Ignite Creation Date:
2025-12-24 @ 10:43 PM
Ignite Modification Date:
2025-12-31 @ 3:11 PM
Study NCT ID:
NCT04936035
Status:
COMPLETED
Last Update Posted:
2025-12-23
First Post:
2021-06-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Evaluate Efficacy and Safety of ALN-AGT01 in Patients With Mild To-Moderate Hypertension
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Germany'], 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-11-20', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@alnylam.com', 'phone': '866-330-0326', 'title': 'Chief Medical Officer', 'organization': 'Alnylam Pharmaceuticals'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).', 'description': 'Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \\& 600 mg Q6M; up to 85 days postdose for pbo \\& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \\& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \\& Post 6-Month DB periods.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Participants received zilebesiran matching placebo, as SC injection, Q3M during the 6-month placebo-controlled DB period.', 'otherNumAtRisk': 75, 'deathsNumAtRisk': 75, 'otherNumAffected': 18, 'seriousNumAtRisk': 75, 'deathsNumAffected': 0, 'seriousNumAffected': 5}, {'id': 'EG001', 'title': 'Zilebesiran 150 mg Q6M', 'description': '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.', 'otherNumAtRisk': 78, 'deathsNumAtRisk': 78, 'otherNumAffected': 21, 'seriousNumAtRisk': 78, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Zilebesiran 300 mg Q6M', 'description': '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.', 'otherNumAtRisk': 73, 'deathsNumAtRisk': 73, 'otherNumAffected': 24, 'seriousNumAtRisk': 73, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'Zilebesiran 300 mg Q3M', 'description': 'Participants received zilebesiran, 300 mg, as SC injection, Q3M, during the 6-month placebo-controlled DB period.', 'otherNumAtRisk': 75, 'deathsNumAtRisk': 75, 'otherNumAffected': 23, 'seriousNumAtRisk': 75, 'deathsNumAffected': 1, 'seriousNumAffected': 4}, {'id': 'EG004', 'title': 'Zilebesiran 600 mg Q6M', 'description': '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.', 'otherNumAtRisk': 76, 'deathsNumAtRisk': 76, 'otherNumAffected': 20, 'seriousNumAtRisk': 76, 'deathsNumAffected': 0, 'seriousNumAffected': 6}, {'id': 'EG005', 'title': 'Placebo/Zilebesiran 150 mg Q6M', 'description': '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.\n\nPrior 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.', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 9, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG006', 'title': 'Placebo/Zilebesiran 300 mg Q6M', 'description': '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.\n\nPrior 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.', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 12, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG007', 'title': 'Placebo/Zilebesiran 300 mg Q3M', 'description': '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.\n\nPrior 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.', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 9, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG008', 'title': 'Placebo/Zilebesiran 600 mg Q6M', 'description': '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.\n\nPrior 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.', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 8, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG009', 'title': 'Zilebesiran/Zilebesiran 150 mg Q6M', 'description': '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.\n\nPrior 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.', 'otherNumAtRisk': 78, 'deathsNumAtRisk': 78, 'otherNumAffected': 53, 'seriousNumAtRisk': 78, 'deathsNumAffected': 1, 'seriousNumAffected': 5}, {'id': 'EG010', 'title': 'Zilebesiran/Zilebesiran 300 mg Q6M', 'description': '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.\n\nPrior 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.', 'otherNumAtRisk': 73, 'deathsNumAtRisk': 73, 'otherNumAffected': 47, 'seriousNumAtRisk': 73, 'deathsNumAffected': 0, 'seriousNumAffected': 5}, {'id': 'EG011', 'title': 'Zilebesiran/Zilebesiran 300 mg Q3M', 'description': 'Participants who received zilebesiran 300 mg Q3M during the 6-month placebo-controlled DB period remained on the same regimen throughout the study.\n\nPrior 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.', 'otherNumAtRisk': 75, 'deathsNumAtRisk': 75, 'otherNumAffected': 49, 'seriousNumAtRisk': 75, 'deathsNumAffected': 1, 'seriousNumAffected': 7}, {'id': 'EG012', 'title': 'Zilebesiran/ Zilebesiran 600 mg Q6M', 'description': '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.\n\nPrior 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.', 'otherNumAtRisk': 76, 'deathsNumAtRisk': 76, 'otherNumAffected': 49, 'seriousNumAtRisk': 76, 'deathsNumAffected': 0, 'seriousNumAffected': 9}], 'otherEvents': [{'term': 'Vertigo positional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 78, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 76, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Thyroid mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 78, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 76, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Conjunctival haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 78, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 76, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Glaucoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 78, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 76, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 78, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 73, 'numAffected': 2}, {'groupId': 'EG011', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 76, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 78, 'numAffected': 4}, {'groupId': 'EG010', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 76, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 16, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 78, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 73, 'numAffected': 2}, {'groupId': 'EG011', 'numAtRisk': 75, 'numAffected': 3}, {'groupId': 'EG012', 'numAtRisk': 76, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 76, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 78, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 73, 'numAffected': 3}, {'groupId': 'EG011', 'numAtRisk': 75, 'numAffected': 2}, {'groupId': 'EG012', 'numAtRisk': 76, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 78, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 73, 'numAffected': 3}, {'groupId': 'EG011', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 76, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Umbilical hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 78, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 76, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 78, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 75, 'numAffected': 2}, {'groupId': 'EG012', 'numAtRisk': 76, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG009', 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{'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 78, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 76, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Paraganglion neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 78, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 76, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Squamous cell carcinoma of the tongue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 78, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 76, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 78, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 76, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 78, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 76, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 78, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 76, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Abnormal behaviour', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 76, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 78, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 76, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 78, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 76, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 78, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 76, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Pulmonary infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 78, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 76, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Aortic aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 76, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 78, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 76, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 78, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 76, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Hypertensive urgency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 78, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 76, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 76, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 78, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 76, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline at Month 3 in 24-hour Mean SBP Assessed by ABPM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}, {'value': '137', 'groupId': 'OG002'}, {'value': '65', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received zilebesiran matching placebo, as SC injection, Q3M during the 6-month placebo-controlled DB period.'}, {'id': 'OG001', 'title': 'Zilebesiran 150 mg Q6M', 'description': '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.'}, {'id': 'OG002', 'title': 'Zilebesiran 300 mg Q6M and Q3M', 'description': "Participants received zilebesiran, 300 mg, as SC injection, Q6M or Q3M during the 6-month placebo-controlled DB period. Participants assigned to the Q6M regimen received placebo at Month 3 of the 6-month DB period to maintain the blind. As specified in the SAP, 'Zilebesiran 300 mg Q6M' and 'Zilebesiran 300 mg Q3M' arms were pooled together to report Month 3 analysis."}, {'id': 'OG003', 'title': 'Zilebesiran 600 mg Q6M', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.8', 'spread': '1.58', 'groupId': 'OG000'}, {'value': '-7.3', 'spread': '1.49', 'groupId': 'OG001'}, {'value': '-10.0', 'spread': '1.05', 'groupId': 'OG002'}, {'value': '-8.9', 'spread': '1.52', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in LS Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-16.7', 'ciLowerLimit': '-21.2', 'ciUpperLimit': '-12.3', 'pValueComment': 'MMRM model included treatment, visit, treatment-by-visit interaction, and race (categorized as Black and all other races) as fixed factors, with baseline 24-hour mean SBP assessed by ABPM as a covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.9', 'groupDescription': "LS Mean Difference between zilebesiran 300 mg Q6M and placebo, 95% CI was calculated using Dunnett's procedure.", 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference in LS Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-15.7', 'ciLowerLimit': '-20.8', 'ciUpperLimit': '-10.6', 'pValueComment': 'The MMRM model included treatment, visit, treatment-by-visit interaction, and race (categorized as Black and all other races) as fixed factors, with baseline 24-hour mean SBP assessed by ABPM as a covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.19', 'groupDescription': "The adjusted 95% CI and p-value are based on Dunnett's test. LS Mean Difference between zilebesiran 600 mg Q6M and placebo, 95% CI was calculated using Dunnett's procedure.", 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Month 3', 'description': '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.', 'unitOfMeasure': 'millimeters of mercury (mmHg)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline at Month 3 in Mean Sitting Office SBP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}, {'value': '133', 'groupId': 'OG002'}, {'value': '64', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received zilebesiran matching placebo, as SC injection, Q3M during the 6-month placebo-controlled DB period.'}, {'id': 'OG001', 'title': 'Zilebesiran 150 mg Q6M', 'description': '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.'}, {'id': 'OG002', 'title': 'Zilebesiran 300 mg Q6M and Q3M', 'description': "Participants received zilebesiran, 300 mg, as SC injection, Q6M or Q3M during the 6-month placebo-controlled DB period. Participants assigned to the Q6M regimen received placebo at Month 3 of the 6-month DB period to maintain the blind. As specified in the SAP, 'Zilebesiran 300 mg Q6M' and 'Zilebesiran 300 mg Q3M' arms were pooled together to report Month 3 analysis."}, {'id': 'OG003', 'title': 'Zilebesiran 600 mg Q6M', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.1', 'spread': '1.57', 'groupId': 'OG000'}, {'value': '-9.7', 'spread': '1.49', 'groupId': 'OG001'}, {'value': '-12.1', 'spread': '1.06', 'groupId': 'OG002'}, {'value': '-9.2', 'spread': '1.52', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in LS Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-12', 'ciLowerLimit': '-15.7', 'ciUpperLimit': '-8.3', 'pValueComment': 'The MMRM model included treatment, visit, treatment-by-visit interaction, and race (categorized as Black and all other races) as fixed factors, with office SBP as a covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.89', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Tested in hierarchical order with success criterion of nominal p-value \\<0.05.'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference in LS Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-9.1', 'ciLowerLimit': '-13.4', 'ciUpperLimit': '-4.8', 'pValueComment': 'The MMRM model included treatment, visit, treatment-by-visit interaction, and race (categorized as Black and all other races) as fixed factors, with office SBP as a covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.19', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Tested in hierarchical order with success criterion of nominal p-value \\<0.05.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Month 3', 'description': '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.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline at Month 6 in 24-hour Mean SBP Assessed by ABPM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}, {'value': '60', 'groupId': 'OG003'}, {'value': '63', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received zilebesiran matching placebo, as SC injection, Q3M during the 6-month placebo-controlled DB period.'}, {'id': 'OG001', 'title': 'Zilebesiran 150 mg Q6M', 'description': '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.'}, {'id': 'OG002', 'title': 'Zilebesiran 300 mg Q6M', 'description': '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.'}, {'id': 'OG003', 'title': 'Zilebesiran 300 mg Q3M', 'description': 'Participants received zilebesiran, 300 mg, as SC injection, Q3M, during the 6-month placebo-controlled DB period.'