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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-004550-15 | EudraCT Number | ||
| 64179375THR2001 | Other Identifier | Janssen Research & Development, LLC |
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The primary purpose of Part 1 in this study is to assess the safety and tolerability of JNJ-64179375 for each dose level for dose escalation and any bleeding events (the composite of major, clinically relevant non-major, and minimal bleeding events) for the selection of doses for Part 2. The primary purpose of Part 2 is to assess the efficacy dose response of JNJ-64179375 for the prevention of total venous thromboembolism (VTE) (proximal and/or distal deep vein thrombosis [DVT] [asymptomatic confirmed by venography assessment of the operated leg or objectively confirmed symptomatic], nonfatal pulmonary embolism [PE], or any death).
This study has 2 parts, dose escalation and dose-response evaluation, and will be conducted in participants undergoing primary unilateral elective Total Knee Replacement (TKR) surgery. Participants will participate in either Part 1 or Part 2 of study only. The study will be conducted in 3 phases: an up to 30-day screening phase before surgery, a 14-day double-blind dosing phase, and a 16-week follow-up phase. Safety evaluations will include monitoring of all nonserious and serious adverse events, clinical laboratory tests, vital signs measurements, and physical examinations. Pharmacokinetics (dense and sparse), pharmacodynamic (PD), health resource utilization, and immunogenicity samples will also be assessed. The total study duration of participant's participation in Part 1 or part 2 after randomization will be approximately 18 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: Cohort 1 (0.3 mg/kg JNJ-64179375/Apixaban) | Experimental | Participants will receive JNJ-64179375 0.3 milligram per kilogram (mg/kg) intravenously (IV) or JNJ-64179375 placebo (saline) IV infusion as a single dose on Day 1 and matching apixaban placebo or 2.5 mg apixaban, orally twice a day for 10 to 14 days. |
|
| Part 1: Cohort 2 (0.6 mg/kg JNJ-64179375/Apixaban) | Experimental | Participants will receive JNJ-64179375 0.6 mg/kg IV or JNJ-64179375 placebo (saline) IV infusion as a single dose on Day 1 and matching apixaban placebo or 2.5 mg apixaban, orally twice a day for 10 to 14 days. |
|
| Part 1: Cohort 3 (1.2 mg/kg JNJ-64179375/Apixaban) | Experimental | Participants will receive JNJ-64179375 1.2 mg/kg IV or JNJ-64179375 placebo (saline) IV infusion as a single dose on Day 1 and matching apixaban placebo or 2.5 mg apixaban, orally twice a day for 10 to 14 days. |
|
| Part 1: Optional Cohort 4 (JNJ-64179375/Apixaban) | Experimental | Participants will receive JNJ-64179375 Dose to be determined (TBD) based on preliminary data (dose may range from 0.1 to 1.8 mg/kg or any dose from the preceding cohorts) IV or JNJ-64179375 placebo (saline) IV infusion as a single dose on Day 1 and matching apixaban placebo or 2.5 mg apixaban, orally twice a day for 10 to 14 days. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ-64179375 0.3 mg/kg | Drug | JNJ-64179375 0.3 milligram per kilogram (mg/kg) intravenous (IV) infusion as a single dose on Day 1. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-emergent Bleeding Events (Clinical Events Committee [CEC]- Adjudicated) | Number of participants with treatment-emergent bleeding events (BE) (adjudicated by CEC) were reported. Bleeding event was defined as the composite of major, clinically relevant nonmajor (CRNM), and minimal bleeding events assessed through the Day 10 to 14. | Up to Day 10 to 14 (visit observation period) |
| Number of Participants With Total Venous Thromboembolism (VTE) (CEC-adjudicated) | Number of participants with total VTE were reported. Total VTE was defined as the composite of CEC-adjudicated proximal and/or distal deep vein thrombosis (DVT) (asymptomatic confirmed by venography assessment of the operated leg or objectively confirmed symptomatic), nonfatal pulmonary embolism (PE), or any death assessed through the Day 10 to 14 visit. 1 participant had an asymptomatic distal clot in the non-operated leg which is not counted in the Total VTE and 2 participants had symptomatic proximal clots at the Day 10 to 14 venography and are counted in both the asymptomatic proximal and symptomatic proximal groups. | Up to Day 10 to 14 (visit observation period) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Composite of Major and CRNM Bleeding Events (CEC-adjudicated) | Number of participants with composite of major and CRNM bleeding events (adjudicated by CEC) were reported. Major Bleeding: Fatal bleeding; Bleeding that is symptomatic and occurs in critical area/organ and/or; Extrasurgical site bleeding causing fall in Hb level of 20 g/L or more, or leading to transfusion of 2 or more units of whole blood or red cells with temporal association within 24-48 hours to bleeding, and/or; Surgical site bleeding that requires second intervention open, arthroscopic, endovascular, or hemarthrosis resulting in prolonged hospitalization or a deep wound infection and/or; Surgical site bleeding that is unexpected and prolonged and/or sufficiently large to cause hemodynamic instability. CRNM bleeding: acute clinically overt bleeding that does not satisfy additional criteria required for bleeding event to be defined as major BE and meets at least 1 of following criteria: Epistaxis, Gastrointestinal bleed, Hematuria, Bruising/ecchymosis, Hemoptysis, Hematoma. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Research Center | Phoenix | Arizona | 85053 | United States | ||
| Harbor-UCLA Medical Center |
The study was planned to be conducted in 2 parts: Part 1 (Dose- Escalation) and Part 2 (Dose-Response). After completion of Part 1, the sponsor made the decision to not move forward with Part 2 as there was sufficient data to make a determination of efficacy in Part 1. Part 2 was not conducted, hence endpoints for Part 2 are not reported.
