Adverse Events Module
For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.
Adverse Events Module path is as follows:
Study -> Results Section -> Adverse Events Module -> Event Groups
Study -> Results Section -> Adverse Events Module -> Serious Events
Study -> Results Section -> Adverse Events Module -> Other Events
Adverse Events Module
Ignite Creation Date:
2025-12-24 @ 9:30 PM
Ignite Modification Date:
2025-12-25 @ 7:15 PM
NCT ID:
NCT05103332
Description:
As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \& continuing it after Month 6 \& those on placebo in DB later \& switching to zilebesiran after Month 6.
Frequency Threshold:
5
Time Frame:
Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.
Study:
NCT05103332
Study Brief:
Zilebesiran as Add-on Therapy in Patients With Hypertension Not Adequately Controlled by a Standard of Care Antihypertensive Medication (KARDIA-2)
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Run-in: Amlodipine | Participants who cleared screening received open-label therapy with amlodipine 5 mg orally QD as their protocol-specified background antihypertensive medication during a Run-in period of at least 4 weeks. | 0 | None | 0 | 238 | 0 | 238 | View |
| Run-in: Olmesartan | Participants who cleared screening received open-label therapy with olmesartan 40 mg orally QD \[or 20 mg orally QD for participants with creatinine clearance ≤ 60 mL/min at screening enrolled at sites outside of the US\] as their protocol-specified background antihypertensive medication during a Run-in period of at least 4 weeks. | 0 | None | 1 | 293 | 0 | 293 | View |
| DB Period: Placebo (Add-on to Indapamide) | Participants received placebo matched to zilebesiran, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to indapamide. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant's protocol-specified background antihypertensive medication per Investigator judgement. | 0 | None | 2 | 64 | 11 | 64 | View |
| DB Period: Zilebesiran (Add-on to Indapamide) | Participants received zilebesiran, 600 mg, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to indapamide. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant's protocol-specified background antihypertensive medication per Investigator judgement. | 0 | None | 0 | 63 | 14 | 63 | View |
| DB Period: Placebo (Add-on to Amlodipine) | Participants received placebo matched to zilebesiran, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to amlodipine. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant's protocol-specified background antihypertensive medication per Investigator judgement. | 0 | None | 1 | 120 | 21 | 120 | View |
| DB Period: Zilebesiran (Add-on to Amlodipine) | Participants received zilebesiran, 600 mg, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to amlodipine. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant's protocol-specified background antihypertensive medication per Investigator judgement. | 0 | None | 3 | 118 | 26 | 118 | View |
| DB Period: Placebo (Add-on to Olmesartan) | Participants received placebo matched to zilebesiran, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to olmesartan. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant's protocol-specified background antihypertensive medication per Investigator judgement. | 0 | None | 4 | 145 | 29 | 145 | View |
| DB Period: Zilebesiran (Add-on to Olmesartan) | Participants received zilebesiran, 600 mg, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to olmesartan. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant's protocol-specified background antihypertensive medication per Investigator judgement. | 0 | None | 4 | 148 | 41 | 148 | View |
| DB Period (Placebo) to OLE Period (Zilebesiran) [Indapamide Cohort] | Prior to Amendment 3, participants who completed the DB period before a separate OLE study was available, entered the OLE period of this study and received treatment with zilebesiran 600 mg SC q6M. Protocol-specified background antihypertensive treatment with indapamide was discontinued at the start of OLE period. | 0 | None | 1 | 26 | 1 | 26 | View |
| DB Period (Zilebesiran) to OLE Period (Zilebesiran) [Indapamide Cohort] | Prior to Amendment 3, participants who completed the DB period before a separate OLE study was available, entered the OLE period of this study and continued treatment with zilebesiran 600 mg SC q6M. Protocol-specified background antihypertensive treatment with indapamide was discontinued at the start of OLE period. | 0 | None | 1 | 63 | 19 | 63 | View |
| DB Period (Placebo) to OLE Period (Zilebesiran) [Amlodipine Cohort] | Prior to Amendment 3, participants who completed the DB period before a separate OLE study was available, entered the OLE period of this study and received treatment with zilebesiran 600 mg SC q6M. Protocol-specified background antihypertensive treatment with amlodipine was discontinued at the start of OLE period. | 0 | None | 1 | 48 | 6 | 48 | View |
| DB Period (Zilebesiran) to OLE Period (Zilebesiran) [Amlodipine Cohort] | Prior to Amendment 3, participants who completed the DB period before a separate OLE study was available, entered the OLE period of this study and continued treatment with zilebesiran 600 mg SC q6M. Protocol-specified background antihypertensive treatment with amlodipine was discontinued at the start of OLE period. | 0 | None | 3 | 118 | 36 | 118 | View |
| DB Period (Placebo) to OLE Period (Zilebesiran) [Olmesartan Cohort] | Prior to Amendment 3, participants who completed the DB period before a separate OLE study was available, entered the OLE period of this study and received treatment with zilebesiran 600 mg SC q6M. Protocol-specified background antihypertensive treatment with olmesartan was discontinued at the start of OLE period. | 0 | None | 3 | 66 | 23 | 66 | View |
| DB Period (Zilebesiran) to OLE Period (Zilebesiran) [Olmesartan Cohort] | Prior to Amendment 3, participants who completed the DB period before a separate OLE study was available, entered the OLE period of this study and continued treatment with zilebesiran 600 mg SC q6M. Protocol-specified background antihypertensive treatment with olmesartan was discontinued at the start of OLE period. | 0 | None | 7 | 148 | 51 | 148 | View |
| DB (Placebo) to SFU [Indapamide Cohort] | Participants treated with placebo during DB period who did not enter the OLE period (prior to Amendment 3) or who discontinued treatment during the DB period entered the SFU period for safety monitoring. No treatment was administered in SFU. | 0 | None | 0 | 38 | 0 | 38 | View |