}, {'id': 'OG004', 'title': 'Zilebesiran 600 mg Q6M', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.6', 'spread': '1.73', 'groupId': 'OG000'}, {'value': '-6.5', 'spread': '1.63', 'groupId': 'OG001'}, {'value': '-9.9', 'spread': '1.58', 'groupId': 'OG002'}, {'value': '-9.5', 'spread': '1.65', 'groupId': 'OG003'}, {'value': '-9.6', 'spread': '1.62', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference in LS Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-14.1', 'ciLowerLimit': '-18.9', 'ciUpperLimit': '-9.4', 'pValueComment': 'The MMRM model included treatment, visit, treatment-by-visit interaction, and race (categorized as Black and all other races) as fixed factors, with baseline 24-hour mean SBP assessed by ABPM as a covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.4', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Tested in hierarchical order with success criterion of nominal p-value \\<0.05.'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Difference in LS Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-14.2', 'ciLowerLimit': '-18.9', 'ciUpperLimit': '-9.5', 'pValueComment': 'The MMRM model included treatment, visit, treatment-by-visit interaction, and race (categorized as Black and all other races) as fixed factors, with baseline 24-hour mean SBP assessed by ABPM as a covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.38', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Tested in hierarchical order with success criterion of nominal p-value \\<0.05.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Month 6', 'description': '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.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline at Month 6 in Mean Sitting Office SBP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}, {'value': '57', 'groupId': 'OG003'}, {'value': '62', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received zilebesiran matching placebo, as SC injection, Q3M during the 6-month placebo-controlled DB period.'}, {'id': 'OG001', 'title': 'Zilebesiran 150 mg Q6M', 'description': '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.'}, {'id': 'OG002', 'title': 'Zilebesiran 300 mg Q6M', 'description': '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.'}, {'id': 'OG003', 'title': 'Zilebesiran 300 mg Q3M', 'description': 'Participants received zilebesiran, 300 mg, as SC injection, Q3M, during the 6-month placebo-controlled DB period.'}, {'id': 'OG004', 'title': 'Zilebesiran 600 mg Q6M', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.6', 'spread': '1.80', 'groupId': 'OG000'}, {'value': '-8.2', 'spread': '1.70', 'groupId': 'OG001'}, {'value': '-11.1', 'spread': '1.67', 'groupId': 'OG002'}, {'value': '-12.8', 'spread': '1.80', 'groupId': 'OG003'}, {'value': '-10.8', 'spread': '1.73', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference in LS Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-12.1', 'ciLowerLimit': '-17.2', 'ciUpperLimit': '-7.1', 'pValueComment': 'The MMRM model included treatment, visit, treatment-by-visit interaction, and race (categorized as Black and all other races) as fixed factors, with office SBP as a covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.55', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Tested in hierarchical order with success criterion of nominal p-value \\<0.05.'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Difference in LS Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-10.2', 'ciLowerLimit': '-15.1', 'ciUpperLimit': '-5.3', 'pValueComment': 'The MMRM model included treatment, visit, treatment-by-visit interaction, and race (categorized as Black and all other races) as fixed factors, with office SBP as a covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.5', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Tested in hierarchical order with success criterion of nominal p-value \\<0.05.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Month 6', 'description': '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.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': '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', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}, {'value': '75', 'groupId': 'OG003'}, {'value': '76', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received zilebesiran matching placebo, as SC injection, Q3M during the 6-month placebo-controlled DB period.'}, {'id': 'OG001', 'title': 'Zilebesiran 150 mg Q6M', 'description': '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.'}, {'id': 'OG002', 'title': 'Zilebesiran 300 mg Q6M', 'description': '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.'}, {'id': 'OG003', 'title': 'Zilebesiran 300 mg Q3M', 'description': 'Participants received zilebesiran, 300 mg, as SC injection, Q3M, during the 6-month placebo-controlled DB period.'}, {'id': 'OG004', 'title': 'Zilebesiran 600 mg Q6M', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.7', 'groupId': 'OG000'}, {'value': '30.8', 'groupId': 'OG001'}, {'value': '50.7', 'groupId': 'OG002'}, {'value': '38.7', 'groupId': 'OG003'}, {'value': '47.4', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '10.73', 'ciLowerLimit': '3.76', 'ciUpperLimit': '30.64', 'pValueComment': 'Logistic regression model included treatment and race (black; all other races) as factors and baseline 24-hour mean SBP as a covariate', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Tested in hierarchical order with success criterion of nominal p-value \\<0.05.'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '17.93', 'ciLowerLimit': '6.24', 'ciUpperLimit': '51.52', 'pValueComment': 'Logistic regression model included treatment and race (black; all other races) as factors and baseline 24-hour mean SBP as a covariate', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Tested in hierarchical order with success criterion of nominal p-value \\<0.05.'}], 'paramType': 'NUMBER', 'timeFrame': 'Month 6', 'description': '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.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set included all randomized participants who received any amount of the study drug.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline at Month 3 in 24-hour Mean DBP Assessed by ABPM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}, {'value': '137', 'groupId': 'OG002'}, {'value': '65', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received zilebesiran matching placebo, as SC injection, Q3M during the 6-month placebo-controlled DB period.'}, {'id': 'OG001', 'title': 'Zilebesiran 150 mg Q6M', 'description': '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.'}, {'id': 'OG002', 'title': 'Zilebesiran 300 mg Q6M and Q3M', 'description': "Participants received zilebesiran, 300 mg, as SC injection, Q6M or Q3M during the 6-month placebo-controlled DB period. Participants assigned to the Q6M regimen received placebo at Month 3 of the 6-month DB period to maintain the blind. As specified in the SAP, 'Zilebesiran 300 mg Q6M' and 'Zilebesiran 300 mg Q3M' arms were pooled together to report Month 3 analysis."}, {'id': 'OG003', 'title': 'Zilebesiran 600 mg Q6M', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.5', 'spread': '0.87', 'groupId': 'OG000'}, {'value': '-4.5', 'spread': '0.82', 'groupId': 'OG001'}, {'value': '-5.7', 'spread': '0.58', 'groupId': 'OG002'}, {'value': '-5.8', 'spread': '0.84', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Month 3', 'description': '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.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline at Month 6 in 24-hour Mean DBP Assessed by ABPM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}, {'value': '60', 'groupId': 'OG003'}, {'value': '63', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received zilebesiran matching placebo, as SC injection, Q3M during the 6-month placebo-controlled DB period.'}, {'id': 'OG001', 'title': 'Zilebesiran 150 mg Q6M', 'description': '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.'