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| ID | Title | Description |
|---|---|---|
| FG000 | JNJ-64179375 0.3 mg/kg and Apixaban Placebo | Participants received a single intravenous (IV) infusion of JNJ-64179375 0.3 milligrams per kilogram (mg/kg) on Day 1 and matching apixaban placebo tablets orally twice daily (BID) for 10 to 14 days. |
| FG001 | JNJ-64179375 0.6 mg/kg and Apixaban Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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 11, 2017 | Nov 5, 2019 |
Double Blinded
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|
| Part 1: Optional Cohort 5 (JNJ-64179375/Apixaban) | Experimental | Participants will receive JNJ-64179375 Dose TBD based on preliminary data (dose may range from 0.1 to 1.8 mg/kg or any dose from the preceding cohorts) IV or JNJ-64179375 placebo (saline) IV infusion as a single dose on Day 1 and matching apixaban placebo or 2.5 mg apixaban, orally twice a day for 10 to 14 days. |
|
| Part 1: Optional Cohort 6 (JNJ-64179375/Apixaban) | Experimental | Participants will receive JNJ-64179375 Dose TBD based on preliminary data (dose may range from 0.1 to 1.8 mg/kg or any dose from the preceding cohorts) IV or JNJ-64179375 placebo (saline) IV infusion as a single dose on Day 1 and matching apixaban placebo or 2.5 mg apixaban, orally twice a day for 10 to 14 days. |
|
| Part 2: Group A: JNJ-64179375 A mg/kg and apixaban placebo | Experimental | Participants will receive JNJ-64179375 Dose A mg/kg (TBD based on review of data from Part 1) IV as a single dose on Day 1 and apixaban placebo orally twice a day for 10 to 14 days. |
|
| Part 2: Group B: JNJ-64179375 B mg/kg and apixaban placebo | Experimental | Participants will receive JNJ-64179375 Dose B mg/kg (TBD based on review of data from Part 1) IV as a single dose on Day 1 and apixaban placebo orally twice a day for 10 to 14 days. |
|
| Part 2: Group C: JNJ-64179375 C mg/kg and apixaban placebo | Experimental | Participants will receive JNJ-64179375 Dose C mg/kg (TBD based on review of data from Part 1) IV as a single dose on Day 1 and apixaban placebo orally twice a day for 10 to 14 days. |
|
| Part 2: Group D: JNJ-64179375 D mg/kg and apixaban placebo | Experimental | Participants will receive JNJ-64179375 Dose D mg/kg (TBD based on review of data from Part 1) IV as a single dose on Day 1 and apixaban placebo orally twice a day for 10 to 14 days. |
|
| Part 2: Group E: JNJ-64179375 placebo IV and apixaban 2.5 mg | Experimental | Participants will receive JNJ-64179375 placebo (saline) IV as a single dose on Day 1 and apixaban 2.5 mg orally twice a day for 10 to 14 days. |
|
| JNJ-64179375 0.6 mg/kg | Drug | JNJ-64179375 0.6 mg/kg IV infusion as a single dose on Day 1. |
|
| JNJ-64179375 1.2 mg/kg | Drug | JNJ-64179375 1.2 mg/kg IV infusion as a single dose on Day 1. |
|
| JNJ-64179375 (Dose to be Determined) | Drug | JNJ-64179375 IV infusion (Dose to be determined) as a single dose on Day 1. |
|
| JNJ-64179375 A mg/kg | Drug | JNJ-64179375 Dose A mg/kg IV as a single dose on Day 1. |
|
| JNJ-64179375 B mg/kg | Drug | JNJ-64179375 Dose B mg/kg IV as a single dose on Day 1. |
|
| JNJ-64179375 C mg/kg | Drug | JNJ-64179375 Dose C mg/kg IV as a single dose on Day 1. |
|
| JNJ-64179375 D mg/kg | Drug | JNJ-64179375 Dose D mg/kg IV as a single dose on Day 1. |
|
| Placebo JNJ-64179375 | Drug | Matching JNJ-64179375 placebo (normal saline) administered as IV infusion as a single dose on Day 1. |
|
| Apixaban placebo | Drug | Matching apixaban placebo administered orally twice a day for 10 to 14 days. |
|
| Apixaban 2.5 mg | Drug | Apixaban 2.5 mg administered orally twice a day for 10 to 14 days. |
|
| Up to Day 10 to 14 (visit observation period) |
| Number of Participants With Major Bleeding Event (CEC-adjudicated) | Number of participants with major bleeding events (BE) (adjudicated by CEC) were reported. Major Bleeding: Fatal bleeding; Bleeding that is symptomatic and occurs in critical area/organ and/or; Extrasurgical site bleeding causing fall in hemoglobin (Hb) level of 20 grams per liter (g/L) or more, or leading to transfusion of 2 or more units of whole blood or red cells with temporal association within 24-48 hours to bleeding, and/or; Surgical site bleeding that requires second intervention open, arthroscopic, endovascular, or hemarthrosis resulting in prolonged hospitalization or a deep wound infection and/or; Surgical site bleeding that is unexpected and prolonged and/or sufficiently large to cause hemodynamic instability. | Up to Day 10 to 14 (visit observation period) |
| Number of Participants With Clinically Relevant Non-major (CRNM) Bleeding Events (CEC-adjudicated) | Number of participants with CRNM bleeding events (adjudicated by CEC) were reported. CRNM bleeding was defined as acute clinically overt bleeding that does not satisfy additional criteria required for bleeding event to be defined as major bleeding event and meets at least 1 of following criteria: Epistaxis, Gastrointestinal bleed, Hematuria, Bruising/ecchymosis, Hemoptysis, Hematoma. | Up to Day 10 to 14 (visit observation period) |
| Number of Participants With Major Bleeding or CRNM Bleeding Events (CEC-adjudicated) | Number of participants with major bleeding or CRNM bleeding events (adjudicated by CEC) were reported. Major Bleeding: Fatal bleeding; Bleeding that is symptomatic and occurs in critical area/organ and/or; Extrasurgical site bleeding causing fall in Hb level of 20 g/L or more, or leading to transfusion of 2 or more units of whole blood or red cells with temporal association within 24-48 hours to bleeding, and/or; Surgical site bleeding that requires second intervention open, arthroscopic, endovascular, or hemarthrosis resulting in prolonged hospitalization or a deep wound infection and/or; Surgical site bleeding that is unexpected and prolonged and/or sufficiently large to cause hemodynamic instability. CRNM bleeding: acute clinically overt bleeding that does not satisfy additional criteria required for bleeding event to be defined as major BE and meets at least 1 of following criteria: Epistaxis, Gastrointestinal bleed, Hematuria, Bruising/ecchymosis, Hemoptysis, Hematoma. | Up to Day 10 and 14 (visit observation period) |
| Number of Participants With Minimal Bleeding Events (CEC-adjudicated) | Number of participants with minimal bleeding events (adjudicated by CEC) were reported. Minimal bleeding event was defined as any bleeding event not met major or CRNM criteria. | Up to Day 10 to 14 (visit observation period) |
