zilebesiran 600 mg Q6M
Serious events: 6 serious events
Other events: 20 other events
Deaths: 0 deaths
Placebo/Zilebesiran 150 mg Q6M
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Placebo/Zilebesiran 300 mg Q6M
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Placebo/Zilebesiran 300 mg Q3M
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Zilebesiran/Zilebesiran 150 mg Q6M
Serious events: 5 serious events
Other events: 53 other events
Deaths: 1 deaths
Zilebesiran/Zilebesiran 300 mg Q6M
Serious events: 5 serious events
Other events: 47 other events
Deaths: 0 deaths
Zilebesiran/Zilebesiran 300 mg Q3M
Serious events: 7 serious events
Other events: 49 other events
Deaths: 1 deaths
Zilebesiran/ Zilebesiran 600 mg Q6M
Serious events: 9 serious events
Other events: 49 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo/Zilebesiran 600 mg Q6M
n=18 participants at risk
Participants who received placebo 6-month placebo-controlled DB period were re-randomized at Month 6 to 1 of the 4 initial zilebesiran regimens. Participants in this arm received zilebesiran, 600 mg, as SC injection Q6M after re-randomization for the remainder of the study. Participants received placebo at the visit where no zilebesiran dose was planned to maintain blinding between the Q3M and Q6M regimens.
Prior to PA6, participants who completed Months 6 to 12 of blinded treatment and pre-dose assessment at Month 12, before a separate OLE study was available, could continue receiving blinded zilebesiran treatment up to additional 24 months in the DB Extension Period. Following PA6, the DB Extension Period was discontinued. Participants who had not yet completed the Month 12 visit at the time of PA6 implementation received their last dose of study drug at Month 9. For participants already in the DB Extension Period at the time of PA6 implementation, dosing depended on scheduled visits: participants whose next visit was at Month 15, 21, 27, or 33 received their planned study drug, while those whose next visit was at Month 18, 24, 30, or 36 did not receive further study drug in the study.
|
Placebo
n=75 participants at risk
Participants received zilebesiran matching placebo, as SC injection, Q3M during the 6-month placebo-controlled DB period.
|
Zilebesiran 150 mg Q6M
n=78 participants at risk
Participants received zilebesiran, 150 mg, as SC injection on Day 1 of the 6-month placebo-controlled DB period. They received placebo at Month 3 of the 6-month placebo-controlled DB period to maintain the blind.
|
Zilebesiran 300 mg Q6M
n=73 participants at risk
Participants received zilebesiran, 300 mg, as SC injection on Day 1 of the 6-month DB period. They received placebo at Month 3 of the 6-month DB period to maintain the blind.
|
Zilebesiran 300 mg Q3M
n=75 participants at risk
Participants received zilebesiran, 300 mg, as SC injection, Q3M, during the 6-month placebo-controlled DB period.
|
Zilebesiran 600 mg Q6M
n=76 participants at risk
Participants received zilebesiran, 600 mg, as SC injection, on Day 1 of the 6-month placebo-controlled DB period. They received placebo at Month 3 of the 6-month placebo-controlled DB period to maintain the blind.
|
Placebo/Zilebesiran 150 mg Q6M
n=16 participants at risk
Participants who received placebo during the 6-month placebo-controlled DB period were re-randomized at Month 6 to 1 of the 4 initial zilebesiran regimens. Participants in this arm received zilebesiran, 150 mg, as SC injection Q6M after re-randomization for the remainder of the study. Participants received placebo at the visit where no zilebesiran dose was planned to maintain blind between the Q3M and Q6M regimens.
