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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-004399-68 | EudraCT Number |
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This was a multi-center, randomized, double-blind, placebo-controlled, parallel group, dose-ranging study to evaluate the efficacy and safety of botulinum toxin type A (AGN-151607) injections into the epicardial fat pads, foci of ganglionic plexi, to prevent Post-Operative Atrial Fibrillation (POAF) in patients undergoing open-chest cardiac surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AGN-151607 (250 U) | Experimental | Injections of 50 U were made into each 1 of 5 fat pads. The total injection volume into each fat pad was 1 mL. One-time treatment. |
|
| AGN-151607 (125 U) | Experimental | Injections of 25 U were made into each 1 of 5 fat pads. The total injection volume into each fat pad was 1 mL. One-time treatment. |
|
| Placebo | Placebo Comparator | Injections of placebo were made into each 1 of 5 fat pads. The total injection volume into each fat pad was 1 mL. One-time treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AGN-151607 | Drug | Injections were made into each 1 of 5 fat pads. The total injection volume into each fat pad was 1 mL. One-time treatment. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With at Least 1 Continuous AF (Atrial Fibrillation or Atrial Flutter) Episode ≥ 30 Seconds During the First 30 Days Post-surgery | At least one episode of continuous AF (atrial fibrillation or atrial flutter) sustained ≥ 30 seconds documented by monitoring ECG measurements using ECG patches (ePatch) placed on the participant's chest. | First 30 days following the initial intensive care unit (ICU) admission date after open-chest cardiac surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Time Spent in Atrial Fibrillation or Atrial Flutter (AF Burden) During the First 30 Days Post-surgery | The proportion of time an individual is in AF (atrial fibrillation or atrial flutter) during a monitoring period (expressed as a percentage) calculated as (the total time spent in AF during the first 30 days post-surgery divided by the total time of analyzable data obtained from the ECG patch during the first 30 days post-surgery) multiplied by 100. The calculation excludes continuous AF episodes < 30 seconds in duration. |
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Inclusion Criteria:
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University School of Med /ID# 236922 | Stanford | California | 94305-2200 | United States | ||
| Yale New Haven Hospital - Yale School of Medicine /ID# 238221 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38661602 | Derived | Piccini JP, Ahlsson A, Dorian P, Gillinov AM, Kowey PR, Mack MJ, Milano CA, Noiseux N, Perrault LP, Ryan W, Steinberg JS, Voisine P, Waldron NH, Gleason KJ, Titanji W, Leaback RD, O'Sullivan A, Ferguson WG, Benussi S; NOVA-AF Investigators. Efficacy and Safety of Botulinum Toxin Type A for the Prevention of Postoperative Atrial Fibrillation. JACC Clin Electrophysiol. 2024 May;10(5):930-940. doi: 10.1016/j.jacep.2024.01.020. Epub 2024 Apr 24. | |
| 34687654 |
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AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
A total of 323 subjects were randomized, of which 319 received study drug (Safety Population).
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Injections of placebo were made into each 1 of 5 fat pads. The total injection volume into each fat pad was 1 mL. One-time treatment. |
| FG001 | AGN-151607 (125 U) | Injections of 25 U were made into each 1 of 5 fat pads. The total injection volume into each fat pad was 1 mL. One-time treatment. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Randomized Population |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 25, 2020 | Mar 4, 2024 |
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| Placebo | Drug | Injections of placebo were made into each 1 of 5 fat pads. The total injection volume into each fat pad was 1 mL. One-time treatment. |
|
| First 30 days following the initial ICU admission date after open-chest cardiac surgery. |
| Percentage of Participants With at Least 1 Event of Symptomatic AF (Atrial Fibrillation or Atrial Flutter) During the First 30 Days Post-surgery | At least 1 event of symptomatic AF (atrial fibrillation or atrial flutter) (symptoms occurring within 2 hours of an AF episode). For symptomatic AF, symptoms that occur in the interval that starts two hours prior to the onset of the AF episode and ends two hours after the conclusion of the AF episode will meet the definition of "within 2 hours of an AF episode". AF episode ≥ 30 seconds. | First 30 days following the initial ICU admission date after open-chest cardiac surgery. |