| Number of Participants With Major VTE (CEC-adjudicated) | Number of participants with major VTE (adjudicated by CEC) were reported. Major VTE was defined as a composite of proximal DVT (asymptomatic confirmed by venography or objectively confirmed symptomatic), nonfatal PE, or any death. 2 participants had symptomatic proximal clots at the Day 10 to 14 venography and are counted in both the asymptomatic proximal and symptomatic proximal groups. | Up to Day 10 to 14 (visit observation period) |
| Number of Participants With Proximal Deep Vein Thrombosis (DVT) (CEC-adjudicated) | Number of participants with proximal DVT (adjudicated by CEC) were reported. DVT asymptomatic confirmed by venography assessment of the operated leg or objectively confirmed symptomatic. 2 participants had symptomatic proximal clots at the Day 10 to 14 venography and are counted in both the asymptomatic proximal and symptomatic proximal groups. | Up to Day 10 to 14 (visit observation period) |
| Number of Participants With Nonfatal Pulmonary Embolism (PE) (CEC-adjudicated) | Number of participants with nonfatal PE (adjudicated by CEC) were reported. | Up to Day 10 to 14 (visit observation period) |
| Number of Participants With Death (CEC-adjudicated) | Number of participants with death (adjudicated by CEC) were reported. | Up to Day 10 to 14 (visit observation period) |
| Number of Participants With Proximal and Distal DVT (CEC-adjudicated) | Number of participants with proximal and distal DVT (adjudicated by CEC) were reported. DVT asymptomatic confirmed by venography assessment of the operated leg or objectively confirmed symptomatic. 2 participants had symptomatic proximal clots at the Day 10 to 14 venography and are counted in both the asymptomatic proximal and symptomatic proximal groups. | Up to Day 10 to 14 (visit observation period) |
| Number of Participants With Distal DVT (CEC-adjudicated) | Number of participants with distal DVT (adjudicated by CEC) were reported. DVT asymptomatic confirmed by venography assessment of the operated leg or objectively confirmed symptomatic. | Up to Day 10 to 14 (visit observation period) |
| Torrance |
| California |
| 90509 |
| United States |
| Denver Metro Orthopedics, PC | Englewood | Colorado | 80113 | United States |
| Florida Research Associates, LLC | DeLand | Florida | 32720 | United States |
| Avanza research | Pensacola | Florida | 32504 | United States |
| University Orthopedic and Joint Replacement Center | Tamarac | Florida | 33321 | United States |
| Memorial Hermann Memorial City Medical Center | Houston | Texas | 77024 | United States |
| Hospital Italiano de Buenos Aires | Caba | C1199ABB | Argentina |
| Clínica Adventista Belgrano | CABA | C1430EGF | Argentina |
| Hospital San Roque | Córdoba | 5000 | Argentina |
| Clínica Chutro | Córdoba | X5000EPU | Argentina |
| Hospital Italiano La Plata | La Plata | B1900AXI | Argentina |
| Sanatorio Britanico de Rosario | Rosario | 2000 | Argentina |
| Sanatorio San Miguel | San Miguel | B1663GFL | Argentina |
| ZNA Middelheim | Antwerp | 2020 | Belgium |
| Ziekenhuis Oost-Limburg | Genk | 3600 | Belgium |
| Jessa Ziekenhuis | Hasselt | 3500 | Belgium |
| ZNA Jan Palfijn | Merksem | 2170 | Belgium |
| Universidade Federal de Minas Gerais (UFMG) - Faculdade de Medicina | Belo Horizonte | 30130-100 | Brazil |
| Hospital Sao Francisco de Assis | Belo Horizonte | 30360-290 | Brazil |
| Unicamp - Hospital de Clinicas | Campinas | 13083-888 | Brazil |
| Uniort.e - Hospital de ortopedia | Londrina | 86050-000 | Brazil |
| Irmandade da Santa Casa de Misericórdia de Marília | Marília | 17515-000 | Brazil |
| Santa Casa de Misericordia de Porto Alegre | Porto Alegre | 90020-090 | Brazil |
| Hospital e Maternidade Dr Christovão da Gama | Santo André | 09030-010 | Brazil |
| Hospital Estadual Mario covas | Santo André | 09190-615 | Brazil |
| Hospital Das Clinicas Da Faculdade De Medicina Da Universidade De Sao Paulo | São Paulo | 05403-010 | Brazil |
| Multiprofile Hospital for Active Treatment Russe | Rousse | 7002 | Bulgaria |
| Acibadem City Clinic Tokuda Hospital | Sofa | 1407 | Bulgaria |
| Military Medical Academy | Sofia | 1606 | Bulgaria |
| Lakeridge Health Ajax | Ajax | Ontario | L1S 2J4 | Canada |
| Source Trial Solutions Inc. | Kitchener | Ontario | N2M 1A1 | Canada |
| The Ottawa Hospital Research Institute | Ottawa | Ontario | K1H 8L6 | Canada |
| Cliniche Humanitas Gavazzeni | Bergamo | 24125 | Italy |
| Azienda Ospedaliera Papa Giovanni XXIII | Bergamo | 24127 | Italy |
| Istituto Ortopedico Rizzoli | Bologna | 40136 | Italy |
| Azienda Ospedaliera Universitaria Careggi | Florence | 50134 | Italy |
| Istituto Clinico Humanitas | Rozzano | 20089 | Italy |
| IRCCS Policlinico San Donato | S. Donato Milanese | 20097 | Italy |
| A.O.U. Città della Salute e della Scienza | Torino | 10126 | Italy |
| Ospedale Mauriziano (Torino) | Torino | 10128 | Italy |
| Matsudo City General Hospital | Chiba | 270-2296 | Japan |
| Hakodate Goryokaku Hospital | Hakodate | 040-8611 | Japan |
| Ritsuzankai Iida Hospital | Iida-shi | 395-8505 | Japan |
| Itami City Hospital | Itami-shi | 664-8540 | Japan |
| Yonemori Hospital | Kagoshima | 890-0062 | Japan |
| Bange Kousei General Hospital | Kawanuma-Gun | 969-6593 | Japan |
| Osaka Saiseikai Nakatsu Hospital | Osaka | 530-0012 | Japan |
| Osaka Rosai Hospital | Osaka | 591-8025 | Japan |
| Tokushima Municipal Hospital | Tokushima | 770-0812 | Japan |
| Yuaikai Tomishiro Central Hospital | Tomishiro | 901-0243 | Japan |
| Regional Hospital of Liepaja | Liepāja | LV-3414 | Latvia |
| Riga 2nd Hospital | Riga | LV1004 | Latvia |
| Hospital of Traumatology and Orthopedics | Riga | LV1005 | Latvia |
| Vidzemes Hospital | Valmiera | LV-4201 | Latvia |
| Hospital of Lithuanian University of Health Sciences Kaunas Clinics | Kaunas | LT50161 | Lithuania |
| Klaipeda University Hospital | Klaipėda | 92288 | Lithuania |
| University Malaya Medical Center | Kuala Lumpur | 59100 | Malaysia |
| Hospital Tengku Ampuan Afzan | Kuantan | 25100 | Malaysia |
| Hospital Miri | Miri | 98000 | Malaysia |
| Hospital Sibu | Sibu | 96000 | Malaysia |
| Hospital Sultan Abdul Halim | Sungai Petani | 08000 | Malaysia |
| Klinika Ortopedii i Traumatologii UMB | Bialystok | 15-276 | Poland |