}, {'id': 'OG002', 'title': 'Zilebesiran 300 mg Q6M', 'description': '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.'}, {'id': 'OG003', 'title': 'Zilebesiran 300 mg Q3M', 'description': 'Participants received zilebesiran, 300 mg, as SC injection, Q3M, during the 6-month placebo-controlled DB period.'}, {'id': 'OG004', 'title': 'Zilebesiran 600 mg Q6M', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.2', 'spread': '0.97', 'groupId': 'OG000'}, {'value': '-4.8', 'spread': '0.91', 'groupId': 'OG001'}, {'value': '-6.1', 'spread': '0.89', 'groupId': 'OG002'}, {'value': '-6.3', 'spread': '0.93', 'groupId': 'OG003'}, {'value': '-6.3', 'spread': '0.91', 'groupId': 'OG004'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Month 6', 'description': '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', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline at Month 3 in Mean Sitting Office DBP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}, {'value': '133', 'groupId': 'OG002'}, {'value': '64', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received zilebesiran matching placebo, as SC injection, Q3M during the 6-month placebo-controlled DB period.'}, {'id': 'OG001', 'title': 'Zilebesiran 150 mg Q6M', 'description': '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.'}, {'id': 'OG002', 'title': 'Zilebesiran 300 mg Q6M and Q3M', 'description': "Participants received zilebesiran, 300 mg, as SC injection, Q6M or Q3M during the 6-month placebo-controlled DB period. Participants assigned to the Q6M regimen received placebo at Month 3 of the 6-month DB period to maintain the blind. As specified in the SAP, 'Zilebesiran 300 mg Q6M' and 'Zilebesiran 300 mg Q3M' arms were pooled together to report Month 3 analysis."}, {'id': 'OG003', 'title': 'Zilebesiran 600 mg Q6M', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.6', 'spread': '1.00', 'groupId': 'OG000'}, {'value': '-5.3', 'spread': '0.94', 'groupId': 'OG001'}, {'value': '-7.0', 'spread': '0.67', 'groupId': 'OG002'}, {'value': '-5.4', 'spread': '0.97', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Month 3', 'description': '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.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Time Adjusted Change From Baseline Through Month 3 in Mean Sitting Office SBP and DBP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}, {'value': '133', 'groupId': 'OG002'}, {'value': '64', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received zilebesiran matching placebo, as SC injection, Q3M during the 6-month placebo-controlled DB period.'}, {'id': 'OG001', 'title': 'Zilebesiran 150 mg Q6M', 'description': '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.'}, {'id': 'OG002', 'title': 'Zilebesiran 300 mg Q6M and Q3M', 'description': "Participants received zilebesiran, 300 mg, as SC injection, Q6M or Q3M during the 6-month placebo-controlled DB period. Participants assigned to the Q6M regimen received placebo at Month 3 of the 6-month DB period to maintain the blind. As specified in the SAP, 'Zilebesiran 300 mg Q6M' and 'Zilebesiran 300 mg Q3M' arms were pooled together to report Month 3 analysis."}, {'id': 'OG003', 'title': 'Zilebesiran 600 mg Q6M', 'description': '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.'}], 'classes': [{'title': 'Office SBP', 'categories': [{'measurements': [{'value': '-0.6', 'spread': '1.29', 'groupId': 'OG000'}, {'value': '-9.1', 'spread': '1.24', 'groupId': 'OG001'}, {'value': '-10.9', 'spread': '0.89', 'groupId': 'OG002'}, {'value': '-10.1', 'spread': '1.26', 'groupId': 'OG003'}]}]}, {'title': 'Office DBP', 'categories': [{'measurements': [{'value': '-0.0', 'spread': '0.80', 'groupId': 'OG000'}, {'value': '-4.8', 'spread': '0.77', 'groupId': 'OG001'}, {'value': '-6.5', 'spread': '0.55', 'groupId': 'OG002'}, {'value': '-6.0', 'spread': '0.78', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Month 3', 'description': '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.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline at Month 6 in Mean Sitting Office DBP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}, {'value': '57', 'groupId': 'OG003'}, {'value': '62', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received zilebesiran matching placebo, as SC injection, Q3M during the 6-month placebo-controlled DB period.'}, {'id': 'OG001', 'title': 'Zilebesiran 150 mg Q6M', 'description': '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.'}, {'id': 'OG002', 'title': 'Zilebesiran 300 mg Q6M', 'description': '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.'}, {'id': 'OG003', 'title': 'Zilebesiran 300 mg Q3M', 'description': 'Participants received zilebesiran, 300 mg, as SC injection, Q3M, during the 6-month placebo-controlled DB period.'}, {'id': 'OG004', 'title': 'Zilebesiran 600 mg Q6M', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.2', 'spread': '1.20', 'groupId': 'OG000'}, {'value': '-4.1', 'spread': '1.13', 'groupId': 'OG001'}, {'value': '-6.8', 'spread': '1.12', 'groupId': 'OG002'}, {'value': '-8.2', 'spread': '1.20', 'groupId': 'OG003'}, {'value': '-5.0', 'spread': '1.16', 'groupId': 'OG004'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Month 6', 'description': '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.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Time Adjusted Change From Baseline Through Month 6 in 24-hour Mean SBP and DBP Assessed by ABPM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}, {'value': '60', 'groupId': 'OG003'}, {'value': '63', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received zilebesiran matching placebo, as SC injection, Q3M during the 6-month placebo-controlled DB period.'}, {'id': 'OG001', 'title': 'Zilebesiran 150 mg Q6M', 'description': '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.'}, {'id': 'OG002', 'title': 'Zilebesiran 300 mg Q6M', 'description': '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.'}, {'id': 'OG003', 'title': 'Zilebesiran 300 mg Q3M', 'description': 'Participants received zilebesiran, 300 mg, as SC injection, Q3M, during the 6-month placebo-controlled DB period.'}, {'id': 'OG004', 'title': 'Zilebesiran 600 mg Q6M', 'description': '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.'}], 'classes': [{'title': '24-hour Mean SBP', 'categories': [{'measurements': [{'value': '5.8', 'spread': '1.26', 'groupId': 'OG000'}, {'value': '-6.3', 'spread': '1.20', 'groupId': 'OG001'}, {'value': '-9.2', 'spread': '1.20', 'groupId': 'OG002'}, {'value': '-9.6', 'spread': '1.22', 'groupId': 'OG003'}, {'value': '-9.1', 'spread': '1.22', 'groupId': 'OG004'}]}]}, {'title': '24-hour Mean DBP', 'categories': [{'measurements': [{'value': '3.1', 'spread': '0.72', 'groupId': 'OG000'}, {'value': '-4.2', 'spread': '0.69', 'groupId': 'OG001'}, {'value': '-5.5', 'spread': '0.69', 'groupId': 'OG002'}, {'value': '-5.8', 'spread': '0.70', 'groupId': 'OG003'}, {'value': '-5.9', 'spread': '0.70', 'groupId': 'OG004'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Month 6', 'description': '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.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Time Adjusted Change From Baseline Through Month 6 in Mean Sitting Office SBP and DBP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}, {'value': '57', 'groupId': 'OG003'}, {'value': '62', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received zilebesiran matching placebo, as SC injection, Q3M during the 6-month placebo-controlled DB period.'}, {'id': 'OG001', 'title': 'Zilebesiran 150 mg Q6M', 'description': '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.'}, {'id': 'OG002', 'title': 'Zilebesiran 300 mg Q6M', 'description': '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.'