COMMANDER HF: A Study to Assess the Effectiveness and Safety of Rivaroxaban in Reducing the Risk of Death, Myocardial Infarction or Stroke in Participants With Heart Failure and Coronary Artery Disease Following an Episode of Decompensated Heart Failure
Sponsor
Janssen Research & Development, LLC (Industry)
Overall Status
Completed
CT.gov ID
NCT01877915
Collaborator
Bayer (Industry)
5,081
578
2
55.3
8.8
0.2
Study Details
Study Description
Brief Summary
The purpose of this study is to assess the effectiveness and safety of rivaroxaban compared with placebo (inactive medication), in reducing the risk of death, myocardial infarction or stroke in participants with heart failure and significant coronary artery disease following an episode of decompensated heart failure.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
This is a randomized (the study medication is assigned by chance), double-blind (neither physician nor participant knows the identity of the assigned treatment), parallel group (each participant group receives different treatments simultaneously), event driven (the study duration is determined by the time taken for a specific number of events to occur), multicenter study to assess the effectiveness and safety of rivaroxaban compared with placebo, in reducing the risk of death, myocardial infarction or stroke in participants with heart failure and significant coronary artery disease following an episode of decompensated heart failure. Participants will be randomly assigned in a 1:1 ratio to receive either rivaroxaban or placebo (each in addition to standard of care for heart failure and coronary artery disease as prescribed by their managing physician). The study will consist of a screening phase, a double-blind treatment phase, and a follow-up after the sponsor-announced global treatment end date (GTED, defined as the date when 1200 primary efficacy outcome events are predicted to have occurred). The double-blind treatment phase is estimated to last for 6 to 54 months. Participants will discontinue study drug after taking both their morning and evening doses on the GTED and will return to the study center for the end-of-study visit (between 15 and 45 days but no sooner than 15 days after the GTED). Patient safety will be monitored throughout the study. The average study duration for participants is expected to be approximately 29 months. The study drug, rivaroxaban, is approved in the United States and in multiple countries around the world for the prevention and treatment of a number of thrombosis-mediated conditions.
Study Design
Study Type:
Interventional
Actual Enrollment
:
5081 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Randomized, Double-blind, Event-driven, Multicenter Study Comparing the Efficacy and Safety of Rivaroxaban With Placebo for Reducing the Risk of Death, Myocardial Infarction or Stroke in Subjects With Heart Failure and Significant Coronary Artery Disease Following an Episode of Decompensated Heart Failure
Actual Study Start Date
:
Sep 10, 2013
Actual Primary Completion Date
:
Apr 19, 2018
Actual Study Completion Date
:
Apr 19, 2018
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Rivaroxaban 2.5 mg Each participant will receive 2.5 mg of rivaroxaban twice daily with standard of care for heart failure and coronary artery disease (as prescribed by the participant's managing physician). |
Drug: Rivaroxaban
Each participant, randomly allocated to the rivaroxaban arm, will receive one 2.5 mg tablet of rivaroxaban orally (by mouth) twice daily (once in the morning and once in the evening at approximately the same time each day) until the global treatment end date (GTED) (defined as the date when 1200 primary efficacy outcome events have occurred). Rivaroxaban will be given with standard of care for heart failure and coronary artery disease (as prescribed by the participant's managing physician).
Other: Standard of care for heart failure and coronary artery disease
Each participant's standard of care for heart failure and coronary artery disease (as prescribed by the participant's managing physician) should be continued throughout the study.
|
| Placebo Comparator: Placebo Each participant will receive matching placebo twice daily with standard of care for heart failure and coronary artery disease (as prescribed by the participant's managing physician). |
Drug: Placebo
Each participant, randomly allocated to the placebo arm, will receive one matching placebo tablet orally twice daily (once in the morning and once in the evening at approximately the same time each day) until the GTED. Placebo will be given with standard of care for heart failure and coronary artery disease (as prescribed by the participant's managing physician).
Other: Standard of care for heart failure and coronary artery disease
Each participant's standard of care for heart failure and coronary artery disease (as prescribed by the participant's managing physician) should be continued throughout the study.
|
Outcome Measures
Primary Outcome Measures
- Event Rate of All-Cause Mortality, Myocardial Infarction (MI), or Stroke [Up to Global treatment end date (approximately 54 months)]
Event Rate of all-cause mortality (ACM), MI, or stroke were assessed. Event rate estimated based on the time to the first occurrence of the event were reported in the study. Event Rate / (100 patient [pt]-year [yr]) = 100*n/(total risk exposure), where n is the number of events.
- Event Rate of Either Fatal Bleeding or Bleeding Into a Critical Space With Potential for Permanent Disability [Up to 227 Weeks]
Event rate of either fatal bleeding or bleeding into critical space with potential for permanent disability were assessed. Fatal bleeding event was death within 7 days after a bleeding event which required hospitalization or met International Society on Thrombosis and Haemostasis(ISTH) major bleeding definition criteria. Fatal bleeding events included those met criteria in 3 categories: 1: Any ISTH major bleeding event consider primary cause of death by investigator; 2: Any ISTH major bleeding event not considered to be primary cause of death by investigator but resulted in death within 7 days;3: Any bleeding event resulted in hospital stay and death within 7 days. Bleeding into critical space with potential for permanent disability included 7 critical spaces: intracranial, intraspinal, intraocular. Event rate estimated based on time to first occurrence of event were reported in the study. Event Rate / (100 pt-yr) = 100*n/(total risk exposure), where n is the number of events.
Secondary Outcome Measures
- Event Rate of Cardio Vascular Death or Re-Hospitalization for Worsening of Heart Failure (RHHF) [Up to Global treatment end date (approximately 54 months)]
Event rate of cardio vascular (CV) death or re-hospitalization for worsening of heart failure were assessed. Event rate estimated based on the time to the first occurrence of the event were reported in the study. Event Rate / (100 pt-yr) = 100*n/(total risk exposure), where n is the number of events.
- Event Rate of Cardio Vascular Death [Up to Global treatment end date (approximately 54 months)]
Event rate of cardio vascular death were assessed. CV death included deaths due to spontaneous bleeding, MI, stroke, worsening HF and arrhythmias, death due to CV procedures and sudden death. Event rate estimated based on the time to the first occurrence of the event were reported in the study. Event Rate / (100 pt-yr) = 100*n/(total risk exposure), where n is the number of events.
- Event Rate of Re-Hospitalization for Worsening of Heart Failure [Up to Global treatment end date (approximately 54 months)]
Event rate of re-hospitalization for worsening of heart failure were assessed. Event rate estimated based on the time to the first occurrence of the event were reported in the study. Event Rate / (100 pt-yr) = 100*n/(total risk exposure), where n is the number of events.
- Event Rate of Re-Hospitalization for Cardio Vascular Events (RHCV) [Up to Global treatment end date (approximately 54 months)]
Event rate due to cardio vascular events were assessed. Hospitalization for a CV Event required that participants be hospitalized (in-patient or emergency department) for greater than 24 hours and must have met the following criterion:Discharge summary with primary reason for admission listed as CV in nature (example, bleeding, arrhythmia, ACS, MI) other than HF which was captured in the HF re-hospitalization. Event rate estimated based on the time to the first occurrence of the event were reported in the study. Event Rate / (100 pt-yr) = 100*n/(total risk exposure), where n is the number of events.
- Event Rate of All-Cause Mortality (ACM) or Re-Hospitalization for Worsening Heart Failure [Up to Global treatment end date (approximately 54 months)]
Event rate of all-Cause Mortality (ACM) or re-Hospitalization for worsening heart failure were assessed. Event rate estimated based on the time to the first occurrence of the event were reported in the study. Event Rate / (100 pt-yr) = 100*n/(total risk exposure), where n is the number of events.
- Event Rate of Bleeding Events That Requiring Hospitalization [Up to 227 Weeks]
Event rate of bleeding events and required Hospitalization were assessed. Event rate estimated based on the time to the first occurrence of the event were reported in the study. Event Rate / (100 pt-yr) = 100*n/(total risk exposure), where n is the number of events.
- Event Rate of International Society on Thrombosis and Haemostasis (ISTH) Major Bleeding Event [Up to 227 Weeks]
Event rate of ISTH major bleeding event were assessed. Event rate estimated based on the time to the first occurrence of the event were reported in the study. Event Rate / (100 pt-yr) = 100*n/(total risk exposure), where n is the number of events.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 95 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Must have symptomatic heart failure for at least 3 months prior to Screening
-
Participants must have an episode of decompensated heart failure (index event) requiring (a) an overnight stay [that is, staying past midnight] in a hospital, emergency department, or medical facility with the capability of treating with intravenous medications and observing heart failure patients before randomization or (b) an unscheduled outpatient visit to a heart failure management center, where parenteral therapy is required for heart failure stabilization. An episode of decompensated heart failure is defined as symptoms of worsening dyspnea or fatigue, objective signs of congestion such as peripheral edema or ascites, and/or adjustment of pre-hospitalization/outpatient visit heart failure medications. Participants are eligible for randomization at discharge from the facility treating the index event and up to 30 days after discharge if they are in stable condition