Prior to PA6, participants who completed Months 6 to 12 of blinded treatment and pre-dose assessment at Month 12, before a separate OLE study was available, could continue receiving blinded zilebesiran treatment up to additional 24 months in the DB Extension Period. Following PA6, the DB Extension Period was discontinued. Participants who had not yet completed the Month 12 visit at the time of PA6 implementation received their last dose of study drug at Month 9. For participants already in the DB Extension Period at the time of PA6 implementation, dosing depended on scheduled visits: participants whose next visit was at Month 15, 21, 27, or 33 received their planned study drug, while those whose next visit was at Month 18, 24, 30, or 36 did not receive further study drug in the study.
|
Placebo/Zilebesiran 300 mg Q6M
n=16 participants at risk
Participants who received placebo during the 6-month placebo-controlled DB period were re-randomized at Month 6 to 1 of the 4 initial zilebesiran regimens. Participants in this arm received zilebesiran, 300 mg, as SC injection Q6M after re-randomization for the remainder of the study. Participants received placebo at the visit where no zilebesiran dose was planned to maintain blinding between the Q3M and Q6M regimens.
Prior to PA6, participants who completed Months 6 to 12 of blinded treatment and pre-dose assessment at Month 12, before a separate OLE study was available, could continue receiving blinded zilebesiran treatment up to additional 24 months in the DB Extension Period. Following PA6, the DB Extension Period was discontinued. Participants who had not yet completed the Month 12 visit at the time of PA6 implementation received their last dose of study drug at Month 9. For participants already in the DB Extension Period at the time of PA6 implementation, dosing depended on scheduled visits: participants whose next visit was at Month 15, 21, 27, or 33 received their planned study drug, while those whose next visit was at Month 18, 24, 30, or 36 did not receive further study drug in the study.
|
Placebo/Zilebesiran 300 mg Q3M
n=16 participants at risk
Participants who received placebo during 6-month placebo-controlled DB period were re-randomized at Month 6 to 1 of the 4 initial zilebesiran regimens. Participants in this arm received zilebesiran, 300 mg, as SC injection Q3M after re-randomization for the remainder of the study.
Prior to PA6, participants who completed Months 6 to 12 of blinded treatment and pre-dose assessment at Month 12, before a separate OLE study was available, could continue receiving blinded zilebesiran treatment up to additional 24 months in the DB Extension Period. Following PA6, the DB Extension Period was discontinued. Participants who had not yet completed the Month 12 visit at the time of PA6 implementation received their last dose of study drug at Month 9. For participants already in the DB Extension Period at the time of PA6 implementation, dosing depended on scheduled visits: participants whose next visit was at Month 15, 21, 27, or 33 received their planned study drug, while those whose next visit was at Month 18, 24, 30, or 36 did not receive further study drug in the study.
|
Zilebesiran/Zilebesiran 150 mg Q6M
n=78 participants at risk
Participants who received zilebesiran 150 mg Q6M during the 6-month placebo-controlled DB period remained on the same regimen throughout the study. Participants received placebo at the visit where no zilebesiran dose was planned to maintain blinding between the Q3M and Q6M regimens.
Prior to PA6, participants who completed Months 6 to 12 of blinded treatment and pre-dose assessment at Month 12, before a separate OLE study was available, could continue receiving blinded zilebesiran treatment up to additional 24 months in the DB Extension Period. Following PA6, the DB Extension Period was discontinued. Participants who had not yet completed the Month 12 visit at the time of PA6 implementation received their last dose of study drug at Month 9. For participants already in the DB Extension Period at the time of PA6 implementation, dosing depended on scheduled visits: participants whose next visit was at Month 15, 21, 27, or 33 received their planned study drug, while those whose next visit was at Month 18, 24, 30, or 36 did not receive further study drug in the study.
|
Zilebesiran/Zilebesiran 300 mg Q6M
n=73 participants at risk
Participants who received zilebesiran 300 mg Q6M during the 6-month placebo-controlled DB period remained on the same regimen throughout the study. Participants received placebo at the visit where no zilebesiran dose was planned to maintain blinding between the Q3M and Q6M regimens.