| Time to First Occurrence of AF (Atrial Fibrillation or Atrial Flutter) During the First 30 Days Post-surgery | Amount of time (days) to first AF (atrial fibrillation or atrial flutter) occurrence defined by first episode of AF lasting for ≥ 30 seconds. | First 30 days following the initial ICU admission date after open-chest cardiac surgery. |
| Percentage of Participants With at Least 1 Continuous AF (Atrial Fibrillation or Atrial Flutter) Episode ≥ 2 Minutes During the First 30 Days Post-surgery | At least one episode of continuous AF (atrial fibrillation or atrial flutter) sustained ≥ 2 minutes documented by monitoring ECG measurements using ECG patches (ePatch) placed on the participant's chest. | First 30 days following the initial ICU admission date after open-chest cardiac surgery. |
| Percentage of Participants With at Least 1 Continuous AF (Atrial Fibrillation or Atrial Flutter) Episode ≥ 5 Minutes During the First 30 Days Post-surgery | At least one episode of continuous AF (atrial fibrillation or atrial flutter) sustained ≥ 5 minutes documented by monitoring ECG measurements using ECG patches (ePatch) placed on the participant's chest. | First 30 days following the initial ICU admission date after open-chest cardiac surgery. |
| Percentage of Participants With at Least 1 Continuous AF (Atrial Fibrillation or Atrial Flutter) Episode ≥ 6 Minutes During the First 30 Days Post-surgery | At least one episode of continuous AF (atrial fibrillation or atrial flutter) sustained ≥ 6 minutes documented by monitoring ECG measurements using ECG patches (ePatch) placed on the participant's chest. | First 30 days following the initial ICU admission date after open-chest cardiac surgery. |
| Percentage of Participants With at Least 1 Continuous AF (Atrial Fibrillation or Atrial Flutter) Episode ≥ 30 Minutes During the First 30 Days Post-surgery | At least one episode of continuous AF (atrial fibrillation or atrial flutter) sustained ≥ 30 minutes documented by monitoring ECG measurements using ECG patches (ePatch) placed on the participant's chest. | First 30 days following the initial ICU admission date after open-chest cardiac surgery. |
| Percentage of Participants With at Least 1 Continuous AF (Atrial Fibrillation or Atrial Flutter) Episode ≥ 1 Hour During the First 30 Days Post-surgery | At least one episode of continuous AF (atrial fibrillation or atrial flutter) sustained ≥ 1 hour documented by monitoring ECG measurements using ECG patches (ePatch) placed on the participant's chest. | First 30 days following the initial ICU admission date after open-chest cardiac surgery. |
| Percentage of Participants With at Least 1 Continuous AF (Atrial Fibrillation or Atrial Flutter) Episode ≥ 4 Hours During the First 30 Days Post-surgery | At least one episode of continuous AF (atrial fibrillation or atrial flutter) sustained ≥ 4 hours documented by monitoring ECG measurements using ECG patches (ePatch) placed on the participant's chest. | First 30 days following the initial ICU admission date after open-chest cardiac surgery. |
| Percentage of Participants With at Least 1 Continuous AF (Atrial Fibrillation or Atrial Flutter) Episode ≥ 6 Hours During the First 30 Days Post-surgery | At least one episode of continuous AF (atrial fibrillation or atrial flutter) sustained ≥ 6 hours documented by monitoring ECG measurements using ECG patches (ePatch) placed on the participant's chest. | First 30 days following the initial ICU admission date after open-chest cardiac surgery. |
| Percentage of Participants With at Least 1 Continuous AF (Atrial Fibrillation or Atrial Flutter) Episode ≥ 12 Hours During the First 30 Days Post-surgery | At least one episode of continuous AF (atrial fibrillation or atrial flutter) sustained ≥ 12 hours documented by monitoring ECG measurements using ECG patches (ePatch) placed on the participant's chest. | First 30 days following the initial ICU admission date after open-chest cardiac surgery. |
| Percentage of Participants With at Least 1 Continuous AF (Atrial Fibrillation or Atrial Flutter) Episode ≥ 24 Hours During the First 30 Days Post-surgery | At least one episode of continuous AF (atrial fibrillation or atrial flutter) sustained ≥ 24 hours documented by monitoring ECG measurements using ECG patches (ePatch) placed on the participant's chest. | First 30 days following the initial ICU admission date after open-chest cardiac surgery. |
| Percentage of Participants With at Least 1 Continuous Atrial Fibrillation (Excluding Atrial Flutter) Episode ≥ 30 Seconds During the First 30 Days Post-surgery | At least one episode of continuous atrial fibrillation (excluding atrial flutter) sustained ≥ 30 seconds documented by monitoring ECG measurements using ECG patches (ePatch) placed on the participant's chest. | First 30 days following the initial ICU admission date after open-chest cardiac surgery. |