-
Must have a documented left ventricular ejection fraction (LVEF) of less than or equal to 40 percent (%) within 1 year before randomization
-
Must have evidence of significant coronary artery disease
-
Must be medically stable in terms of their heart failure clinical status at the time of randomization
-
Must have a brain natriuretic peptide (BNP) level greater than or equal to (>=) 200 picogram per milliliter (pg/mL) or N-terminal-proBNP (NT-proBNP) level >=800 pg/mL (preferred assay) during the Screening period and before randomization
Exclusion Criteria:
-
Any condition that, in the opinion of the investigator, contraindicates anticoagulant therapy or would have an unacceptable risk of bleeding, such as, but not limited to, active internal bleeding, clinically significant bleeding, bleeding at a noncompressible site, or bleeding diathesis within 28 days of randomization
-
Severe concomitant disease such as (a) atrial fibrillation (AFib) or another condition that requires chronic anticoagulation (participants with isolated transient AFib may be allowed at the discretion of the treating physician investigator) and (b) Documented acute myocardial infarction (MI) during index event
-
Prior stroke within 90 days of randomization
-
Has been hospitalized for longer than 21 days during the index event
-
Planned intermittent outpatient treatment with positive inotropic drugs administered intravenously
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Alexander City | Alabama | United States | ||
| 2 | Birmingham | Alabama | United States | ||
| 3 | Mobile | Alabama | United States | ||
| 4 | Anchorage | Alaska | United States | ||
| 5 | Tucson | Arizona | United States | ||
| 6 | Jonesboro | Arkansas | United States | ||
| 7 | Beverly Hills | California | United States | ||
| 8 | Chula Vista | California | United States | ||
| 9 | El Cajon | California | United States | ||
| 10 | Glendale | California | United States | ||
| 11 | La Mesa | California | United States | ||
| 12 | Los Angeles | California | United States | ||
| 13 | Newport Beach | California | United States | ||
| 14 | Orange | California | United States | ||
| 15 | Stockton | California | United States | ||
| 16 | Torrance | California | United States | ||
| 17 | Aurora | Colorado | United States | ||
| 18 | Denver | Colorado | United States | ||
| 19 | New Haven | Connecticut | United States | ||
| 20 | Atlantis | Florida | United States | ||
| 21 | Daytona Beach | Florida | United States | ||
| 22 | Jupiter | Florida | United States | ||
| 23 | Orlando | Florida | United States | ||
| 24 | Saint Petersburg | Florida | United States | ||
| 25 | Tallahassee | Florida | United States | ||
| 26 | Wellington | Florida | United States | ||
| 27 | Winter Haven | Florida | United States | ||
| 28 | Athens | Georgia | United States | ||
| 29 | Atlanta | Georgia | United States | ||
| 30 | Cumming | Georgia | United States | ||
| 31 | Macon | Georgia | United States | ||
| 32 | Tucker | Georgia | United States | ||
| 33 | Chicago | Illinois | United States | ||
| 34 | Evanston | Illinois | United States | ||
| 35 | Fairview Heights | Illinois | United States | ||
| 36 | Peoria | Illinois | United States | ||
| 37 | Rockford | Illinois | United States | ||
| 38 | Urbana | Illinois | United States | ||
| 39 | Anderson | Indiana | United States | ||
| 40 | Indianapolis | Indiana | United States | ||
| 41 | Merrillville | Indiana | United States | ||
| 42 | Munster | Indiana | United States | ||
| 43 | South Bend | Indiana | United States | ||
| 44 | Iowa City | Iowa | United States | ||
| 45 | Elizabethtown | Kentucky | United States | ||
| 46 | Lexington | Kentucky | United States | ||
| 47 | Louisville | Kentucky | United States | ||
| 48 | Owensboro | Kentucky | United States | ||
| 49 | Bossier City | Louisiana | United States | ||
| 50 | Hammond | Louisiana | United States | ||
| 51 | Shreveport | Louisiana | United States | ||
| 52 | Slidell | Louisiana | United States | ||
| 53 | Biddeford | Maine | United States | ||
| 54 | Baltimore | Maryland | United States | ||
| 55 | Columbia | Maryland | United States | ||
| 56 | Randallstown | Maryland | United States | ||
| 57 | Bay City | Michigan | United States | ||
| 58 | Grand Blanc | Michigan | United States | ||
| 59 | Mount Clemens | Michigan | United States | ||
| 60 | Pontiac | Michigan | United States | ||
| 61 | Ypsilanti | Michigan | United States | ||
| 62 | Saint Paul | Minnesota | United States | ||
| 63 | Saint Louis | Missouri | United States | ||
| 64 | Springfield | Missouri | United States | ||
| 65 | Washington | Missouri | United States | ||
| 66 | Lincoln | Nebraska | United States | ||
| 67 | Las Vegas | Nevada | United States | ||
| 68 | Bridgewater | New Jersey | United States | ||
| 69 | Elmer | New Jersey | United States | ||
| 70 | Haddon Heights | New Jersey | United States | ||
| 71 | Manalapan | New Jersey | United States | ||
| 72 | Ridgewood | New Jersey | United States | ||
| 73 | Sewell | New Jersey | United States | ||
| 74 | Albuquerque | New Mexico | United States | ||
| 75 | Buffalo | New York | United States | ||
| 76 | Cortlandt Manor | New York | United States | ||
| 77 | Jamaica | New York | United States | ||
| 78 | Mineola | New York | United States | ||
| 79 | New York | New York | United States | ||
| 80 | Charlotte | North Carolina | United States | ||
| 81 | High Point | North Carolina | United States | ||
| 82 | Pinehurst | North Carolina | United States | ||
| 83 | Canton | Ohio | United States | ||
| 84 | Cincinnati | Ohio | United States | ||
| 85 | Columbus | Ohio | United States | ||
| 86 | Dayton | Ohio | United States | ||
| 87 | Fairfield | Ohio | United States | ||
| 88 | Kettering | Ohio | United States | ||
| 89 | Bartlesville | Oklahoma | United States | ||
| 90 | Oklahoma City | Oklahoma | United States | ||
| 91 | Tulsa | Oklahoma | United States | ||
| 92 | Portland | Oregon | United States | ||
| 93 | Doylestown | Pennsylvania | United States | ||
| 94 | Philadelphia | Pennsylvania | United States | ||
| 95 | Sayre | Pennsylvania | United States | ||
| 96 | Sellersville | Pennsylvania | United States | ||
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| 98 | Yardley | Pennsylvania | United States | ||
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| 100 | Charleston | South Carolina | United States | ||
| 101 | Sioux Falls | South Dakota | United States | ||
| 102 | Nashville | Tennessee | United States | ||
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| 105 | Fort Worth | Texas | United States | ||
| 106 | Houston | Texas | United States | ||
| 107 | Huntsville | Texas | United States | ||
| 108 | Kingwood | Texas | United States | ||
| 109 | Lubbock | Texas | United States | ||
| 110 | McKinney | Texas | United States | ||
| 111 | Burlington | Vermont | United States | ||
| 112 | Newport News | Virginia | United States | ||
| 113 | Bellingham | Washington | United States | ||
| 114 | Tacoma | Washington | United States | ||
| 115 | Huntington | West Virginia | United States | ||
| 116 | Bahia Blanca | Argentina | |||
| 117 | Buenos Aires | Argentina | |||
| 118 | Caba | Argentina | |||
| 119 | Ciudad Autonoma de Buenos Aires | Argentina | |||
| 120 | Cordoba | Argentina | |||
| 121 | Córdoba | Argentina | |||
| 122 | La Plata | Argentina | |||
| 123 | Mar del Plata | Argentina | |||
| 124 | Mendoza | Argentina | |||
| 125 | Merlo | Argentina | |||
| 126 | Quilmes | Argentina | |||
| 127 | Resistencia | Argentina | |||
| 128 | Rosario | Argentina | |||
| 129 | San Miguel de Tucuman | Argentina | |||
| 130 | San Nicolas | Argentina | |||
| 131 | Santa Fe | Argentina | |||
| 132 | Santiago del Estero | Argentina | |||
| 133 | Tucuman | Argentina | |||
| 134 | Vicente Lopez | Argentina | |||
| 135 | Bedford | Australia | |||
| 136 | Cairns | Australia | |||
| 137 | Concord | Australia | |||
| 138 | Darlinghurst | Australia | |||
| 139 | Hobart | Australia | |||
| 140 | Launceston | Australia | |||
| 141 | Perth | Australia | |||
| 142 | Sydney | Australia | |||
| 143 | Wollongong | Australia | |||
| 144 | Woolloongabba | Australia | |||
| 145 | Belo Horizonte | Brazil | |||
| 146 | Belém | Brazil | |||
| 147 | Blumenal | Brazil | |||
| 148 | Brasília | Brazil | |||
| 149 | Campina Grande do Sul | Brazil | |||
| 150 | Campinas | Brazil | |||
| 151 | Campo Grande | Brazil | |||
| 152 | Canoas | Brazil | |||
| 153 | Curitiba | Brazil | |||
| 154 | Goiania | Brazil | |||
| 155 | Goiânia | Brazil | |||
| 156 | Marília | Brazil | |||
| 157 | Passo Fundo | Brazil | |||
| 158 | Porto Alegre | Brazil | |||
| 159 | Recife | Brazil | |||
| 160 | Ribeirão Preto | Brazil | |||
| 161 | Rio de Janeiro | Brazil | |||
| 162 | Salvador | Brazil | |||
| 163 | São Jose do Rio Preto | Brazil | |||
| 164 | São Paulo | Brazil | |||
| 165 | São Pedro | Brazil | |||
| 166 | Tatuí | Brazil | |||
| 167 | Uberlândia | Brazil | |||
| 168 | Votuporanga | Brazil | |||
| 169 | Blagoevgrad | Bulgaria | |||
| 170 | Burgas | Bulgaria | |||
| 171 | Dimitrovgrad | Bulgaria | |||
| 172 | Kazanlak | Bulgaria | |||
| 173 | Pazardzhik | Bulgaria | |||
| 174 | Pleven | Bulgaria | |||
| 175 | Plovdiv | Bulgaria | |||
| 176 | Ruse | Bulgaria | |||
| 177 | Sofia | Bulgaria | |||
| 178 | Stara Zagora | Bulgaria | |||
| 179 | Varna | Bulgaria | |||
| 180 | Veliko Tarnovo | Bulgaria | |||
| 181 | Edmonton | Alberta | Canada | ||
| 182 | Maple Ridge | British Columbia | Canada | ||
| 183 | St. John's | Newfoundland and Labrador | Canada | ||
| 184 | Halifax | Nova Scotia | Canada | ||
| 185 | Cambridge | Ontario | Canada | ||
| 186 | Kitchener | Ontario | Canada | ||
| 187 | London | Ontario | Canada | ||
| 188 | Ottawa | Ontario | Canada | ||
| 189 | Scarborough | Ontario | Canada | ||
| 190 | Toronto | Ontario | Canada | ||
| 191 | Montreal | Quebec | Canada | ||
| 192 | Montréal | Quebec | Canada | ||
| 193 | Baotou | China | |||
| 194 | Beijing | China | |||
| 195 | Changchun | China | |||
| 196 | Changsha | China | |||