Prior to PA6, participants who completed Months 6 to 12 of blinded treatment and pre-dose assessment at Month 12, before a separate OLE study was available, could continue receiving blinded zilebesiran treatment up to additional 24 months in the DB Extension Period. Following PA6, the DB Extension Period was discontinued. Participants who had not yet completed the Month 12 visit at the time of PA6 implementation received their last dose of study drug at Month 9. For participants already in the DB Extension Period at the time of PA6 implementation, dosing depended on scheduled visits: participants whose next visit was at Month 15, 21, 27, or 33 received their planned study drug, while those whose next visit was at Month 18, 24, 30, or 36 did not receive further study drug in the study.
|
Zilebesiran/Zilebesiran 300 mg Q3M
n=75 participants at risk
Participants who received zilebesiran 300 mg Q3M during the 6-month placebo-controlled DB period remained on the same regimen throughout the study.
Prior to PA6, participants who completed Months 6 to 12 of blinded treatment and pre-dose assessment at Month 12, before a separate OLE study was available, could continue receiving blinded zilebesiran treatment up to additional 24 months in the DB Extension Period. Following PA6, the DB Extension Period was discontinued. Participants who had not yet completed the Month 12 visit at the time of PA6 implementation received their last dose of study drug at Month 9. For participants already in the DB Extension Period at the time of PA6 implementation, dosing depended on scheduled visits: participants whose next visit was at Month 15, 21, 27, or 33 received their planned study drug, while those whose next visit was at Month 18, 24, 30, or 36 did not receive further study drug in the study.
|
Zilebesiran/ Zilebesiran 600 mg Q6M
n=76 participants at risk
Participants who received zilebesiran 600 mg Q6M during the 6-month placebo-controlled DB period remained on the same regimen throughout the study. Participants received placebo at the visit where no zilebesiran dose was planned to maintain blinding between the Q3M and Q6M regimens.
Prior to PA6, participants who completed Months 6 to 12 of blinded treatment and pre-dose assessment at Month 12, before a separate OLE study was available, could continue receiving blinded zilebesiran treatment up to additional 24 months in the DB Extension Period. Following PA6, the DB Extension Period was discontinued. Participants who had not yet completed the Month 12 visit at the time of PA6 implementation received their last dose of study drug at Month 9. For participants already in the DB Extension Period at the time of PA6 implementation, dosing depended on scheduled visits: participants whose next visit was at Month 15, 21, 27, or 33 received their planned study drug, while those whose next visit was at Month 18, 24, 30, or 36 did not receive further study drug in the study.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/18 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
1.3%
1/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
1.3%
1/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
|
Vascular disorders
Hypertension
|
0.00%
0/18 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
1.3%
1/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/18 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
1.3%
1/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
1.3%
1/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/18 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
1.3%
1/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
1.3%
1/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/18 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
1.3%
1/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
1.3%
1/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/18 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
1.3%
1/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
1.3%
1/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.00%
0/18 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
1.4%
1/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
1.4%
1/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/18 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
1.3%
1/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
|
Gastrointestinal disorders
Obstructive pancreatitis
|
0.00%
0/18 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
1.3%
1/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/18 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
1.3%
1/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
|
General disorders
Gait disturbance
|
0.00%
0/18 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
1.3%
1/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
|
Infections and infestations
Endocarditis
|
0.00%
0/18 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
1.3%
1/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
1.3%
1/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/18 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
1.3%
1/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
1.3%
1/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/18 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
1.3%
1/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
1.3%
1/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/18 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
6.2%
1/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
1.3%
1/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
|
Injury, poisoning and procedural complications
Coronary bypass stenosis
|
0.00%
0/18 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
1.3%
1/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
1.3%
1/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/18 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
1.3%
1/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
1.4%
1/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.00%
0/18 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
1.3%