| Oddzial Ortopedii i Traumatologii - Szpital Ogolny im. W.Ginela | Grajewo | 19-203 | Poland |
| Klinika Ortopedii Gornoslaskie Centrum Medyczne | Katowice | 40-635 | Poland |
| Oddzial Ortopedii i Traumatologii Szpital Specjalistyczny im. L.Rydygiera | Krakow | 31-826 | Poland |
| SP ZOZ MSWiA w Krakowie Oddzial Urazowo-Ortopedyczny | Krakow | 33-332 | Poland |
| CSK UM Klinika Ortopedii | Lodz | 92-213 | Poland |
| Oddzial Urazowo-Ortopedyczny Wojewodzki Szpital Specjalistyczny | Lublin | 20-718 | Poland |
| Klinika Ortopedii I Traumatologii,Szpital Kliniczny Ortopedyczno-Rehabilitacyjny UM | Poznan | 61-545 | Poland |
| Oddzial Ortopedii Specjalistyczny Szpital im. E.Szczeklika | Tarnów | 33-100 | Poland |
| Oddzial Chirurgii Urazowej iOrtopedycznej,Wojewodzki Szpital Brodnowski, SPZOZ | Warsaw | 03-242 | Poland |
| Barnaul Federal Center of Traumatology, Orthopedics and Endoprothesis replacement | Barnaul | 656045 | Russia |
| Russian Ilizarov Scientific Center For Restorative Traumatology And Ortopaedics | Kurgan | 640014 | Russia |
| Moscow City Clinical Hospital #1 n.a. N.I.Pirogov | Moscow | 117049 | Russia |
| Privolzhsky Research Medical University of Ministry of Health of Russian Federation | Nizhny Novgorod | 603155 | Russia |
| St. Petersburg State Medical Institution City Multifunctional Hospital #2 | Saint Petersburg | 194354 | Russia |
| Russian Research Institute of Traumatology and Orthopaedics n.a.R.R.Vreden | Saint Petersburg | 195427 | Russia |
| State Healthcare Institution Samara Regional Clinical Hospital named after V.D.Seredavin | Samara | 443095 | Russia |
| Clinical Emergency Hospital n.a. N.V. Solovyev | Yaroslavl | 150003 | Russia |
| Hosp. Univ. Germans Trias I Pujol | Badalona | 08916 | Spain |
| Hosp. Clinico San Carlos | Madrid | 28040 | Spain |
| Hosp. Univ. Fund. Jimenez Diaz | Madrid | 28040 | Spain |
| Hosp. Univ. 12 de Octubre | Madrid | 28041 | Spain |
| Hosp. Univ. La Paz | Madrid | 28046 | Spain |
| Corporacio Sanitari Parc Tauli | Sabadell | 08208 | Spain |
| Hosp. Clinico Univ. de Santiago | Santiago de Compostela | 15706 | Spain |
| Hosp. Univ. I Politecni La Fe | Valencia | 46026 | Spain |
| Ankara Numune Research and Training Hospital | Ankara | 06100 | Turkey (Türkiye) |
| Dışkapı Yıldırım Beyazıd Training and Research Hospital | Ankara | 06110 | Turkey (Türkiye) |
| Yıldırım Beyazıt University Yenimahalle Training and Research Hospital | Ankara | 06370 | Turkey (Türkiye) |
| Yildirim Beyazit University Medical Faculty Ankara Atatürk Research and Training Hospital | Ankara | 06800 | Turkey (Türkiye) |
| Bakirkoy Training and Research Hospital | Istanbul | 34147 | Turkey (Türkiye) |
| Umraniye Training and Research Hospital | Istanbul | 34764 | Turkey (Türkiye) |
| Izmir Tepecik Training and Research Hospital | Izmir | 35180 | Turkey (Türkiye) |
| Municipal Institution Cherkasy Regional Hospital of Cherkasy Regional Council | Cherkasy | 18009 | Ukraine |
| Ivano-Frankivsk Regional Clinical Hospital | Ivano-Frankivsk | 76008 | Ukraine |
| Institute of Spine and JointPathology named after Prof.Sytenko of NationalAcademy of MedicalSciences | Kharkiv | 61024 | Ukraine |
| Municipal Institution of Health Care 'Kharkiv Regional Clinical Traumatology Hospital' | Kharkiv | 61176 | Ukraine |
| Kyiv Regional Clinical Hospital | Kyiv | 04107 | Ukraine |
| Communal Institution of Lviv Regional Council 'Lypa Lviv Regional Hospital' | Lviv-Vynnyky | 79495 | Ukraine |
| Vinnytsya Regional Clinical Hospital named after M.I.Pirogov | Vinnytsia | 21018 | Ukraine |
| Zaporizhzhia Regional Clinical Hospital | Zaporizhzhia | 69600 | Ukraine |
Participants received a single IV infusion of JNJ-64179375 0.6 mg/kg on Day 1 and matching apixaban placebo tablets orally BID for 10 to 14 days. |
| FG002 | JNJ-64179375 1.2 mg/kg and Apixaban Placebo | Participants received a single IV infusion of JNJ-64179375 1.2 mg/kg on Day 1 and matching apixaban placebo tablets orally BID for 10 to 14 days. |
| FG003 | JNJ-64179375 1.8 mg/kg and Apixaban Placebo | Participants received a single IV infusion of JNJ-64179375 1.8 mg/kg on Day 1 and matching apixaban placebo tablets orally BID for 10 to 14 days. |
| FG004 | Apixaban 2.5 mg and JNJ-64179375 Placebo IV | Participants received a single IV infusion of matching JNJ-64179375 placebo on Day 1 and apixaban 2.5 mg tablet orally BID for 10 to 14 days. |
| Treated |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Safety analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | JNJ-64179375 0.3 mg/kg and Apixaban Placebo | Participants received a single intravenous (IV) infusion of JNJ-64179375 0.3 milligrams per kilogram (mg/kg) on Day 1 and matching apixaban placebo tablets orally twice daily (BID) for 10 to 14 days. |
| BG001 | JNJ-64179375 0.6 mg/kg and Apixaban Placebo | Participants received a single IV infusion of JNJ-64179375 0.6 mg/kg on Day 1 and matching apixaban placebo tablets orally BID for 10 to 14 days. |
| BG002 | JNJ-64179375 1.2 mg/kg and Apixaban Placebo | Participants received a single IV infusion of JNJ-64179375 1.2 mg/kg on Day 1 and matching apixaban placebo tablets orally BID for 10 to 14 days. |
| BG003 | JNJ-64179375 1.8 mg/kg and Apixaban Placebo | Participants received a single IV infusion of JNJ-64179375 1.8 mg/kg on Day 1 and matching apixaban placebo tablets orally BID for 10 to 14 days. |
| BG004 | Apixaban 2.5 mg and JNJ-64179375 Placebo IV | Participants received a single IV infusion of matching JNJ-64179375 placebo on Day 1 and apixaban 2.5 mg tablet orally BID for 10 to 14 days. |
| BG005 | 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, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | Participants |
| ||||||||||||||||
| Region of Enrollment | 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 | Number of Participants With Treatment-emergent Bleeding Events (Clinical Events Committee [CEC]- Adjudicated) | Number of participants with treatment-emergent bleeding events (BE) (adjudicated by CEC) were reported. Bleeding event was defined as the composite of major, clinically relevant nonmajor (CRNM), and minimal bleeding events assessed through the Day 10 to 14. | Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban). | Posted | Count of Participants | Participants | Up to Day 10 to 14 (visit observation period) |
|
|