| 197 | Chengdu | China | |||
| 198 | Daqing | China | |||
| 199 | Guangzhou | China | |||
| 200 | Haikou | China | |||
| 201 | Hangzhou | China | |||
| 202 | Hunan | China | |||
| 203 | Jinan | China | |||
| 204 | Jining | China | |||
| 205 | Lanzhou | China | |||
| 206 | Nanchang | China | |||
| 207 | Nanjing | China | |||
| 208 | Nanning | China | |||
| 209 | Qingdao | China | |||
| 210 | Shanghai | China | |||
| 211 | Shenyang | China | |||
| 212 | Shijiazhuang | China | |||
| 213 | Suzhou | China | |||
| 214 | Taiyuan | China | |||
| 215 | Tianjin | China | |||
| 216 | Wuhan | China | |||
| 217 | Xi'an | China | |||
| 218 | Xian | China | |||
| 219 | Yang Zhou | China | |||
| 220 | Yichang | China | |||
| 221 | Brno | Czechia | |||
| 222 | Hodonín | Czechia | |||
| 223 | Hradec Králové | Czechia | |||
| 224 | Hranice | Czechia | |||
| 225 | Karlovy Vary | Czechia | |||
| 226 | Kladno | Czechia | |||
| 227 | Kolín | Czechia | |||
| 228 | Litomyšl | Czechia | |||
| 229 | Mladá Boleslav | Czechia | |||
| 230 | Olomouc | Czechia | |||
| 231 | Plze?-Bory | Czechia | |||
| 232 | Praha 10 | Czechia | |||
| 233 | Praha 8 - Libe? | Czechia | |||
| 234 | Praha | Czechia | |||
| 235 | Slany | Czechia | |||
| 236 | Teplice | Czechia | |||
| 237 | Uherské Hradišt? | Czechia | |||
| 238 | Valašské Mezi?í?í | Czechia | |||
| 239 | Esbjerg | Denmark | |||
| 240 | Herlev | Denmark | |||
| 241 | Hjørring | Denmark | |||
| 242 | Hvidovre | Denmark | |||
| 243 | Køge | Denmark | |||
| 244 | Tallinn | Estonia | |||
| 245 | Besancon | France | |||
| 246 | Bron Cedex | France | |||
| 247 | Chambray-Lès-Tours | France | |||
| 248 | Corbeil Essonnes | France | |||
| 249 | Lille | France | |||
| 250 | Montpellier | France | |||
| 251 | Nantes | France | |||
| 252 | Nice | France | |||
| 253 | Pau | France | |||
| 254 | Rouen | France | |||
| 255 | Toulouse | France | |||
| 256 | Vandoeuvre-les-nancy | France | |||
| 257 | Berlin | Germany | |||
| 258 | Bielefeld | Germany | |||
| 259 | Bonn | Germany | |||
| 260 | Coburg | Germany | |||
| 261 | Dresden | Germany | |||
| 262 | Halle | Germany | |||
| 263 | Hamburg | Germany | |||
| 264 | Heidelberg | Germany | |||
| 265 | Konstanz | Germany | |||
| 266 | Langen | Germany | |||
| 267 | Leipzig | Germany | |||
| 268 | Ludwigshafen | Germany | |||
| 269 | Magdeburg | Germany | |||
| 270 | Mainz | Germany | |||
| 271 | Markkleeberg | Germany | |||
| 272 | Papenburg | Germany | |||
| 273 | Stuttgart | Germany | |||
| 274 | Ulm | Germany | |||
| 275 | Witten | Germany | |||
| 276 | Athens | Greece | |||
| 277 | Heraklion -Crete | Greece | |||
| 278 | Larisa | Greece | |||
| 279 | Thessalonikis | Greece | |||
| 280 | Voula | Greece | |||
| 281 | Balatonfüred | Hungary | |||
| 282 | Berettyóújfalu | Hungary | |||
| 283 | Budapest | Hungary | |||
| 284 | Gyor | Hungary | |||
| 285 | Miskolc | Hungary | |||
| 286 | Nagykanizsa | Hungary | |||
| 287 | Szekszárd | Hungary | |||
| 288 | Szolnok | Hungary | |||
| 289 | Székesfehérvár | Hungary | |||
| 290 | Zalaegerszeg | Hungary | |||
| 291 | Aichi | Japan | |||
| 292 | Chiba | Japan | |||
| 293 | Chikushino-shi | Japan | |||
| 294 | Ehime | Japan | |||
| 295 | Fukuoka | Japan | |||
| 296 | Gifu | Japan | |||
| 297 | Gunma | Japan | |||
| 298 | Hatsukaichi | Japan | |||
| 299 | Hitachi | Japan | |||
| 300 | Hokkaido | Japan | |||
| 301 | Hyogo | Japan | |||
| 302 | Ibaraki | Japan | |||
| 303 | Ishikawa | Japan | |||
| 304 | Izumo | Japan | |||
| 305 | Kagawa | Japan | |||
| 306 | Kahoku-District | Japan | |||
| 307 | Kanagawa | Japan | |||
| 308 | Kobe-shi | Japan | |||
| 309 | Komatsushima-shi | Japan | |||
| 310 | Koshigaya-shi | Japan | |||
| 311 | Kumamoto | Japan | |||
| 312 | Kyoto | Japan | |||
| 313 | Miyazaki | Japan | |||
| 314 | Nagano-shi | Japan | |||
| 315 | Nagano | Japan | |||
| 316 | Nagasaki | Japan | |||
| 317 | Nagoya | Japan | |||
| 318 | Niigata | Japan | |||
| 319 | Oita | Japan | |||
| 320 | Okayama | Japan | |||
| 321 | Okinawa | Japan | |||
| 322 | Osaka-shi | Japan | |||
| 323 | Osaka | Japan | |||
| 324 | Saga | Japan | |||
| 325 | Saitama | Japan | |||
| 326 | Sapporo | Japan | |||
| 327 | Sendai | Japan | |||
| 328 | Shiga | Japan | |||
| 329 | Shimane | Japan | |||
| 330 | Shizuoka | Japan | |||
| 331 | Tachikawa | Japan | |||
| 332 | Takaraduka | Japan | |||
| 333 | Tochigi | Japan | |||
| 334 | Tokushima | Japan | |||
| 335 | Tokyo | Japan | |||
| 336 | Toyama | Japan | |||
| 337 | Toyoake | Japan | |||
| 338 | Tsu | Japan | |||
| 339 | Wakayama | Japan | |||
| 340 | Yamaguchi | Japan | |||
| 341 | Yatsushiro | Japan | |||
| 342 | Yokohama | Japan | |||
| 343 | Yonago | Japan | |||
| 344 | Busan | Korea, Republic of | |||
| 345 | Cheongju | Korea, Republic of | |||
| 346 | Daegu | Korea, Republic of | |||
| 347 | Daejeon | Korea, Republic of | |||
| 348 | Gwangju | Korea, Republic of | |||
| 349 | Seongnam-si | Korea, Republic of | |||
| 350 | Seoul | Korea, Republic of | |||
| 351 | Wonju | Korea, Republic of | |||
| 352 | Daugavpils | Latvia | |||
| 353 | Kuldiga | Latvia | |||
| 354 | Liepaja | Latvia | |||
| 355 | Riga | Latvia | |||
| 356 | Sigulda | Latvia | |||
| 357 | Ventspils | Latvia | |||
| 358 | Alytus | Lithuania | |||
| 359 | Kaunas | Lithuania | |||
| 360 | Klaipeda | Lithuania | |||
| 361 | Panevezys | Lithuania | |||
| 362 | Siauliai | Lithuania | |||
| 363 | Vilnius | Lithuania | |||
| 364 | Cheras | Malaysia | |||
| 365 | Johor Bahru | Malaysia | |||
| 366 | Kota Kinabalu | Malaysia | |||
| 367 | Kuala Lumpur | Malaysia | |||
| 368 | Kuching | Malaysia | |||
| 369 | Penang | Malaysia | |||
| 370 | Selangor | Malaysia | |||
| 371 | Selayang | Malaysia | |||
| 372 | Aguascalientes | Mexico | |||
| 373 | Benito Juárez | Mexico | |||
| 374 | Chihuahua | Mexico | |||
| 375 | Culiacan | Mexico | |||
| 376 | Durango | Mexico | |||
| 377 | Guadalajara | Mexico | |||
| 378 | León | Mexico | |||
| 379 | Mexico City | Mexico | |||
| 380 | Mexico | Mexico | |||
| 381 | Oaxaca | Mexico | |||
| 382 | Pachuca | Mexico | |||
| 383 | Puebla | Mexico | |||
| 384 | Queretaro | Mexico | |||
| 385 | San Luis Potosí | Mexico | |||
| 386 | Tampico | Mexico | |||
| 387 | Veracruz | Mexico | |||
| 388 | Almere | Netherlands | |||
| 389 | Amsterdam | Netherlands | |||
| 390 | Blaricum | Netherlands | |||
| 391 | Breda | Netherlands | |||
| 392 | Deventer | Netherlands | |||
| 393 | Doetinchem | Netherlands | |||
| 394 | Ede | Netherlands | |||
| 395 | Groningen | Netherlands | |||
| 396 | Heerlen | Netherlands | |||
| 397 | Helmond | Netherlands | |||
| 398 | Maastricht | Netherlands | |||
| 399 | Meppel | Netherlands | |||
| 400 | Tilburg | Netherlands | |||
| 401 | Będzin | Poland | |||
| 402 | Gdynia | Poland | |||
| 403 | Gliwice | Poland | |||
| 404 | Grodzisk Mazowiecki | Poland | |||
| 405 | Inowrocław | Poland | |||
| 406 | Katowice | Poland | |||
| 407 | Kielce | Poland | |||
| 408 | Krakow | Poland | |||
| 409 | Kraków | Poland | |||
| 410 | Kutno | Poland | |||
| 411 | Lodz | Poland | |||
| 412 | Lubin | Poland | |||
| 413 | Lublin | Poland | |||
| 414 | Myslenice | Poland | |||
| 415 | Olsztyn | Poland | |||
| 416 | Ostroleka | Poland | |||
| 417 | Ostrowiec Swietokrzyski | Poland | |||
| 418 | Oswiecim | Poland | |||
| 419 | Plock | Poland | |||
| 420 | Pulawy | Poland | |||
| 421 | Rabka-Zdrój | Poland | |||
| 422 | Skierniewice | Poland | |||
| 423 | Starogard Gdanski | Poland | |||
| 424 | Szczecin | Poland | |||
| 425 | Torun | Poland | |||
| 426 | Warszawa | Poland | |||
| 427 | Wloclawek | Poland | |||
| 428 | Wrocław | Poland | |||
| 429 | Zabrze | Poland | |||
| 430 | Zamosc | Poland | |||
| 431 | Łódż | Poland | |||
| 432 | Almada | Portugal | |||
| 433 | Aveiro | Portugal | |||
| 434 | Braga | Portugal | |||
| 435 | Carnaxide | Portugal | |||
| 436 | Coimbra | Portugal | |||
| 437 | Covilhã | Portugal | |||
| 438 | Leiria | Portugal | |||
| 439 | Lisboa | Portugal | |||
| 440 | Matosinhos | Portugal | |||
| 441 | Viana do Castelo | Portugal | |||
| 442 | Vila Real | Portugal | |||
| 443 | Bacau | Romania | |||
| 444 | Baia Mare | Romania | |||
| 445 | Braila | Romania | |||
| 446 | Brasov | Romania | |||
| 447 | Bucharest | Romania | |||
| 448 | Bucuresti | Romania | |||
| 449 | Buzau | Romania | |||
| 450 | Cluj Napoca | Romania | |||
| 451 | Cluj-Napoca | Romania | |||
| 452 | Craiova | Romania | |||
| 453 | Focsani | Romania | |||
| 454 | Galati | Romania | |||
| 455 | Iasi | Romania | |||
| 456 | Oradea | Romania | |||
| 457 | Pitesti | Romania | |||
| 458 | Sibiu | Romania | |||
| 459 | Targu Mures | Romania | |||
| 460 | Targu-Mures | Romania | |||
| 461 | Timisoara | Romania | |||
| 462 | Arkhangelsk | Russian Federation | |||
| 463 | Barnaul | Russian Federation | |||
| 464 | Chita | Russian Federation | |||
| 465 | Ekaterinburg | Russian Federation | |||
| 466 | Ivanovo | Russian Federation | |||
| 467 | Izhevsk | Russian Federation | |||
| 468 | Kaluga | Russian Federation | |||
| 469 | Kemerovo | Russian Federation | |||
| 470 | Kirov | Russian Federation | |||
| 471 | Krasnoyarsk | Russian Federation | |||
| 472 | Kursk | Russian Federation | |||
| 473 | Moscow, Zelenograd | Russian Federation | |||
| 474 | Moscow | Russian Federation | |||
| 475 | Nizhniy Novgorod | Russian Federation | |||
| 476 | Nizhny Novgorod | Russian Federation | |||
| 477 | Novosibirsk | Russian Federation | |||
| 478 | Orenburg | Russian Federation | |||
| 479 | Perm | Russian Federation | |||
| 480 | Rostov on Don | Russian Federation | |||
| 481 | Ryazan | Russian Federation | |||
| 482 | Saint Petersburg | Russian Federation | |||
| 483 | Samara | Russian Federation | |||
| 484 | Saratov | Russian Federation | |||
| 485 | Syktyvkar | Russian Federation | |||
| 486 | Tomsk | Russian Federation | |||
| 487 | Tyumen | Russian Federation | |||
| 488 | Voronezh | Russian Federation | |||
| 489 | Yaroslavl | Russian Federation | |||
| 490 | Banska Bystrica | Slovakia | |||
| 491 | Bardejov | Slovakia | |||
| 492 | Kosice | Slovakia | |||
| 493 | Lucenec | Slovakia | |||
| 494 | Moldava nad Bodvou | Slovakia | |||
| 495 | Nitra | Slovakia | |||
| 496 | Povazska Bystrica | Slovakia | |||
| 497 | Svidnik | Slovakia | |||
| 498 | Bloemfontein | South Africa | |||
| 499 | Cape Town | South Africa | |||
| 500 | Centurion | South Africa | |||
| 501 | Durban | South Africa | |||
| 502 | Pinelands | South Africa | |||
| 503 | Pretoria | South Africa | |||
| 504 | Tongaat | South Africa | |||