1/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/18 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
6.2%
1/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/18 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
6.2%
1/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/18 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
1.3%
1/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/18 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
1.3%
1/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/18 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
1.4%
1/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign salivary gland neoplasm
|
0.00%
0/18 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
1.3%
1/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
1.3%
1/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer stage II
|
0.00%
0/18 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
1.3%
1/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
1.3%
1/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma stage III
|
0.00%
0/18 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
1.3%
1/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Paraganglion neoplasm
|
0.00%
0/18 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
1.4%
1/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of the tongue
|
0.00%
0/18 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
1.3%
1/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
1.3%
1/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/18 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
1.3%
1/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
|
Nervous system disorders
Syncope
|
0.00%
0/18 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
1.3%
1/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
1.4%
1/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/18 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
1.3%
1/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
|
Psychiatric disorders
Abnormal behaviour
|
0.00%
0/18 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
1.3%
1/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
1.3%
1/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/18 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
6.2%
1/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
1.3%
1/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/18 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
1.3%
1/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary infarction
|
0.00%
0/18 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
1.3%
1/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
|
Vascular disorders
Aortic aneurysm
|
0.00%
0/18 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
1.3%
1/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
1.3%
1/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
|
Vascular disorders
Hypertensive urgency
|
0.00%
0/18 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
1.3%
1/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/18 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
1.3%
1/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
1.3%
1/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
Other adverse events
| Measure |
Placebo/Zilebesiran 600 mg Q6M
n=18 participants at risk
Participants who received placebo 6-month placebo-controlled DB period were re-randomized at Month 6 to 1 of the 4 initial zilebesiran regimens. Participants in this arm received zilebesiran, 600 mg, as SC injection Q6M after re-randomization for the remainder of the study. Participants received placebo at the visit where no zilebesiran dose was planned to maintain blinding between the Q3M and Q6M regimens.
Prior to PA6, participants who completed Months 6 to 12 of blinded treatment and pre-dose assessment at Month 12, before a separate OLE study was available, could continue receiving blinded zilebesiran treatment up to additional 24 months in the DB Extension Period. Following PA6, the DB Extension Period was discontinued. Participants who had not yet completed the Month 12 visit at the time of PA6 implementation received their last dose of study drug at Month 9. For participants already in the DB Extension Period at the time of PA6 implementation, dosing depended on scheduled visits: participants whose next visit was at Month 15, 21, 27, or 33 received their planned study drug, while those whose next visit was at Month 18, 24, 30, or 36 did not receive further study drug in the study.
|
Placebo
n=75 participants at risk
Participants received zilebesiran matching placebo, as SC injection, Q3M during the 6-month placebo-controlled DB period.
|
Zilebesiran 150 mg Q6M
n=78 participants at risk
Participants received zilebesiran, 150 mg, as SC injection on Day 1 of the 6-month placebo-controlled DB period. They received placebo at Month 3 of the 6-month placebo-controlled DB period to maintain the blind.
|
Zilebesiran 300 mg Q6M
n=73 participants at risk
Participants received zilebesiran, 300 mg, as SC injection on Day 1 of the 6-month DB period. They received placebo at Month 3 of the 6-month DB period to maintain the blind.
|
Zilebesiran 300 mg Q3M
n=75 participants at risk
Participants received zilebesiran, 300 mg, as SC injection, Q3M, during the 6-month placebo-controlled DB period.
|
Zilebesiran 600 mg Q6M
n=76 participants at risk
Participants received zilebesiran, 600 mg, as SC injection, on Day 1 of the 6-month placebo-controlled DB period. They received placebo at Month 3 of the 6-month placebo-controlled DB period to maintain the blind.
|
Placebo/Zilebesiran 150 mg Q6M
n=16 participants at risk
Participants who received placebo during the 6-month placebo-controlled DB period were re-randomized at Month 6 to 1 of the 4 initial zilebesiran regimens. Participants in this arm received zilebesiran, 150 mg, as SC injection Q6M after re-randomization for the remainder of the study. Participants received placebo at the visit where no zilebesiran dose was planned to maintain blind between the Q3M and Q6M regimens.