}, {'id': 'OG003', 'title': 'Zilebesiran 300 mg Q3M', 'description': 'Participants received zilebesiran, 300 mg, as SC injection, Q3M, during the 6-month placebo-controlled DB period.'}, {'id': 'OG004', 'title': 'Zilebesiran 600 mg Q6M', 'description': '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.'}], 'classes': [{'title': 'Office SBP', 'categories': [{'measurements': [{'value': '-0.5', 'spread': '1.25', 'groupId': 'OG000'}, {'value': '-9.0', 'spread': '1.20', 'groupId': 'OG001'}, {'value': '-12.1', 'spread': '1.21', 'groupId': 'OG002'}, {'value': '-11.0', 'spread': '1.24', 'groupId': 'OG003'}, {'value': '-10.0', 'spread': '1.22', 'groupId': 'OG004'}]}]}, {'title': 'Office DBP', 'categories': [{'measurements': [{'value': '-0.6', 'spread': '0.80', 'groupId': 'OG000'}, {'value': '-4.7', 'spread': '0.76', 'groupId': 'OG001'}, {'value': '-7.2', 'spread': '0.77', 'groupId': 'OG002'}, {'value': '-6.7', 'spread': '0.79', 'groupId': 'OG003'}, {'value': '-5.5', 'spread': '0.78', 'groupId': 'OG004'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Month 6', 'description': 'Time adjusted change is the AUC between Month 1 and 6 visits divided by the duration of time period.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Daytime/Nighttime Mean SBP and DBP Assessed by ABPM at Each Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '70', 'groupId': 'OG002'}, {'value': '71', 'groupId': 'OG003'}, {'value': '69', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received zilebesiran matching placebo, as SC injection, Q3M during the 6-month placebo-controlled DB period.'}, {'id': 'OG001', 'title': 'Zilebesiran 150 mg Q6M', 'description': '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.'}, {'id': 'OG002', 'title': 'Zilebesiran 300 mg Q6M', 'description': '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.'}, {'id': 'OG003', 'title': 'Zilebesiran 300 mg Q3M', 'description': 'Participants received zilebesiran, 300 mg, as SC injection, Q3M, during the 6-month placebo-controlled DB period.'}, {'id': 'OG004', 'title': 'Zilebesiran 600 mg Q6M', 'description': '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.'}], 'classes': [{'title': 'Change in Daytime Mean SBP at Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '66', 'groupId': 'OG002'}, {'value': '71', 'groupId': 'OG003'}, {'value': '69', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '4.3', 'spread': '1.50', 'groupId': 'OG000'}, {'value': '-3.6', 'spread': '1.45', 'groupId': 'OG001'}, {'value': '-6.4', 'spread': '1.51', 'groupId': 'OG002'}, {'value': '-9.6', 'spread': '1.46', 'groupId': 'OG003'}, {'value': '-9.1', 'spread': '1.48', 'groupId': 'OG004'}]}]}, {'title': 'Change in Daytime Mean SBP at Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}, {'value': '70', 'groupId': 'OG002'}, {'value': '67', 'groupId': 'OG003'}, {'value': '65', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '6.7', 'spread': '1.62', 'groupId': 'OG000'}, {'value': '-7.6', 'spread': '1.53', 'groupId': 'OG001'}, {'value': '-10.7', 'spread': '1.52', 'groupId': 'OG002'}, {'value': '-9.8', 'spread': '1.54', 'groupId': 'OG003'}, {'value': '-8.9', 'spread': '1.56', 'groupId': 'OG004'}]}]}, {'title': 'Change in Daytime Mean SBP at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}, {'value': '60', 'groupId': 'OG003'}, {'value': '63', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '4.5', 'spread': '1.83', 'groupId': 'OG000'}, {'value': '-6.9', 'spread': '1.72', 'groupId': 'OG001'}, {'value': '-10.4', 'spread': '1.66', 'groupId': 'OG002'}, {'value': '-9.3', 'spread': '1.74', 'groupId': 'OG003'}, {'value': '-8.8', 'spread': '1.71', 'groupId': 'OG004'}]}]}, {'title': 'Change in Nighttime Mean SBP at Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '66', 'groupId': 'OG002'}, {'value': '71', 'groupId': 'OG003'}, {'value': '69', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '4.7', 'spread': '1.64', 'groupId': 'OG000'}, {'value': '-3.4', 'spread': '1.59', 'groupId': 'OG001'}, {'value': '-5.1', 'spread': '1.64', 'groupId': 'OG002'}, {'value': '-9.5', 'spread': '1.60', 'groupId': 'OG003'}, {'value': '-8.0', 'spread': '1.62', 'groupId': 'OG004'}]}]}, {'title': 'Change in Nighttime Mean SBP at Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}, {'value': '70', 'groupId': 'OG002'}, {'value': '67', 'groupId': 'OG003'}, {'value': '65', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '7.0', 'spread': '1.85', 'groupId': 'OG000'}, {'value': '-6.4', 'spread': '1.76', 'groupId': 'OG001'}, {'value': '-8.2', 'spread': '1.74', 'groupId': 'OG002'}, {'value': '-9.7', 'spread': '1.77', 'groupId': 'OG003'}, {'value': '-8.5', 'spread': '1.79', 'groupId': 'OG004'}]}]}, {'title': 'Change in Nighttime Mean SBP at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}, {'value': '60', 'groupId': 'OG003'}, {'value': '63', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '4.7', 'spread': '1.86', 'groupId': 'OG000'}, {'value': '-5.8', 'spread': '1.75', 'groupId': 'OG001'}, {'value': '-8.9', 'spread': '1.69', 'groupId': 'OG002'}, {'value': '-10.2', 'spread': '1.78', 'groupId': 'OG003'}, {'value': '-11.1', 'spread': '1.74', 'groupId': 'OG004'}]}]}, {'title': 'Change in Daytime Mean DBP at Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '70', 'groupId': 'OG002'}, {'value': '71', 'groupId': 'OG003'}, {'value': '69', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '2.9', 'spread': '0.91', 'groupId': 'OG000'}, {'value': '-2.7', 'spread': '0.88', 'groupId': 'OG001'}, {'value': '-4.0', 'spread': '0.91', 'groupId': 'OG002'}, {'value': '-5.9', 'spread': '0.89', 'groupId': 'OG003'}, {'value': '-5.8', 'spread': '0.89', 'groupId': 'OG004'}]}]}, {'title': 'Change in Daytime Mean DBP at Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}, {'value': '70', 'groupId': 'OG002'}, {'value': '67', 'groupId': 'OG003'}, {'value': '65', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '3.5', 'spread': '0.94', 'groupId': 'OG000'}, {'value': '-4.8', 'spread': '0.89', 'groupId': 'OG001'}, {'value': '-6.1', 'spread': '0.88', 'groupId': 'OG002'}, {'value': '-5.7', 'spread': '0.90', 'groupId': 'OG003'}, {'value': '-5.6', 'spread': '0.90', 'groupId': 'OG004'}]}]}, {'title': 'Change in Daytime Mean DBP at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}, {'value': '60', 'groupId': 'OG003'}, {'value': '63', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '2.1', 'spread': '1.07', 'groupId': 'OG000'}, {'value': '-4.8', 'spread': '1.01', 'groupId': 'OG001'}, {'value': '-6.2', 'spread': '0.98', 'groupId': 'OG002'}, {'value': '-6.1', 'spread': '1.02', 'groupId': 'OG003'}, {'value': '-5.7', 'spread': '1.00', 'groupId': 'OG004'}]}]}, {'title': 'Change in Nighttime Mean DBP at Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '66', 'groupId': 'OG002'}, {'value': '71', 'groupId': 'OG003'}, {'value': '69', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '3.2', 'spread': '1.01', 'groupId': 'OG000'}, {'value': '-2.4', 'spread': '0.98', 'groupId': 'OG001'}, {'value': '-3.5', 'spread': '1.02', 'groupId': 'OG002'}, {'value': '-5.9', 'spread': '0.99', 'groupId': 'OG003'}, {'value': '-5.4', 'spread': '1.00', 'groupId': 'OG004'}]}]}, {'title': 'Change in Nighttime Mean DBP at Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}, {'value': '70', 'groupId': 'OG002'}, {'value': '67', 'groupId': 'OG003'}, {'value': '65', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '3.7', 'spread': '1.08', 'groupId': 'OG000'}, {'value': '-3.6', 'spread': '1.02', 'groupId': 'OG001'}, {'value': '-5.1', 'spread': '1.01', 'groupId': 'OG002'}, {'value': '-4.8', 'spread': '1.03', 'groupId': 'OG003'}, {'value': '-5.8', 'spread': '1.04', 'groupId': 'OG004'}]}]}, {'title': 'Change in Nighttime Mean DBP at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}, {'value': '60', 'groupId': 'OG003'}, {'value': '63', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '2.2', 'spread': '1.09', 'groupId': 'OG000'}, {'value': '-4.3', 'spread': '1.03', 'groupId': 'OG001'}, {'value': '-5.9', 'spread': '1.00', 'groupId': 'OG002'}, {'value': '-6.7', 'spread': '1.05', 'groupId': 'OG003'}, {'value': '-7.6', 'spread': '1.03', 'groupId': 'OG004'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, and Months 1, 3 and 6', 'description': '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.