| ||||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Total Venous Thromboembolism (VTE) (CEC-adjudicated) | Number of participants with total VTE were reported. Total VTE was defined as the composite of CEC-adjudicated proximal and/or distal deep vein thrombosis (DVT) (asymptomatic confirmed by venography assessment of the operated leg or objectively confirmed symptomatic), nonfatal pulmonary embolism (PE), or any death assessed through the Day 10 to 14 visit. 1 participant had an asymptomatic distal clot in the non-operated leg which is not counted in the Total VTE and 2 participants had symptomatic proximal clots at the Day 10 to 14 venography and are counted in both the asymptomatic proximal and symptomatic proximal groups. | Modified Intent-to-treat (mITT) analysis set included all randomized participants with an evaluable venography assessment or a confirmed symptomatic VTE event, or any death adjudicated by CEC. | Posted | Count of Participants | Participants | Up to Day 10 to 14 (visit observation period) |
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Composite of Major and CRNM Bleeding Events (CEC-adjudicated) | Number of participants with composite of major and CRNM bleeding events (adjudicated by CEC) were reported. Major Bleeding: Fatal bleeding; Bleeding that is symptomatic and occurs in critical area/organ and/or; Extrasurgical site bleeding causing fall in Hb level of 20 g/L or more, or leading to transfusion of 2 or more units of whole blood or red cells with temporal association within 24-48 hours to bleeding, and/or; Surgical site bleeding that requires second intervention open, arthroscopic, endovascular, or hemarthrosis resulting in prolonged hospitalization or a deep wound infection and/or; Surgical site bleeding that is unexpected and prolonged and/or sufficiently large to cause hemodynamic instability. CRNM bleeding: acute clinically overt bleeding that does not satisfy additional criteria required for bleeding event to be defined as major BE and meets at least 1 of following criteria: Epistaxis, Gastrointestinal bleed, Hematuria, Bruising/ecchymosis, Hemoptysis, Hematoma. | Safety analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug. | Posted | Count of Participants | Participants | Up to Day 10 to 14 (visit observation period) |
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Major Bleeding Event (CEC-adjudicated) | Number of participants with major bleeding events (BE) (adjudicated by CEC) were reported. Major Bleeding: Fatal bleeding; Bleeding that is symptomatic and occurs in critical area/organ and/or; Extrasurgical site bleeding causing fall in hemoglobin (Hb) level of 20 grams per liter (g/L) or more, or leading to transfusion of 2 or more units of whole blood or red cells with temporal association within 24-48 hours to bleeding, and/or; Surgical site bleeding that requires second intervention open, arthroscopic, endovascular, or hemarthrosis resulting in prolonged hospitalization or a deep wound infection and/or; Surgical site bleeding that is unexpected and prolonged and/or sufficiently large to cause hemodynamic instability. | Safety analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug. | Posted | Count of Participants | Participants | Up to Day 10 to 14 (visit observation period) |
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Clinically Relevant Non-major (CRNM) Bleeding Events (CEC-adjudicated) | Number of participants with CRNM bleeding events (adjudicated by CEC) were reported. CRNM bleeding was defined as acute clinically overt bleeding that does not satisfy additional criteria required for bleeding event to be defined as major bleeding event and meets at least 1 of following criteria: Epistaxis, Gastrointestinal bleed, Hematuria, Bruising/ecchymosis, Hemoptysis, Hematoma. | Safety analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug. | Posted | Count of Participants | Participants | Up to Day 10 to 14 (visit observation period) |
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Major Bleeding or CRNM Bleeding Events (CEC-adjudicated) | Number of participants with major bleeding or CRNM bleeding events (adjudicated by CEC) were reported. Major Bleeding: Fatal bleeding; Bleeding that is symptomatic and occurs in critical area/organ and/or; Extrasurgical site bleeding causing fall in Hb level of 20 g/L or more, or leading to transfusion of 2 or more units of whole blood or red cells with temporal association within 24-48 hours to bleeding, and/or; Surgical site bleeding that requires second intervention open, arthroscopic, endovascular, or hemarthrosis resulting in prolonged hospitalization or a deep wound infection and/or; Surgical site bleeding that is unexpected and prolonged and/or sufficiently large to cause hemodynamic instability. CRNM bleeding: acute clinically overt bleeding that does not satisfy additional criteria required for bleeding event to be defined as major BE and meets at least 1 of following criteria: Epistaxis, Gastrointestinal bleed, Hematuria, Bruising/ecchymosis, Hemoptysis, Hematoma. | Safety analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug. | Posted | Count of Participants | Participants | Up to Day 10 and 14 (visit observation period) |
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Minimal Bleeding Events (CEC-adjudicated) | Number of participants with minimal bleeding events (adjudicated by CEC) were reported. Minimal bleeding event was defined as any bleeding event not met major or CRNM criteria. | Safety analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug. | Posted | Count of Participants | Participants | Up to Day 10 to 14 (visit observation period) |
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Major VTE (CEC-adjudicated) | Number of participants with major VTE (adjudicated by CEC) were reported. Major VTE was defined as a composite of proximal DVT (asymptomatic confirmed by venography or objectively confirmed symptomatic), nonfatal PE, or any death. 2 participants had symptomatic proximal clots at the Day 10 to 14 venography and are counted in both the asymptomatic proximal and symptomatic proximal groups. | mITT analysis set included all randomized participants with an evaluable venography assessment or a confirmed symptomatic VTE event or any death. | Posted | Count of Participants | Participants | Up to Day 10 to 14 (visit observation period) |