Prior to PA6, participants who completed Months 6 to 12 of blinded treatment and pre-dose assessment at Month 12, before a separate OLE study was available, could continue receiving blinded zilebesiran treatment up to additional 24 months in the DB Extension Period. Following PA6, the DB Extension Period was discontinued. Participants who had not yet completed the Month 12 visit at the time of PA6 implementation received their last dose of study drug at Month 9. For participants already in the DB Extension Period at the time of PA6 implementation, dosing depended on scheduled visits: participants whose next visit was at Month 15, 21, 27, or 33 received their planned study drug, while those whose next visit was at Month 18, 24, 30, or 36 did not receive further study drug in the study.
|
Placebo/Zilebesiran 300 mg Q6M
n=16 participants at risk
Participants who received placebo during the 6-month placebo-controlled DB period were re-randomized at Month 6 to 1 of the 4 initial zilebesiran regimens. Participants in this arm received zilebesiran, 300 mg, as SC injection Q6M after re-randomization for the remainder of the study. Participants received placebo at the visit where no zilebesiran dose was planned to maintain blinding between the Q3M and Q6M regimens.
Prior to PA6, participants who completed Months 6 to 12 of blinded treatment and pre-dose assessment at Month 12, before a separate OLE study was available, could continue receiving blinded zilebesiran treatment up to additional 24 months in the DB Extension Period. Following PA6, the DB Extension Period was discontinued. Participants who had not yet completed the Month 12 visit at the time of PA6 implementation received their last dose of study drug at Month 9. For participants already in the DB Extension Period at the time of PA6 implementation, dosing depended on scheduled visits: participants whose next visit was at Month 15, 21, 27, or 33 received their planned study drug, while those whose next visit was at Month 18, 24, 30, or 36 did not receive further study drug in the study.
|
Placebo/Zilebesiran 300 mg Q3M
n=16 participants at risk
Participants who received placebo during 6-month placebo-controlled DB period were re-randomized at Month 6 to 1 of the 4 initial zilebesiran regimens. Participants in this arm received zilebesiran, 300 mg, as SC injection Q3M after re-randomization for the remainder of the study.
Prior to PA6, participants who completed Months 6 to 12 of blinded treatment and pre-dose assessment at Month 12, before a separate OLE study was available, could continue receiving blinded zilebesiran treatment up to additional 24 months in the DB Extension Period. Following PA6, the DB Extension Period was discontinued. Participants who had not yet completed the Month 12 visit at the time of PA6 implementation received their last dose of study drug at Month 9. For participants already in the DB Extension Period at the time of PA6 implementation, dosing depended on scheduled visits: participants whose next visit was at Month 15, 21, 27, or 33 received their planned study drug, while those whose next visit was at Month 18, 24, 30, or 36 did not receive further study drug in the study.
|
Zilebesiran/Zilebesiran 150 mg Q6M
n=78 participants at risk
Participants who received zilebesiran 150 mg Q6M during the 6-month placebo-controlled DB period remained on the same regimen throughout the study. Participants received placebo at the visit where no zilebesiran dose was planned to maintain blinding between the Q3M and Q6M regimens.
Prior to PA6, participants who completed Months 6 to 12 of blinded treatment and pre-dose assessment at Month 12, before a separate OLE study was available, could continue receiving blinded zilebesiran treatment up to additional 24 months in the DB Extension Period. Following PA6, the DB Extension Period was discontinued. Participants who had not yet completed the Month 12 visit at the time of PA6 implementation received their last dose of study drug at Month 9. For participants already in the DB Extension Period at the time of PA6 implementation, dosing depended on scheduled visits: participants whose next visit was at Month 15, 21, 27, or 33 received their planned study drug, while those whose next visit was at Month 18, 24, 30, or 36 did not receive further study drug in the study.
|
Zilebesiran/Zilebesiran 300 mg Q6M
n=73 participants at risk
Participants who received zilebesiran 300 mg Q6M during the 6-month placebo-controlled DB period remained on the same regimen throughout the study. Participants received placebo at the visit where no zilebesiran dose was planned to maintain blinding between the Q3M and Q6M regimens.