| 505 | A Coruña | Spain | |||
| 506 | Alicante | Spain | |||
| 507 | Almería | Spain | |||
| 508 | Avila | Spain | |||
| 509 | Barcelona | Spain | |||
| 510 | Burgos | Spain | |||
| 511 | Cáceres | Spain | |||
| 512 | Elche | Spain | |||
| 513 | Granada | Spain | |||
| 514 | La Coruña | Spain | |||
| 515 | Lorca | Spain | |||
| 516 | Madrid | Spain | |||
| 517 | Majadahonda | Spain | |||
| 518 | Murcia | Spain | |||
| 519 | Olot | Spain | |||
| 520 | Orihuela | Spain | |||
| 521 | Palma de Mallorca | Spain | |||
| 522 | San Juan | Spain | |||
| 523 | Sanlúcar de Barrameda | Spain | |||
| 524 | Sant Joan Despí | Spain | |||
| 525 | Santander | Spain | |||
| 526 | Sevilla | Spain | |||
| 527 | Terrassa | Spain | |||
| 528 | Torrevieja | Spain | |||
| 529 | Valencia | Spain | |||
| 530 | Vigo | Spain | |||
| 531 | Viladecans | Spain | |||
| 532 | Falun | Sweden | |||
| 533 | Jönköping | Sweden | |||
| 534 | Ljungby | Sweden | |||
| 535 | Stockholm | Sweden | |||
| 536 | Uppsala | Sweden | |||
| 537 | Ankara | Turkey | |||
| 538 | Bursa | Turkey | |||
| 539 | Diyarbakir | Turkey | |||
| 540 | Eskisehir | Turkey | |||
| 541 | Istanbul | Turkey | |||
| 542 | Kahramanmaras | Turkey | |||
| 543 | Kocaeli | Turkey | |||
| 544 | Konya | Turkey | |||
| 545 | Kırıkkale | Turkey | |||
| 546 | Mersin | Turkey | |||
| 547 | Sivas | Turkey | |||
| 548 | Cherkassy | Ukraine | |||
| 549 | Cherkasy | Ukraine | |||
| 550 | Dnipro | Ukraine | |||
| 551 | Donetsk | Ukraine | |||
| 552 | Kharkiv | Ukraine | |||
| 553 | Kyiv | Ukraine | |||
| 554 | Lutsk | Ukraine | |||
| 555 | Lviv | Ukraine | |||
| 556 | Odesa | Ukraine | |||
| 557 | Poltava | Ukraine | |||
| 558 | Sumy | Ukraine | |||
| 559 | Vinnitsa | Ukraine | |||
| 560 | Vinnytsia | Ukraine | |||
| 561 | Zaporizhzhia | Ukraine | |||
| 562 | Zaporizhzhya | Ukraine | |||
| 563 | Zhytomir | Ukraine | |||
| 564 | Aberdeen | United Kingdom | |||
| 565 | Airdrie | United Kingdom | |||
| 566 | Birmingham | United Kingdom | |||
| 567 | Chesterfield | United Kingdom | |||
| 568 | Chichester | United Kingdom | |||
| 569 | Clydebank | United Kingdom | |||
| 570 | Cottingham | United Kingdom | |||
| 571 | Dudley | United Kingdom | |||
| 572 | Dundee | United Kingdom | |||
| 573 | East Kilbride | United Kingdom | |||
| 574 | Exeter | United Kingdom | |||
| 575 | Inverness | United Kingdom | |||
| 576 | Manchester | United Kingdom | |||
| 577 | Ta1 5da | United Kingdom | |||
| 578 | Wirral | United Kingdom |
Sponsors and Collaborators
- Janssen Research & Development, LLC
- Bayer
Investigators
- Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT01877915
Other Study ID Numbers:
- CR101940
- RIVAROXHFA3001
- 2013-000046-19
First Posted:
Jun 14, 2013
Last Update Posted:
May 10, 2019
Last Verified:
Apr 1, 2019
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Janssen Research & Development, LLC
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | A total of 3 participants randomized twice were only counted once in the ITT analysis set (comprised of 5,022 participants). |
| Arm/Group Title | Rivaroxaban | Placebo |
|---|---|---|
| Arm/Group Description | Participants received 2.5 milligram (mg) tablet of rivaroxaban orally twice daily with standard of care for heart failure and coronary artery disease (as prescribed by the participant's managing physician). | Participants received matching placebo orally twice daily with standard of care for heart failure and coronary artery disease (as prescribed by the participant's managing physician). |
| Period Title: Overall Study | ||
| STARTED | 2507 | 2515 |
| COMPLETED | 2453 | 2447 |
| NOT COMPLETED | 54 | 68 |
Baseline Characteristics
| Arm/Group Title | Rivaroxaban | Placebo | Total |
|---|---|---|---|
| Arm/Group Description | Participants received 2.5 milligram (mg) tablet of rivaroxaban orally twice daily with standard of care for heart failure and coronary artery disease (as prescribed by the participant's managing physician). | Participants received matching placebo orally twice daily with standard of care for heart failure and coronary artery disease (as prescribed by the participant's managing physician). | Total of all reporting groups |
| Overall Participants | 2507 | 2515 | 5022 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
66.5
(10.07)
|
66.3
(10.27)
|
66.4
(10.17)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
551
22%
|
599
23.8%
|
1150
22.9%
|
| Male |
1956
78%
|
1916
76.2%
|
3872
77.1%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||
| Hispanic or Latino |
309
12.3%
|
300
11.9%
|
609
12.1%
|
| Not Hispanic or Latino |
2186
87.2%
|
2203
87.6%
|
4389
87.4%
|
| Unknown or Not Reported |
12
0.5%
|
12
0.5%
|
24
0.5%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
11
0.4%
|
10
0.4%
|
21
0.4%
|
| Asian |
362
14.4%
|
365
14.5%
|
727
14.5%
|
| Native Hawaiian or Other Pacific Islander |
2
0.1%
|
0
0%
|
2
0%
|
| Black or African American |
29
1.2%
|
36
1.4%
|
65
1.3%
|
| White |
2063
82.3%
|
2065
82.1%
|
4128
82.2%
|
| More than one race |
4
0.2%
|
5
0.2%
|
9
0.2%
|
| Unknown or Not Reported |
36
1.4%
|
34
1.4%
|
70
1.4%
|
| Race/Ethnicity, Customized (Count of Participants) | |||
| Asian |
362
14.4%
|
365
14.5%
|
727
14.5%
|
| Black or African American |
29
1.2%
|
36
1.4%
|
65
1.3%
|
| Other |
59
2.4%
|
56
2.2%
|
115
2.3%
|
| White Hispanic or Latino |
258
10.3%
|
251
10%
|
509
10.1%
|
| White Non-Hispanic |
1799
71.8%
|
1807
71.8%
|
3606
71.8%
|
| Region of Enrollment (Count of Participants) | |||
| ARGENTINA |
76
3%
|
76
3%
|
152
3%
|
| AUSTRALIA |
7
0.3%
|
7
0.3%
|
14
0.3%
|
| BRAZIL |
80
3.2%
|
80
3.2%
|
160
3.2%
|
| BULGARIA |
314
12.5%
|
314
12.5%
|
628
12.5%
|
| CANADA |
14
0.6%
|
14
0.6%
|
28
0.6%
|
| CHINA |
186
7.4%
|
186
7.4%
|
372
7.4%
|
| CZECH REPUBLIC |
35
1.4%
|
34
1.4%
|
69
1.4%
|
| DENMARK |
9
0.4%
|
9
0.4%
|
18
0.4%
|
| FRANCE |
10
0.4%
|
10
0.4%
|
20
0.4%
|
| GERMANY |
32
1.3%
|
32
1.3%
|
64
1.3%
|
| GREECE |
8
0.3%
|
8
0.3%
|
16
0.3%
|
| HUNGARY |
69
2.8%
|
69
2.7%
|
138
2.7%
|
| ITALY |
35
1.4%
|
36
1.4%
|
71
1.4%
|
| JAPAN |
133
5.3%
|
132
5.2%
|
265
5.3%
|
| LATVIA |
12
0.5%
|
13
0.5%
|
25
0.5%
|
| LITHUANIA |
17
0.7%
|
18
0.7%
|
35
0.7%
|
| MALAYSIA |
17
0.7%
|
17
0.7%
|
34
0.7%
|
| MEXICO |
73
2.9%
|
73
2.9%
|
146
2.9%
|
| NETHERLANDS |
1
0%
|
2
0.1%
|
3
0.1%
|
| POLAND |
288
11.5%
|
290
11.5%
|
578
11.5%
|
| PORTUGAL |
20
0.8%
|
22
0.9%
|
42
0.8%
|
| ROMANIA |
200
8%
|
198
7.9%
|
398
7.9%
|
| RUSSIAN FEDERATION |
274
10.9%
|
276
11%
|
550
11%
|
| SLOVAKIA |
41
1.6%
|
41
1.6%
|
82
1.6%
|
| SOUTH AFRICA |
8
0.3%
|
8
0.3%
|
16
0.3%
|
| SOUTH KOREA |
24
1%
|
24
1%
|
48
1%
|
| SPAIN |
89
3.6%
|
89
3.5%
|
178
3.5%
|
| SWEDEN |
2
0.1%
|
3
0.1%
|
5
0.1%
|
| TURKEY |
96
3.8%
|
96
3.8%
|
192
3.8%
|
| UKRAINE |
264
10.5%
|
265
10.5%
|
529
10.5%
|
| UNITED KINGDOM |
13
0.5%
|
12
0.5%
|
25
0.5%
|
| UNITED STATES |
60
2.4%
|
61
2.4%
|
121
2.4%
|
Outcome Measures
| Title | Event Rate of All-Cause Mortality, Myocardial Infarction (MI), or Stroke |
|---|---|
| Description | Event Rate of all-cause mortality (ACM), MI, or stroke were assessed. Event rate estimated based on the time to the first occurrence of the event were reported in the study. Event Rate / (100 patient [pt]-year [yr]) = 100*n/(total risk exposure), where n is the number of events. |
| Time Frame | Up to Global treatment end date (approximately 54 months) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent-to-Treat analysis set included all randomized unique participants who signed a valid informed consent. Participants were analyzed according to the treatment group assigned, irrespective of the actual treatment received. |
| Arm/Group Title | Rivaroxaban | Placebo |
|---|---|---|
| Arm/Group Description | Participants received 2.5 milligram (mg) tablet of rivaroxaban orally twice daily with standard of care for heart failure and coronary artery disease (as prescribed by the participant's managing physician). | Participants received matching placebo orally twice daily with standard of care for heart failure and coronary artery disease (as prescribed by the participant's managing physician). |
| Measure Participants | 2507 | 2515 |
| Number [Event rate per 100 patient-year] |
13.44
|
14.27
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Rivaroxaban, Placebo |
|---|---|---|
| Comments | Statistical Analysis 1 | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.270 |
| Comments | ||
| Method | Log Rank | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.94 | |
| Confidence Interval |
(2-Sided) 95% 0.84 to 1.05 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Event Rate of Cardio Vascular Death or Re-Hospitalization for Worsening of Heart Failure (RHHF) |
|---|---|
| Description | Event rate of cardio vascular (CV) death or re-hospitalization for worsening of heart failure were assessed. Event rate estimated based on the time to the first occurrence of the event were reported in the study. Event Rate / (100 pt-yr) = 100*n/(total risk exposure), where n is the number of events. |
| Time Frame | Up to Global treatment end date (approximately 54 months) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent-to-Treat analysis set included all randomized unique participants who signed a valid informed consent. Participants were analyzed according to the treatment group assigned, irrespective of the actual treatment received. |
| Arm/Group Title | Rivaroxaban | Placebo |
|---|---|---|
| Arm/Group Description | Participants received 2.5 milligram (mg) tablet of rivaroxaban orally twice daily with standard of care for heart failure and coronary artery disease (as prescribed by the participant's managing physician). | Participants received matching placebo orally twice daily with standard of care for heart failure and coronary artery disease (as prescribed by the participant's managing physician). |
| Measure Participants | 2507 | 2515 |
| Number [Event rate per 100 patient-year] |
23.32
|
23.46
|
| Title | Event Rate of Cardio Vascular Death |
|---|---|
| Description | Event rate of cardio vascular death were assessed. CV death included deaths due to spontaneous bleeding, MI, stroke, worsening HF and arrhythmias, death due to CV procedures and sudden death. Event rate estimated based on the time to the first occurrence of the event were reported in the study. Event Rate / (100 pt-yr) = 100*n/(total risk exposure), where n is the number of events. |