| Percentage of Participants With at Least 1 Continuous Atrial Flutter Episode ≥ 30 Seconds During the First 30 Days Post-surgery | At least one episode of continuous atrial flutter sustained ≥ 30 seconds documented by monitoring ECG measurements using ECG patches (ePatch) placed on the participant's chest. | First 30 days following the initial ICU admission date after open-chest cardiac surgery. |
| Percentage of Participants With at Least 1 Continuous Atrial Tachycardia Episode (Defined as the Duration of the Longest Supraventricular Tachycardia [SVT] Run) ≥ 30 Seconds During the First 30 Days Post-surgery | At least one episode of continuous atrial tachycardia sustained ≥ 30 seconds documented by monitoring ECG measurements using ECG patches (ePatch) placed on the participant's chest. | First 30 days following the initial ICU admission date after open-chest cardiac surgery. |
| Percentage of Participants With at Least 1 Continuous Episode of Either Atrial Fibrillation or Atrial Flutter or Atrial Tachycardia ≥ 30 Seconds During the First 30 Days Post-surgery | At least one episode of continuous atrial fibrillation or atrial flutter or atrial tachycardia sustained ≥ 30 seconds documented by monitoring ECG measurements using ECG patches (ePatch) placed on the participant's chest. | First 30 days following the initial ICU admission date after open-chest cardiac surgery. |
| New Haven |
| Connecticut |
| 06510-3206 |
| United States |
| Medstar Washington Hospital Center /ID# 234322 | Washington D.C. | District of Columbia | 20010-3017 | United States |
| Emory Saint Joseph's Hospital /ID# 234334 | Atlanta | Georgia | 30342-1731 | United States |
| Lutheran Medical Group /ID# 237990 | Fort Wayne | Indiana | 46804 | United States |
| Ochsner Medical Center /ID# 238004 | New Orleans | Louisiana | 70121-2429 | United States |
| University of Maryland Medical Center /ID# 234352 | Baltimore | Maryland | 21201-1544 | United States |
| University of Michigan /ID# 236228 | Ann Arbor | Michigan | 48109-5000 | United States |
| Washington University-School of Medicine /ID# 238121 | St Louis | Missouri | 63110 | United States |
| Dartmouth-Hitchcock Medical Center /ID# 237530 | Lebanon | New Hampshire | 03756 | United States |
| Icahn School of Medicine at Mount Sinai - The Mount Sinai Medical Center /ID# 234449 | New York | New York | 10029 | United States |
| Mission Hospital /ID# 237231 | Asheville | North Carolina | 28801 | United States |
| Duke University Medical Center /ID# 234314 | Durham | North Carolina | 27705-4410 | United States |
| East Carolina University /ID# 237820 | Greenville | North Carolina | 27858 | United States |
| Ohio State University Medical Center /ID# 234408 | Columbus | Ohio | 43210 | United States |
| Medical University of South Carolina /ID# 236476 | Charleston | South Carolina | 29425 | United States |
| Baylor Scott & White Research Institute /ID# 235937 | Plano | Texas | 75093 | United States |
| University of Utah /ID# 237601 | Salt Lake City | Utah | 84112-5500 | United States |
| University of Virginia /ID# 237611 | Charlottesville | Virginia | 22908 | United States |
| Medizinische Universitaet Wien /ID# 238259 | Vienna | State of Vienna | 1090 | Austria |
| University of Ottawa Heart Institute /ID# 236012 | Ottawa | Ontario | K1Y 4W7 | Canada |
| Toronto General Hospital /ID# 237680 | Toronto | Ontario | M5G 2C4 | Canada |
| Montreal Heart Insitute /ID# 234859 | Montreal | Quebec | H1T 1C8 | Canada |
| CHUM - Centre hospitalier de l'Universite de Montréal /ID# 238163 | Montreal | Quebec | H2X 3E4 | Canada |
| CIUSSS du Nord-de-l'ile-de-Montréal_Hopital du Sacré-Coeur de Montréal /ID# 234316 | Montreal | Quebec | H4J 1C5 | Canada |
| Institut universitaire de cardiologie et de pneumologie de Québec - Université L /ID# 237166 | Québec | Quebec | G1V 4G5 | Canada |
| Asklepios Klinik Harburg-Hamburg /ID# 234855 | Hamburg | 21075 | Germany |
| ASST degli Spedali Civili di Brescia /ID# 234861 | Brescia | 25123 | Italy |
| Academisch Medisch Centrum /ID# 237113 | Amsterdam | 1105 AZ | Netherlands |
| Hospital Clínic. University of Barcelona /ID# 234853 | Barcelona | 08039 | Spain |
| Orebro University Hospital Sweden /ID# 236047 | Örebro | Örebro County | 702 12 | Sweden |
| University Hospital Plymouth NHS Trust /ID# 234423 | Plymouth | PL6 5FP | United Kingdom |
| Derived |
| Piccini JP, Ahlsson A, Dorian P, Gillinov MA, Kowey PR, Mack MJ, Milano CA, Perrault LP, Steinberg JS, Waldron NH, Adams LM, Bharucha DB, Brin MF, Ferguson WG, Benussi S. Design and Rationale of a Phase 2 Study of NeurOtoxin (Botulinum Toxin Type A) for the PreVention of Post-Operative Atrial Fibrillation - The NOVA Study. Am Heart J. 2022 Mar;245:51-59. doi: 10.1016/j.ahj.2021.10.114. Epub 2021 Oct 20. |