Prior to PA6, participants who completed Months 6 to 12 of blinded treatment and pre-dose assessment at Month 12, before a separate OLE study was available, could continue receiving blinded zilebesiran treatment up to additional 24 months in the DB Extension Period. Following PA6, the DB Extension Period was discontinued. Participants who had not yet completed the Month 12 visit at the time of PA6 implementation received their last dose of study drug at Month 9. For participants already in the DB Extension Period at the time of PA6 implementation, dosing depended on scheduled visits: participants whose next visit was at Month 15, 21, 27, or 33 received their planned study drug, while those whose next visit was at Month 18, 24, 30, or 36 did not receive further study drug in the study.
|
Zilebesiran/Zilebesiran 300 mg Q3M
n=75 participants at risk
Participants who received zilebesiran 300 mg Q3M during the 6-month placebo-controlled DB period remained on the same regimen throughout the study.
Prior to PA6, participants who completed Months 6 to 12 of blinded treatment and pre-dose assessment at Month 12, before a separate OLE study was available, could continue receiving blinded zilebesiran treatment up to additional 24 months in the DB Extension Period. Following PA6, the DB Extension Period was discontinued. Participants who had not yet completed the Month 12 visit at the time of PA6 implementation received their last dose of study drug at Month 9. For participants already in the DB Extension Period at the time of PA6 implementation, dosing depended on scheduled visits: participants whose next visit was at Month 15, 21, 27, or 33 received their planned study drug, while those whose next visit was at Month 18, 24, 30, or 36 did not receive further study drug in the study.
|
Zilebesiran/ Zilebesiran 600 mg Q6M
n=76 participants at risk
Participants who received zilebesiran 600 mg Q6M during the 6-month placebo-controlled DB period remained on the same regimen throughout the study. Participants received placebo at the visit where no zilebesiran dose was planned to maintain blinding between the Q3M and Q6M regimens.
Prior to PA6, participants who completed Months 6 to 12 of blinded treatment and pre-dose assessment at Month 12, before a separate OLE study was available, could continue receiving blinded zilebesiran treatment up to additional 24 months in the DB Extension Period. Following PA6, the DB Extension Period was discontinued. Participants who had not yet completed the Month 12 visit at the time of PA6 implementation received their last dose of study drug at Month 9. For participants already in the DB Extension Period at the time of PA6 implementation, dosing depended on scheduled visits: participants whose next visit was at Month 15, 21, 27, or 33 received their planned study drug, while those whose next visit was at Month 18, 24, 30, or 36 did not receive further study drug in the study.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Ear and labyrinth disorders
Vertigo positional
|
0.00%
0/18 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
6.2%
1/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
1.3%
1/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
|
Endocrine disorders
Thyroid mass
|
0.00%
0/18 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
6.2%
1/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
|
Eye disorders
Conjunctival haemorrhage
|
5.6%
1/18 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
1.3%
1/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
|
Eye disorders
Glaucoma
|
0.00%
0/18 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
6.2%
1/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/18 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
6.2%
1/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
2.7%
2/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
1.3%
1/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/18 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
5.1%
4/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/18 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
12.5%
2/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
1.3%
1/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
2.7%
2/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
4.0%
3/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
1.3%
1/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/18 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
1.3%
1/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
6.2%
1/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
4.1%
3/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
2.7%
2/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
1.3%
1/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/18 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
6.2%
1/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
6.2%
1/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
1.3%
1/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
4.1%
3/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
2.6%
2/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.00%
0/18 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
6.2%
1/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
|
Gastrointestinal disorders
Vomiting
|
5.6%
1/18 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
1.4%
1/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
2.7%
2/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
2.6%
2/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
|
General disorders
Discomfort
|
0.00%
0/18 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
6.2%
1/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
|
General disorders
Fatigue
|
5.6%
1/18 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
6.2%
1/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
2.6%
2/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
1.4%
1/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
2.7%
2/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
3.9%
3/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
|
General disorders
Injection site reaction
|
5.6%
1/18 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
3.8%
3/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
5.5%
4/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
10.7%
8/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
5.3%
4/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
18.8%
3/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
6.2%
1/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
6.4%
5/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
11.0%
8/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
17.3%
13/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
11.8%
9/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
|
General disorders
Malaise
|
5.6%
1/18 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.00%
0/18 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
6.2%
1/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
1.4%
1/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
|
Immune system disorders
Seasonal allergy
|
5.6%
1/18 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
1.3%
1/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/18 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
6.2%
1/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
1.3%
1/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
|
Infections and infestations
Bronchitis
|
5.6%
1/18 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
6.2%
1/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
2.6%
2/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
2.7%
2/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
1.3%
1/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
2.6%
2/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
|
Infections and infestations
Coronavirus Disease of 2019 (COVID-19)
|
0.00%
0/18 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
4.0%
3/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