| Time Frame | Up to Global treatment end date (approximately 54 months) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent-to-Treat analysis set included all randomized unique participants who signed a valid informed consent. Participants were analyzed according to the treatment group assigned, irrespective of the actual treatment received. |
| Arm/Group Title | Rivaroxaban | Placebo |
|---|---|---|
| Arm/Group Description | Participants received 2.5 milligram (mg) tablet of rivaroxaban orally twice daily with standard of care for heart failure and coronary artery disease (as prescribed by the participant's managing physician). | Participants received matching placebo orally twice daily with standard of care for heart failure and coronary artery disease (as prescribed by the participant's managing physician). |
| Measure Participants | 2507 | 2515 |
| Number [Event rate per 100 patient-year] |
9.46
|
9.96
|
| Title | Event Rate of Re-Hospitalization for Worsening of Heart Failure |
|---|---|
| Description | Event rate of re-hospitalization for worsening of heart failure were assessed. Event rate estimated based on the time to the first occurrence of the event were reported in the study. Event Rate / (100 pt-yr) = 100*n/(total risk exposure), where n is the number of events. |
| Time Frame | Up to Global treatment end date (approximately 54 months) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent-to-Treat analysis set included all randomized unique participants who signed a valid informed consent. Participants were analyzed according to the treatment group assigned, irrespective of the actual treatment received. |
| Arm/Group Title | Rivaroxaban | Placebo |
|---|---|---|
| Arm/Group Description | Participants received 2.5 milligram (mg) tablet of rivaroxaban orally twice daily with standard of care for heart failure and coronary artery disease (as prescribed by the participant's managing physician). | Participants received matching placebo orally twice daily with standard of care for heart failure and coronary artery disease (as prescribed by the participant's managing physician). |
| Measure Participants | 2507 | 2515 |
| Number [Event rate per 100 patient-year] |
17.24
|
17.45
|
| Title | Event Rate of Re-Hospitalization for Cardio Vascular Events (RHCV) |
|---|---|
| Description | Event rate due to cardio vascular events were assessed. Hospitalization for a CV Event required that participants be hospitalized (in-patient or emergency department) for greater than 24 hours and must have met the following criterion:Discharge summary with primary reason for admission listed as CV in nature (example, bleeding, arrhythmia, ACS, MI) other than HF which was captured in the HF re-hospitalization. Event rate estimated based on the time to the first occurrence of the event were reported in the study. Event Rate / (100 pt-yr) = 100*n/(total risk exposure), where n is the number of events. |
| Time Frame | Up to Global treatment end date (approximately 54 months) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent-to-Treat analysis set included all randomized unique participants who signed a valid informed consent. Participants were analyzed according to the treatment group assigned, irrespective of the actual treatment received. |
| Arm/Group Title | Rivaroxaban | Placebo |
|---|---|---|
| Arm/Group Description | Participants received 2.5 milligram (mg) tablet of rivaroxaban orally twice daily with standard of care for heart failure and coronary artery disease (as prescribed by the participant's managing physician). | Participants received matching placebo orally twice daily with standard of care for heart failure and coronary artery disease (as prescribed by the participant's managing physician). |
| Measure Participants | 2507 | 2515 |
| Number [Event rate per 100 patient-year] |
13.30
|
14.04
|
| Title | Event Rate of All-Cause Mortality (ACM) or Re-Hospitalization for Worsening Heart Failure |
|---|---|
| Description | Event rate of all-Cause Mortality (ACM) or re-Hospitalization for worsening heart failure were assessed. Event rate estimated based on the time to the first occurrence of the event were reported in the study. Event Rate / (100 pt-yr) = 100*n/(total risk exposure), where n is the number of events. |
| Time Frame | Up to Global treatment end date (approximately 54 months) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent-to-Treat analysis set included all randomized unique participants who signed a valid informed consent. Participants were analyzed according to the treatment group assigned, irrespective of the actual treatment received. |
| Arm/Group Title | Rivaroxaban | Placebo |
|---|---|---|
| Arm/Group Description | Participants received 2.5 milligram (mg) tablet of rivaroxaban orally twice daily with standard of care for heart failure and coronary artery disease (as prescribed by the participant's managing physician). | Participants received matching placebo orally twice daily with standard of care for heart failure and coronary artery disease (as prescribed by the participant's managing physician). |
| Measure Participants | 2507 | 2515 |
| Number [Event rate per 100 patient-year] |
24.84
|
24.57
|
| Title | Event Rate of Either Fatal Bleeding or Bleeding Into a Critical Space With Potential for Permanent Disability |
|---|---|
| Description | Event rate of either fatal bleeding or bleeding into critical space with potential for permanent disability were assessed. Fatal bleeding event was death within 7 days after a bleeding event which required hospitalization or met International Society on Thrombosis and Haemostasis(ISTH) major bleeding definition criteria. Fatal bleeding events included those met criteria in 3 categories: 1: Any ISTH major bleeding event consider primary cause of death by investigator; 2: Any ISTH major bleeding event not considered to be primary cause of death by investigator but resulted in death within 7 days;3: Any bleeding event resulted in hospital stay and death within 7 days. Bleeding into critical space with potential for permanent disability included 7 critical spaces: intracranial, intraspinal, intraocular. Event rate estimated based on time to first occurrence of event were reported in the study. Event Rate / (100 pt-yr) = 100*n/(total risk exposure), where n is the number of events. |
| Time Frame | Up to 227 Weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Analysis Set included all intent-to-treat participants who received at least one dose of study drug. Here 'N' signifies number of participants who were evaluable for this outcome measure. |
| Arm/Group Title | Rivaroxaban | Placebo |
|---|---|---|
| Arm/Group Description | Participants received 2.5 milligram (mg) tablet of rivaroxaban orally twice daily with standard of care for heart failure and coronary artery disease (as prescribed by the participant's managing physician). | Participants received matching placebo orally twice daily with standard of care for heart failure and coronary artery disease (as prescribed by the participant's managing physician). |
| Measure Participants | 2499 | 2509 |
| Fatal Bleeding |
0.22
|
0.22
|
| Critical Space Bleeding with Permanent Disability |
0.32
|
0.48
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Rivaroxaban, Placebo |
|---|---|---|
| Comments | Statistical Analysis 1 (Fatal Bleeding) | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.951 |
| Comments | ||
| Method | Log Rank | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 1.03 | |
| Confidence Interval |
(2-Sided) 95% 0.41 to 2.59 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Rivaroxaban, Placebo |
|---|---|---|
| Comments | Statistical Analysis 2 (Bleeding in Critical Space with Potential for Permanent Disability) | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.253 |
| Comments | ||
| Method | Log Rank | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.67 | |
| Confidence Interval |
(2-Sided) 95% 0.33 to 1.34 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Event Rate of Bleeding Events That Requiring Hospitalization |
|---|---|
| Description | Event rate of bleeding events and required Hospitalization were assessed. Event rate estimated based on the time to the first occurrence of the event were reported in the study. Event Rate / (100 pt-yr) = 100*n/(total risk exposure), where n is the number of events. |
| Time Frame | Up to 227 Weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Analysis Set included all intent-to-treat participants who received at least one dose of study drug. Here 'N' signifies number of participants who were evaluable for this outcome measure. |
| Arm/Group Title | Rivaroxaban | Placebo |
|---|---|---|
| Arm/Group Description | Participants received 2.5 milligram (mg) tablet of rivaroxaban orally twice daily with standard of care for heart failure and coronary artery disease (as prescribed by the participant's managing physician). | Participants received matching placebo orally twice daily with standard of care for heart failure and coronary artery disease (as prescribed by the participant's managing physician). |
| Measure Participants | 2499 | 2509 |
| Number [Event rate per 100 patient-year] |
1.52
|
1.16
|
| Title | Event Rate of International Society on Thrombosis and Haemostasis (ISTH) Major Bleeding Event |
|---|---|
| Description | Event rate of ISTH major bleeding event were assessed. Event rate estimated based on the time to the first occurrence of the event were reported in the study. Event Rate / (100 pt-yr) = 100*n/(total risk exposure), where n is the number of events. |
| Time Frame | Up to 227 Weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Analysis Set included all intent-to-treat participants who received at least one dose of study drug. Here 'N' signifies number of participants who were evaluable for this outcome measure. |
| Arm/Group Title | Rivaroxaban | Placebo |
|---|---|---|
| Arm/Group Description | Participants received 2.5 milligram (mg) tablet of rivaroxaban orally twice daily with standard of care for heart failure and coronary artery disease (as prescribed by the participant's managing physician). | Participants received matching placebo orally twice daily with standard of care for heart failure and coronary artery disease (as prescribed by the participant's managing physician). |
| Measure Participants | 2499 | 2509 |
| Number [Event rate per 100 patient-year] |
2.04
|
1.21
|
Adverse Events