| FG002 | AGN-151607 (250 U) | Injections of 50 U were made into each 1 of 5 fat pads. The total injection volume into each fat pad was 1 mL. One-time treatment. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Treated (Safety) Population |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Injections of placebo were made into each 1 of 5 fat pads. The total injection volume into each fat pad was 1 mL. One-time treatment. |
| BG001 | AGN-151607 (125 U) | Injections of 25 U were made into each 1 of 5 fat pads. The total injection volume into each fat pad was 1 mL. One-time treatment. |
| BG002 | AGN-151607 (250 U) | Injections of 50 U were made into each 1 of 5 fat pads. The total injection volume into each fat pad was 1 mL. One-time treatment. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Type of Surgery | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With at Least 1 Continuous AF (Atrial Fibrillation or Atrial Flutter) Episode ≥ 30 Seconds During the First 30 Days Post-surgery | At least one episode of continuous AF (atrial fibrillation or atrial flutter) sustained ≥ 30 seconds documented by monitoring ECG measurements using ECG patches (ePatch) placed on the participant's chest. | All randomized participants who received study treatment and had at least 1 post-dose ECG (by ePatch) by Day 30 post-surgery. | Posted | Number | percentage of participants | First 30 days following the initial intensive care unit (ICU) admission date after open-chest cardiac surgery. |
|
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| Secondary | Percentage of Time Spent in Atrial Fibrillation or Atrial Flutter (AF Burden) During the First 30 Days Post-surgery | The proportion of time an individual is in AF (atrial fibrillation or atrial flutter) during a monitoring period (expressed as a percentage) calculated as (the total time spent in AF during the first 30 days post-surgery divided by the total time of analyzable data obtained from the ECG patch during the first 30 days post-surgery) multiplied by 100. The calculation excludes continuous AF episodes < 30 seconds in duration. | All randomized participants who received study treatment and had at least 1 post-dose ECG (by ePatch) by Day 30 post-surgery. | Posted | Mean | Standard Deviation | percentage of time | First 30 days following the initial ICU admission date after open-chest cardiac surgery. |
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| Secondary | Percentage of Participants With at Least 1 Event of Symptomatic AF (Atrial Fibrillation or Atrial Flutter) During the First 30 Days Post-surgery | At least 1 event of symptomatic AF (atrial fibrillation or atrial flutter) (symptoms occurring within 2 hours of an AF episode). For symptomatic AF, symptoms that occur in the interval that starts two hours prior to the onset of the AF episode and ends two hours after the conclusion of the AF episode will meet the definition of "within 2 hours of an AF episode". AF episode ≥ 30 seconds. | All randomized participants who received study treatment and had at least 1 post-dose ECG (by ePatch) by Day 30 post-surgery. | Posted | Number | percentage of participants | First 30 days following the initial ICU admission date after open-chest cardiac surgery. |
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| Secondary | Time to First Occurrence of AF (Atrial Fibrillation or Atrial Flutter) During the First 30 Days Post-surgery | Amount of time (days) to first AF (atrial fibrillation or atrial flutter) occurrence defined by first episode of AF lasting for ≥ 30 seconds. | All randomized participants who received study treatment and had at least 1 post-dose ECG (by ePatch) by Day 30 post-surgery. | Posted | Median | 95% Confidence Interval | Days | First 30 days following the initial ICU admission date after open-chest cardiac surgery. |
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| Secondary | Percentage of Participants With at Least 1 Continuous AF (Atrial Fibrillation or Atrial Flutter) Episode ≥ 2 Minutes During the First 30 Days Post-surgery | At least one episode of continuous AF (atrial fibrillation or atrial flutter) sustained ≥ 2 minutes documented by monitoring ECG measurements using ECG patches (ePatch) placed on the participant's chest. | All randomized participants who received study treatment and had at least 1 post-dose ECG (by ePatch) by Day 30 post-surgery. | Posted | Number | percentage of participants | First 30 days following the initial ICU admission date after open-chest cardiac surgery. |