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Percentage Change From Baseline in Serum Angiotensinogen (AGT) Through Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}, {'value': '75', 'groupId': 'OG003'}, {'value': '76', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received zilebesiran matching placebo, as SC injection, Q3M during the 6-month placebo-controlled DB period.'}, {'id': 'OG001', 'title': 'Zilebesiran 150 mg Q6M', 'description': '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.'}, {'id': 'OG002', 'title': 'Zilebesiran 300 mg Q6M', 'description': '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.'}, {'id': 'OG003', 'title': 'Zilebesiran 300 mg Q3M', 'description': 'Participants received zilebesiran, 300 mg, as SC injection, Q3M, during the 6-month placebo-controlled DB period.'}, {'id': 'OG004', 'title': 'Zilebesiran 600 mg Q6M', 'description': '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.'}], 'classes': [{'title': 'Percent Change from Baseline at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}, {'value': '73', 'groupId': 'OG003'}, {'value': '71', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-0.05', 'spread': '23.99', 'groupId': 'OG000'}, {'value': '-88.34', 'spread': '9.96', 'groupId': 'OG001'}, {'value': '-92.68', 'spread': '4.40', 'groupId': 'OG002'}, {'value': '-92.77', 'spread': '4.03', 'groupId': 'OG003'}, {'value': '-94.49', 'spread': '5.52', 'groupId': 'OG004'}]}]}, {'title': 'Percent Change from Baseline at Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}, {'value': '72', 'groupId': 'OG003'}, {'value': '73', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '1.61', 'spread': '22.96', 'groupId': 'OG000'}, {'value': '-94.48', 'spread': '9.04', 'groupId': 'OG001'}, {'value': '-97.38', 'spread': '1.72', 'groupId': 'OG002'}, {'value': '-97.20', 'spread': '2.30', 'groupId': 'OG003'}, {'value': '-98.22', 'spread': '2.69', 'groupId': 'OG004'}]}]}, {'title': 'Percent Change from Baseline at Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}, {'value': '72', 'groupId': 'OG003'}, {'value': '73', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-2.06', 'spread': '21.87', 'groupId': 'OG000'}, {'value': '-94.47', 'spread': '12.38', 'groupId': 'OG001'}, {'value': '-97.74', 'spread': '2.04', 'groupId': 'OG002'}, {'value': '-97.64', 'spread': '2.15', 'groupId': 'OG003'}, {'value': '-98.70', 'spread': '0.74', 'groupId': 'OG004'}]}]}, {'title': 'Percent Change from Baseline at Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}, {'value': '72', 'groupId': 'OG003'}, {'value': '71', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-2.19', 'spread': '22.86', 'groupId': 'OG000'}, {'value': '-93.31', 'spread': '9.94', 'groupId': 'OG001'}, {'value': '-97.26', 'spread': '2.78', 'groupId': 'OG002'}, {'value': '-97.00', 'spread': '2.61', 'groupId': 'OG003'}, {'value': '-98.25', 'spread': '1.60', 'groupId': 'OG004'}]}]}, {'title': 'Percent Change from Baseline at Month 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}, {'value': '70', 'groupId': 'OG003'}, {'value': '69', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '1.39', 'spread': '26.06', 'groupId': 'OG000'}, {'value': '-91.89', 'spread': '11.61', 'groupId': 'OG001'}, {'value': '-95.94', 'spread': '5.23', 'groupId': 'OG002'}, {'value': '-98.38', 'spread': '1.08', 'groupId': 'OG003'}, {'value': '-97.98', 'spread': '1.74', 'groupId': 'OG004'}]}]}, {'title': 'Percent Change from Baseline at Month 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}, {'value': '70', 'groupId': 'OG002'}, {'value': '70', 'groupId': 'OG003'}, {'value': '69', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-2.27', 'spread': '21.18', 'groupId': 'OG000'}, {'value': '-90.10', 'spread': '12.48', 'groupId': 'OG001'}, {'value': '-94.85', 'spread': '6.58', 'groupId': 'OG002'}, {'value': '-98.23', 'spread': '1.13', 'groupId': 'OG003'}, {'value': '-97.38', 'spread': '2.41', 'groupId': 'OG004'}]}]}, {'title': 'Percent Change from Baseline at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}, {'value': '70', 'groupId': 'OG002'}, {'value': '68', 'groupId': 'OG003'}, {'value': '69', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-4.97', 'spread': '24.90', 'groupId': 'OG000'}, {'value': '-87.84', 'spread': '13.82', 'groupId': 'OG001'}, {'value': '-93.13', 'spread': '8.29', 'groupId': 'OG002'}, {'value': '-97.71', 'spread': '1.91', 'groupId': 'OG003'}, {'value': '-96.41', 'spread': '4.04', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 2 and Months 1, 2, 3, 4, 5 and 6', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Participants received zilebesiran matching placebo, as subcutaneous (SC) injection, once every 3 months (Q3M) during the 6-month placebo-controlled double-blind (DB) period.'}, {'id': 'FG001', 'title': 'Zilebesiran 150 Milligrams (mg) Once Every 6 Months (Q6M)', 'description': '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.'}, {'id': 'FG002', 'title': 'Zilebesiran 300 mg Q6M', 'description': '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.'}, {'id': 'FG003', 'title': 'Zilebesiran 300 mg Q3M', 'description': 'Participants received zilebesiran, 300 mg, as SC injection, Q3M, during the 6-month placebo-controlled DB period.'}, {'id': 'FG004', 'title': 'Zilebesiran 600 mg Q6M', 'description': '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.'}, {'id': 'FG005', 'title': 'Placebo/Zilebesiran 150 mg Q6M', 'description': '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.\n\nPrior 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.'}, {'id': 'FG006', 'title': 'Placebo/Zilebesiran 300 mg Q6M', 'description': '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.\n\nPrior 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.'}, {'id': 'FG007', 'title': 'Placebo/Zilebesiran 300 mg Q3M', 'description': '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.\n\nPrior 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.'}, {'id': 'FG008', 'title': 'Placebo/Zilebesiran 600 mg Q6M', 'description': '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.\n\nPrior 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.'}, {'id': 'FG009', 'title': 'Zilebesiran/Zilebesiran 150 mg Q6M', 'description': '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.\n\nPrior 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.'}, {'id': 'FG010', 'title': 'Zilebesiran/Zilebesiran 300 mg Q6M', 'description': '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.\n\nPrior 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.'}, {'id': 'FG011', 'title': 'Zilebesiran/Zilebesiran 300 mg Q3M', 'description': 'Participants who received zilebesiran 300 mg Q3M during the 6-month placebo-controlled DB period remained on the same regimen throughout the study.\n\nPrior 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.'}, {'id': 'FG012', 'title': 'Zilebesiran/Zilebesiran 600 mg Q6M', 'description': '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.\n\nPrior 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.'