| Time Frame | Up to 54 Months | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Rivaroxaban | Placebo | ||
| Arm/Group Description | Participants received 2.5 milligram (mg) tablet of rivaroxaban orally twice daily with standard of care for heart failure and coronary artery disease (as prescribed by the participant's managing physician). | Participants received matching placebo orally twice daily with standard of care for heart failure and coronary artery disease (as prescribed by the participant's managing physician). | ||
All Cause Mortality |
||||
| Rivaroxaban | Placebo | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 565/2507 (22.5%) | 571/2515 (22.7%) | ||
Serious Adverse Events |
||||
| Rivaroxaban | Placebo | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 479/2507 (19.1%) | 451/2515 (17.9%) | ||
| Blood and lymphatic system disorders | ||||
| Anaemia | 12/2507 (0.5%) | 7/2515 (0.3%) | ||
| Anaemia Vitamin B12 Deficiency | 1/2507 (0%) | 0/2515 (0%) | ||
| Aplastic Anaemia | 0/2507 (0%) | 1/2515 (0%) | ||
| Disseminated Intravascular Coagulation | 0/2507 (0%) | 1/2515 (0%) | ||
| Iron Deficiency Anaemia | 0/2507 (0%) | 1/2515 (0%) | ||
| Lymphadenopathy | 0/2507 (0%) | 1/2515 (0%) | ||
| Thrombocytopenia | 0/2507 (0%) | 3/2515 (0.1%) | ||
| Cardiac disorders | ||||
| Atrial Fibrillation | 1/2507 (0%) | 0/2515 (0%) | ||
| Cardiac Failure | 0/2507 (0%) | 1/2515 (0%) | ||
| Cardiac Ventricular Thrombosis | 1/2507 (0%) | 1/2515 (0%) | ||
| Cardiogenic Shock | 0/2507 (0%) | 2/2515 (0.1%) | ||
| Cardiorenal Syndrome | 1/2507 (0%) | 0/2515 (0%) | ||
| Myocarditis | 0/2507 (0%) | 1/2515 (0%) | ||
| Palpitations | 1/2507 (0%) | 1/2515 (0%) | ||
| Congenital, familial and genetic disorders | ||||
| Arteriovenous Malformation | 0/2507 (0%) | 1/2515 (0%) | ||
| Buried Penis Syndrome | 1/2507 (0%) | 0/2515 (0%) | ||
| Hydrocele | 1/2507 (0%) | 0/2515 (0%) | ||
| Ear and labyrinth disorders | ||||
| Vertigo | 1/2507 (0%) | 2/2515 (0.1%) | ||
| Vertigo Positional | 1/2507 (0%) | 0/2515 (0%) | ||
| Endocrine disorders | ||||
| Basedow's Disease | 0/2507 (0%) | 1/2515 (0%) | ||
| Hypothyroidism | 1/2507 (0%) | 1/2515 (0%) | ||
| Eye disorders | ||||
| Cataract | 7/2507 (0.3%) | 2/2515 (0.1%) | ||
| Cataract Nuclear | 1/2507 (0%) | 0/2515 (0%) | ||
| Diabetic Retinopathy | 1/2507 (0%) | 0/2515 (0%) | ||
| Macular Hole | 1/2507 (0%) | 0/2515 (0%) | ||
| Ophthalmoplegia | 0/2507 (0%) | 1/2515 (0%) | ||
| Retinal Detachment | 1/2507 (0%) | 0/2515 (0%) | ||
| Retinopathy Hypertensive | 0/2507 (0%) | 1/2515 (0%) | ||
| Subretinal Fibrosis | 0/2507 (0%) | 1/2515 (0%) | ||
| Visual Acuity Reduced | 1/2507 (0%) | 0/2515 (0%) | ||
| Gastrointestinal disorders | ||||
| Abdominal Adhesions | 1/2507 (0%) | 0/2515 (0%) | ||
| Abdominal Pain | 6/2507 (0.2%) | 7/2515 (0.3%) | ||
| Abdominal Pain Upper | 1/2507 (0%) | 1/2515 (0%) | ||
| Abdominal Tenderness | 0/2507 (0%) | 1/2515 (0%) | ||
| Anal Fissure | 0/2507 (0%) | 1/2515 (0%) | ||
| Ascites | 0/2507 (0%) | 1/2515 (0%) | ||
| Chronic Gastritis | 3/2507 (0.1%) | 1/2515 (0%) | ||
| Coeliac Disease | 1/2507 (0%) | 0/2515 (0%) | ||
| Colitis | 1/2507 (0%) | 0/2515 (0%) | ||
| Constipation | 2/2507 (0.1%) | 1/2515 (0%) | ||
| Dental Caries | 1/2507 (0%) | 0/2515 (0%) | ||
| Diarrhoea | 4/2507 (0.2%) | 2/2515 (0.1%) | ||
| Diverticulum Intestinal | 1/2507 (0%) | 0/2515 (0%) | ||
| Duodenal Obstruction | 0/2507 (0%) | 1/2515 (0%) | ||
| Duodenal Ulcer | 0/2507 (0%) | 1/2515 (0%) | ||
| Dyspepsia | 2/2507 (0.1%) | 3/2515 (0.1%) | ||
| Dysphagia | 1/2507 (0%) | 1/2515 (0%) | ||
| Enteritis | 1/2507 (0%) | 0/2515 (0%) | ||
| Erosive Duodenitis | 1/2507 (0%) | 0/2515 (0%) | ||
| Food Poisoning | 0/2507 (0%) | 1/2515 (0%) | ||
| Gastric Ulcer | 1/2507 (0%) | 3/2515 (0.1%) | ||
| Gastritis | 2/2507 (0.1%) | 4/2515 (0.2%) | ||
| Gastritis Erosive | 1/2507 (0%) | 0/2515 (0%) | ||
| Gastrointestinal Angiodysplasia | 1/2507 (0%) | 0/2515 (0%) | ||
| Gastrointestinal Disorder | 1/2507 (0%) | 0/2515 (0%) | ||
| Gastrointestinal Necrosis | 1/2507 (0%) | 0/2515 (0%) | ||
| Gastrooesophageal Reflux Disease | 3/2507 (0.1%) | 1/2515 (0%) | ||
| Gastrooesophageal Sphincter Insufficiency | 0/2507 (0%) | 1/2515 (0%) | ||
| Hernial Eventration | 1/2507 (0%) | 0/2515 (0%) | ||
| Ileus | 0/2507 (0%) | 1/2515 (0%) | ||
| Ileus Paralytic | 1/2507 (0%) | 0/2515 (0%) | ||
| Incarcerated Inguinal Hernia | 1/2507 (0%) | 2/2515 (0.1%) | ||
| Incarcerated Umbilical Hernia | 0/2507 (0%) | 1/2515 (0%) | ||
| Inflammatory Bowel Disease | 0/2507 (0%) | 1/2515 (0%) | ||
| Inguinal Hernia | 7/2507 (0.3%) | 9/2515 (0.4%) | ||
| Intestinal Infarction | 1/2507 (0%) | 0/2515 (0%) | ||
| Intestinal Obstruction | 5/2507 (0.2%) | 0/2515 (0%) | ||
| Ischaemic Enteritis | 0/2507 (0%) | 1/2515 (0%) | ||
| Large Intestinal Obstruction | 1/2507 (0%) | 0/2515 (0%) | ||
| Large Intestine Polyp | 4/2507 (0.2%) | 1/2515 (0%) | ||
| Nausea | 2/2507 (0.1%) | 1/2515 (0%) | ||
| Pancreatic Disorder | 0/2507 (0%) | 1/2515 (0%) | ||
| Pancreatic Necrosis | 0/2507 (0%) | 1/2515 (0%) | ||
| Pancreatitis Acute | 3/2507 (0.1%) | 3/2515 (0.1%) | ||
| Pancreatitis Chronic | 2/2507 (0.1%) | 1/2515 (0%) | ||
| Small Intestinal Obstruction | 1/2507 (0%) | 0/2515 (0%) | ||
| Subileus | 1/2507 (0%) | 0/2515 (0%) | ||
| Ulcerative Gastritis | 1/2507 (0%) | 0/2515 (0%) | ||
| Volvulus of Small Bowel | 1/2507 (0%) | 0/2515 (0%) | ||
| Vomiting | 3/2507 (0.1%) | 2/2515 (0.1%) | ||
| General disorders | ||||
| Asthenia | 5/2507 (0.2%) | 1/2515 (0%) | ||
| Chest Discomfort | 0/2507 (0%) | 1/2515 (0%) | ||
| Chest Pain | 0/2507 (0%) | 1/2515 (0%) | ||
| Death | 0/2507 (0%) | 3/2515 (0.1%) | ||
| Disuse Syndrome | 1/2507 (0%) | 1/2515 (0%) | ||
| Drug Withdrawal Syndrome | 0/2507 (0%) | 1/2515 (0%) | ||
| Fatigue | 0/2507 (0%) | 2/2515 (0.1%) | ||
| General Physical Health Deterioration | 1/2507 (0%) | 0/2515 (0%) | ||
| Heteroplasia | 0/2507 (0%) | 1/2515 (0%) | ||
| Hyperthermia Malignant | 1/2507 (0%) | 0/2515 (0%) | ||
| Impaired Healing | 1/2507 (0%) | 1/2515 (0%) | ||
| Multiple Organ Dysfunction Syndrome | 5/2507 (0.2%) | 3/2515 (0.1%) | ||
| Non-Cardiac Chest Pain | 7/2507 (0.3%) | 6/2515 (0.2%) | ||
| Pain | 1/2507 (0%) | 0/2515 (0%) | ||
| Pyrexia | 4/2507 (0.2%) | 4/2515 (0.2%) | ||
| Soft Tissue Inflammation | 1/2507 (0%) | 0/2515 (0%) | ||
| Sudden Death | 1/2507 (0%) | 0/2515 (0%) | ||
| Hepatobiliary disorders | ||||
| Acute Hepatic Failure | 1/2507 (0%) | 0/2515 (0%) | ||
| Bile Duct Stone | 0/2507 (0%) | 1/2515 (0%) | ||
| Biliary Colic | 1/2507 (0%) | 0/2515 (0%) | ||
| Biliary Dilatation | 1/2507 (0%) | 0/2515 (0%) | ||
| Cardiac Cirrhosis | 2/2507 (0.1%) | 1/2515 (0%) | ||
| Cholangitis | 3/2507 (0.1%) | 1/2515 (0%) | ||
| Cholangitis Acute | 1/2507 (0%) | 0/2515 (0%) | ||
| Cholecystitis | 10/2507 (0.4%) | 5/2515 (0.2%) | ||
| Cholecystitis Acute | 1/2507 (0%) | 7/2515 (0.3%) | ||
| Cholecystitis Chronic | 1/2507 (0%) | 0/2515 (0%) | ||
| Cholelithiasis | 2/2507 (0.1%) | 3/2515 (0.1%) | ||
| Cirrhosis Alcoholic | 1/2507 (0%) | 0/2515 (0%) | ||
| Hepatic Cirrhosis | 0/2507 (0%) | 2/2515 (0.1%) | ||
| Hepatic Failure | 2/2507 (0.1%) | 1/2515 (0%) | ||
| Hepatic Function Abnormal | 1/2507 (0%) | 1/2515 (0%) | ||
| Hepatic Lesion | 0/2507 (0%) | 1/2515 (0%) | ||
| Hepatitis Acute | 1/2507 (0%) | 0/2515 (0%) | ||
| Hepatorenal Failure | 0/2507 (0%) | 1/2515 (0%) | ||
| Jaundice | 1/2507 (0%) | 1/2515 (0%) | ||
| Liver Disorder | 1/2507 (0%) | 0/2515 (0%) | ||
| Portal Hypertension | 1/2507 (0%) | 0/2515 (0%) | ||
| Immune system disorders | ||||
| Hypersensitivity | 0/2507 (0%) | 1/2515 (0%) | ||
| Sarcoidosis | 1/2507 (0%) | 0/2515 (0%) | ||
| Infections and infestations | ||||
| Abdominal Abscess | 1/2507 (0%) | 0/2515 (0%) | ||
| Abscess | 0/2507 (0%) | 1/2515 (0%) | ||
| Abscess Limb | 1/2507 (0%) | 0/2515 (0%) | ||
| Abscess Soft Tissue | 1/2507 (0%) | 0/2515 (0%) | ||
| Anal Abscess | 1/2507 (0%) | 0/2515 (0%) | ||
| Appendicitis | 3/2507 (0.1%) | 1/2515 (0%) | ||
| Arthritis Bacterial | 0/2507 (0%) | 1/2515 (0%) | ||
| Bacterial Infection | 0/2507 (0%) | 1/2515 (0%) | ||
| Bacterial Sepsis | 0/2507 (0%) | 1/2515 (0%) | ||
| Bronchitis | 12/2507 (0.5%) | 9/2515 (0.4%) | ||
| Bronchitis Bacterial | 1/2507 (0%) | 0/2515 (0%) | ||
| Bursitis Infective | 1/2507 (0%) | 0/2515 (0%) | ||
| Carbuncle | 1/2507 (0%) | 0/2515 (0%) | ||
| Cellulitis | 7/2507 (0.3%) | 7/2515 (0.3%) | ||
| Cellulitis Gangrenous | 0/2507 (0%) | 1/2515 (0%) | ||
| Cholecystitis Infective | 2/2507 (0.1%) | 0/2515 (0%) | ||
| Chronic Tonsillitis | 1/2507 (0%) | 0/2515 (0%) | ||
| Clostridium Difficile Colitis | 1/2507 (0%) | 1/2515 (0%) | ||
| Clostridium Difficile Infection | 0/2507 (0%) | 2/2515 (0.1%) | ||
| Cystitis | 1/2507 (0%) | 0/2515 (0%) | ||
| Dengue Fever | 0/2507 (0%) | 1/2515 (0%) | ||
| Device Related Infection | 1/2507 (0%) | 1/2515 (0%) | ||
| Diabetic Foot Infection | 2/2507 (0.1%) | 1/2515 (0%) | ||
| Diabetic Gangrene | 1/2507 (0%) | 3/2515 (0.1%) | ||
| Diverticulitis | 0/2507 (0%) | 1/2515 (0%) | ||
| Douglas' Abscess | 0/2507 (0%) | 1/2515 (0%) | ||
| Encephalitis | 1/2507 (0%) | 0/2515 (0%) | ||
| Endocarditis | 1/2507 (0%) | 2/2515 (0.1%) | ||
| Enteritis Infectious | 0/2507 (0%) | 1/2515 (0%) | ||
| Enterobacter Infection | 0/2507 (0%) | 1/2515 (0%) | ||
| Epididymitis | 1/2507 (0%) | 0/2515 (0%) | ||
| Erysipelas | 2/2507 (0.1%) | 1/2515 (0%) | ||
| Escherichia Bacteraemia | 1/2507 (0%) | 0/2515 (0%) | ||
| Escherichia Infection | 1/2507 (0%) | 0/2515 (0%) | ||
| Escherichia Pyelonephritis | 0/2507 (0%) | 1/2515 (0%) | ||
| Escherichia Sepsis | 0/2507 (0%) | 3/2515 (0.1%) | ||
| Escherichia Urinary Tract Infection | 0/2507 (0%) | 1/2515 (0%) | ||
| Gangrene | 7/2507 (0.3%) | 4/2515 (0.2%) | ||
| Gastritis Viral | 1/2507 (0%) | 0/2515 (0%) | ||
| Gastroenteritis | 6/2507 (0.2%) | 4/2515 (0.2%) | ||
| Gastroenteritis Shigella | 0/2507 (0%) | 1/2515 (0%) | ||
| Gastroenteritis Viral | 1/2507 (0%) | 0/2515 (0%) | ||
| Haemorrhagic Pneumonia | 0/2507 (0%) | 1/2515 (0%) | ||
| Hepatitis E | 1/2507 (0%) | 0/2515 (0%) | ||
| Herpes Zoster | 0/2507 (0%) | 1/2515 (0%) | ||
| Herpes Zoster Infection Neurological | 0/2507 (0%) | 1/2515 (0%) | ||
| Infected Dermal Cyst | 1/2507 (0%) | 0/2515 (0%) | ||
| Infected Skin Ulcer | 1/2507 (0%) | 0/2515 (0%) | ||
| Infection | 1/2507 (0%) | 0/2515 (0%) | ||
| Infective Spondylitis | 0/2507 (0%) | 1/2515 (0%) | ||
| Influenza | 7/2507 (0.3%) | 2/2515 (0.1%) | ||
| Intervertebral Discitis | 1/2507 (0%) | 0/2515 (0%) | ||