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Proximal Deep Vein Thrombosis (DVT) (CEC-adjudicated) | Number of participants with proximal DVT (adjudicated by CEC) were reported. DVT asymptomatic confirmed by venography assessment of the operated leg or objectively confirmed symptomatic. 2 participants had symptomatic proximal clots at the Day 10 to 14 venography and are counted in both the asymptomatic proximal and symptomatic proximal groups. | mITT analysis set included all randomized participants with an evaluable venography assessment or a confirmed symptomatic VTE event, or any death. | Posted | Count of Participants | Participants | Up to Day 10 to 14 (visit observation period) |
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Nonfatal Pulmonary Embolism (PE) (CEC-adjudicated) | Number of participants with nonfatal PE (adjudicated by CEC) were reported. | mITT analysis set included all randomized participants with an evaluable venography assessment or a confirmed symptomatic VTE event, or any death. | Posted | Count of Participants | Participants | Up to Day 10 to 14 (visit observation period) |
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Death (CEC-adjudicated) | Number of participants with death (adjudicated by CEC) were reported. | mITT analysis set included all randomized participants with an evaluable venography assessment or a confirmed symptomatic VTE event, or any death. | Posted | Count of Participants | Participants | Up to Day 10 to 14 (visit observation period) |
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Proximal and Distal DVT (CEC-adjudicated) | Number of participants with proximal and distal DVT (adjudicated by CEC) were reported. DVT asymptomatic confirmed by venography assessment of the operated leg or objectively confirmed symptomatic. 2 participants had symptomatic proximal clots at the Day 10 to 14 venography and are counted in both the asymptomatic proximal and symptomatic proximal groups. | mITT analysis set included all randomized participants with an evaluable venography assessment or a confirmed symptomatic VTE event, or any death. | Posted | Count of Participants | Participants | Up to Day 10 to 14 (visit observation period) |
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Distal DVT (CEC-adjudicated) | Number of participants with distal DVT (adjudicated by CEC) were reported. DVT asymptomatic confirmed by venography assessment of the operated leg or objectively confirmed symptomatic. | mITT analysis set included all randomized participants with an evaluable venography assessment or a confirmed symptomatic VTE event, or any death. | Posted | Count of Participants | Participants | Up to Day 10 to 14 (visit observation period) |
|
Up to 18 weeks
Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | JNJ-64179375 0.3 mg/kg and Apixaban Placebo | Participants received a single intravenous (IV) infusion of JNJ-64179375 0.3 milligrams per kilogram (mg/kg) on Day 1 and matching apixaban placebo tablets orally twice daily (BID) for 10 to 14 days. | 0 | 38 | 2 | 38 | 19 | 38 |
| EG001 | JNJ-64179375 0.6 mg/kg and Apixaban Placebo | Participants received a single IV infusion of JNJ-64179375 0.6 mg/kg on Day 1 and matching apixaban placebo tablets orally BID for 10 to 14 days. | 0 | 40 | 2 | 40 | 17 | 40 |
| EG002 | JNJ-64179375 1.2 mg/kg and Apixaban Placebo | Participants received a single IV infusion of JNJ-64179375 1.2 mg/kg on Day 1 and matching apixaban placebo tablets orally BID for 10 to 14 days. | 0 | 42 | 4 | 42 | 26 | 42 |
| EG003 | JNJ-64179375 1.8 mg/kg and Apixaban Placebo | Participants received a single IV infusion of JNJ-64179375 1.8 mg/kg on Day 1 and matching apixaban placebo tablets orally BID for 10 to 14 days. | 0 | 122 | 13 | 122 | 37 | 122 |
| EG004 | Apixaban 2.5 mg and JNJ-64179375 Placebo IV | Participants received a single IV infusion of matching JNJ-64179375 placebo on Day 1 and apixaban 2.5 mg tablet orally BID for 10 to 14 days. | 0 | 63 | 5 | 63 | 20 | 63 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina Unstable | Cardiac disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Primary Hyperaldosteronism | Endocrine disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Impaired Healing | General disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Oedema Peripheral | General disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Peripheral Swelling | General disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Herpes Zoster | Infections and infestations | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Postoperative Wound Infection | Infections and infestations | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Postoperative Wound Complication | Injury, poisoning and procedural complications | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Tendon Rupture | Injury, poisoning and procedural complications | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Wound Haemorrhage | Injury, poisoning and procedural complications | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Haemarthrosis | Musculoskeletal and connective tissue disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Joint Contracture | Musculoskeletal and connective tissue disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Basal Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Bladder Cancer Stage 0, with Cancer in Situ | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Transient Ischaemic Attack | Nervous system disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Bloody Discharge | Vascular disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Deep Vein Thrombosis | Vascular disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Post Thrombotic Syndrome | Vascular disorders | MedDRA Version 21.