| DB (Zilebesiran) to SFU or OLE to SFU [Indapamide Cohort] | Prior to Amendment 3, participants treated with zilebesiran who did not enter the OLE Period or who discontinued treatment (zilebesiran) during the DB period entered the SFU period for safety monitoring. Upon implementation of Amendment 3, participants who completed the DB period entered the SFU period directly. Participants who were already in OLE period (after completing treatment with zilebesiran/placebo in DB period) did not receive any additional study drug in OLE and transitioned to the SFU period for safety monitoring. No treatment was administered in SFU. | 0 | None | 1 | 89 | 0 | 89 | View |
| DB (Placebo) to SFU [Amlodipine Cohort] | Participants treated with placebo during DB period who did not enter the OLE period (prior to Amendment 3) or who discontinued treatment during the DB period entered the SFU period for safety monitoring. No treatment was administered in SFU. | 1 | None | 0 | 72 | 0 | 72 | View |
| DB (Zilebesiran) to SFU or OLE to SFU [Amlodipine Cohort] | Prior to Amendment 3, participants treated with zilebesiran who did not enter the OLE Period or who discontinued treatment (zilebesiran) during the DB period entered the SFU period for safety monitoring. Upon implementation of Amendment 3, participants who completed the DB period entered the SFU period directly. Participants who were already in OLE period (after completing treatment with zilebesiran/placebo in DB period) did not receive any additional study drug in OLE and transitioned to the SFU period for safety monitoring. No treatment was administered in SFU. | 0 | None | 0 | 166 | 0 | 166 | View |
| DB (Placebo) to SFU [Olmesartan Cohort] | Participants treated with placebo during DB period who did not enter the OLE period (prior to Amendment 3) or who discontinued treatment during the DB period entered the SFU period for safety monitoring. No treatment was administered in SFU. | 0 | None | 0 | 79 | 0 | 79 | View |
| DB (Zilebesiran) to SFU or OLE to SFU [Olmesartan Cohort] | Prior to Amendment 3, participants treated with zilebesiran who did not enter the OLE Period or who discontinued treatment (zilebesiran) during the DB period entered the SFU period for safety monitoring. Upon implementation of Amendment 3, participants who completed the DB period entered the SFU period directly. Participants who were already in OLE period (after completing treatment with zilebesiran/placebo in DB period) did not receive any additional study drug in OLE and transitioned to the SFU period for safety monitoring. No treatment was administered in SFU. | 1 | None | 1 | 214 | 0 | 214 | View |
| Run-in: Indapamide | Participants who cleared screening received open-label therapy with indapamide 2.5 mg orally once daily (QD) as their protocol-specified background antihypertensive medication during a Run-in period of at least 4 weeks. | 0 | None | 0 | 127 | 0 | 127 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Atrial fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA26.0 | View |
| Cardiac failure chronic | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA26.0 | View |
| Cardiac failure congestive | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA26.0 | View |
| Myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA26.0 | View |
| Impaired gastric emptying | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA26.0 | View |
| Incarcerated umbilical hernia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA26.0 | View |
| Proctitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA26.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA26.0 | View |
| Chills | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA26.0 | View |
| Non-cardiac chest pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA26.0 | View |
| Oedema peripheral | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA26.0 | View |
| Cholelithiasis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA26.0 | View |
| Appendicitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA26.0 | View |
| Cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA26.0 | View |
| Helicobacter gastritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA26.0 | View |
| Tracheobronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA26.0 | View |
| Concussion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA26.0 | View |
| Overdose | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA26.0 | View |
| Pelvic fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA26.0 | View |
| Road traffic accident | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA26.0 | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA26.0 | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA26.0 | View |
| Osteoarthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA26.0 | View |
| Osteonecrosis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA26.0 | View |
| Renal cell carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA26.0 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA26.0 | View |
| Acute kidney injury | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA26.0 | View |
| Erectile dysfunction | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA26.0 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA26.0 | View |
| Respiratory failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA26.0 | View |
| Deep vein thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA26.0 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA26.0 | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA26.0 | View |
| Postoperative wound infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA26.0 | View |
| Hospitalisation | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA26.0 | View |
| Cholecystitis acute | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA26.0 | View |
| Acute myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA26.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Injection site reaction | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA26.0 | View |
| COVID-19 | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA26.0 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA26.0 | View |
| Hyperkalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA26.0 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA26.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA26.0 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA26.0 | View |