| Localised Infection | 3/2507 (0.1%) | 1/2515 (0%) | ||
| Lower Respiratory Tract Infection | 2/2507 (0.1%) | 0/2515 (0%) | ||
| Lung Abscess | 0/2507 (0%) | 1/2515 (0%) | ||
| Lung Infection | 8/2507 (0.3%) | 6/2515 (0.2%) | ||
| Medical Device Site Infection | 1/2507 (0%) | 3/2515 (0.1%) | ||
| Meningitis | 0/2507 (0%) | 1/2515 (0%) | ||
| Myiasis | 1/2507 (0%) | 0/2515 (0%) | ||
| Osteomyelitis | 4/2507 (0.2%) | 1/2515 (0%) | ||
| Pancreas Infection | 0/2507 (0%) | 1/2515 (0%) | ||
| Parotid Abscess | 0/2507 (0%) | 1/2515 (0%) | ||
| Periodontitis | 2/2507 (0.1%) | 1/2515 (0%) | ||
| Peritonitis | 5/2507 (0.2%) | 3/2515 (0.1%) | ||
| Pharyngeal Abscess | 1/2507 (0%) | 0/2515 (0%) | ||
| Pharyngitis | 2/2507 (0.1%) | 0/2515 (0%) | ||
| Pneumonia | 68/2507 (2.7%) | 72/2515 (2.9%) | ||
| Pneumonia Bacterial | 1/2507 (0%) | 5/2515 (0.2%) | ||
| Pneumonia Klebsiella | 1/2507 (0%) | 0/2515 (0%) | ||
| Pneumonia Staphylococcal | 1/2507 (0%) | 0/2515 (0%) | ||
| Post Procedural Infection | 1/2507 (0%) | 0/2515 (0%) | ||
| Postoperative Wound Infection | 1/2507 (0%) | 0/2515 (0%) | ||
| Pulmonary Tuberculosis | 0/2507 (0%) | 1/2515 (0%) | ||
| Pyelonephritis | 2/2507 (0.1%) | 0/2515 (0%) | ||
| Pyelonephritis Acute | 0/2507 (0%) | 3/2515 (0.1%) | ||
| Pyuria | 0/2507 (0%) | 1/2515 (0%) | ||
| Respiratory Tract Infection | 10/2507 (0.4%) | 8/2515 (0.3%) | ||
| Sepsis | 16/2507 (0.6%) | 7/2515 (0.3%) | ||
| Septic Shock | 4/2507 (0.2%) | 6/2515 (0.2%) | ||
| Sinusitis | 0/2507 (0%) | 1/2515 (0%) | ||
| Staphylococcal Sepsis | 1/2507 (0%) | 0/2515 (0%) | ||
| Syphilis | 1/2507 (0%) | 0/2515 (0%) | ||
| Tracheitis | 1/2507 (0%) | 0/2515 (0%) | ||
| Upper Respiratory Tract Infection | 5/2507 (0.2%) | 1/2515 (0%) | ||
| Urinary Tract Infection | 14/2507 (0.6%) | 9/2515 (0.4%) | ||
| Urinary Tract Infection Bacterial | 0/2507 (0%) | 1/2515 (0%) | ||
| Urosepsis | 1/2507 (0%) | 0/2515 (0%) | ||
| Viral Myocarditis | 0/2507 (0%) | 1/2515 (0%) | ||
| Wound Infection | 1/2507 (0%) | 2/2515 (0.1%) | ||
| Injury, poisoning and procedural complications | ||||
| Accidental Overdose | 2/2507 (0.1%) | 2/2515 (0.1%) | ||
| Alcohol Poisoning | 1/2507 (0%) | 0/2515 (0%) | ||
| Ankle Fracture | 1/2507 (0%) | 1/2515 (0%) | ||
| Bone Fissure | 1/2507 (0%) | 0/2515 (0%) | ||
| Burns Third Degree | 1/2507 (0%) | 0/2515 (0%) | ||
| Cervical Vertebral Fracture | 0/2507 (0%) | 1/2515 (0%) | ||
| Contusion | 1/2507 (0%) | 0/2515 (0%) | ||
| Craniocerebral Injury | 0/2507 (0%) | 1/2515 (0%) | ||
| Fall | 5/2507 (0.2%) | 3/2515 (0.1%) | ||
| Femoral Neck Fracture | 1/2507 (0%) | 3/2515 (0.1%) | ||
| Femur Fracture | 8/2507 (0.3%) | 4/2515 (0.2%) | ||
| Fibula Fracture | 0/2507 (0%) | 1/2515 (0%) | ||
| Foot Fracture | 0/2507 (0%) | 1/2515 (0%) | ||
| Foreign Body | 1/2507 (0%) | 0/2515 (0%) | ||
| Gun Shot Wound | 0/2507 (0%) | 1/2515 (0%) | ||
| Hand Fracture | 0/2507 (0%) | 1/2515 (0%) | ||
| Head Injury | 1/2507 (0%) | 0/2515 (0%) | ||
| Hip Fracture | 6/2507 (0.2%) | 1/2515 (0%) | ||
| Humerus Fracture | 0/2507 (0%) | 2/2515 (0.1%) | ||
| Intentional Overdose | 0/2507 (0%) | 1/2515 (0%) | ||
| Limb Injury | 1/2507 (0%) | 1/2515 (0%) | ||
| Lower Limb Fracture | 0/2507 (0%) | 1/2515 (0%) | ||
| Multiple Fractures | 2/2507 (0.1%) | 1/2515 (0%) | ||
| Patella Fracture | 0/2507 (0%) | 1/2515 (0%) | ||
| Pneumothorax Traumatic | 0/2507 (0%) | 1/2515 (0%) | ||
| Post Procedural Complication | 1/2507 (0%) | 0/2515 (0%) | ||
| Postoperative Renal Failure | 1/2507 (0%) | 0/2515 (0%) | ||
| Postoperative Wound Complication | 2/2507 (0.1%) | 0/2515 (0%) | ||
| Radiation Pneumonitis | 0/2507 (0%) | 1/2515 (0%) | ||
| Radius Fracture | 0/2507 (0%) | 1/2515 (0%) | ||
| Rib Fracture | 1/2507 (0%) | 1/2515 (0%) | ||
| Road Traffic Accident | 3/2507 (0.1%) | 3/2515 (0.1%) | ||
| Spinal Compression Fracture | 2/2507 (0.1%) | 3/2515 (0.1%) | ||
| Tendon Rupture | 1/2507 (0%) | 0/2515 (0%) | ||
| Thermal Burn | 2/2507 (0.1%) | 3/2515 (0.1%) | ||
| Thoracic Vertebral Fracture | 0/2507 (0%) | 1/2515 (0%) | ||
| Tibia Fracture | 0/2507 (0%) | 1/2515 (0%) | ||
| Ulna Fracture | 0/2507 (0%) | 1/2515 (0%) | ||
| Wound Dehiscence | 1/2507 (0%) | 0/2515 (0%) | ||
| Investigations | ||||
| Biopsy Pleura | 0/2507 (0%) | 1/2515 (0%) | ||
| Biopsy Prostate | 1/2507 (0%) | 0/2515 (0%) | ||
| Blood Creatine Phosphokinase Increased | 0/2507 (0%) | 1/2515 (0%) | ||
| Blood Creatinine Increased | 0/2507 (0%) | 2/2515 (0.1%) | ||
| Blood Glucose Abnormal | 1/2507 (0%) | 0/2515 (0%) | ||
| Blood Glucose Fluctuation | 0/2507 (0%) | 1/2515 (0%) | ||
| Hepatic Enzyme Increased | 3/2507 (0.1%) | 0/2515 (0%) | ||
| Liver Function Test Increased | 0/2507 (0%) | 1/2515 (0%) | ||
| Oesophagogastroduodenoscopy | 0/2507 (0%) | 1/2515 (0%) | ||
| Platelet Count Decreased | 1/2507 (0%) | 0/2515 (0%) | ||
| Metabolism and nutrition disorders | ||||
| Acidosis | 1/2507 (0%) | 1/2515 (0%) | ||
| Cachexia | 1/2507 (0%) | 0/2515 (0%) | ||
| Decreased Appetite | 0/2507 (0%) | 2/2515 (0.1%) | ||
| Dehydration | 1/2507 (0%) | 3/2515 (0.1%) | ||
| Diabetes Mellitus | 7/2507 (0.3%) | 8/2515 (0.3%) | ||
| Diabetes Mellitus Inadequate Control | 9/2507 (0.4%) | 3/2515 (0.1%) | ||
| Diabetic Ketosis | 0/2507 (0%) | 1/2515 (0%) | ||
| Diabetic Metabolic Decompensation | 2/2507 (0.1%) | 4/2515 (0.2%) | ||
| Electrolyte Imbalance | 0/2507 (0%) | 1/2515 (0%) | ||
| Fluid Retention | 1/2507 (0%) | 0/2515 (0%) | ||
| Hypercalcaemia | 0/2507 (0%) | 1/2515 (0%) | ||
| Hyperglycaemia | 3/2507 (0.1%) | 3/2515 (0.1%) | ||
| Hyperglycaemic Hyperosmolar Nonketotic Syndrome | 0/2507 (0%) | 1/2515 (0%) | ||
| Hyperkalaemia | 4/2507 (0.2%) | 7/2515 (0.3%) | ||
| Hypervolaemia | 1/2507 (0%) | 0/2515 (0%) | ||
| Hypoglycaemia | 5/2507 (0.2%) | 5/2515 (0.2%) | ||
| Hypokalaemia | 1/2507 (0%) | 1/2515 (0%) | ||
| Hyponatraemia | 0/2507 (0%) | 5/2515 (0.2%) | ||
| Hypovolaemia | 1/2507 (0%) | 0/2515 (0%) | ||
| Insulin-Requiring Type 2 Diabetes Mellitus | 0/2507 (0%) | 1/2515 (0%) | ||
| Lactic Acidosis | 1/2507 (0%) | 0/2515 (0%) | ||
| Metabolic Disorder | 1/2507 (0%) | 1/2515 (0%) | ||
| Type 1 Diabetes Mellitus | 1/2507 (0%) | 0/2515 (0%) | ||
| Type 2 Diabetes Mellitus | 5/2507 (0.2%) | 3/2515 (0.1%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| Arthralgia | 1/2507 (0%) | 0/2515 (0%) | ||
| Arthritis | 2/2507 (0.1%) | 0/2515 (0%) | ||
| Back Pain | 0/2507 (0%) | 3/2515 (0.1%) | ||
| Foot Deformity | 0/2507 (0%) | 1/2515 (0%) | ||
| Gouty Arthritis | 1/2507 (0%) | 0/2515 (0%) | ||
| Intervertebral Disc Degeneration | 1/2507 (0%) | 0/2515 (0%) | ||
| Intervertebral Disc Disorder | 1/2507 (0%) | 0/2515 (0%) | ||
| Intervertebral Disc Protrusion | 4/2507 (0.2%) | 1/2515 (0%) | ||
| Lumbar Spinal Stenosis | 0/2507 (0%) | 1/2515 (0%) | ||
| Muscle Spasms | 0/2507 (0%) | 1/2515 (0%) | ||
| Muscular Weakness | 1/2507 (0%) | 0/2515 (0%) | ||
| Musculoskeletal Chest Pain | 1/2507 (0%) | 2/2515 (0.1%) | ||
| Myopathy | 1/2507 (0%) | 0/2515 (0%) | ||
| Osteitis | 1/2507 (0%) | 0/2515 (0%) | ||
| Osteoarthritis | 0/2507 (0%) | 4/2515 (0.2%) | ||
| Osteochondrosis | 1/2507 (0%) | 1/2515 (0%) | ||
| Pain in Extremity | 1/2507 (0%) | 1/2515 (0%) | ||
| Polymyalgia Rheumatica | 0/2507 (0%) | 1/2515 (0%) | ||
| Rheumatoid Arthritis | 0/2507 (0%) | 1/2515 (0%) | ||
| Spinal Osteoarthritis | 2/2507 (0.1%) | 0/2515 (0%) | ||
| Spinal Pain | 1/2507 (0%) | 2/2515 (0.1%) | ||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| Acute Myeloid Leukaemia | 0/2507 (0%) | 1/2515 (0%) | ||
| Adenocarcinoma of Colon | 1/2507 (0%) | 1/2515 (0%) | ||
| Bladder Cancer | 6/2507 (0.2%) | 3/2515 (0.1%) | ||
| Bladder Cancer Recurrent | 1/2507 (0%) | 0/2515 (0%) | ||
| Brain Neoplasm | 1/2507 (0%) | 1/2515 (0%) | ||
| Breast Cancer Stage Ii | 1/2507 (0%) | 0/2515 (0%) | ||
| Breast Neoplasm | 1/2507 (0%) | 0/2515 (0%) | ||
| Bronchial Carcinoma | 1/2507 (0%) | 0/2515 (0%) | ||
| Cervix Carcinoma | 1/2507 (0%) | 0/2515 (0%) | ||
| Chronic Lymphocytic Leukaemia | 0/2507 (0%) | 1/2515 (0%) | ||
| Clear Cell Renal Cell Carcinoma | 1/2507 (0%) | 0/2515 (0%) | ||
| Colon Cancer | 7/2507 (0.3%) | 3/2515 (0.1%) | ||
| Colon Cancer Metastatic | 1/2507 (0%) | 0/2515 (0%) | ||
| Colon Cancer Recurrent | 0/2507 (0%) | 1/2515 (0%) | ||
| Colon Neoplasm | 1/2507 (0%) | 0/2515 (0%) | ||
| Colorectal Adenocarcinoma | 1/2507 (0%) | 0/2515 (0%) | ||
| Colorectal Cancer | 0/2507 (0%) | 1/2515 (0%) | ||
| Ear Neoplasm Malignant | 0/2507 (0%) | 1/2515 (0%) | ||
| Endometrial Cancer Metastatic | 1/2507 (0%) | 0/2515 (0%) | ||
| Epiglottic Carcinoma | 0/2507 (0%) | 1/2515 (0%) | ||
| Gallbladder Cancer | 1/2507 (0%) | 0/2515 (0%) | ||
| Gastric Cancer | 2/2507 (0.1%) | 0/2515 (0%) | ||
| Gastric Cancer Recurrent | 1/2507 (0%) | 0/2515 (0%) | ||
| Gastrooesophageal Cancer | 1/2507 (0%) | 0/2515 (0%) | ||
| Hepatic Cancer | 0/2507 (0%) | 1/2515 (0%) | ||
| Hepatic Cancer Stage Iv | 0/2507 (0%) | 1/2515 (0%) | ||
| Hypopharyngeal Cancer | 0/2507 (0%) | 1/2515 (0%) | ||
| Intestinal Adenocarcinoma | 0/2507 (0%) | 1/2515 (0%) | ||
| Lipoma | 1/2507 (0%) | 0/2515 (0%) | ||
| Lung Adenocarcinoma | 0/2507 (0%) | 2/2515 (0.1%) | ||
| Lung Cancer Metastatic | 1/2507 (0%) | 2/2515 (0.1%) | ||
| Lung Carcinoma Cell Type Unspecified Stage Ii | 1/2507 (0%) | 0/2515 (0%) | ||
| Lung Neoplasm | 1/2507 (0%) | 4/2515 (0.2%) | ||
| Lung Neoplasm Malignant | 7/2507 (0.3%) | 7/2515 (0.3%) | ||
| Lymphoma | 0/2507 (0%) | 1/2515 (0%) | ||
| Malignant Melanoma | 0/2507 (0%) | 1/2515 (0%) | ||
| Malignant Neoplasm of Unknown Primary Site | 1/2507 (0%) | 0/2515 (0%) | ||
| Meningioma | 0/2507 (0%) | 1/2515 (0%) | ||
| Metastases to Bone | 0/2507 (0%) | 1/2515 (0%) | ||
| Metastases to Central Nervous System | 1/2507 (0%) | 1/2515 (0%) | ||
| Metastases to Liver | 4/2507 (0.2%) | 1/2515 (0%) | ||
| Metastases to Lung | 0/2507 (0%) | 2/2515 (0.1%) | ||
| Metastatic Neoplasm | 2/2507 (0.1%) | 0/2515 (0%) | ||
| Metastatic Renal Cell Carcinoma | 1/2507 (0%) | 0/2515 (0%) | ||
| Monoclonal Gammopathy | 0/2507 (0%) | 1/2515 (0%) | ||
| Neoplasm Malignant | 1/2507 (0%) | 0/2515 (0%) | ||
| Neoplasm of Orbit | 0/2507 (0%) | 1/2515 (0%) | ||
| Non-Hodgkin's Lymphoma | 1/2507 (0%) | 0/2515 (0%) | ||
| Oesophageal Adenocarcinoma | 1/2507 (0%) | 0/2515 (0%) | ||
| Oropharyngeal Squamous Cell Carcinoma | 0/2507 (0%) | 1/2515 (0%) | ||
| Pancreatic Carcinoma | 2/2507 (0.1%) | 1/2515 (0%) | ||
| Pancreatic Carcinoma Metastatic | 0/2507 (0%) | 2/2515 (0.1%) | ||
| Plasma Cell Myeloma | 1/2507 (0%) | 2/2515 (0.1%) | ||