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| Secondary | Percentage of Participants With at Least 1 Continuous AF (Atrial Fibrillation or Atrial Flutter) Episode ≥ 5 Minutes During the First 30 Days Post-surgery | At least one episode of continuous AF (atrial fibrillation or atrial flutter) sustained ≥ 5 minutes documented by monitoring ECG measurements using ECG patches (ePatch) placed on the participant's chest. | All randomized participants who received study treatment and had at least 1 post-dose ECG (by ePatch) by Day 30 post-surgery. | Posted | Number | percentage of participants | First 30 days following the initial ICU admission date after open-chest cardiac surgery. |
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| Secondary | Percentage of Participants With at Least 1 Continuous AF (Atrial Fibrillation or Atrial Flutter) Episode ≥ 6 Minutes During the First 30 Days Post-surgery | At least one episode of continuous AF (atrial fibrillation or atrial flutter) sustained ≥ 6 minutes documented by monitoring ECG measurements using ECG patches (ePatch) placed on the participant's chest. | All randomized participants who received study treatment and had at least 1 post-dose ECG (by ePatch) by Day 30 post-surgery. | Posted | Number | percentage of participants | First 30 days following the initial ICU admission date after open-chest cardiac surgery. |
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| Secondary | Percentage of Participants With at Least 1 Continuous AF (Atrial Fibrillation or Atrial Flutter) Episode ≥ 30 Minutes During the First 30 Days Post-surgery | At least one episode of continuous AF (atrial fibrillation or atrial flutter) sustained ≥ 30 minutes documented by monitoring ECG measurements using ECG patches (ePatch) placed on the participant's chest. | All randomized participants who received study treatment and had at least 1 post-dose ECG (by ePatch) by Day 30 post-surgery. | Posted | Number | percentage of participants | First 30 days following the initial ICU admission date after open-chest cardiac surgery. |
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| Secondary | Percentage of Participants With at Least 1 Continuous AF (Atrial Fibrillation or Atrial Flutter) Episode ≥ 1 Hour During the First 30 Days Post-surgery | At least one episode of continuous AF (atrial fibrillation or atrial flutter) sustained ≥ 1 hour documented by monitoring ECG measurements using ECG patches (ePatch) placed on the participant's chest. | All randomized participants who received study treatment and had at least 1 post-dose ECG (by ePatch) by Day 30 post-surgery. | Posted | Number | percentage of participants | First 30 days following the initial ICU admission date after open-chest cardiac surgery. |
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| Secondary | Percentage of Participants With at Least 1 Continuous AF (Atrial Fibrillation or Atrial Flutter) Episode ≥ 4 Hours During the First 30 Days Post-surgery | At least one episode of continuous AF (atrial fibrillation or atrial flutter) sustained ≥ 4 hours documented by monitoring ECG measurements using ECG patches (ePatch) placed on the participant's chest. | All randomized participants who received study treatment and had at least 1 post-dose ECG (by ePatch) by Day 30 post-surgery. | Posted | Number | percentage of participants | First 30 days following the initial ICU admission date after open-chest cardiac surgery. |
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| Secondary | Percentage of Participants With at Least 1 Continuous AF (Atrial Fibrillation or Atrial Flutter) Episode ≥ 6 Hours During the First 30 Days Post-surgery | At least one episode of continuous AF (atrial fibrillation or atrial flutter) sustained ≥ 6 hours documented by monitoring ECG measurements using ECG patches (ePatch) placed on the participant's chest. | All randomized participants who received study treatment and had at least 1 post-dose ECG (by ePatch) by Day 30 post-surgery. | Posted | Number | percentage of participants | First 30 days following the initial ICU admission date after open-chest cardiac surgery. |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With at Least 1 Continuous AF (Atrial Fibrillation or Atrial Flutter) Episode ≥ 12 Hours During the First 30 Days Post-surgery | At least one episode of continuous AF (atrial fibrillation or atrial flutter) sustained ≥ 12 hours documented by monitoring ECG measurements using ECG patches (ePatch) placed on the participant's chest. | All randomized participants who received study treatment and had at least 1 post-dose ECG (by ePatch) by Day 30 post-surgery. | Posted | Number | percentage of participants | First 30 days following the initial ICU admission date after open-chest cardiac surgery. |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With at Least 1 Continuous AF (Atrial Fibrillation or Atrial Flutter) Episode ≥ 24 Hours During the First 30 Days Post-surgery | At least one episode of continuous AF (atrial fibrillation or atrial flutter) sustained ≥ 24 hours documented by monitoring ECG measurements using ECG patches (ePatch) placed on the participant's chest. | All randomized participants who received study treatment and had at least 1 post-dose ECG (by ePatch) by Day 30 post-surgery. | Posted | Number | percentage of participants | First 30 days following the initial ICU admission date after open-chest cardiac surgery. |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With at Least 1 Continuous Atrial Fibrillation (Excluding Atrial Flutter) Episode ≥ 30 Seconds During the First 30 Days Post-surgery | At least one episode of continuous atrial fibrillation (excluding atrial flutter) sustained ≥ 30 seconds documented by monitoring ECG measurements using ECG patches (ePatch) placed on the participant's chest. | All randomized participants who received study treatment and had at least 1 post-dose ECG (by ePatch) by Day 30 post-surgery. | Posted | Number | percentage of participants | First 30 days following the initial ICU admission date after open-chest cardiac surgery. |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With at Least 1 Continuous Atrial Flutter Episode ≥ 30 Seconds During the First 30 Days Post-surgery | At least one episode of continuous atrial flutter sustained ≥ 30 seconds documented by monitoring ECG measurements using ECG patches (ePatch) placed on the participant's chest. | All randomized participants who received study treatment and had at least 1 post-dose ECG (by ePatch) by Day 30 post-surgery. | Posted | Number | percentage of participants | First 30 days following the initial ICU admission date after open-chest cardiac surgery. |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With at Least 1 Continuous Atrial Tachycardia Episode (Defined as the Duration of the Longest Supraventricular Tachycardia [SVT] Run) ≥ 30 Seconds During the First 30 Days Post-surgery | At least one episode of continuous atrial tachycardia sustained ≥ 30 seconds documented by monitoring ECG measurements using ECG patches (ePatch) placed on the participant's chest. | All randomized participants who received study treatment and had at least 1 post-dose ECG (by ePatch) by Day 30 post-surgery. | Posted | Number | percentage of participants | First 30 days following the initial ICU admission date after open-chest cardiac surgery. |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With at Least 1 Continuous Episode of Either Atrial Fibrillation or Atrial Flutter or Atrial Tachycardia ≥ 30 Seconds During the First 30 Days Post-surgery | At least one episode of continuous atrial fibrillation or atrial flutter or atrial tachycardia sustained ≥ 30 seconds documented by monitoring ECG measurements using ECG patches (ePatch) placed on the participant's chest. | All randomized participants who received study treatment and had at least 1 post-dose ECG (by ePatch) by Day 30 post-surgery. | Posted | Number | percentage of participants | First 30 days following the initial ICU admission date after open-chest cardiac surgery. |
|
The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Injections of placebo were made into each 1 of 5 fat pads. The total injection volume into each fat pad was 1 mL. One-time treatment. | 1 | 108 | 36 | 105 | 86 | 105 |
| EG001 | AGN-151607 (125 U) | Injections of 25 U were made into each 1 of 5 fat pads. The total injection volume into each fat pad was 1 mL. One-time treatment. | 0 | 106 | 38 | 105 | 84 | 105 |
| EG002 | AGN-151607 (250 U) | Injections of 50 U were made into each 1 of 5 fat pads. The total injection volume into each fat pad was 1 mL. One-time treatment. | 2 | 109 | 28 | 109 | 94 | 109 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| BLOOD LOSS ANAEMIA | Blood and lymphatic system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| COAGULOPATHY | Blood and lymphatic system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| THROMBOCYTOSIS | Blood and lymphatic system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| ACUTE LEFT VENTRICULAR FAILURE | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
| |
| ACUTE MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
| |
| AORTIC VALVE INCOMPETENCE | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
| |
| ATRIAL FIBRILLATION | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
| |
| ATRIAL FLUTTER | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
| |
| ATRIOVENTRICULAR BLOCK | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
| |
| ATRIOVENTRICULAR BLOCK COMPLETE | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
| |