3.8%
3/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
8.2%
6/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
8.0%
6/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
5.3%
4/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
6.2%
1/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
9.0%
7/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
9.6%
7/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
12.0%
9/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
10.5%
8/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
|
Nervous system disorders
Dizziness
|
5.6%
1/18 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
5.3%
4/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
2.6%
2/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
2.7%
2/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
4.0%
3/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
3.9%
3/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
3.8%
3/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
4.1%
3/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
5.3%
4/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
10.5%
8/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/18 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
6.2%
1/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
1.3%
1/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
2.6%
2/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/18 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
6.2%
1/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
1.3%
1/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/18 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
6.2%
1/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/18 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
1.3%
1/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
5.5%
4/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
6.7%
5/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
2.6%
2/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
|
Infections and infestations
Onychomycosis
|
0.00%
0/18 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
6.2%
1/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
|
Infections and infestations
Paronychia
|
0.00%
0/18 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
6.2%
1/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
|
Infections and infestations
Pneumonia mycoplasmal
|
0.00%
0/18 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
6.2%
1/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
|
Infections and infestations
Sinusitis
|
5.6%
1/18 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
6.2%
1/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
2.6%
2/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
5.3%
4/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
3.9%
3/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.6%
1/18 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
1.3%
1/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
3.8%
3/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
5.5%
4/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
2.7%
2/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
1.3%
1/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
12.5%
2/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
6.2%
1/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
7.7%
6/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
6.8%
5/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
8.0%
6/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
5.3%
4/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
|
Infections and infestations
Urinary tract infection
|
5.6%
1/18 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
6.2%
1/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
18.8%
3/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
3.8%
3/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
6.8%
5/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
12.0%
9/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
3.9%
3/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
5.6%
1/18 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
2.7%
2/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.00%
0/18 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
6.2%
1/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
1.3%
1/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
|
Injury, poisoning and procedural complications
Brain contusion
|
0.00%
0/18 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
6.2%
1/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
|
Injury, poisoning and procedural complications
Fall
|
5.6%
1/18 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
1.3%
1/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
1.3%
1/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
5.6%
1/18 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
1.4%
1/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
1.3%
1/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
5.6%
1/18 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
5.1%
4/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
1.4%
1/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
|
Injury, poisoning and procedural complications
Muscle injury
|
0.00%
0/18 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
6.2%
1/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
|
Injury, poisoning and procedural complications
Post-traumatic neck syndrome
|
0.00%
0/18 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
6.2%
1/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
|
Investigations
Blood cholesterol increased
|
5.6%
1/18 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
|
Investigations
Blood creatine increased
|
0.00%
0/18 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
6.2%
1/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/18 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
6.2%
1/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
3.8%
3/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
2.7%
2/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
1.3%
1/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
|
Investigations
Blood uric acid increased
|
0.00%
0/18 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
6.2%
1/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
1.3%
1/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
1.4%
1/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
1.3%
1/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
1.3%
1/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
|
Investigations
Glomerular filtration rate decreased
|
0.00%
0/18 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
6.2%
1/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
2.6%
2/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
1.3%
1/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
|
Investigations
Glycosylated haemoglobin increased
|
5.6%
1/18 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
2.6%
2/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
1.3%
1/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
|
Investigations
Transaminases increased
|
0.00%
0/18 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
6.2%
1/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
1.3%
1/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/18 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
6.2%
1/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
2.6%
2/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
1.4%
1/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
2.7%
2/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
3.9%
3/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
0.00%
0/18 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
6.2%
1/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
6.2%
1/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
1.4%
1/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/18 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
6.2%