| Prostate Cancer | 4/2507 (0.2%) | 4/2515 (0.2%) | ||
| Prostate Cancer Metastatic | 0/2507 (0%) | 1/2515 (0%) | ||
| Prostate Cancer Stage Iv | 1/2507 (0%) | 0/2515 (0%) | ||
| Prostatic Adenoma | 1/2507 (0%) | 1/2515 (0%) | ||
| Rectal Adenocarcinoma | 1/2507 (0%) | 0/2515 (0%) | ||
| Rectal Cancer Stage Iii | 0/2507 (0%) | 1/2515 (0%) | ||
| Rectal Neoplasm | 0/2507 (0%) | 1/2515 (0%) | ||
| Renal Cancer | 2/2507 (0.1%) | 2/2515 (0.1%) | ||
| Renal Cancer Metastatic | 1/2507 (0%) | 0/2515 (0%) | ||
| Renal Cell Carcinoma | 0/2507 (0%) | 1/2515 (0%) | ||
| Renal Neoplasm | 1/2507 (0%) | 0/2515 (0%) | ||
| Small Cell Carcinoma | 1/2507 (0%) | 0/2515 (0%) | ||
| Small Intestine Carcinoma | 0/2507 (0%) | 1/2515 (0%) | ||
| Squamous Cell Carcinoma | 1/2507 (0%) | 0/2515 (0%) | ||
| Testis Cancer | 0/2507 (0%) | 1/2515 (0%) | ||
| Throat Cancer | 0/2507 (0%) | 1/2515 (0%) | ||
| Thyroid Cancer | 1/2507 (0%) | 0/2515 (0%) | ||
| Tongue Neoplasm | 1/2507 (0%) | 0/2515 (0%) | ||
| Tongue Neoplasm Malignant Stage Unspecified | 0/2507 (0%) | 1/2515 (0%) | ||
| Transitional Cell Carcinoma | 1/2507 (0%) | 0/2515 (0%) | ||
| Nervous system disorders | ||||
| Amyotrophic Lateral Sclerosis | 1/2507 (0%) | 0/2515 (0%) | ||
| Brain Injury | 1/2507 (0%) | 0/2515 (0%) | ||
| Brain Oedema | 0/2507 (0%) | 1/2515 (0%) | ||
| Carpal Tunnel Syndrome | 0/2507 (0%) | 1/2515 (0%) | ||
| Cervicobrachial Syndrome | 0/2507 (0%) | 1/2515 (0%) | ||
| Dementia | 2/2507 (0.1%) | 0/2515 (0%) | ||
| Diabetic Neuropathy | 0/2507 (0%) | 1/2515 (0%) | ||
| Dizziness Postural | 1/2507 (0%) | 1/2515 (0%) | ||
| Encephalopathy | 1/2507 (0%) | 1/2515 (0%) | ||
| Epilepsy | 2/2507 (0.1%) | 1/2515 (0%) | ||
| Headache | 0/2507 (0%) | 1/2515 (0%) | ||
| Hemianopia | 0/2507 (0%) | 1/2515 (0%) | ||
| Hypoglycaemic Coma | 0/2507 (0%) | 1/2515 (0%) | ||
| Hypoxic-Ischaemic Encephalopathy | 0/2507 (0%) | 1/2515 (0%) | ||
| Intercostal Neuralgia | 0/2507 (0%) | 1/2515 (0%) | ||
| Ischaemic Neuropathy | 0/2507 (0%) | 1/2515 (0%) | ||
| Loss of Consciousness | 2/2507 (0.1%) | 1/2515 (0%) | ||
| Lumbosacral Radiculopathy | 0/2507 (0%) | 1/2515 (0%) | ||
| Metabolic Encephalopathy | 0/2507 (0%) | 1/2515 (0%) | ||
| Neuroglycopenia | 0/2507 (0%) | 1/2515 (0%) | ||
| Neuropathy Peripheral | 2/2507 (0.1%) | 0/2515 (0%) | ||
| Sciatica | 0/2507 (0%) | 1/2515 (0%) | ||
| Seizure | 1/2507 (0%) | 0/2515 (0%) | ||
| Syncope | 6/2507 (0.2%) | 3/2515 (0.1%) | ||
| Transient Ischaemic Attack | 0/2507 (0%) | 1/2515 (0%) | ||
| Vertebrobasilar Insufficiency | 1/2507 (0%) | 0/2515 (0%) | ||
| Product Issues | ||||
| Device Dislocation | 0/2507 (0%) | 2/2515 (0.1%) | ||
| Psychiatric disorders | ||||
| Alcohol Abuse | 1/2507 (0%) | 0/2515 (0%) | ||
| Alcohol Withdrawal Syndrome | 1/2507 (0%) | 0/2515 (0%) | ||
| Alcoholism | 1/2507 (0%) | 0/2515 (0%) | ||
| Antisocial Personality Disorder | 0/2507 (0%) | 1/2515 (0%) | ||
| Anxiety Disorder | 0/2507 (0%) | 1/2515 (0%) | ||
| Confusional State | 1/2507 (0%) | 0/2515 (0%) | ||
| Delirium | 1/2507 (0%) | 1/2515 (0%) | ||
| Depression | 2/2507 (0.1%) | 1/2515 (0%) | ||
| Illness Anxiety Disorder | 0/2507 (0%) | 1/2515 (0%) | ||
| Major Depression | 1/2507 (0%) | 2/2515 (0.1%) | ||
| Psychotic Disorder Due to A General Medical Condition | 0/2507 (0%) | 1/2515 (0%) | ||
| Self-Injurious Ideation | 0/2507 (0%) | 1/2515 (0%) | ||
| Suicidal Ideation | 0/2507 (0%) | 1/2515 (0%) | ||
| Suicide Attempt | 0/2507 (0%) | 1/2515 (0%) | ||
| Renal and urinary disorders | ||||
| Acute Kidney Injury | 17/2507 (0.7%) | 28/2515 (1.1%) | ||
| Calculus Urinary | 1/2507 (0%) | 1/2515 (0%) | ||
| Chronic Kidney Disease | 14/2507 (0.6%) | 7/2515 (0.3%) | ||
| Diabetic Nephropathy | 1/2507 (0%) | 1/2515 (0%) | ||
| Dysuria | 1/2507 (0%) | 0/2515 (0%) | ||
| End Stage Renal Disease | 2/2507 (0.1%) | 1/2515 (0%) | ||
| Glomerulonephritis | 1/2507 (0%) | 0/2515 (0%) | ||
| Iga Nephropathy | 0/2507 (0%) | 1/2515 (0%) | ||
| Nephrolithiasis | 3/2507 (0.1%) | 0/2515 (0%) | ||
| Nephropathy Toxic | 1/2507 (0%) | 0/2515 (0%) | ||
| Nephrotic Syndrome | 0/2507 (0%) | 1/2515 (0%) | ||
| Prerenal Failure | 2/2507 (0.1%) | 0/2515 (0%) | ||
| Renal Artery Stenosis | 1/2507 (0%) | 0/2515 (0%) | ||
| Renal Colic | 1/2507 (0%) | 0/2515 (0%) | ||
| Renal Failure | 12/2507 (0.5%) | 12/2515 (0.5%) | ||
| Renal Impairment | 4/2507 (0.2%) | 9/2515 (0.4%) | ||
| Ureterolithiasis | 2/2507 (0.1%) | 0/2515 (0%) | ||
| Urethral Stenosis | 1/2507 (0%) | 0/2515 (0%) | ||
| Urinary Retention | 3/2507 (0.1%) | 1/2515 (0%) | ||
| Urinary Tract Disorder | 1/2507 (0%) | 0/2515 (0%) | ||
| Urinary Tract Obstruction | 0/2507 (0%) | 1/2515 (0%) | ||
| Reproductive system and breast disorders | ||||
| Benign Prostatic Hyperplasia | 4/2507 (0.2%) | 1/2515 (0%) | ||
| Cystocele | 0/2507 (0%) | 1/2515 (0%) | ||
| Gynaecomastia | 1/2507 (0%) | 1/2515 (0%) | ||
| Ovarian Cyst Torsion | 1/2507 (0%) | 0/2515 (0%) | ||
| Prostatitis | 1/2507 (0%) | 0/2515 (0%) | ||
| Uterine Polyp | 0/2507 (0%) | 1/2515 (0%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Acute Pulmonary Oedema | 0/2507 (0%) | 3/2515 (0.1%) | ||
| Acute Respiratory Failure | 2/2507 (0.1%) | 2/2515 (0.1%) | ||
| Asthma | 5/2507 (0.2%) | 2/2515 (0.1%) | ||
| Atelectasis | 1/2507 (0%) | 1/2515 (0%) | ||
| Bronchiectasis | 2/2507 (0.1%) | 0/2515 (0%) | ||
| Bronchitis Chronic | 4/2507 (0.2%) | 1/2515 (0%) | ||
| Bronchospasm | 1/2507 (0%) | 0/2515 (0%) | ||
| Chronic Obstructive Pulmonary Disease | 15/2507 (0.6%) | 16/2515 (0.6%) | ||
| Cough | 1/2507 (0%) | 0/2515 (0%) | ||
| Dyspnoea | 4/2507 (0.2%) | 2/2515 (0.1%) | ||
| Dyspnoea Paroxysmal Nocturnal | 0/2507 (0%) | 1/2515 (0%) | ||
| Emphysema | 0/2507 (0%) | 1/2515 (0%) | ||
| Hypoxia | 0/2507 (0%) | 1/2515 (0%) | ||
| Interstitial Lung Disease | 1/2507 (0%) | 2/2515 (0.1%) | ||
| Lung Disorder | 1/2507 (0%) | 0/2515 (0%) | ||
| Lung Infiltration | 0/2507 (0%) | 1/2515 (0%) | ||
| Necrotising Bronchiolitis | 0/2507 (0%) | 1/2515 (0%) | ||
| Pleural Effusion | 3/2507 (0.1%) | 2/2515 (0.1%) | ||
| Pleurisy | 1/2507 (0%) | 0/2515 (0%) | ||
| Pneumonia Aspiration | 4/2507 (0.2%) | 1/2515 (0%) | ||
| Pneumothorax | 1/2507 (0%) | 1/2515 (0%) | ||
| Pulmonary Fibrosis | 1/2507 (0%) | 0/2515 (0%) | ||
| Pulmonary Hypertension | 0/2507 (0%) | 1/2515 (0%) | ||
| Pulmonary Mass | 2/2507 (0.1%) | 1/2515 (0%) | ||
| Pulmonary Oedema | 0/2507 (0%) | 3/2515 (0.1%) | ||
| Respiratory Arrest | 1/2507 (0%) | 0/2515 (0%) | ||
| Respiratory Failure | 9/2507 (0.4%) | 5/2515 (0.2%) | ||
| Respiratory Tract Inflammation | 1/2507 (0%) | 0/2515 (0%) | ||
| Sleep Apnoea Syndrome | 0/2507 (0%) | 1/2515 (0%) | ||
| Vocal Cord Thickening | 0/2507 (0%) | 1/2515 (0%) | ||
| Skin and subcutaneous tissue disorders | ||||
| Angioedema | 1/2507 (0%) | 1/2515 (0%) | ||
| Decubitus Ulcer | 1/2507 (0%) | 0/2515 (0%) | ||
| Diabetic Foot | 6/2507 (0.2%) | 4/2515 (0.2%) | ||
| Dyshidrotic Eczema | 0/2507 (0%) | 1/2515 (0%) | ||
| Hypersensitivity Vasculitis | 0/2507 (0%) | 2/2515 (0.1%) | ||
| Necrobiosis Lipoidica Diabeticorum | 0/2507 (0%) | 1/2515 (0%) | ||
| Rash Generalised | 1/2507 (0%) | 0/2515 (0%) | ||
| Rash Macular | 0/2507 (0%) | 1/2515 (0%) | ||
| Skin Lesion | 0/2507 (0%) | 1/2515 (0%) | ||
| Skin Ulcer | 1/2507 (0%) | 2/2515 (0.1%) | ||
| Toxic Epidermal Necrolysis | 0/2507 (0%) | 1/2515 (0%) | ||
| Surgical and medical procedures | ||||
| Anal Sphincterotomy | 1/2507 (0%) | 0/2515 (0%) | ||
| Bile Duct Stent Removal | 0/2507 (0%) | 1/2515 (0%) | ||
| Breast Tumour Excision | 1/2507 (0%) | 0/2515 (0%) | ||
| Cataract Operation | 3/2507 (0.1%) | 2/2515 (0.1%) | ||
| Chemotherapy | 0/2507 (0%) | 1/2515 (0%) | ||
| Cyst Removal | 0/2507 (0%) | 1/2515 (0%) | ||
| Debridement | 1/2507 (0%) | 0/2515 (0%) | ||
| Diabetes Mellitus Management | 1/2507 (0%) | 0/2515 (0%) | ||
| Drug Therapy | 0/2507 (0%) | 1/2515 (0%) | ||
| Hernia Repair | 0/2507 (0%) | 1/2515 (0%) | ||
| Ileostomy | 1/2507 (0%) | 0/2515 (0%) | ||
| Inguinal Hernia Repair | 2/2507 (0.1%) | 0/2515 (0%) | ||
| Insertion of Ambulatory Peritoneal Catheter | 1/2507 (0%) | 0/2515 (0%) | ||
| Leg Amputation | 1/2507 (0%) | 0/2515 (0%) | ||
| Peripheral Artery Bypass | 1/2507 (0%) | 0/2515 (0%) | ||
| Prosthetic Vessel Implantation | 1/2507 (0%) | 0/2515 (0%) | ||
| Removal of Ambulatory Peritoneal Catheter | 1/2507 (0%) | 0/2515 (0%) | ||
| Spinal Fusion Surgery | 1/2507 (0%) | 0/2515 (0%) | ||
| Spinal Laminectomy | 1/2507 (0%) | 0/2515 (0%) | ||
| Transurethral Prostatectomy | 0/2507 (0%) | 1/2515 (0%) | ||
| Vascular disorders | ||||
| Aortic Aneurysm | 1/2507 (0%) | 0/2515 (0%) | ||
| Aortic Dissection | 1/2507 (0%) | 0/2515 (0%) | ||
| Arterial Haemorrhage | 1/2507 (0%) | 0/2515 (0%) | ||
| Arteriosclerosis | 0/2507 (0%) | 1/2515 (0%) | ||
| Circulatory Collapse | 2/2507 (0.1%) | 1/2515 (0%) | ||
| Cryoglobulinaemia | 0/2507 (0%) | 1/2515 (0%) | ||
| Diabetic Vascular Disorder | 0/2507 (0%) | 1/2515 (0%) | ||
| Extremity Necrosis | 3/2507 (0.1%) | 0/2515 (0%) | ||
| Hypertension | 0/2507 (0%) | 2/2515 (0.1%) | ||
| Hypotension | 4/2507 (0.2%) | 2/2515 (0.1%) | ||
| Hypovolaemic Shock | 2/2507 (0.1%) | 0/2515 (0%) | ||
| Orthostatic Hypotension | 0/2507 (0%) | 2/2515 (0.1%) | ||
| Peripheral Arterial Occlusive Disease | 0/2507 (0%) | 1/2515 (0%) | ||
| Peripheral Ischaemia | 2/2507 (0.1%) | 0/2515 (0%) | ||
| Peripheral Vascular Disorder | 1/2507 (0%) | 0/2515 (0%) | ||
| Phlebitis Superficial | 0/2507 (0%) | 1/2515 (0%) | ||
| Subclavian Artery Stenosis | 1/2507 (0%) | 0/2515 (0%) | ||
| Thrombophlebitis | 1/2507 (0%) | 0/2515 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Rivaroxaban | Placebo | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 53/2507 (2.1%) | 60/2515 (2.4%) | ||
| Infections and infestations | ||||
| Nasopharyngitis | 53/2507 (2.1%) | 60/2515 (2.4%) | ||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring 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 in writing, such publication will be withheld for up to an additional 60 days.
Results Point of Contact
| Name/Title | SENIOR DIRECTOR, CLINICAL LEADER CV |
|---|---|
| Organization | Janssen Research & Development, LLC |
| Phone | 844-434-4210 |
| ClinicalTrialDisclosure@its.jnj.com |
Responsible Party:
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT01877915
Other Study ID Numbers:
- CR101940
- RIVAROXHFA3001
- 2013-000046-19
First Posted:
Jun 14, 2013
Last Update Posted:
May 10, 2019
Last Verified:
Apr 1, 2019