}], 'periods': [{'title': '6-Month Placebo-controlled DB Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '76'}, {'groupId': 'FG001', 'numSubjects': '78'}, {'groupId': 'FG002', 'numSubjects': '73'}, {'groupId': 'FG003', 'numSubjects': '75'}, {'groupId': 'FG004', 'numSubjects': '76'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '70'}, {'groupId': 'FG001', 'numSubjects': '70'}, {'groupId': 'FG002', 'numSubjects': '70'}, {'groupId': 'FG003', 'numSubjects': '70'}, {'groupId': 'FG004', 'numSubjects': '71'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}]}, {'type': 'Protocol Deviation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}]}, {'type': 'Subject Stopped Participation in the Study', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}]}, {'type': 'Reason Unknown', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}]}]}, {'title': 'Post-6-Month DB Period (30months)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '17'}, {'groupId': 'FG006', 'numSubjects': '17'}, {'groupId': 'FG007', 'numSubjects': '16'}, {'groupId': 'FG008', 'numSubjects': '18'}, {'groupId': 'FG009', 'numSubjects': '69'}, {'groupId': 'FG010', 'numSubjects': '67'}, {'groupId': 'FG011', 'numSubjects': '66'}, {'groupId': 'FG012', 'numSubjects': '65'}]}, {'type': 'Completed Month 12 Visit', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '13'}, {'groupId': 'FG006', 'numSubjects': '16'}, {'groupId': 'FG007', 'numSubjects': '16'}, {'groupId': 'FG008', 'numSubjects': '18'}, {'groupId': 'FG009', 'numSubjects': '65'}, {'groupId': 'FG010', 'numSubjects': '62'}, {'groupId': 'FG011', 'numSubjects': '65'}, {'groupId': 'FG012', 'numSubjects': '61'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '12'}, {'groupId': 'FG006', 'numSubjects': '15'}, {'groupId': 'FG007', 'numSubjects': '15'}, {'groupId': 'FG008', 'numSubjects': '18'}, {'groupId': 'FG009', 'numSubjects': '60'}, {'groupId': 'FG010', 'numSubjects': '57'}, {'groupId': 'FG011', 'numSubjects': '59'}, {'groupId': 'FG012', 'numSubjects': '58'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '5'}, {'groupId': 'FG006', 'numSubjects': '2'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '9'}, {'groupId': 'FG010', 'numSubjects': '10'}, {'groupId': 'FG011', 'numSubjects': '7'}, {'groupId': 'FG012', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Participant Stopped Participation in the Study', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '2'}, {'groupId': 'FG010', 'numSubjects': '7'}, {'groupId': 'FG011', 'numSubjects': '5'}, {'groupId': 'FG012', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '3'}, {'groupId': 'FG010', 'numSubjects': '1'}, {'groupId': 'FG011', 'numSubjects': '1'}, {'groupId': 'FG012', 'numSubjects': '4'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '2'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '1'}, {'groupId': 'FG012', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '1'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}]}, {'type': 'Reason Not Specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '1'}, {'groupId': 'FG010', 'numSubjects': '2'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}]}]}], 'recruitmentDetails': '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\\].', 'preAssignmentDetails': "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."}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}, {'value': '75', 'groupId': 'BG003'}, {'value': '76', 'groupId': 'BG004'}, {'value': '377', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Participants received zilebesiran matching placebo, as SC injection, Q3M during the 6-month placebo-controlled DB period.'}, {'id': 'BG001', 'title': 'Zilebesiran 150 mg Q6M', 'description': '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.'}, {'id': 'BG002', 'title': 'Zilebesiran 300 mg Q6M', 'description': '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.'}, {'id': 'BG003', 'title': 'Zilebesiran 300 mg Q3M', 'description': 'Participants received zilebesiran, 300 mg, as SC injection, Q3M, during the 6-month placebo-controlled DB period.'}, {'id': 'BG004', 'title': 'Zilebesiran 600 mg Q6M', 'description': '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.'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56.8', 'spread': '11.2', 'groupId': 'BG000'}, {'value': '55.5', 'spread': '10.6', 'groupId': 'BG001'}, {'value': '56.4', 'spread': '10.3', 'groupId': 'BG002'}, {'value': '57.7', 'spread': '10.6', 'groupId': 'BG003'}, {'value': '57.4', 'spread': '10.2', 'groupId': 'BG004'}, {'value': '56.8', 'spread': '10.6', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}, {'value': '31', 'groupId': 'BG004'}, {'value': '167', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}, {'value': '45', 'groupId': 'BG003'}, {'value': '45', 'groupId': 'BG004'}, {'value': '210', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '20', 'groupId': 'BG004'}, {'value': '74', 'groupId': 'BG005'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '66', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}, {'value': '65', 'groupId': 'BG003'}, {'value': '56', 'groupId': 'BG004'}, {'value': '303', 'groupId': 'BG005'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}]}, {'title': 'Asian', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '23', 'groupId': 'BG005'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}]}, {'title': 'Black or African American', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}, {'value': '19', 'groupId': 'BG004'}, {'value': '93', 'groupId': 'BG005'}]}, {'title': 'White', 'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}, {'value': '48', 'groupId': 'BG003'}, {'value': '52', 'groupId': 'BG004'}, {'value': '259', 'groupId': 'BG005'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': '24-hour Mean Systolic Blood Pressure (SBP) Assessed by Ambulatory Blood Pressure Monitoring (ABPM)', 'classes': [{'categories': [{'measurements': [{'value': '141.1', 'spread': '7.9', 'groupId': 'BG000'}, {'value': '140.6', 'spread': '8.5', 'groupId': 'BG001'}, {'value': '142.5', 'spread': '8.8', 'groupId': 'BG002'}, {'value': '141.6', 'spread': '7.7', 'groupId': 'BG003'}, {'value': '143.1', 'spread': '9.0', 'groupId': 'BG004'}, {'value': '141.8', 'spread': '8.4', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'description': '24 hour ABPM was programmed to take readings every 20 minutes during day (6 am -9:59 pm) and every 30 minutes during the night (10 pm-5:59 am). ABPM was considered adequate if: 1. the number of successful daytime readings were ≥33, 2. the number of successful nighttime readings were ≥11, 3. no more than 3 hours are not represented (i.e.,3 sections of 60 minutes where 0 valid readings were obtained). To summarize 24 hour ABPM, the hourly adjusted mean was calculated. Hourly mean was the average of blood pressure (BP) by each hour of the day. The 24 hour mean was average of the hourly means.', 'unitOfMeasure': 'millimeter of mercury (mmHg)', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'The Full Analysis Set included all randomized participants who received any amount of the study drug.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-09-06', 'size': 13894240, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-10-25T14:58', 'hasProtocol': True}, {'date': '2024-09-05', 'size': 3915314, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-10-25T14:58', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 394}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-07-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'dispFirstSubmitDate': '2024-02-15', 'completionDateStruct': {'date': '2024-12-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-05', 'studyFirstSubmitDate': '2021-06-14', 'resultsFirstSubmitDate': '2024-10-25', 'studyFirstSubmitQcDate': '2021-06-14', 'dispFirstPostDateStruct': {'date': '2024-12-27', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2025-12-23', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2024-12-20', 'studyFirstPostDateStruct': {'date': '2021-06-23', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-12-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline at Month 3 in 24-hour Mean SBP Assessed by ABPM', 'timeFrame': 'Baseline and Month 3', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline at Month 3 in Mean Sitting Office SBP', 'timeFrame': 'Baseline and Month 3', 'description': '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.'