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Thrombocytosis | Blood and lymphatic system disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Conjunctival Haemorrhage | Eye disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Aphthous Ulcer | Gastrointestinal disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Food Poisoning | Gastrointestinal disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Catheter Site Haemorrhage | General disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Fat Necrosis | General disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Feeling Hot | General disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Hyperthermia | General disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Impaired Healing | General disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Injection Site Irritation | General disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Non-Cardiac Chest Pain | General disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Oedema Peripheral | General disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Peripheral Swelling | General disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Wound Infection | Infections and infestations | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Patella Fracture | Injury, poisoning and procedural complications | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Post Procedural Haematoma | Injury, poisoning and procedural complications | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Post Procedural Swelling | Injury, poisoning and procedural complications | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Procedural Haemorrhage | Injury, poisoning and procedural complications | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Procedural Pain | Injury, poisoning and procedural complications | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Tendon Rupture | Injury, poisoning and procedural complications | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Wound Haemorrhage | Injury, poisoning and procedural complications | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Blood Glucose Increased | Investigations | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Blood Thyroid Stimulating Hormone Increased | Investigations | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Blood Triglycerides Increased | Investigations | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Body Temperature Increased | Investigations | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Cardiovascular Evaluation | Investigations | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Gamma-Glutamyltransferase Decreased | Investigations | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Platelet Count Increased | Investigations | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Haemarthrosis | Musculoskeletal and connective tissue disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Dizziness Exertional | Nervous system disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Dizziness Postural | Nervous system disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Neuralgia | Nervous system disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Restlessness | Psychiatric disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Renal Colic | Renal and urinary disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Decubitus Ulcer | Skin and subcutaneous tissue disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Dermatitis Contact | Skin and subcutaneous tissue disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Dry Skin | Skin and subcutaneous tissue disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Pruritus Generalised | Skin and subcutaneous tissue disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Rash Pruritic | Skin and subcutaneous tissue disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Bloody Discharge | Vascular disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Deep Vein Thrombosis | Vascular disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Haemorrhage | Vascular disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Peripheral Venous Disease | Vascular disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Thrombophlebitis | Vascular disorders | MedDRA Version 21.0 | Non-systematic Assessment |
|
If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Director | Janssen Research & Development, LLC | 844-434-4210 | ClinicalTrialDisclosure@its.jnj.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 18, 2017 | Nov 5, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| C522181 | apixaban |
Not provided
Not provided
Not provided
| Male |
|
| Black |
|
| White |
|
| Unspecified |
|
| Belgium |
|
| Bulgaria |
|
| Canada |
|
| Italy |
|
| Japan |
|
| Latvia |
|
| Lithuania |
|
| Malaysia |
|
| Poland |
|
| Russian Federation |
|
| Spain |
|
| Turkey |
|
| Ukraine |
|
| United States |
|
| OG002 | JNJ-64179375 1.2 mg/kg and Apixaban Placebo | Participants received a single IV infusion of JNJ-64179375 1.2 mg/kg on Day 1 and matching apixaban placebo tablets orally BID for 10 to 14 days. |
| OG003 | JNJ-64179375 1.8 mg/kg and Apixaban Placebo | Participants received a single IV infusion of JNJ-64179375 1.8 mg/kg on Day 1 and matching apixaban placebo tablets orally BID for 10 to 14 days. |
| OG004 | Apixaban 2.5 mg and JNJ-64179375 Placebo IV | Participants received a single IV infusion of matching JNJ-64179375 placebo on Day 1 and apixaban 2.5 mg tablet orally BID for 10 to 14 days. |
|
|
| JNJ-64179375 0.6 mg/kg and Apixaban Placebo |
Participants received a single IV infusion of JNJ-64179375 0.6 mg/kg on Day 1 and matching apixaban placebo tablets orally BID for 10 to 14 days. |
| OG002 | JNJ-64179375 1.2 mg/kg and Apixaban Placebo | Participants received a single IV infusion of JNJ-64179375 1.2 mg/kg on Day 1 and matching apixaban placebo tablets orally BID for 10 to 14 days. |
| OG003 | JNJ-64179375 1.8 mg/kg and Apixaban Placebo | Participants received a single IV infusion of JNJ-64179375 1.8 mg/kg on Day 1 and matching apixaban placebo tablets orally BID for 10 to 14 days. |
| OG004 | Apixaban 2.5 mg and JNJ-64179375 Placebo IV | Participants received a single IV infusion of matching JNJ-64179375 placebo on Day 1 and apixaban 2.5 mg tablet orally BID for 10 to 14 days. |
|
|
| OG002 | JNJ-64179375 1.2 mg/kg and Apixaban Placebo | Participants received a single IV infusion of JNJ-64179375 1.2 mg/kg on Day 1 and matching apixaban placebo tablets orally BID for 10 to 14 days. |
| OG003 | JNJ-64179375 1.8 mg/kg and Apixaban Placebo | Participants received a single IV infusion of JNJ-64179375 1.8 mg/kg on Day 1 and matching apixaban placebo tablets orally BID for 10 to 14 days. |
| OG004 | Apixaban 2.5 mg and JNJ-64179375 Placebo IV | Participants received a single IV infusion of matching JNJ-64179375 placebo on Day 1 and apixaban 2.5 mg tablet orally BID for 10 to 14 days. |
|
|
Participants received a single IV infusion of JNJ-64179375 1.2 mg/kg on Day 1 and matching apixaban placebo tablets orally BID for 10 to 14 days.