| BRADYCARDIA | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
| |
| CARDIAC ARREST | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
| |
| CARDIAC FAILURE | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
| |
| CARDIAC FAILURE ACUTE | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
| |
| CARDIOGENIC SHOCK | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
| |
| CORONARY ARTERY DISEASE | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
| |
| CORONARY ARTERY PERFORATION | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
| |
| MYOCARDIAL ISCHAEMIA | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
| |
| NODAL RHYTHM | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
| |
| PERICARDIAL EFFUSION | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
| |
| PERICARDITIS | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
| |
| SUPRAVENTRICULAR TACHYCARDIA | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
| |
| DIPLOPIA | Eye disorders | MedDRA 25.1 | Systematic Assessment |
| |
| AORTO-OESOPHAGEAL FISTULA | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| DYSPHAGIA | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| GASTROINTESTINAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| ILEUS | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| MELAENA | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| ASTHENIA | General disorders | MedDRA 25.1 | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA 25.1 | Systematic Assessment |
| |
| CHOLECYSTITIS ACUTE | Hepatobiliary disorders | MedDRA 25.1 | Systematic Assessment |
| |
| APPENDICITIS | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| BACTERAEMIA | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| BRONCHITIS | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| CELLULITIS | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| COLONIC ABSCESS | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| COVID-19 PNEUMONIA | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| DIVERTICULITIS | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| ENDOCARDITIS | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| MEDIASTINITIS | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| OSTEOMYELITIS | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| SEPSIS | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| WOUND INFECTION | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| CORONARY SINUS INJURY | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
| |
| FALL | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
| |
| PERIPROCEDURAL MYOCARDIAL INFARCTION | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
| |
| POST PROCEDURAL HAEMORRHAGE | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
| |
| POSTOPERATIVE ILEUS | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
| |
| PROCEDURAL HAEMORRHAGE | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
| |
| SUBDURAL HAEMATOMA | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
| |
| TRANSFUSION-RELATED ACUTE LUNG INJURY | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
| |
| VASCULAR GRAFT OCCLUSION | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
| |
| VASCULAR PROCEDURE COMPLICATION | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
| |
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 25.1 | Systematic Assessment |
| |
| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 25.1 | Systematic Assessment |
| |
| BLOOD CREATINE PHOSPHOKINASE INCREASED | Investigations | MedDRA 25.1 | Systematic Assessment |
| |
| ELECTROENCEPHALOGRAM ABNORMAL | Investigations | MedDRA 25.1 | Systematic Assessment |
| |
| HAEMOGLOBIN DECREASED | Investigations | MedDRA 25.1 | Systematic Assessment |
| |
| INTERNATIONAL NORMALISED RATIO INCREASED | Investigations | MedDRA 25.1 | Systematic Assessment |
| |
| LACTIC ACIDOSIS | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
| |
| MUSCULAR WEAKNESS | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| ROTATOR CUFF SYNDROME | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| LUNG ADENOCARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | Systematic Assessment |
| |
| LUNG NEOPLASM | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | Systematic Assessment |
| |
| NON-SMALL CELL LUNG CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | Systematic Assessment |
| |
| RENAL CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | Systematic Assessment |
| |
| AMYOTROPHIC LATERAL SCLEROSIS | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| BELL'S PALSY | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| CEREBRAL ISCHAEMIA | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| CEREBROVASCULAR ACCIDENT | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| ENCEPHALOPATHY | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| FACIAL PARALYSIS | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| LOSS OF CONSCIOUSNESS | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| MYASTHENIA GRAVIS | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| SYNCOPE | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| TRANSIENT ISCHAEMIC ATTACK | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| MENTAL STATUS CHANGES | Psychiatric disorders | MedDRA 25.1 | Systematic Assessment |
| |
| ACUTE KIDNEY INJURY | Renal and urinary disorders | MedDRA 25.1 | Systematic Assessment |
| |
| HAEMATURIA | Renal and urinary disorders | MedDRA 25.1 | Systematic Assessment |
| |
| NEPHROLITHIASIS | Renal and urinary disorders | MedDRA 25.1 | Systematic Assessment |
| |
| URINARY RETENTION | Renal and urinary disorders | MedDRA 25.1 | Systematic Assessment |
| |
| ACUTE RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| ASPIRATION | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| CHRONIC OBSTRUCTIVE PULMONARY DISEASE | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| DIAPHRAGMATIC PARALYSIS | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| DYSPNOEA EXERTIONAL | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| HAEMOTHORAX | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| PLEURAL EFFUSION | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| PNEUMOTHORAX | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| PULMONARY OEDEMA | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| AORTIC PERFORATION | Vascular disorders | MedDRA 25.1 | Systematic Assessment |
| |
| DEEP VEIN THROMBOSIS | Vascular disorders | MedDRA 25.1 | Systematic Assessment |
| |
| HAEMATOMA | Vascular disorders | MedDRA 25.1 | Systematic Assessment |
| |
| HAEMORRHAGE | Vascular disorders | MedDRA 25.1 | Systematic Assessment |
| |
| HYPERTENSION | Vascular disorders | MedDRA 25.1 | Systematic Assessment |
| |
| INTERMITTENT CLAUDICATION | Vascular disorders | MedDRA 25.1 | Systematic Assessment |
| |
| ORTHOSTATIC HYPOTENSION | Vascular disorders | MedDRA 25.1 | Systematic Assessment |
| |
| SHOCK HAEMORRHAGIC | Vascular disorders | MedDRA 25.1 | Systematic Assessment |
| |
| THROMBOSIS | Vascular disorders | MedDRA 25.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| ATRIAL FIBRILLATION | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
| |
| ATRIAL FLUTTER | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
| |
| BRADYCARDIA | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
| |
| PALPITATIONS | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
| |
| SINUS TACHYCARDIA | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
| |
| TACHYCARDIA | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA 25.1 | Systematic Assessment |
| |
| OEDEMA PERIPHERAL | General disorders | MedDRA 25.1 | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA 25.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| PROCEDURAL PAIN | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
| |
| VASOPLEGIA SYNDROME | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
| |
| HYPERGLYCAEMIA | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
| |
| HYPERVOLAEMIA | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
| |
| HYPOKALAEMIA | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
| |
| HYPOPHOSPHATAEMIA | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
| |
| MUSCULOSKELETAL CHEST PAIN | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| ANXIETY | Psychiatric disorders | MedDRA 25.1 | Systematic Assessment |
| |
| DELIRIUM | Psychiatric disorders | MedDRA 25.1 | Systematic Assessment |
| |
| INSOMNIA | Psychiatric disorders | MedDRA 25.1 | Systematic Assessment |
| |
| ATELECTASIS | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| PLEURAL EFFUSION | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| PNEUMOTHORAX | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| DERMATITIS CONTACT | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| HYPERTENSION | Vascular disorders | MedDRA 25.1 | Systematic Assessment |
| |
| HYPOTENSION | Vascular disorders | MedDRA 25.1 | Systematic Assessment |
|
AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie | 800-633-9110 | abbvieclinicaltrials@abbvie.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 31, 2022 | Mar 4, 2024 | SAP_001.pdf |
Not provided
| Lost to Follow-up |
|
| Death |
|
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Valve only Surgery |
|
| CABG and Valve Surgery |
|
P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (< 65 or ≥ 65 years). |
| Cochran-Mantel-Haenszel |
| 0.7789 |
| Risk Ratio (RR) |
| 1.04 |
| 2-Sided |
| 95 |
| 0.79 |
| 1.37 |
| Superiority |
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