}, {'measure': 'Change From Baseline at Month 6 in 24-hour Mean SBP Assessed by ABPM', 'timeFrame': 'Baseline and Month 6', 'description': '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.'}, {'measure': 'Change From Baseline at Month 6 in Mean Sitting Office SBP', 'timeFrame': 'Baseline and Month 6', 'description': '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.'}, {'measure': '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', 'timeFrame': 'Month 6', 'description': '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.'}, {'measure': 'Change From Baseline at Month 3 in 24-hour Mean DBP Assessed by ABPM', 'timeFrame': 'Baseline and Month 3', 'description': '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.'}, {'measure': 'Change From Baseline at Month 6 in 24-hour Mean DBP Assessed by ABPM', 'timeFrame': 'Baseline and Month 6', 'description': '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'}, {'measure': 'Change From Baseline at Month 3 in Mean Sitting Office DBP', 'timeFrame': 'Baseline and Month 3', 'description': '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.'}, {'measure': 'Time Adjusted Change From Baseline Through Month 3 in Mean Sitting Office SBP and DBP', 'timeFrame': 'Baseline and Month 3', 'description': '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.'}, {'measure': 'Change From Baseline at Month 6 in Mean Sitting Office DBP', 'timeFrame': 'Baseline and Month 6', 'description': '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.'}, {'measure': 'Time Adjusted Change From Baseline Through Month 6 in 24-hour Mean SBP and DBP Assessed by ABPM', 'timeFrame': 'Baseline and Month 6', 'description': '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.'}, {'measure': 'Time Adjusted Change From Baseline Through Month 6 in Mean Sitting Office SBP and DBP', 'timeFrame': 'Baseline and Month 6', 'description': 'Time adjusted change is the AUC between Month 1 and 6 visits divided by the duration of time period.'}, {'measure': 'Change From Baseline in Daytime/Nighttime Mean SBP and DBP Assessed by ABPM at Each Visit', 'timeFrame': 'Baseline, and Months 1, 3 and 6', 'description': '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.'}, {'measure': 'Percentage Change From Baseline in Serum Angiotensinogen (AGT) Through Month 6', 'timeFrame': 'Baseline, Week 2 and Months 1, 2, 3, 4, 5 and 6'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['High blood pressure', 'Hypertension', 'Hypertensive', 'siRNA', 'Angiotensinogen', 'AGT'], 'conditions': ['Hypertension']}, 'referencesModule': {'references': [{'pmid': '38363577', 'type': 'DERIVED', 'citation': 'Bakris GL, Saxena M, Gupta A, Chalhoub F, Lee J, Stiglitz D, Makarova N, Goyal N, Guo W, Zappe D, Desai AS; KARDIA-1 Study Group. RNA Interference With Zilebesiran for Mild to Moderate Hypertension: The KARDIA-1 Randomized Clinical Trial. JAMA. 2024 Mar 5;331(9):740-749. doi: 10.1001/jama.2024.0728.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effect of ALN-AGT01 on systolic and diastolic blood pressure and to characterize the pharmacodynamic (PD) effects and safety of ALN-AGT01.', 'detailedDescription': 'Participants will receive ALN-AGT01 or placebo for the first 6 months of the 12-month double-blind (DB) treatment period. Participants randomized to placebo will be re-randomized at Month 6 to 1 of the 4 initial ALN-AGT01 regimens until the end of the 12-month DB treatment period. Participants randomized to ALN-AGT01 regimens will remain on their originally assigned regimens through remainder of the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Daytime mean SBP ≥135 mmHg and ≤160 mmHg by ABPM, without antihypertensive medication\n\nExclusion Criteria:\n\n* Secondary hypertension, orthostatic hypotension\n* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\>2× upper limit of normal (ULN)\n* Elevated potassium \\>5 mEq/L\n* Estimated glomerular filtration rate (eGFR) of ≤30 mL/min/1.73m\\^2\n* Received an investigational agent within the last 30 days\n* Type 1 diabetes mellitus, poorly controlled Type 2 diabetes mellitus, newly diagnosed Type 2 diabetes mellitus\n* History of any cardiovascular event within 6 months prior to randomization\n* History of intolerance to SC injection(s)'}, 'identificationModule': {'nctId': 'NCT04936035', 'acronym': 'KARDIA-1', 'briefTitle': 'A Study to Evaluate Efficacy and Safety of ALN-AGT01 in Patients With Mild To-Moderate Hypertension', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alnylam Pharmaceuticals'}, 'officialTitle': 'A Randomized, Double-blind, Placebo-Controlled, Dose-Ranging Multicenter Study to Evaluate the Efficacy and Safety of ALN-AGT01 in Patients With Mild-to-Moderate Hypertension', 'orgStudyIdInfo': {'id': 'ALN-AGT01-002'}, 'secondaryIdInfos': [{'id': '2021-001248-82', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants received zilebesiran matching placebo, subcutaneous (SC) injection, once every 3 months (Q3M), with re-randomization at Month 6 to 1 of the initial 4 zilebesiran regimens. Participants will continue their respective zilebesiran regimen up to Month 12 in the DB period and up to 24 additional months in the DB Extension period. Upon implementation of Amendment 6, the DB Extension period was closed.', 'interventionNames': ['Drug: Placebo', 'Drug: ALN-AGT01']}, {'type': 'EXPERIMENTAL', 'label': 'Zilebesiran 150 Milligrams (mg) Once Every 6 Months (Q6M)', 'description': 'Participants receive zilebesiran, 150 mg, SC injection, Q6M, during the 12-month DB period. Participants will continue receiving the same zilebesiran regimen for up to 24 additional months in the DB Extension period. Participants in this arm will receive a placebo during those dosing visits when they do not receive zilebesiran to maintain the blind. Upon implementation of Amendment 6, the DB Extension period was closed.', 'interventionNames': ['Drug: Placebo', 'Drug: ALN-AGT01']}, {'type': 'EXPERIMENTAL', 'label': 'Zilebesiran 300 mg Q6M', 'description': 'Participants receive zilebesiran, 300 mg, SC injection, Q6M, during the 12-month DB period. Participants will continue receiving the same zilebesiran regimen for up to 24 additional months in the DB Extension period. Participants in this arm will receive a placebo during those dosing visits when they do not receive zilebesiran to maintain the blind. Upon implementation of Amendment 6, the DB Extension period was closed.', 'interventionNames': ['Drug: Placebo', 'Drug: ALN-AGT01']}, {'type': 'EXPERIMENTAL', 'label': 'Zilebesiran 300 mg Q3M', 'description': 'Participants receive zilebesiran, 300 mg, SC injection, Q3M, during the 12-month DB period. Participants continue receiving the same zilebesiran regimen for up to 24 additional months in the DB Extension period. Upon implementation of Amendment 6, the DB Extension period was closed.', 'interventionNames': ['Drug: ALN-AGT01']}, {'type': 'EXPERIMENTAL', 'label': 'Zilebesiran 600 mg Q6M', 'description': 'Participants receive zilebesiran, 600 mg, SC injection, Q6M, during the 12-month DB period. Participants will continue receiving the same zilebesiran regimen for up to 24 additional months in the DB Extension period. Participants in this arm will receive a placebo during those dosing visits when they do not receive zilebesiran to maintain the blind. 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Requests for access to data can be submitted via the website www.vivli.org.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alnylam Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}