| OG003 | JNJ-64179375 1.8 mg/kg and Apixaban Placebo | Participants received a single IV infusion of JNJ-64179375 1.8 mg/kg on Day 1 and matching apixaban placebo tablets orally BID for 10 to 14 days. |
| OG004 | Apixaban 2.5 mg and JNJ-64179375 Placebo IV | Participants received a single IV infusion of matching JNJ-64179375 placebo on Day 1 and apixaban 2.5 mg tablet orally BID for 10 to 14 days. |
|
|
| JNJ-64179375 0.6 mg/kg and Apixaban Placebo |
Participants received a single IV infusion of JNJ-64179375 0.6 mg/kg on Day 1 and matching apixaban placebo tablets orally BID for 10 to 14 days. |
| OG002 | JNJ-64179375 1.2 mg/kg and Apixaban Placebo | Participants received a single IV infusion of JNJ-64179375 1.2 mg/kg on Day 1 and matching apixaban placebo tablets orally BID for 10 to 14 days. |
| OG003 | JNJ-64179375 1.8 mg/kg and Apixaban Placebo | Participants received a single IV infusion of JNJ-64179375 1.8 mg/kg on Day 1 and matching apixaban placebo tablets orally BID for 10 to 14 days. |
| OG004 | Apixaban 2.5 mg and JNJ-64179375 Placebo IV | Participants received a single IV infusion of matching JNJ-64179375 placebo on Day 1 and apixaban 2.5 mg tablet orally BID for 10 to 14 days. |
|
|
| OG003 | JNJ-64179375 1.8 mg/kg and Apixaban Placebo | Participants received a single IV infusion of JNJ-64179375 1.8 mg/kg on Day 1 and matching apixaban placebo tablets orally BID for 10 to 14 days. |
| OG004 | Apixaban 2.5 mg and JNJ-64179375 Placebo IV | Participants received a single IV infusion of matching JNJ-64179375 placebo on Day 1 and apixaban 2.5 mg tablet orally BID for 10 to 14 days. |
|
|
Participants received a single IV infusion of JNJ-64179375 1.2 mg/kg on Day 1 and matching apixaban placebo tablets orally BID for 10 to 14 days.
| OG003 | JNJ-64179375 1.8 mg/kg and Apixaban Placebo | Participants received a single IV infusion of JNJ-64179375 1.8 mg/kg on Day 1 and matching apixaban placebo tablets orally BID for 10 to 14 days. |
| OG004 | Apixaban 2.5 mg and JNJ-64179375 Placebo IV | Participants received a single IV infusion of matching JNJ-64179375 placebo on Day 1 and apixaban 2.5 mg tablet orally BID for 10 to 14 days. |
|
|
Participants received a single IV infusion of JNJ-64179375 1.2 mg/kg on Day 1 and matching apixaban placebo tablets orally BID for 10 to 14 days.
| OG003 | JNJ-64179375 1.8 mg/kg and Apixaban Placebo | Participants received a single IV infusion of JNJ-64179375 1.8 mg/kg on Day 1 and matching apixaban placebo tablets orally BID for 10 to 14 days. |
| OG004 | Apixaban 2.5 mg and JNJ-64179375 Placebo IV | Participants received a single IV infusion of matching JNJ-64179375 placebo on Day 1 and apixaban 2.5 mg tablet orally BID for 10 to 14 days. |
|
|
| JNJ-64179375 1.8 mg/kg and Apixaban Placebo |
Participants received a single IV infusion of JNJ-64179375 1.8 mg/kg on Day 1 and matching apixaban placebo tablets orally BID for 10 to 14 days. |
| OG004 | Apixaban 2.5 mg and JNJ-64179375 Placebo IV | Participants received a single IV infusion of matching JNJ-64179375 placebo on Day 1 and apixaban 2.5 mg tablet orally BID for 10 to 14 days. |
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|
Participants received a single IV infusion of JNJ-64179375 1.8 mg/kg on Day 1 and matching apixaban placebo tablets orally BID for 10 to 14 days. |
| OG004 | Apixaban 2.5 mg and JNJ-64179375 Placebo IV | Participants received a single IV infusion of matching JNJ-64179375 placebo on Day 1 and apixaban 2.5 mg tablet orally BID for 10 to 14 days. |
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Participants received a single IV infusion of JNJ-64179375 1.2 mg/kg on Day 1 and matching apixaban placebo tablets orally BID for 10 to 14 days.
| OG003 | JNJ-64179375 1.8 mg/kg and Apixaban Placebo | Participants received a single IV infusion of JNJ-64179375 1.8 mg/kg on Day 1 and matching apixaban placebo tablets orally BID for 10 to 14 days. |
| OG004 | Apixaban 2.5 mg and JNJ-64179375 Placebo IV | Participants received a single IV infusion of matching JNJ-64179375 placebo on Day 1 and apixaban 2.5 mg tablet orally BID for 10 to 14 days. |
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| OG003 | JNJ-64179375 1.8 mg/kg and Apixaban Placebo | Participants received a single IV infusion of JNJ-64179375 1.8 mg/kg on Day 1 and matching apixaban placebo tablets orally BID for 10 to 14 days. |
| OG004 | Apixaban 2.5 mg and JNJ-64179375 Placebo IV | Participants received a single IV infusion of matching JNJ-64179375 placebo on Day 1 and apixaban 2.5 mg tablet orally BID for 10 to 14 days. |
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