1/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
1.3%
1/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
2.7%
2/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/18 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
1.3%
1/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
6.4%
5/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
5.5%
4/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
6.7%
5/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
6.6%
5/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
6.2%
1/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
7.7%
6/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
6.8%
5/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
9.3%
7/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
6.6%
5/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/18 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
6.2%
1/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
1.3%
1/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/18 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
6.2%
1/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
1.3%
1/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
1.3%
1/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/18 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
6.2%
1/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
1.4%
1/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.1%
2/18 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
2.7%
2/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
2.6%
2/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
5.5%
4/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
2.7%
2/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
3.8%
3/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
8.2%
6/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
5.3%
4/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/18 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
12.5%
2/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
2.6%
2/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
4.1%
3/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
4.0%
3/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
2.6%
2/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
5.6%
1/18 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
5.6%
1/18 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/18 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
6.2%
1/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
2.6%
2/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
1.4%
1/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
4.0%
3/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/18 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
6.2%
1/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/18 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
6.2%
1/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
1.3%
1/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/18 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
5.1%
4/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
4.0%
3/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.6%
1/18 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
1.3%
1/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
1.4%
1/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
4.0%
3/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
1.3%
1/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/18 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
6.2%
1/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
1.4%
1/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
|
Nervous system disorders
Headache
|
0.00%
0/18 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
9.3%
7/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
5.5%
4/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
2.7%
2/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
1.3%
1/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
2.6%
2/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
8.2%
6/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
6.7%
5/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
3.9%
3/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/18 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
6.2%
1/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
|
Nervous system disorders
Syncope
|
0.00%
0/18 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
6.2%
1/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
2.6%
2/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
1.3%
1/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
|
Psychiatric disorders
Depression
|
0.00%
0/18 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
6.2%
1/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
1.3%
1/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
1.4%
1/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
|
Renal and urinary disorders
Renal cyst
|
0.00%
0/18 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
6.2%
1/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/18 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
6.2%
1/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
1.3%
1/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
1.3%
1/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
5.6%
1/18 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
1.3%
1/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
1.3%
1/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/18 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
6.2%
1/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
1.3%
1/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
2.7%
2/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
1.3%
1/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal discomfort
|
5.6%
1/18 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/18 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
6.2%
1/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
1.3%
1/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
1.3%
1/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/18 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
6.2%
1/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
2.6%
2/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
2.7%
2/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
1.3%
1/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/18 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
6.2%
1/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
|
Vascular disorders
Hypertension
|
0.00%
0/18 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
6.7%
5/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
5.1%
4/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
4.0%
3/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
6.6%
5/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
6.2%
1/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
6.2%
1/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
11.5%
9/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
4.1%
3/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
5.3%
4/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
11.8%
9/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
|
Vascular disorders
Hypotension
|
0.00%
0/18 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
12.5%
2/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
2.6%
2/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
1.4%
1/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
2.7%
2/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
2.6%
2/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/18 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/16 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
5.1%
4/78 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
5.5%
4/73 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
0.00%
0/75 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
5.3%
4/76 • 6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER