Acute Medically Ill VTE Prevention With Extended Duration Betrixaban Study (The APEX Study)
Sponsor
Portola Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT01583218
Collaborator
(none)
7,513
463
2
46
16.2
0.4
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate whether extended prophylaxis with oral betrixaban can prevent blood clots in the leg and lung that sometime occur in patients hospitalized for an acute medical illness and to compare these results with standard of care enoxaparin. The safety of betrixaban will also be studied.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
7513 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
(Apex) Multicenter, Randomized, Active-Controlled Efficacy And Safety Study Comparing Extended Duration Betrixaban With Standard Of Care Enoxaparin For The Prevention Of Venous Thromboembolism In Acute Medically Ill Patients
Study Start Date
:
Mar 1, 2012
Actual Primary Completion Date
:
Dec 1, 2015
Actual Study Completion Date
:
Jan 1, 2016
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Betrixaban Daily oral (PO) betrixaban capsules for 35 to 42 days and subcutaneous (SQ) injections of enoxaparin placebo for 10 ± 4 days |
Drug: Betrixaban
Betrixaban 80 mg PO once daily (QD) for 35 day + 7 days.
Enoxaparin Placebo: Once daily, 6-14 days
|
| Active Comparator: Enoxaparin Daily subcutaneous (SQ) injections of enoxaparin for 10 ± 4 days and oral (PO) betrixaban placebo capsules for 35 to 42 days |
Drug: Enoxaparin
Enoxaparin 40 mg subcutaneous (SC) QD for 10 ± 4 days.
Betrixaban Placebo: once daily, 35 days
|
Outcome Measures
Primary Outcome Measures
- Modified Intent-to-Treat (mITT) Cohort 1: Percentage of Participants Experiencing the Composite Event of Symptomatic Deep Vein Thrombosis (DVT), Non-fatal Pulmonary Emboli (PE), VTE-related Death, or Asymptomatic Proximal DVT, Through Visit 3 [mITT Cohort 1: Between randomization and Day 47 (max)]
mITT Cohort 1: Percentage of participants experiencing either symptomatic DVT, non-fatal PE, venous thromboembolism (VTE) related death adjudicated by a blinded independent Clinical Events Committee (CEC) between randomization and on or before Visit 3 or Day 42 if patient did not have a Visit 3, or a blinded ultrasound core laboratory measuring of asymptomatic proximal DVT between randomization and Day 47. Visit 3 is between day 35-42 after randomization (day 1).
- mITT Cohort 2: Percentage of Participants Experiencing the Composite Event of Symptomatic DVT, Non-fatal PE, VTE-related Death, or Asymptomatic Proximal DVT, Through Visit 3 [mITT Cohort 2: Between randomization and Day 47 (max)]
mITT Cohort 2: Percentage of participants experiencing either symptomatic DVT, non-fatal PE, VTE related death adjudicated by a blinded independent CEC between randomization and on or before Visit 3 or Day 42 if patient did not have a Visit 3, or a blinded ultrasound core laboratory measuring of asymptomatic proximal DVT between randomization and Day 47. Visit 3 is between day 35-42 after randomization (day 1).
- mITT: Percentage of Participants Experiencing the Composite Event of Symptomatic DVT, Non-fatal PE, VTE-related Death, or Asymptomatic Proximal DVT, Through Visit 3 [mITT: Between randomization and Day 47 (max)]
mITT: Percentage of participants experiencing either symptomatic DVT, non-fatal PE, VTE related death adjudicated by a blinded independent CEC between randomization and on or before Visit 3 or Day 42 if patient did not have a Visit 3, or a blinded ultrasound core laboratory measuring of asymptomatic proximal DVT between randomization and Day 47. Visit 3 is between day 35-42 after randomization (day 1).
- Percentage of Participants Experiencing Major Bleeding Through Seven Days After Discontinuation of All Study Medication [Between randomization and Day 49 (max)]
Percentage of participants experiencing at least one major bleeding adjudicated by a blinded independent CEC between randomization (day 1) and up to seven days after discontinuation of all study medication.
Secondary Outcome Measures
- mITT Cohort 1: Percentage of Participants Experiencing the Composite Event of Symptomatic DVT, Non-fatal PE, or VTE-related Death, Through Visit 3 [mITT Cohort 1: Between randomization and Day 42 (max)]
mITT Cohort 1: Percentage of participants experiencing either symptomatic DVT, non-fatal PE, or VTE related death adjudicated by a blinded independent CEC between randomization and on or before Visit 3 or Day 42 if patient did not have a Visit 3. Visit 3 is between day 35-42 after randomization (day 1).
- mITT Cohort 2: Percentage of Participants Experiencing the Composite Event of Symptomatic DVT, Non-fatal PE, or VTE-related Death, Through Visit 3 [mITT Cohort 2: Between randomization and Day 42 (max)]
mITT Cohort 2: Percentage of participants experiencing either symptomatic DVT, non-fatal PE, or VTE related death adjudicated by a blinded independent CEC between randomization and on or before Visit 3 or Day 42 if patient did not have a Visit 3. Visit 3 is between day 35-42 after randomization (day 1).
- mITT: Percentage of Participants Experiencing the Composite Event of Symptomatic DVT, Non-fatal PE, or VTE-related Death, Through Visit 3 [mITT: Between randomization and Day 42 (max)]
mITT: Percentage of participants experiencing either symptomatic DVT, non-fatal PE, or VTE related death adjudicated by a blinded independent CEC between randomization and on or before Visit 3 or Day 42 if patient did not have a Visit 3. Visit 3 is between day 35-42 after randomization (day 1).
Eligibility Criteria
Criteria
Ages Eligible for Study:
40 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
men and non-pregnant, non-breastfeeding women
-
anticipated to be severely immobilized for at least 24 hours after randomization
-
hospitalized with one of the following
-
congestive heart failure
-
acute respiratory failure,
-
acute infection without septic shock,
-
acute rheumatic disorders
-
acute ischemic stroke with lower extremity hemiparesis or hemi paralysis
Exclusion Criteria:
-
a condition requiring prolonged anticoagulation or anti-platelets
-
active bleeding or at high risk of bleeding
-
contraindication to anticoagulant therapy
-
general conditions in which subjects are not suitable to participate in the study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Birmingham | Alabama | United States | 35294 | |
| 2 | Bakersfield | California | United States | 93308 | |
| 3 | Fresno | California | United States | 93701 | |
| 4 | La Mesa | California | United States | 91942 | |
| 5 | Long Beach | California | United States | 90822 | |
| 6 | Los Angeles | California | United States | 90073 | |
| 7 | Modesto | California | United States | 95350 | |
| 8 | San Diego | California | United States | 92120 | |
| 9 | Stanford | California | United States | 94305 | |
| 10 | Torrance | California | United States | 90509 | |
| 11 | Englewood | Colorado | United States | 80113 | |
| 12 | Bay Pines | Florida | United States | 33744 | |
| 13 | Clearwater | Florida | United States | 33756 | |
| 14 | Jacksonville | Florida | United States | 32216 | |
| 15 | Miami | Florida | United States | 33143 | |
| 16 | Pensacola | Florida | United States | 32504 | |
| 17 | Sarasota | Florida | United States | 34232 | |
| 18 | Vero Beach | Florida | United States | 32960 | |
| 19 | Columbus | Georgia | United States | 31904 | |
| 20 | Decatur | Georgia | United States | 30030 | |
| 21 | Chicago | Illinois | United States | 60611 | |
| 22 | Oak Park | Illinois | United States | 60302 | |
| 23 | Carmel | Indiana | United States | 46032 | |
| 24 | Davenport | Iowa | United States | 52803 | |
| 25 | Windsor Heights | Iowa | United States | 50324 | |
| 26 | Topeka | Kansas | United States | 66604 | |
| 27 | Hazard | Kentucky | United States | 41701 | |
| 28 | Annapolis | Maryland | United States | 21401 | |
| 29 | Baltimore | Maryland | United States | 21287 | |
| 30 | Detroit | Michigan | United States | 48202 | |
| 31 | Grand Blanc | Michigan | United States | 48439 | |
| 32 | Royal Oak | Michigan | United States | 48073 | |
| 33 | Troy | Michigan | United States | 48085 | |
| 34 | Duluth | Minnesota | United States | 55805 | |
| 35 | Picayune | Mississippi | United States | 39466 | |
| 36 | Kansas City | Missouri | United States | 64111 | |
| 37 | Saint Louis | Missouri | United States | 63110 | |
| 38 | Butte | Montana | United States | 59701 | |
| 39 | Omaha | Nebraska | United States | 68131 | |
| 40 | Las Vegas | Nevada | United States | 89109 | |
| 41 | Reno | Nevada | United States | 89502 | |
| 42 | Atlantic City | New Jersey | United States | 08401 | |
| 43 | Pomona | New Jersey | United States | 08240 | |
| 44 | Somerville | New Jersey | United States | 08876 | |
| 45 | Summit | New Jersey | United States | 07901 | |
| 46 | Buffalo | New York | United States | 14209 | |
| 47 | Manhasset | New York | United States | 11030 | |
| 48 | Staten Island | New York | United States | 10305 | |
| 49 | Valhalla | New York | United States | 10595 | |
| 50 | Durham | North Carolina | United States | 27710 | |
| 51 | Cincinnati | Ohio | United States | 45267 | |
| 52 | Cleveland | Ohio | United States | 44106-5072 | |
| 53 | Columbus | Ohio | United States | 43210 | |
| 54 | Camp Hill | Pennsylvania | United States | 17011 | |
| 55 | Philadelphia | Pennsylvania | United States | 19107 | |
| 56 | Charleston | South Carolina | United States | 29425 | |
| 57 | Orangeburg | South Carolina | United States | 29118 | |
| 58 | Austin | Texas | United States | 78705 | |
| 59 | Austin | Texas | United States | 78752 | |
| 60 | Bellaire | Texas | United States | 77401 | |
| 61 | Corsicana | Texas | United States | 75110 | |
| 62 | Dallas | Texas | United States | 75216 | |
| 63 | Fort Worth | Texas | United States | 76104 | |
| 64 | Houston | Texas | United States | 77024 | |
| 65 | Houston | Texas | United States | 77030 | |
| 66 | McAllen | Texas | United States | 78501 | |
| 67 | Mission | Texas | United States | 78572 | |
| 68 | San Antonio | Texas | United States | 78205 | |
| 69 | San Antonio | Texas | United States | 78258 | |
| 70 | Victoria | Texas | United States | 77901 | |
| 71 | Colchester | Vermont | United States | 05401 | |
| 72 | Charlottesville | Virginia | United States | 22908 | |
| 73 | Richmond | Virginia | United States | 23249 | |
| 74 | Everett | Washington | United States | 98201 | |
| 75 | Huntington | West Virginia | United States | 25701 | |
| 76 | Buenos Aires | Argentina | 1280 | ||
| 77 | Ciudad Autónoma de Buenos Aires | Argentina | C1181ACH | ||
| 78 | Cordoba | Argentina | 5000 | ||
| 79 | Coronel Suarez, Buenos Aires | Argentina | B7540DOL | ||
| 80 | Corrientes | Argentina | W3400AMZ | ||
| 81 | Córdoba | Argentina | 5000 | ||
| 82 | El Talar | Argentina | 1618 | ||
| 83 | Rosario, Santa Fe | Argentina | S2000DSV | ||
| 84 | San Miguel de Tucumán | Argentina | T4000JCU | ||
| 85 | Redcliffe | Queensland | Australia | 4020 | |
| 86 | Bedford Park | South Australia | Australia | 5042 | |
| 87 | Nedlands | Western Australia | Australia | 6009 | |
| 88 | Milton | Australia | Qld 4064 | ||
| 89 | Parkville | Australia | Vic 3050 | ||
| 90 | Randwick | Australia | |||
| 91 | Richmond | Australia | Vic 3121 | ||
| 92 | Feldkirch | Austria | 6800 | ||
| 93 | Gratwein | Austria | 8112 | ||
| 94 | Graz | Austria | 8036 | ||
| 95 | Hartberg | Austria | 8230 | ||
| 96 | Linz | Austria | 4020 | ||
| 97 | Wien | Austria | 1100 | ||
| 98 | Wien | Austria | 1160 | ||
| 99 | Zams | Austria | 6511 | ||
| 100 | Bruxelles | Belgium | 1070 | ||
| 101 | Huy | Belgium | 4500 | ||
| 102 | Leper | Belgium | 8900 | ||
| 103 | Leuven | Belgium | 3000 | ||
| 104 | Yvoir | Belgium | 5530 | ||
| 105 | Belo Horizonte - MG | Brazil | 30150-221 | ||
| 106 | Botucatu | Brazil | 18618-970 | ||
| 107 | Brasilia/DF | Brazil | 70710-905 | ||
| 108 | Brasilia | Brazil | 70710 | ||
| 109 | Campinas, Sao Paulo | Brazil | 13059-740 | ||
| 110 | Campinas | Brazil | 13083-970 | ||
| 111 | Curitiba - PR | Brazil | 80030-001 | ||
| 112 | Porto Alegre/RS | Brazil | 90620-001 | ||
| 113 | Porto Alegre | Brazil | 90620-001 | ||
| 114 | Porto Alegre | Brazil | 90880-480 | ||
| 115 | Salvador/BA | Brazil | 40140-110 | ||
| 116 | Salvador/BA | Brazil | 41810-011 | ||
| 117 | Salvador | Brazil | 41810-011 | ||
| 118 | Sao Paulo | Brazil | 04012-909 | ||
| 119 | São José Do Rio Preto- SP | Brazil | 15090-000 | ||
| 120 | São Paulo | Brazil | 01308-050 | ||
| 121 | SãO Paulo | Brazil | 01323-903 | ||
| 122 | Gabrovo | Bulgaria | 5300 | ||
| 123 | Pleven | Bulgaria | 5800 | ||
| 124 | Plovdiv | Bulgaria | 4002 | ||
| 125 | Sandanski | Bulgaria | 2800 | ||
| 126 | Sliven | Bulgaria | 8800 | ||
| 127 | Sofia | Bulgaria | 1202 | ||
| 128 | Sofia | Bulgaria | 1233 | ||
| 129 | Sofia | Bulgaria | 1407 | ||
| 130 | Sofia | Bulgaria | 1606 | ||
| 131 | Sofia | Bulgaria | 1784 | ||
| 132 | Sofia | Bulgaria | |||
| 133 | Yambol | Bulgaria | 8600 | ||
| 134 | Edmonton | Alberta | Canada | T6K4B3 | |
| 135 | Halifax | Nova Scotia | Canada | B3H 3A7 | |
| 136 | Hamilton | Ontario | Canada | L8L 2X2 | |
| 137 | Hamilton | Ontario | Canada | L8N 4A6 | |
| 138 | Kitchener | Ontario | Canada | N2M1B2 | |
| 139 | Ottawa | Ontario | Canada | K1H 8L6 | |
| 140 | Thunder Bay | Ontario | Canada | P7B 6R4 | |
| 141 | Montreal | Quebec | Canada | H1T2M4 | |
| 142 | Ontario | Canada | N8X 5A6 | ||
| 143 | Quebec | Canada | G1V 4G5 | ||
| 144 | La Serena | Chile | 170000 | ||
| 145 | Osorno | Chile | |||
| 146 | Santiago | Chile | 7650568 | ||
| 147 | Santiago | Chile | |||
| 148 | Temuco | Chile | 4781173 | ||
| 149 | Viña del Mar | Chile | 2570017 | ||
| 150 | Krapinske Toplice | Croatia | 49217 | ||
| 151 | Pula | Croatia | 52100 | ||
| 152 | Rijeka | Croatia | 51000 | ||
| 153 | Varazdin | Croatia | 42000 | ||
| 154 | Zadar | Croatia | 23000 | ||
| 155 | Zagreb | Croatia | 10000 | ||
| 156 | Zagreb | Croatia | 1000 | ||
| 157 | Caslav | Czechia | 286 01 | ||
| 158 | Chrudim | Czechia | 537 27 | ||
| 159 | Hradec Kralove | Czechia | 500 05 | ||
| 160 | Kladno | Czechia | 272 01 | ||
| 161 | Kromeriz | Czechia | 76701 | ||
| 162 | Kyjov | Czechia | 697 33 | ||
| 163 | Liberec | Czechia | 460 63 | ||
| 164 | Litomysl | Czechia | 570 14 | ||
| 165 | Olomouc | Czechia | 771 11 | ||
| 166 | Ostrava | Czechia | 703 84 | ||
| 167 | Plzen - Bory | Czechia | 305 99 | ||
| 168 | Praha 10 | Czechia | 100 34 | ||
| 169 | Praha 1 | Czechia | 110 00 | ||
| 170 | Praha 1 | Czechia | 118 00 | ||
| 171 | Praha 5 | Czechia | 150 06 | ||
| 172 | Praha | Czechia | 128 08 | ||
| 173 | Slany | Czechia | 274 01 | ||
| 174 | Strakonice | Czechia | 386 29 | ||
| 175 | Teplice | Czechia | 415 29 | ||
| 176 | Usti nad Labem | Czechia | 401 13 | ||
| 177 | Zlin | Czechia | 762 75 | ||
| 178 | Znojmo | Czechia | 669 02 | ||
| 179 | Aarhus N | Denmark | DK-8200 | ||
| 180 | Frederiksberg | Denmark | DK-2000 | ||
| 181 | Glostrup | Denmark | DK-2600 | ||
| 182 | Haderslev | Denmark | DK-6100 | ||
| 183 | Hellerup | Denmark | DK-2900 | ||
| 184 | Hillerod | Denmark | DK-3400 | ||
| 185 | Hvidovre | Denmark | DK-2650 | ||
| 186 | Kobenhavn NV | Denmark | DK-2400 | ||
| 187 | Silkeborg | Denmark | DK-8600 | ||
| 188 | Slagelse | Denmark | DK-4200 | ||
| 189 | Tallinn | Estonia | EE-10138 | ||
| 190 | Tallinn | Estonia | EE-13419 | ||
| 191 | Tartu | Estonia | EE-51014 | ||
| 192 | Helsinki | Finland | FI-00290 | ||
| 193 | Jyväskylä | Finland | FI-40620 | ||
| 194 | Kouvola | Finland | FI-45750 | ||
| 195 | Mikkeli | Finland | FI-50100 | ||
| 196 | Pori | Finland | FI-28500 | ||
| 197 | Tampere | Finland | |||
| 198 | Turku | Finland | FI-20520 | ||
| 199 | Angers | France | 49100 | ||
| 200 | Arras | France | 62022 | ||
| 201 | Avignon | France | 84918 | ||
| 202 | Bois-Guillaume | France | 76230 | ||
| 203 | Bordeaux | France | 33075 | ||
| 204 | Brest | France | 29200 | ||
| 205 | Brest | France | 29609 | ||
| 206 | Cambrai | France | 59400 | ||
| 207 | Castelnau-le-Lez | France | 34170 | ||
| 208 | Clermont-Ferrand | France | 63003 | ||
| 209 | Colombes | France | 92700 | ||
| 210 | Dijon | France | 21079 | ||
| 211 | La Tronche | France | 38043 | ||
| 212 | Le Mans | France | 72037 | ||
| 213 | Lille | France | 59020 | ||
| 214 | Limoges | France | 87 042 | ||
| 215 | Montpellier | France | 34295 | ||
| 216 | Nantes | France | 44093 | ||
| 217 | Nimes | France | 30029 cedex 9 | ||
| 218 | Paris | France | 75004 | ||
| 219 | Paris | France | 75010 | ||
| 220 | Paris | France | 75908 | ||
| 221 | Pierre Benite | France | 69495 | ||
| 222 | Quimper | France | 29107 | ||
| 223 | Rennes | France | 35203 | ||
| 224 | Saint-Priest En Jarrez | France | 42055 | ||
| 225 | Tourcoing | France | 59200 | ||
| 226 | Valenciennes | France | 59300 | ||
| 227 | Vernon | France | 27207 | ||
| 228 | Tbilisi | Georgia | 0144 | ||
| 229 | Tbilisi | Georgia | 0159 | ||
| 230 | Tbilisi | Georgia | 0183 | ||
| 231 | Altenburg | Germany | 04600 | ||
| 232 | Bad Friedrichshall | Germany | 74173 | ||
| 233 | Berlin | Germany | 10787 | ||
| 234 | Bonn | Germany | 53115 | ||
| 235 | Dresden | Germany | 01067 | ||
| 236 | Dresden | Germany | 01307 | ||
| 237 | Essen | Germany | 45147 | ||
| 238 | Hamburg | Germany | 22559 | ||
| 239 | Heidelberg | Germany | 69120 | ||
| 240 | Karlbad | Germany | 76307 | ||
| 241 | Ludwigshafen | Germany | 67063 | ||
| 242 | Magdeburg | Germany | 39120 | ||
| 243 | Mainz | Germany | 55131 | ||
| 244 | Minden | Germany | 32429 | ||
| 245 | Möchengladbach | Germany | 41063 | ||
| 246 | Neuss | Germany | 41464 | ||
| 247 | Oberhausen | Germany | 46045 | ||
| 248 | Paderborn | Germany | 33098 | ||
| 249 | Rüsselsheim | Germany | 65428 | ||
| 250 | Troisdorf | Germany | |||
| 251 | Weiden | Germany | 92637 | ||
| 252 | Wesel | Germany | 46483 | ||
| 253 | Wiesbaden | Germany | 65199 | ||
| 254 | Witten | Germany | 58455 | ||
| 255 | Baja | Hungary | 6500 | ||
| 256 | Balassagyarmat | Hungary | 2660 | ||
| 257 | Balatonfüred | Hungary | 8231 | ||
| 258 | Berettyóújfalu | Hungary | 4100 | ||
| 259 | Budapest, | Hungary | 1134 | ||
| 260 | Budapest | Hungary | 1097 | ||
| 261 | Budapest | Hungary | 1122 | ||
| 262 | Budapest | Hungary | 1125 | ||
| 263 | Budapest | Hungary | 1145 | ||
| 264 | Cegléd | Hungary | 2700 | ||
| 265 | Debrecen | Hungary | 4032 | ||
| 266 | Debrecen | Hungary | H-4012 | ||
| 267 | Eger | Hungary | 3300 | ||
| 268 | Gyula | Hungary | 5700 | ||
| 269 | Hódmezövásárhely | Hungary | 6800 | ||
| 270 | Kistarcsa | Hungary | 2143 | ||
| 271 | Mohács | Hungary | 7700 | ||
| 272 | Nagykanizsa | Hungary | 8800 | ||
| 273 | Szekszárd | Hungary | 7100 | ||
| 274 | Szolnok | Hungary | 5000 | ||
| 275 | Veszprém | Hungary | 8200 | ||
| 276 | Zalaegerszeg | Hungary | 8900 | ||
| 277 | Afula | Israel | 18101 | ||
| 278 | Ashkelon | Israel | 78278 | ||
| 279 | Haifa | Israel | 31048 | ||
| 280 | Haifa | Israel | 31096 | ||
| 281 | Jerusalem | Israel | 91120 | ||
| 282 | Kfar Saba | Israel | 44281 | ||
| 283 | Petach Tikva | Israel | 49100 | ||
| 284 | Safed | Israel | 13100 | ||
| 285 | Tel Aviv | Israel | 64239 | ||
| 286 | Zerifin | Israel | 70300 | ||
| 287 | Castelfranco Veneto | Treviso | Italy | 31033 | |
| 288 | Bollate | Italy | 20021 | ||
| 289 | Frenze | Italy | 50134 | ||
| 290 | Genova | Italy | 16128 | ||
| 291 | Milano | Italy | 20085 | ||
| 292 | Milano | Italy | 20132 | ||
| 293 | Napoli | Italy | 80131 | ||
| 294 | Parma | Italy | 43100 | ||
| 295 | Pavia | Italy | 27100 | ||
| 296 | Piacenza | Italy | 29121 | ||
| 297 | Reggio Emilia | Italy | 42100 | ||
| 298 | Roma | Italy | 00168 | ||
| 299 | Varese | Italy | 21100 | ||
| 300 | Venezia | Italy | 30122 | ||
| 301 | Vittorio Veneto TV | Italy | 31029 | ||
| 302 | Daugavpils | Latvia | LV-5417 | ||
| 303 | Liepaja | Latvia | LV-3414 | ||
| 304 | Riga | Latvia | LV-1002 | ||
| 305 | Riga | Latvia | LV-1038 | ||
| 306 | Valmiera | Latvia | LV-4201 | ||
| 307 | Alytus | Lithuania | LT-62114 | ||
| 308 | Kaunas | Lithuania | LT-44320 | ||
| 309 | Kaunas | Lithuania | LT-45130 | ||
| 310 | Kaunas | Lithuania | LT-47144 | ||
| 311 | Klaipeda | Lithuania | LT-92231 | ||
| 312 | Klaipeda | Lithuania | LT-92288 | ||
| 313 | Siauliai | Lithuania | LT-76231 | ||
| 314 | Utena | Lithuania | 28151 | ||
| 315 | Vilnius | Lithuania | LT-04130 | ||
| 316 | Vilnius | Lithuania | LT-08411 | ||
| 317 | Vilnius | Lithuania | LT-10207 | ||
| 318 | Picayune | MS | Montserrat | 39466 | |
| 319 | Arequipa | Peru | 05154 | ||
| 320 | Callao | Peru | CALLAO 2 | ||
| 321 | Lima | Peru | 01 | ||
| 322 | Lima | Peru | 18 | ||
| 323 | Lima | Peru | Lima 11 | ||
| 324 | Lima | Peru | LIMA 13 | ||
| 325 | Bialystok | Poland | 15-276 | ||
| 326 | Bydgoszcz | Poland | 85-168 | ||
| 327 | Bydgoszcz | Poland | 85-681 | ||
| 328 | Czeladz | Poland | 41-250 | ||
| 329 | Gdansk | Poland | 80-803 | ||
| 330 | Krakow | Poland | 31-121 | ||
| 331 | Krakow | Poland | 31-913 | ||
| 332 | Skierniewice | Poland | 96-100 | ||
| 333 | Tarnobrzeg | Poland | 39-400 | ||
| 334 | Warszawa | Poland | 01-138 | ||
| 335 | Warszawa | Poland | 02-097 | ||
| 336 | Wloclawek | Poland | 87-800 | ||
| 337 | Baia | Romania | 430031 | ||
| 338 | Bucharest | Romania | 020475 | ||
| 339 | Bucharest | Romania | 021659 | ||
| 340 | Bucharest | Romania | 022328 | ||
| 341 | Bucharest | Romania | 041915 | ||
| 342 | Cluj Napoca | Romania | 400006 | ||
| 343 | Cluj-Napoca | Romania | 40001 | ||
| 344 | Craiova | Romania | 200642 | ||
| 345 | Iasi | Romania | 700620 | ||
| 346 | Oradea | Romania | 410169 | ||
| 347 | Pitesti | Romania | 110884 | ||
| 348 | Targu Mures | Romania | 540136 | ||
| 349 | Timisoara | Romania | 300736 | ||
| 350 | Arkhangelsk | Russian Federation | 163045 | ||
| 351 | Barnaul | Russian Federation | 656024 | ||
| 352 | Barnaul | Russian Federation | 656045 | ||
| 353 | Belgorod | Russian Federation | 308007 | ||
| 354 | Chelyabinsk | Russian Federation | 454048 | ||
| 355 | Chelyabinsk | Russian Federation | 454091 | ||
| 356 | Ekaterinburg | Russian Federation | 620039 | ||
| 357 | Ekaterinburg | Russian Federation | 620219 | ||
| 358 | Irkutsk | Russian Federation | 664049 | ||
| 359 | Kaluga | Russian Federation | 428007 | ||
| 360 | Kazan | Russian Federation | 420012 | ||
| 361 | Kazan | Russian Federation | 420043 | ||
| 362 | Kemerovo | Russian Federation | 650002 | ||
| 363 | Kirov | Russian Federation | 610014 | ||
| 364 | Krasnodar | Russian Federation | 350086 | ||
| 365 | Lubertsy | Russian Federation | 140006 | ||
| 366 | Moscow | Russian Federation | 111539 | ||
| 367 | Moscow | Russian Federation | 117292 | ||
| 368 | Moscow | Russian Federation | 119881 | ||
| 369 | Moscow | Russian Federation | 119992 | ||
| 370 | Moscow | Russian Federation | 121552 | ||
| 371 | Moscow | Russian Federation | 127473 | ||
| 372 | Murmansk | Russian Federation | 183047 | ||
| 373 | Novosibirsk | Russian Federation | 630007 | ||
| 374 | Novosibirsk | Russian Federation | 630051 | ||
| 375 | Novosibirsk | Russian Federation | 630054 | ||
| 376 | Rostov-on-Don | Russian Federation | 344022 | ||
| 377 | Samara | Russian Federation | 443070 | ||
| 378 | Saratov | Russian Federation | 410028 | ||
| 379 | Saratov | Russian Federation | 410053 | ||
| 380 | Saratov | Russian Federation | 410054 | ||
| 381 | Smolensk | Russian Federation | 214018 | ||
| 382 | St. Petersburg | Russian Federation | 192242 | ||
| 383 | St. Petersburg | Russian Federation | 195067 | ||
| 384 | St. Petersburg | Russian Federation | 196247 | ||
| 385 | St. Petersburg | Russian Federation | 197022 | ||
| 386 | St. Petersburg | Russian Federation | 198205 | ||
| 387 | St. Petersburg | Russian Federation | 199106 | ||
| 388 | St.Petersburg | Russian Federation | 191025 | ||
| 389 | Tomsk | Russian Federation | 643012 | ||
| 390 | Yaroslavl | Russian Federation | 150003 | ||
| 391 | Yaroslavl | Russian Federation | 150030 | ||
| 392 | Belgrade | Serbia | 11000 | ||
| 393 | Kragujevac | Serbia | 34000 | ||
| 394 | Niska Banja | Serbia | 18205 | ||
| 395 | Nis | Serbia | 18000 | ||
| 396 | Pancevo | Serbia | 26000 | ||
| 397 | Sremska Kamenica | Serbia | 21204 | ||
| 398 | Singapore | Singapore | 119074 | ||
| 399 | Singapore | Singapore | 169608 | ||
| 400 | Singapore | Singapore | 169609 | ||
| 401 | Bratislava | Slovakia | 83305 | ||
| 402 | Nitra | Slovakia | 949 01 | ||
| 403 | Nitra | Slovakia | 94901 | ||
| 404 | Johannesburg | Gauteng | South Africa | 2021 | |
| 405 | Johannesburg | Gauteng | South Africa | 2193 | |
| 406 | Cape Town | Western Cape | South Africa | 7530 | |
| 407 | Pretoria | South Africa | Gauteng 0084 | ||
| 408 | Worcester | South Africa | 6850 | ||
| 409 | Barcelona | Cataluña | Spain | 08003 | |
| 410 | Barcelona | Cataluña | Spain | 08036 | |
| 411 | L'Hospitalet de Llobregat | Cataluña | Spain | 08907 | |
| 412 | Sabadell | Cataluña | Spain | 08208 | |
| 413 | Sant Boi de Llobregat | Cataluña | Spain | '08830 | |
| 414 | Tarragona | Cataluña | Spain | 43007 | |
| 415 | Madrid | Communidad De | Spain | 28007 | |
| 416 | Orihuela | Comunidad Valenciana | Spain | 03314 | |
| 417 | Vigo | Galicia | Spain | 36204 | |
| 418 | Madrid | Madrid, Communidad De | Spain | 28034 | |
| 419 | Majadahonda | Madrid, Communidad De | Spain | 28222 | |
| 420 | San Sebastián de los Reyes | Madrid, Communidad De | Spain | 28702 | |
| 421 | Barcelona | Spain | 08023 | ||
| 422 | Barcelona | Spain | 08041 | ||
| 423 | Cartagena | Spain | 30202 | ||
| 424 | Girona | Spain | 17007 | ||
| 425 | Olot | Spain | 17800 | ||
| 426 | Pontevedra | Spain | 36001 | ||
| 427 | Salamanca | Spain | 37007 | ||
| 428 | Terrassa | Spain | 08221 | ||
| 429 | Donetsk | Ukraine | 83045 | ||
| 430 | Donetsk | Ukraine | 83114 | ||
| 431 | Ivano-Frankivsk | Ukraine | 76008 | ||
| 432 | Ivano-Frankivsk | Ukraine | |||
| 433 | Kharkiv, | Ukraine | 61058 | ||
| 434 | Kharkiv | Ukraine | 61018 | ||
| 435 | Kharkiv | Ukraine | 61039 | ||
| 436 | Kharkiv | Ukraine | 61176 | ||
| 437 | Kherson | Ukraine | 73039 | ||
| 438 | Kirovograd | Ukraine | 25006 | ||
| 439 | Kyiv | Ukraine | 01023 | ||
| 440 | Kyiv | Ukraine | 02091 | ||
| 441 | Kyiv | Ukraine | 02660 | ||
| 442 | Kyiv | Ukraine | 03680 | ||
| 443 | Kyiv | Ukraine | 04060 | ||
| 444 | Lugansk | Ukraine | 91011 | ||
| 445 | Lutsk | Ukraine | 43024 | ||
| 446 | Lviv | Ukraine | 79010 | ||
| 447 | Odesa | Ukraine | 65009 | ||
| 448 | Odesa | Ukraine | 65014 | ||
| 449 | Odesa | Ukraine | 65025 | ||
| 450 | Rivne | Ukraine | 33001 | ||
| 451 | Simferopol | Ukraine | 95026 | ||
| 452 | Uzhgorod | Ukraine | 88000 | ||
| 453 | Vinnytsya | Ukraine | 21005 | ||
| 454 | Yevpatoriya | Ukraine | 97400 | ||
| 455 | Zaporizhzhya | Ukraine | 69000 | ||
| 456 | Zaporizhzhya | Ukraine | 69065 | ||
| 457 | London | United Kingdom | EC1M 6BQ | ||
| 458 | London | United Kingdom | SE5 9RS | ||
| 459 | London | United Kingdom | WC1E 6HX | ||
| 460 | Manchester | United Kingdom | M23 9LT | ||
| 461 | Newcastle Upon Tyne | United Kingdom | NE7 7DN | ||
| 462 | Romford | United Kingdom | RM7 0AG | ||
| 463 | Southall | United Kingdom | UB1 3HW |
Sponsors and Collaborators
- Portola Pharmaceuticals
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Portola Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01583218
Other Study ID Numbers:
- 11-019
First Posted:
Apr 23, 2012
Last Update Posted:
Sep 26, 2018
Last Verified:
Jun 1, 2016
Keywords provided by Portola Pharmaceuticals
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | First patient was enrolled on 3/29/2012 and last patient completed the study on 1/15/2016. Patients meeting the inclusion and none of the exclusion criteria at screening were randomized 1:1 to either the betrixaban or enoxaparin treatment group. |
|---|---|
| Pre-assignment Detail | To maintain the blind, patients either received betrixaban capsules for 35 to 42 days and daily subcutaneous (SQ) injections of enoxaparin placebo for 10 ± 4 days, or received daily SQ injections of enoxaparin for 10 ± 4 days and betrixaban placebo capsules for 35 to 42 days. |
| Arm/Group Title | Betrixaban | Enoxaparin |
|---|---|---|
| Arm/Group Description | Daily oral (PO) betrixaban capsules for 35 to 42 days and subcutaneous (SQ) injections of enoxaparin placebo for 10 ± 4 days | Daily subcutaneous (SQ) injections of enoxaparin for 10 ± 4 days and oral (PO) betrixaban placebo capsules for 35 to 42 days |
| Period Title: Overall Study | ||
| STARTED | 3759 | 3754 |
| COMPLETED | 3470 | 3471 |
| NOT COMPLETED | 289 | 283 |
Baseline Characteristics
| Arm/Group Title | Betrixaban | Enoxaparin | Total |
|---|---|---|---|
| Arm/Group Description | Daily oral (PO) betrixaban capsules for 35 to 42 days and subcutaneous (SQ) injections of enoxaparin placebo for 10 ± 4 days | Daily subcutaneous (SQ) injections of enoxaparin for 10 ± 4 days and oral (PO) betrixaban placebo capsules for 35 to 42 days | Total of all reporting groups |
| Overall Participants | 3759 | 3754 | 7513 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
76.6
(8.46)
|
76.2
(8.31)
|
76.4
(8.39)
|
| Age, Customized (Count of Participants) | |||
| <75 years |
1184
31.5%
|
1237
33%
|
2421
32.2%
|
| >=75 years |
2575
68.5%
|
2517
67%
|
5092
67.8%
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
2054
54.6%
|
2034
54.2%
|
4088
54.4%
|
| Male |
1705
45.4%
|
1720
45.8%
|
3425
45.6%
|
Outcome Measures
| Title | Modified Intent-to-Treat (mITT) Cohort 1: Percentage of Participants Experiencing the Composite Event of Symptomatic Deep Vein Thrombosis (DVT), Non-fatal Pulmonary Emboli (PE), VTE-related Death, or Asymptomatic Proximal DVT, Through Visit 3 |
|---|---|
| Description | mITT Cohort 1: Percentage of participants experiencing either symptomatic DVT, non-fatal PE, venous thromboembolism (VTE) related death adjudicated by a blinded independent Clinical Events Committee (CEC) between randomization and on or before Visit 3 or Day 42 if patient did not have a Visit 3, or a blinded ultrasound core laboratory measuring of asymptomatic proximal DVT between randomization and Day 47. Visit 3 is between day 35-42 after randomization (day 1). |
| Time Frame | mITT Cohort 1: Between randomization and Day 47 (max) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Cohort 1 (participants with baseline D-dimer ≥ 2 x upper limit normal (ULN) as determined by the local lab) of the mITT population which consisted of all participants who had taken at least one dose of study drug and who had follow-up assessment data on one or more primary or secondary efficacy components. |
| Arm/Group Title | Betrixaban | Enoxaparin |
|---|---|---|
| Arm/Group Description | Daily oral (PO) betrixaban capsules for 35 to 42 days and subcutaneous (SQ) injections of enoxaparin placebo for 10 ± 4 days | Daily subcutaneous (SQ) injections of enoxaparin for 10 ± 4 days and oral (PO) betrixaban placebo capsules for 35 to 42 days |
| Measure Participants | 2314 | 2313 |
| Number (95% Confidence Interval) [Percentage of Participants] |
5.70
0.2%
|
7.18
0.2%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Betrixaban, Enoxaparin |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.038 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Relative Risk Reduction (RRR) |
| Estimated Value | 0.209 | |
| Confidence Interval |
(2-Sided) 95% 0.013 to 0.366 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | mITT Cohort 2: Percentage of Participants Experiencing the Composite Event of Symptomatic DVT, Non-fatal PE, VTE-related Death, or Asymptomatic Proximal DVT, Through Visit 3 |
|---|---|
| Description | mITT Cohort 2: Percentage of participants experiencing either symptomatic DVT, non-fatal PE, VTE related death adjudicated by a blinded independent CEC between randomization and on or before Visit 3 or Day 42 if patient did not have a Visit 3, or a blinded ultrasound core laboratory measuring of asymptomatic proximal DVT between randomization and Day 47. Visit 3 is between day 35-42 after randomization (day 1). |
| Time Frame | mITT Cohort 2: Between randomization and Day 47 (max) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Cohort 2 (encompasses "both" participants over 75 and participants with baseline D-dimer ≥ 2 x ULN as determined by the local lab) of the mITT population which consisted of all participants who had taken at least one dose of study drug and who had follow-up assessment data on one or more primary or secondary efficacy components. |
| Arm/Group Title | Betrixaban | Enoxaparin |
|---|---|---|
| Arm/Group Description | Daily oral (PO) betrixaban capsules for 35 to 42 days and subcutaneous (SQ) injections of enoxaparin placebo for 10 ± 4 days | Daily subcutaneous (SQ) injections of enoxaparin for 10 ± 4 days and oral (PO) betrixaban placebo capsules for 35 to 42 days |
| Measure Participants | 3407 | 3391 |
| Number (95% Confidence Interval) [Percentage of Participants] |
4.70
0.1%
|
6.02
0.2%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Betrixaban, Enoxaparin |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.018 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Relative Risk Reduction (RRR) |
| Estimated Value | 0.216 | |
| Confidence Interval |
(2-Sided) 95% 0.041 to 0.359 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | mITT: Percentage of Participants Experiencing the Composite Event of Symptomatic DVT, Non-fatal PE, VTE-related Death, or Asymptomatic Proximal DVT, Through Visit 3 |
|---|---|
| Description | mITT: Percentage of participants experiencing either symptomatic DVT, non-fatal PE, VTE related death adjudicated by a blinded independent CEC between randomization and on or before Visit 3 or Day 42 if patient did not have a Visit 3, or a blinded ultrasound core laboratory measuring of asymptomatic proximal DVT between randomization and Day 47. Visit 3 is between day 35-42 after randomization (day 1). |
| Time Frame | mITT: Between randomization and Day 47 (max) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The mITT population which consisted of all participants who had taken at least one dose of study drug and who had follow-up assessment data on one or more primary or secondary efficacy components. |
| Arm/Group Title | Betrixaban | Enoxaparin |
|---|---|---|
| Arm/Group Description | Daily oral (PO) betrixaban capsules for 35 to 42 days and subcutaneous (SQ) injections of enoxaparin placebo for 10 ± 4 days | Daily subcutaneous (SQ) injections of enoxaparin for 10 ± 4 days and oral (PO) betrixaban placebo capsules for 35 to 42 days |
| Measure Participants | 3721 | 3720 |
| Number (95% Confidence Interval) [Percentage of Participants] |
4.43
0.1%
|
5.99
0.2%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Betrixaban, Enoxaparin |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.003 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Relative Risk Reduction (RRR) |
| Estimated Value | 0.254 | |
| Confidence Interval |
(2-Sided) 95% 0.092 to 0.387 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Percentage of Participants Experiencing Major Bleeding Through Seven Days After Discontinuation of All Study Medication |
|---|---|
| Description | Percentage of participants experiencing at least one major bleeding adjudicated by a blinded independent CEC between randomization (day 1) and up to seven days after discontinuation of all study medication. |
| Time Frame | Between randomization and Day 49 (max) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety population which consisted of all participants who had taken at least one dose of study drug. |
| Arm/Group Title | Betrixaban | Enoxaparin |
|---|---|---|
| Arm/Group Description | Daily oral (PO) betrixaban capsules for 35 to 42 days and subcutaneous (SQ) injections of enoxaparin placebo for 10 ± 4 days | Daily subcutaneous (SQ) injections of enoxaparin for 10 ± 4 days and oral (PO) betrixaban placebo capsules for 35 to 42 days |
| Measure Participants | 3716 | 3716 |
| Number (95% Confidence Interval) [Percentage of Participants] |
0.67
0%
|
0.57
0%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Betrixaban, Enoxaparin |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.554 |
| Comments | ||
| Method | Chi-squared | |
| Comments | ||
| Title | mITT Cohort 1: Percentage of Participants Experiencing the Composite Event of Symptomatic DVT, Non-fatal PE, or VTE-related Death, Through Visit 3 |
|---|---|
| Description | mITT Cohort 1: Percentage of participants experiencing either symptomatic DVT, non-fatal PE, or VTE related death adjudicated by a blinded independent CEC between randomization and on or before Visit 3 or Day 42 if patient did not have a Visit 3. Visit 3 is between day 35-42 after randomization (day 1). |
| Time Frame | mITT Cohort 1: Between randomization and Day 42 (max) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Cohort 1 (participants with baseline D-dimer ≥ 2 x ULN as determined by the local lab) of the mITT population which consisted of all participants who had taken at least one dose of study drug and who had follow-up assessment data on one or more primary or secondary efficacy components. |
| Arm/Group Title | Betrixaban | Enoxaparin |
|---|---|---|
| Arm/Group Description | Daily oral (PO) betrixaban capsules for 35 to 42 days and subcutaneous (SQ) injections of enoxaparin placebo for 10 ± 4 days | Daily subcutaneous (SQ) injections of enoxaparin for 10 ± 4 days and oral (PO) betrixaban placebo capsules for 35 to 42 days |
| Measure Participants | 2314 | 2313 |
| Number (95% Confidence Interval) [Percentage of Participants] |
1.30
0%
|
1.90
0.1%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Betrixaban, Enoxaparin |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.092 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Relative Risk Reduction (RRR) |
| Estimated Value | 0.326 | |
| Confidence Interval |
(2-Sided) 95% -0.069 to 0.576 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | mITT Cohort 2: Percentage of Participants Experiencing the Composite Event of Symptomatic DVT, Non-fatal PE, or VTE-related Death, Through Visit 3 |
|---|---|
| Description | mITT Cohort 2: Percentage of participants experiencing either symptomatic DVT, non-fatal PE, or VTE related death adjudicated by a blinded independent CEC between randomization and on or before Visit 3 or Day 42 if patient did not have a Visit 3. Visit 3 is between day 35-42 after randomization (day 1). |
| Time Frame | mITT Cohort 2: Between randomization and Day 42 (max) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Cohort 2 (encompasses "both" participants over 75 and participants with baseline D-dimer ≥ 2 x ULN as determined by the local lab) of the mITT population which consisted of all participants who had taken at least one dose of study drug and who had follow-up assessment data on one or more primary or secondary efficacy components. |
| Arm/Group Title | Betrixaban | Enoxaparin |
|---|---|---|
| Arm/Group Description | Daily oral (PO) betrixaban capsules for 35 to 42 days and subcutaneous (SQ) injections of enoxaparin placebo for 10 ± 4 days | Daily subcutaneous (SQ) injections of enoxaparin for 10 ± 4 days and oral (PO) betrixaban placebo capsules for 35 to 42 days |
| Measure Participants | 3407 | 3391 |
| Number (95% Confidence Interval) [Percentage of Participants] |
1.03
0%
|
1.45
0%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Betrixaban, Enoxaparin |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.11 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Relative Risk Reduction (RRR) |
| Estimated Value | 0.295 | |
| Confidence Interval |
(2-Sided) 95% -0.085 to 0.542 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | mITT: Percentage of Participants Experiencing the Composite Event of Symptomatic DVT, Non-fatal PE, or VTE-related Death, Through Visit 3 |
|---|---|
| Description | mITT: Percentage of participants experiencing either symptomatic DVT, non-fatal PE, or VTE related death adjudicated by a blinded independent CEC between randomization and on or before Visit 3 or Day 42 if patient did not have a Visit 3. Visit 3 is between day 35-42 after randomization (day 1). |
| Time Frame | mITT: Between randomization and Day 42 (max) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The mITT population which consisted of all participants who had taken at least one dose of study drug and who had follow-up assessment data on one or more primary or secondary efficacy components. |
| Arm/Group Title | Betrixaban | Enoxaparin |
|---|---|---|
| Arm/Group Description | Daily oral (PO) betrixaban capsules for 35 to 42 days and subcutaneous (SQ) injections of enoxaparin placebo for 10 ± 4 days | Daily subcutaneous (SQ) injections of enoxaparin for 10 ± 4 days and oral (PO) betrixaban placebo capsules for 35 to 42 days |
| Measure Participants | 3721 | 3720 |
| Number (95% Confidence Interval) [Percentage of Participants] |
0.94
0%
|
1.45
0%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Betrixaban, Enoxaparin |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.039 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Relative Risk Reduction (RRR) |
| Estimated Value | 0.358 | |
| Confidence Interval |
(2-Sided) 95% 0.020 to 0.580 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Adverse Events
| Time Frame | From first dose date (including) till the end of study | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | The number of patients at risk by study arm in the Adverse Events Results is based on Safety population, defined as patients who were randomized and received at least one dose of study drug. It leads to 3716 safety subjects in Betrixaban arm and 3716 in Enoxaprin arm which corresponds to the number of patients at risk in Adverse Events Results. | |||
| Arm/Group Title | Betrixaban | Enoxaparin | ||
| Arm/Group Description | Daily oral (PO) betrixaban capsules for 35 to 42 days and subcutaneous (SQ) injections of enoxaparin placebo for 10 ± 4 days | Daily subcutaneous (SQ) injections of enoxaparin for 10 ± 4 days and oral (PO) betrixaban placebo capsules for 35 to 42 days | ||
All Cause Mortality |
||||
| Betrixaban | Enoxaparin | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Betrixaban | Enoxaparin | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 657/3716 (17.7%) | 615/3716 (16.6%) | ||
| Blood and lymphatic system disorders | ||||
| Anaemia | 8/3716 (0.2%) | 4/3716 (0.1%) | ||
| Iron deficiency anaemia | 1/3716 (0%) | 1/3716 (0%) | ||
| Thrombocytopenia | 1/3716 (0%) | 1/3716 (0%) | ||
| Coagulopathy | 1/3716 (0%) | 0/3716 (0%) | ||
| Haemorrhagic anaemia | 1/3716 (0%) | 0/3716 (0%) | ||
| Polycythaemia | 0/3716 (0%) | 1/3716 (0%) | ||
| Spontaneous haematoma | 1/3716 (0%) | 0/3716 (0%) | ||
| Cardiac disorders | ||||
| Cardiac failure | 83/3716 (2.2%) | 66/3716 (1.8%) | ||
| Atrial fibrillation | 11/3716 (0.3%) | 23/3716 (0.6%) | ||
| Cardiac failure congestive | 10/3716 (0.3%) | 15/3716 (0.4%) | ||
| Cardiac failure acute | 10/3716 (0.3%) | 12/3716 (0.3%) | ||
| Cardiac failure chronic | 13/3716 (0.3%) | 9/3716 (0.2%) | ||
| Acute myocardial infarction | 6/3716 (0.2%) | 12/3716 (0.3%) | ||
| Myocardial infarction | 7/3716 (0.2%) | 10/3716 (0.3%) | ||
| Cardiogenic shock | 9/3716 (0.2%) | 6/3716 (0.2%) | ||
| Cardiac arrest | 7/3716 (0.2%) | 5/3716 (0.1%) | ||
| Coronary artery disease | 8/3716 (0.2%) | 3/3716 (0.1%) | ||
| Angina unstable | 3/3716 (0.1%) | 7/3716 (0.2%) | ||
| Acute coronary syndrome | 6/3716 (0.2%) | 3/3716 (0.1%) | ||
| Atrioventricular block complete | 5/3716 (0.1%) | 3/3716 (0.1%) | ||
| Myocardial ischaemia | 2/3716 (0.1%) | 6/3716 (0.2%) | ||
| Angina pectoris | 5/3716 (0.1%) | 0/3716 (0%) | ||
| Cardio-respiratory arrest | 3/3716 (0.1%) | 2/3716 (0.1%) | ||
| Cardiopulmonary failure | 1/3716 (0%) | 4/3716 (0.1%) | ||
| Ventricular tachycardia | 4/3716 (0.1%) | 1/3716 (0%) | ||
| Coronary artery insufficiency | 2/3716 (0.1%) | 2/3716 (0.1%) | ||
| Atrioventricular block | 1/3716 (0%) | 2/3716 (0.1%) | ||
| Cardiovascular disorder | 1/3716 (0%) | 2/3716 (0.1%) | ||
| Cardiovascular insufficiency | 0/3716 (0%) | 3/3716 (0.1%) | ||
| Ventricular fibrillation | 1/3716 (0%) | 2/3716 (0.1%) | ||
| Atrial flutter | 0/3716 (0%) | 2/3716 (0.1%) | ||
| Atrioventricular block second degree | 1/3716 (0%) | 1/3716 (0%) | ||
| Bradycardia | 2/3716 (0.1%) | 0/3716 (0%) | ||
| Cardiomyopathy | 1/3716 (0%) | 1/3716 (0%) | ||
| Cor pulmonale | 1/3716 (0%) | 1/3716 (0%) | ||
| Pericardial effusion | 1/3716 (0%) | 1/3716 (0%) | ||
| Sick sinus syndrome | 1/3716 (0%) | 1/3716 (0%) | ||
| Supraventricular tachycardia | 2/3716 (0.1%) | 0/3716 (0%) | ||
| Acute left ventricular failure | 0/3716 (0%) | 1/3716 (0%) | ||
| Aortic valve incompetence | 0/3716 (0%) | 1/3716 (0%) | ||
| Aortic valve stenosis | 0/3716 (0%) | 1/3716 (0%) | ||
| Cardiac ventricular thrombosis | 1/3716 (0%) | 0/3716 (0%) | ||
| Congestive cardiomyopathy | 0/3716 (0%) | 1/3716 (0%) | ||
| Coronary artery stenosis | 0/3716 (0%) | 1/3716 (0%) | ||
| Ischaemic cardiomyopathy | 1/3716 (0%) | 0/3716 (0%) | ||
| Mitral valve incompetence | 0/3716 (0%) | 1/3716 (0%) | ||
| Pericardial haemorrhage | 1/3716 (0%) | 0/3716 (0%) | ||
| Sinoatrial block | 0/3716 (0%) | 1/3716 (0%) | ||
| Stress cardiomyopathy | 0/3716 (0%) | 1/3716 (0%) | ||
| Tricuspid valve incompetence | 1/3716 (0%) | 0/3716 (0%) | ||
| Trifascicular block | 1/3716 (0%) | 0/3716 (0%) | ||
| Ventricular extrasystoles | 1/3716 (0%) | 0/3716 (0%) | ||
| Ventricular hypokinesia | 0/3716 (0%) | 1/3716 (0%) | ||
| Ear and labyrinth disorders | ||||
| Vertigo | 1/3716 (0%) | 1/3716 (0%) | ||
| Endocrine disorders | ||||
| Goitre | 1/3716 (0%) | 0/3716 (0%) | ||
| Hypoparathyroidism | 0/3716 (0%) | 1/3716 (0%) | ||
| Eye disorders | ||||
| Conjunctival haemorrhage | 1/3716 (0%) | 1/3716 (0%) | ||
| Diabetic retinopathy | 0/3716 (0%) | 1/3716 (0%) | ||
| Retinal haemorrhage | 0/3716 (0%) | 1/3716 (0%) | ||
| Gastrointestinal disorders | ||||
| Gastrointestinal haemorrhage | 18/3716 (0.5%) | 5/3716 (0.1%) | ||
| Rectal haemorrhage | 15/3716 (0.4%) | 3/3716 (0.1%) | ||
| Abdominal pain | 2/3716 (0.1%) | 3/3716 (0.1%) | ||
| Gastric ulcer haemorrhage | 3/3716 (0.1%) | 2/3716 (0.1%) | ||
| Intestinal obstruction | 1/3716 (0%) | 4/3716 (0.1%) | ||
| Haemorrhoidal haemorrhage | 1/3716 (0%) | 3/3716 (0.1%) | ||
| Vomiting | 0/3716 (0%) | 4/3716 (0.1%) | ||
| Colitis | 0/3716 (0%) | 3/3716 (0.1%) | ||
| Diarrhoea | 1/3716 (0%) | 2/3716 (0.1%) | ||
| Duodenal ulcer haemorrhage | 2/3716 (0.1%) | 1/3716 (0%) | ||
| Upper gastrointestinal haemorrhage | 1/3716 (0%) | 2/3716 (0.1%) | ||
| Gastric haemorrhage | 2/3716 (0.1%) | 0/3716 (0%) | ||
| Gastric ulcer | 2/3716 (0.1%) | 0/3716 (0%) | ||
| Gingival bleeding | 1/3716 (0%) | 1/3716 (0%) | ||
| Intestinal haemorrhage | 0/3716 (0%) | 2/3716 (0.1%) | ||
| Intestinal ischaemia | 2/3716 (0.1%) | 0/3716 (0%) | ||
| Melaena | 1/3716 (0%) | 1/3716 (0%) | ||
| Pharyngo-oesophageal diverticulum | 1/3716 (0%) | 1/3716 (0%) | ||
| Abdominal strangulated hernia | 1/3716 (0%) | 0/3716 (0%) | ||
| Abdominal wall haematoma | 1/3716 (0%) | 0/3716 (0%) | ||
| Acute abdomen | 0/3716 (0%) | 1/3716 (0%) | ||
| Constipation | 1/3716 (0%) | 0/3716 (0%) | ||
| Duodenal ulcer | 1/3716 (0%) | 0/3716 (0%) | ||
| Faecaloma | 0/3716 (0%) | 1/3716 (0%) | ||
| Gastric ulcer perforation | 0/3716 (0%) | 1/3716 (0%) | ||
| Gastroduodenal haemorrhage | 1/3716 (0%) | 0/3716 (0%) | ||
| Gastrointestinal disorder | 1/3716 (0%) | 0/3716 (0%) | ||
| Gastrointestinal necrosis | 0/3716 (0%) | 1/3716 (0%) | ||
| Gastrointestinal polyp haemorrhage | 1/3716 (0%) | 0/3716 (0%) | ||
| Intestinal perforation | 0/3716 (0%) | 1/3716 (0%) | ||
| Large intestinal haemorrhage | 1/3716 (0%) | 0/3716 (0%) | ||
| Lower gastrointestinal haemorrhage | 1/3716 (0%) | 0/3716 (0%) | ||
| Mechanical ileus | 0/3716 (0%) | 1/3716 (0%) | ||
| Nausea | 0/3716 (0%) | 1/3716 (0%) | ||
| Pancreatitis | 0/3716 (0%) | 1/3716 (0%) | ||
| Pancreatitis acute | 1/3716 (0%) | 0/3716 (0%) | ||
| Peptic ulcer haemorrhage | 0/3716 (0%) | 1/3716 (0%) | ||
| Volvulus | 0/3716 (0%) | 1/3716 (0%) | ||
| General disorders | ||||
| Death | 9/3716 (0.2%) | 16/3716 (0.4%) | ||
| Sudden cardiac death | 6/3716 (0.2%) | 5/3716 (0.1%) | ||
| Multi-organ failure | 3/3716 (0.1%) | 6/3716 (0.2%) | ||
| General physical health deterioration | 6/3716 (0.2%) | 2/3716 (0.1%) | ||
| Sudden death | 3/3716 (0.1%) | 3/3716 (0.1%) | ||
| Non-cardiac chest pain | 2/3716 (0.1%) | 1/3716 (0%) | ||
| Pyrexia | 3/3716 (0.1%) | 0/3716 (0%) | ||
| Cardiac death | 1/3716 (0%) | 1/3716 (0%) | ||
| Chest pain | 1/3716 (0%) | 1/3716 (0%) | ||
| Fatigue | 1/3716 (0%) | 1/3716 (0%) | ||
| Asthenia | 0/3716 (0%) | 1/3716 (0%) | ||
| Catheter site haemorrhage | 0/3716 (0%) | 1/3716 (0%) | ||
| Condition aggravated | 1/3716 (0%) | 0/3716 (0%) | ||
| Device malfunction | 1/3716 (0%) | 0/3716 (0%) | ||
| Discomfort | 0/3716 (0%) | 1/3716 (0%) | ||
| Fibrosis | 1/3716 (0%) | 0/3716 (0%) | ||
| Generalised oedema | 0/3716 (0%) | 1/3716 (0%) | ||
| Hyperthermia | 1/3716 (0%) | 0/3716 (0%) | ||
| Impaired healing | 1/3716 (0%) | 0/3716 (0%) | ||
| Injection site haemorrhage | 0/3716 (0%) | 1/3716 (0%) | ||
| Necrosis | 1/3716 (0%) | 0/3716 (0%) | ||
| Oedema peripheral | 1/3716 (0%) | 0/3716 (0%) | ||
| Puncture site haemorrhage | 0/3716 (0%) | 1/3716 (0%) | ||
| Ulcer | 1/3716 (0%) | 0/3716 (0%) | ||
| Hepatobiliary disorders | ||||
| Cholecystitis | 4/3716 (0.1%) | 0/3716 (0%) | ||
| Bile duct stone | 2/3716 (0.1%) | 0/3716 (0%) | ||
| Cholecystitis acute | 2/3716 (0.1%) | 0/3716 (0%) | ||
| Cholecystitis chronic | 2/3716 (0.1%) | 0/3716 (0%) | ||
| Cholangitis | 0/3716 (0%) | 1/3716 (0%) | ||
| Cholelithiasis | 1/3716 (0%) | 0/3716 (0%) | ||
| Hepatitis | 1/3716 (0%) | 0/3716 (0%) | ||
| Hepatocellular injury | 1/3716 (0%) | 0/3716 (0%) | ||
| Ischaemic hepatitis | 0/3716 (0%) | 1/3716 (0%) | ||
| Portal vein thrombosis | 1/3716 (0%) | 0/3716 (0%) | ||
| Immune system disorders | ||||
| Drug hypersensitivity | 1/3716 (0%) | 1/3716 (0%) | ||
| Anaphylactic reaction | 0/3716 (0%) | 1/3716 (0%) | ||
| Hypersensitivity | 0/3716 (0%) | 1/3716 (0%) | ||
| Infections and infestations | ||||
| Pneumonia | 46/3716 (1.2%) | 64/3716 (1.7%) | ||
| Urinary tract infection | 13/3716 (0.3%) | 11/3716 (0.3%) | ||
| Sepsis | 13/3716 (0.3%) | 7/3716 (0.2%) | ||
| Septic shock | 7/3716 (0.2%) | 8/3716 (0.2%) | ||
| Cellulitis | 3/3716 (0.1%) | 7/3716 (0.2%) | ||
| Bronchitis | 1/3716 (0%) | 6/3716 (0.2%) | ||
| Respiratory tract infection | 4/3716 (0.1%) | 3/3716 (0.1%) | ||
| Erysipelas | 4/3716 (0.1%) | 2/3716 (0.1%) | ||
| Gastroenteritis | 4/3716 (0.1%) | 0/3716 (0%) | ||
| Bronchopneumonia | 2/3716 (0.1%) | 1/3716 (0%) | ||
| Clostridium difficile colitis | 1/3716 (0%) | 2/3716 (0.1%) | ||
| Endocarditis | 1/3716 (0%) | 2/3716 (0.1%) | ||
| Infected skin ulcer | 2/3716 (0.1%) | 1/3716 (0%) | ||
| Lobar pneumonia | 1/3716 (0%) | 2/3716 (0.1%) | ||
| Pyelonephritis | 2/3716 (0.1%) | 1/3716 (0%) | ||
| Pyelonephritis acute | 1/3716 (0%) | 2/3716 (0.1%) | ||
| Wound infection | 2/3716 (0.1%) | 1/3716 (0%) | ||
| Appendicitis | 1/3716 (0%) | 1/3716 (0%) | ||
| Clostridium colitis | 0/3716 (0%) | 2/3716 (0.1%) | ||
| Infection | 2/3716 (0.1%) | 0/3716 (0%) | ||
| Osteomyelitis | 2/3716 (0.1%) | 0/3716 (0%) | ||
| Pseudomembranous colitis | 2/3716 (0.1%) | 0/3716 (0%) | ||
| Pulmonary sepsis | 2/3716 (0.1%) | 0/3716 (0%) | ||
| Pulmonary tuberculosis | 2/3716 (0.1%) | 0/3716 (0%) | ||
| Tracheobronchitis | 1/3716 (0%) | 1/3716 (0%) | ||
| Urosepsis | 1/3716 (0%) | 1/3716 (0%) | ||
| Abscess bacterial | 0/3716 (0%) | 1/3716 (0%) | ||
| Appendicitis perforated | 1/3716 (0%) | 0/3716 (0%) | ||
| Arthritis bacterial | 0/3716 (0%) | 1/3716 (0%) | ||
| Atypical pneumonia | 0/3716 (0%) | 1/3716 (0%) | ||
| Bacteraemia | 1/3716 (0%) | 0/3716 (0%) | ||
| Bone abscess | 1/3716 (0%) | 0/3716 (0%) | ||
| Bronchitis bacterial | 1/3716 (0%) | 0/3716 (0%) | ||
| Clostridial infection | 0/3716 (0%) | 1/3716 (0%) | ||
| Clostridium difficile infection | 0/3716 (0%) | 1/3716 (0%) | ||
| Cystitis | 1/3716 (0%) | 0/3716 (0%) | ||
| Device related infection | 1/3716 (0%) | 0/3716 (0%) | ||
| Diverticulitis | 0/3716 (0%) | 1/3716 (0%) | ||
| Empyema | 1/3716 (0%) | 0/3716 (0%) | ||
| Endocarditis bacterial | 0/3716 (0%) | 1/3716 (0%) | ||
| Enterococcal infection | 1/3716 (0%) | 0/3716 (0%) | ||
| Epididymitis | 1/3716 (0%) | 0/3716 (0%) | ||
| Escherichia bacteraemia | 1/3716 (0%) | 0/3716 (0%) | ||
| Febrile infection | 1/3716 (0%) | 0/3716 (0%) | ||
| Gallbladder empyema | 0/3716 (0%) | 1/3716 (0%) | ||
| Gastrointestinal bacterial infection | 0/3716 (0%) | 1/3716 (0%) | ||
| Infectious pleural effusion | 0/3716 (0%) | 1/3716 (0%) | ||
| Infective exacerbation of chronic obstructive airways | 0/3716 (0%) | 1/3716 (0%) | ||
| Influenza | 1/3716 (0%) | 0/3716 (0%) | ||
| Intervertebral discitis | 0/3716 (0%) | 1/3716 (0%) | ||
| Localised infection | 0/3716 (0%) | 1/3716 (0%) | ||
| Mastoiditis | 1/3716 (0%) | 0/3716 (0%) | ||
| Nosocomial infection | 0/3716 (0%) | 1/3716 (0%) | ||
| Oral candidiasis | 0/3716 (0%) | 1/3716 (0%) | ||
| Pneumonia staphylococcal | 1/3716 (0%) | 0/3716 (0%) | ||
| Pneumonia streptococcal | 1/3716 (0%) | 0/3716 (0%) | ||
| Pseudomonal sepsis | 0/3716 (0%) | 1/3716 (0%) | ||
| Pseudomonas infection | 0/3716 (0%) | 1/3716 (0%) | ||
| Psoas abscess | 1/3716 (0%) | 0/3716 (0%) | ||
| Pyelocystitis | 0/3716 (0%) | 1/3716 (0%) | ||
| Sinusitis | 0/3716 (0%) | 1/3716 (0%) | ||
| Skin infection | 1/3716 (0%) | 0/3716 (0%) | ||
| Soft tissue infection | 0/3716 (0%) | 1/3716 (0%) | ||
| Staphylococcal sepsis | 0/3716 (0%) | 1/3716 (0%) | ||
| Subcutaneous abscess | 0/3716 (0%) | 1/3716 (0%) | ||
| Upper respiratory tract infection | 0/3716 (0%) | 1/3716 (0%) | ||
| Viral upper respiratory tract infection | 1/3716 (0%) | 0/3716 (0%) | ||
| Injury, poisoning and procedural complications | ||||
| Hip fracture | 1/3716 (0%) | 3/3716 (0.1%) | ||
| Fall | 3/3716 (0.1%) | 0/3716 (0%) | ||
| Rib fracture | 0/3716 (0%) | 3/3716 (0.1%) | ||
| Cervical vertebral fracture | 1/3716 (0%) | 1/3716 (0%) | ||
| Contusion | 1/3716 (0%) | 1/3716 (0%) | ||
| Head injury | 1/3716 (0%) | 1/3716 (0%) | ||
| Lumbar vertebral fracture | 2/3716 (0.1%) | 0/3716 (0%) | ||
| Accident | 0/3716 (0%) | 1/3716 (0%) | ||
| Accidental overdose | 0/3716 (0%) | 1/3716 (0%) | ||
| Concussion | 1/3716 (0%) | 0/3716 (0%) | ||
| Femur fracture | 1/3716 (0%) | 0/3716 (0%) | ||
| Humerus fracture | 1/3716 (0%) | 0/3716 (0%) | ||
| Iatrogenic injury | 0/3716 (0%) | 1/3716 (0%) | ||
| Joint dislocation | 1/3716 (0%) | 0/3716 (0%) | ||
| Patella fracture | 1/3716 (0%) | 0/3716 (0%) | ||
| Pneumothorax traumatic | 0/3716 (0%) | 1/3716 (0%) | ||
| Post procedural haemorrhage | 0/3716 (0%) | 1/3716 (0%) | ||
| Procedural haemorrhage | 1/3716 (0%) | 0/3716 (0%) | ||
| Pubis fracture | 0/3716 (0%) | 1/3716 (0%) | ||
| Skin injury | 1/3716 (0%) | 0/3716 (0%) | ||
| Spinal compression fracture | 1/3716 (0%) | 0/3716 (0%) | ||
| Spinal cord injury | 1/3716 (0%) | 0/3716 (0%) | ||
| Subdural haematoma | 0/3716 (0%) | 1/3716 (0%) | ||
| Tendon rupture | 1/3716 (0%) | 0/3716 (0%) | ||
| Traumatic fracture | 1/3716 (0%) | 0/3716 (0%) | ||
| Traumatic haematoma | 1/3716 (0%) | 0/3716 (0%) | ||
| Upper limb fracture | 1/3716 (0%) | 0/3716 (0%) | ||
| Investigations | ||||
| Hepatic enzyme increased | 2/3716 (0.1%) | 5/3716 (0.1%) | ||
| Aspiration bronchial | 2/3716 (0.1%) | 1/3716 (0%) | ||
| Alanine aminotransferase increased | 1/3716 (0%) | 1/3716 (0%) | ||
| General physical condition abnormal | 1/3716 (0%) | 1/3716 (0%) | ||
| Blood alkaline phosphatase increased | 1/3716 (0%) | 0/3716 (0%) | ||
| Blood creatinine increased | 1/3716 (0%) | 0/3716 (0%) | ||
| Blood urea increased | 1/3716 (0%) | 0/3716 (0%) | ||
| Blood urine present | 1/3716 (0%) | 0/3716 (0%) | ||
| Catheterisation cardiac | 0/3716 (0%) | 1/3716 (0%) | ||
| Transaminases increased | 1/3716 (0%) | 0/3716 (0%) | ||
| Metabolism and nutrition disorders | ||||
| Type 2 diabetes mellitus | 1/3716 (0%) | 3/3716 (0.1%) | ||
| Dehydration | 1/3716 (0%) | 2/3716 (0.1%) | ||
| Diabetes mellitus | 0/3716 (0%) | 2/3716 (0.1%) | ||
| Gout | 1/3716 (0%) | 1/3716 (0%) | ||
| Hypokalaemia | 2/3716 (0.1%) | 0/3716 (0%) | ||
| Hyponatraemia | 1/3716 (0%) | 1/3716 (0%) | ||
| Failure to thrive | 0/3716 (0%) | 1/3716 (0%) | ||
| Hypercalcaemia | 1/3716 (0%) | 0/3716 (0%) | ||
| Hyperglycaemia | 0/3716 (0%) | 1/3716 (0%) | ||
| Hyperkalaemia | 0/3716 (0%) | 1/3716 (0%) | ||
| Hypernatraemia | 0/3716 (0%) | 1/3716 (0%) | ||
| Hyperphosphataemia | 0/3716 (0%) | 1/3716 (0%) | ||
| Hypoglycaemia | 1/3716 (0%) | 0/3716 (0%) | ||
| Hypovolaemia | 0/3716 (0%) | 1/3716 (0%) | ||
| Type 1 diabetes mellitus | 1/3716 (0%) | 0/3716 (0%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| Arthritis | 2/3716 (0.1%) | 0/3716 (0%) | ||
| Musculoskeletal chest pain | 1/3716 (0%) | 1/3716 (0%) | ||
| Arthralgia | 1/3716 (0%) | 0/3716 (0%) | ||
| Cervical spinal stenosis | 1/3716 (0%) | 0/3716 (0%) | ||
| Chondrocalcinosis | 1/3716 (0%) | 0/3716 (0%) | ||
| Coccydynia | 1/3716 (0%) | 0/3716 (0%) | ||
| Intervertebral disc degeneration | 1/3716 (0%) | 0/3716 (0%) | ||
| Intervertebral disc disorder | 1/3716 (0%) | 0/3716 (0%) | ||
| Intervertebral disc protrusion | 0/3716 (0%) | 1/3716 (0%) | ||
| Osteoarthritis | 0/3716 (0%) | 1/3716 (0%) | ||
| Osteochondrosis | 1/3716 (0%) | 0/3716 (0%) | ||
| Polymyositis | 0/3716 (0%) | 1/3716 (0%) | ||
| Scleroderma | 0/3716 (0%) | 1/3716 (0%) | ||
| Synovial cyst | 1/3716 (0%) | 0/3716 (0%) | ||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| Lung neoplasm malignant | 10/3716 (0.3%) | 8/3716 (0.2%) | ||
| Cervix carcinoma | 2/3716 (0.1%) | 1/3716 (0%) | ||
| Metastases to central nervous system | 3/3716 (0.1%) | 0/3716 (0%) | ||
| Adenocarcinoma of colon | 2/3716 (0.1%) | 0/3716 (0%) | ||
| Gastric cancer | 1/3716 (0%) | 1/3716 (0%) | ||
| Metastatic neoplasm | 2/3716 (0.1%) | 0/3716 (0%) | ||
| Ovarian cancer | 2/3716 (0.1%) | 0/3716 (0%) | ||
| Rectal cancer | 2/3716 (0.1%) | 0/3716 (0%) | ||
| Adenocarcinoma | 0/3716 (0%) | 1/3716 (0%) | ||
| Brain neoplasm | 1/3716 (0%) | 0/3716 (0%) | ||
| Breast cancer metastatic | 1/3716 (0%) | 0/3716 (0%) | ||
| Bronchial carcinoma | 1/3716 (0%) | 0/3716 (0%) | ||
| Chronic lymphocytic leukaemia | 1/3716 (0%) | 0/3716 (0%) | ||
| Colon cancer | 0/3716 (0%) | 1/3716 (0%) | ||
| Colorectal adenocarcinoma | 0/3716 (0%) | 1/3716 (0%) | ||
| Colorectal cancer | 1/3716 (0%) | 0/3716 (0%) | ||
| Gastrointestinal stromal tumour | 1/3716 (0%) | 0/3716 (0%) | ||
| Leukaemia | 1/3716 (0%) | 0/3716 (0%) | ||
| Lung carcinoma cell type unspecified stage IV | 1/3716 (0%) | 0/3716 (0%) | ||
| Malignant pleural effusion | 0/3716 (0%) | 1/3716 (0%) | ||
| Meningioma | 1/3716 (0%) | 0/3716 (0%) | ||
| Metastases to bone | 0/3716 (0%) | 1/3716 (0%) | ||
| Metastases to liver | 1/3716 (0%) | 0/3716 (0%) | ||
| Metastases to peritoneum | 1/3716 (0%) | 0/3716 (0%) | ||
| Metastasis | 0/3716 (0%) | 1/3716 (0%) | ||
| Myeloid leukaemia | 1/3716 (0%) | 0/3716 (0%) | ||
| Neoplasm malignant | 0/3716 (0%) | 1/3716 (0%) | ||
| Non-Hodgkin's lymphoma | 0/3716 (0%) | 1/3716 (0%) | ||
| Oesophageal carcinoma | 0/3716 (0%) | 1/3716 (0%) | ||
| Pancreatic carcinoma metastatic | 1/3716 (0%) | 0/3716 (0%) | ||
| Plasma cell myeloma | 1/3716 (0%) | 0/3716 (0%) | ||
| Plasmacytoma | 1/3716 (0%) | 0/3716 (0%) | ||
| Pleural mesothelioma | 0/3716 (0%) | 1/3716 (0%) | ||
| Rectosigmoid cancer | 1/3716 (0%) | 0/3716 (0%) | ||
| Small cell lung cancer | 1/3716 (0%) | 0/3716 (0%) | ||
| Throat cancer | 1/3716 (0%) | 0/3716 (0%) | ||
| Transitional cell carcinoma | 0/3716 (0%) | 1/3716 (0%) | ||
| Vulval cancer | 1/3716 (0%) | 0/3716 (0%) | ||
| Nervous system disorders | ||||
| Ischaemic stroke | 19/3716 (0.5%) | 35/3716 (0.9%) | ||
| Brain oedema | 8/3716 (0.2%) | 10/3716 (0.3%) | ||
| Cerebrovascular accident | 7/3716 (0.2%) | 6/3716 (0.2%) | ||
| Syncope | 4/3716 (0.1%) | 4/3716 (0.1%) | ||
| Cerebral infarction | 3/3716 (0.1%) | 3/3716 (0.1%) | ||
| Transient ischaemic attack | 2/3716 (0.1%) | 4/3716 (0.1%) | ||
| Convulsion | 2/3716 (0.1%) | 3/3716 (0.1%) | ||
| Loss of consciousness | 4/3716 (0.1%) | 1/3716 (0%) | ||
| Haemorrhagic stroke | 1/3716 (0%) | 2/3716 (0.1%) | ||
| Subarachnoid haemorrhage | 1/3716 (0%) | 2/3716 (0.1%) | ||
| Coma | 2/3716 (0.1%) | 0/3716 (0%) | ||
| Dizziness | 1/3716 (0%) | 1/3716 (0%) | ||
| Encephalopathy | 0/3716 (0%) | 2/3716 (0.1%) | ||
| Epilepsy | 1/3716 (0%) | 1/3716 (0%) | ||
| Haemorrhagic transformation stroke | 0/3716 (0%) | 2/3716 (0.1%) | ||
| Sciatica | 1/3716 (0%) | 1/3716 (0%) | ||
| Carotid artery stenosis | 0/3716 (0%) | 1/3716 (0%) | ||
| Cerebellar infarction | 0/3716 (0%) | 1/3716 (0%) | ||
| Cerebral haemorrhage | 0/3716 (0%) | 1/3716 (0%) | ||
| Cerebral ischaemia | 0/3716 (0%) | 1/3716 (0%) | ||
| Hydrocephalus | 1/3716 (0%) | 0/3716 (0%) | ||
| Hypoglycaemic coma | 1/3716 (0%) | 0/3716 (0%) | ||
| Intraventricular haemorrhage | 0/3716 (0%) | 1/3716 (0%) | ||
| Nervous system disorder | 1/3716 (0%) | 0/3716 (0%) | ||
| Neuroglycopenia | 1/3716 (0%) | 0/3716 (0%) | ||
| Neurological decompensation | 0/3716 (0%) | 1/3716 (0%) | ||
| Paralysis flaccid | 1/3716 (0%) | 0/3716 (0%) | ||
| Polyneuropathy | 0/3716 (0%) | 1/3716 (0%) | ||
| Presyncope | 0/3716 (0%) | 1/3716 (0%) | ||
| Unresponsive to stimuli | 1/3716 (0%) | 0/3716 (0%) | ||
| Psychiatric disorders | ||||
| Confusional state | 2/3716 (0.1%) | 0/3716 (0%) | ||
| Depression | 0/3716 (0%) | 2/3716 (0.1%) | ||
| Anxiety | 1/3716 (0%) | 0/3716 (0%) | ||
| Delirium | 0/3716 (0%) | 1/3716 (0%) | ||
| Major depression | 1/3716 (0%) | 0/3716 (0%) | ||
| Mental disorder | 1/3716 (0%) | 0/3716 (0%) | ||
| Renal and urinary disorders | ||||
| Renal failure | 10/3716 (0.3%) | 15/3716 (0.4%) | ||
| Renal failure acute | 12/3716 (0.3%) | 11/3716 (0.3%) | ||
| Haematuria | 17/3716 (0.5%) | 5/3716 (0.1%) | ||
| Renal failure chronic | 8/3716 (0.2%) | 4/3716 (0.1%) | ||
| Haemorrhage urinary tract | 2/3716 (0.1%) | 1/3716 (0%) | ||
| Renal impairment | 3/3716 (0.1%) | 0/3716 (0%) | ||
| Acute prerenal failure | 1/3716 (0%) | 1/3716 (0%) | ||
| Urinary retention | 1/3716 (0%) | 1/3716 (0%) | ||
| Cystitis haemorrhagic | 0/3716 (0%) | 1/3716 (0%) | ||
| Glomerulonephritis rapidly progressive | 1/3716 (0%) | 0/3716 (0%) | ||
| Nephropathy | 0/3716 (0%) | 1/3716 (0%) | ||
| Renal colic | 1/3716 (0%) | 0/3716 (0%) | ||
| Urethral haemorrhage | 1/3716 (0%) | 0/3716 (0%) | ||
| Reproductive system and breast disorders | ||||
| Benign prostatic hyperplasia | 1/3716 (0%) | 0/3716 (0%) | ||
| Cervix haemorrhage uterine | 1/3716 (0%) | 0/3716 (0%) | ||
| Genital haemorrhage | 1/3716 (0%) | 0/3716 (0%) | ||
| Vaginal haemorrhage | 1/3716 (0%) | 0/3716 (0%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Chronic obstructive pulmonary disease | 38/3716 (1%) | 43/3716 (1.2%) | ||
| Respiratory failure | 30/3716 (0.8%) | 17/3716 (0.5%) | ||
| Pulmonary embolism | 11/3716 (0.3%) | 26/3716 (0.7%) | ||
| Acute respiratory failure | 13/3716 (0.3%) | 9/3716 (0.2%) | ||
| Epistaxis | 10/3716 (0.3%) | 5/3716 (0.1%) | ||
| Pulmonary oedema | 6/3716 (0.2%) | 4/3716 (0.1%) | ||
| Pulmonary fibrosis | 3/3716 (0.1%) | 5/3716 (0.1%) | ||
| Pleural effusion | 2/3716 (0.1%) | 5/3716 (0.1%) | ||
| Asthma | 3/3716 (0.1%) | 3/3716 (0.1%) | ||
| Dyspnoea | 6/3716 (0.2%) | 0/3716 (0%) | ||
| Pneumothorax | 3/3716 (0.1%) | 3/3716 (0.1%) | ||
| Acute pulmonary oedema | 3/3716 (0.1%) | 1/3716 (0%) | ||
| Pneumonia aspiration | 2/3716 (0.1%) | 2/3716 (0.1%) | ||
| Chronic respiratory failure | 1/3716 (0%) | 2/3716 (0.1%) | ||
| Haemoptysis | 2/3716 (0.1%) | 1/3716 (0%) | ||
| Respiratory distress | 2/3716 (0.1%) | 1/3716 (0%) | ||
| Bronchiectasis | 1/3716 (0%) | 1/3716 (0%) | ||
| Bronchitis chronic | 1/3716 (0%) | 1/3716 (0%) | ||
| Bronchospasm | 0/3716 (0%) | 2/3716 (0.1%) | ||
| Haemothorax | 1/3716 (0%) | 1/3716 (0%) | ||
| Hypoxia | 1/3716 (0%) | 1/3716 (0%) | ||
| Interstitial lung disease | 0/3716 (0%) | 2/3716 (0.1%) | ||
| Lung disorder | 0/3716 (0%) | 2/3716 (0.1%) | ||
| Pulmonary hypertension | 1/3716 (0%) | 1/3716 (0%) | ||
| Respiratory arrest | 0/3716 (0%) | 2/3716 (0.1%) | ||
| Sleep apnoea syndrome | 1/3716 (0%) | 1/3716 (0%) | ||
| Acute respiratory distress syndrome | 0/3716 (0%) | 1/3716 (0%) | ||
| Alveolitis allergic | 0/3716 (0%) | 1/3716 (0%) | ||
| Bronchial obstruction | 0/3716 (0%) | 1/3716 (0%) | ||
| Chylothorax | 0/3716 (0%) | 1/3716 (0%) | ||
| Emphysema | 1/3716 (0%) | 0/3716 (0%) | ||
| Paranasal cyst | 0/3716 (0%) | 1/3716 (0%) | ||
| Pneumonitis | 1/3716 (0%) | 0/3716 (0%) | ||
| Pneumothorax spontaneous | 1/3716 (0%) | 0/3716 (0%) | ||
| Pulmonary haemorrhage | 0/3716 (0%) | 1/3716 (0%) | ||
| Skin and subcutaneous tissue disorders | ||||
| Skin ulcer | 3/3716 (0.1%) | 1/3716 (0%) | ||
| Decubitus ulcer | 0/3716 (0%) | 2/3716 (0.1%) | ||
| Acute generalised exanthematous pustulosis | 0/3716 (0%) | 1/3716 (0%) | ||
| Dermatitis bullous | 0/3716 (0%) | 1/3716 (0%) | ||
| Ecchymosis | 0/3716 (0%) | 1/3716 (0%) | ||
| Pemphigoid | 1/3716 (0%) | 0/3716 (0%) | ||
| Petechiae | 0/3716 (0%) | 1/3716 (0%) | ||
| Skin disorder | 0/3716 (0%) | 1/3716 (0%) | ||
| Social circumstances | ||||
| Activities of daily living impaired | 0/3716 (0%) | 1/3716 (0%) | ||
| Surgical and medical procedures | ||||
| Coronary artery bypass | 1/3716 (0%) | 0/3716 (0%) | ||
| Glaucoma surgery | 1/3716 (0%) | 0/3716 (0%) | ||
| Hip arthroplasty | 1/3716 (0%) | 0/3716 (0%) | ||
| Hospitalisation | 1/3716 (0%) | 0/3716 (0%) | ||
| Hysterectomy | 1/3716 (0%) | 0/3716 (0%) | ||
| Leg amputation | 0/3716 (0%) | 1/3716 (0%) | ||
| Mitral valve repair | 0/3716 (0%) | 1/3716 (0%) | ||
| Surgery | 1/3716 (0%) | 0/3716 (0%) | ||
| Vascular disorders | ||||
| Deep vein thrombosis | 16/3716 (0.4%) | 38/3716 (1%) | ||
| Hypotension | 8/3716 (0.2%) | 3/3716 (0.1%) | ||
| Haematoma | 5/3716 (0.1%) | 1/3716 (0%) | ||
| Peripheral arterial occlusive disease | 1/3716 (0%) | 2/3716 (0.1%) | ||
| Peripheral ischaemia | 1/3716 (0%) | 2/3716 (0.1%) | ||
| Aortic aneurysm | 1/3716 (0%) | 1/3716 (0%) | ||
| Aortic dissection | 1/3716 (0%) | 1/3716 (0%) | ||
| Aortic stenosis | 2/3716 (0.1%) | 0/3716 (0%) | ||
| Arteriosclerosis | 1/3716 (0%) | 1/3716 (0%) | ||
| Haemorrhage | 2/3716 (0.1%) | 0/3716 (0%) | ||
| Haemorrhagic vasculitis | 1/3716 (0%) | 1/3716 (0%) | ||
| Hypertensive crisis | 1/3716 (0%) | 1/3716 (0%) | ||
| Venous thrombosis | 0/3716 (0%) | 2/3716 (0.1%) | ||
| Aneurysm | 0/3716 (0%) | 1/3716 (0%) | ||
| Angiopathy | 1/3716 (0%) | 0/3716 (0%) | ||
| Arterial disorder | 1/3716 (0%) | 0/3716 (0%) | ||
| Arterial stenosis | 1/3716 (0%) | 0/3716 (0%) | ||
| Bleeding varicose vein | 1/3716 (0%) | 0/3716 (0%) | ||
| Embolism arterial | 1/3716 (0%) | 0/3716 (0%) | ||
| Essential hypertension | 1/3716 (0%) | 0/3716 (0%) | ||
| Femoral artery aneurysm | 0/3716 (0%) | 1/3716 (0%) | ||
| Hypertension | 1/3716 (0%) | 0/3716 (0%) | ||
| Intra-abdominal haematoma | 0/3716 (0%) | 1/3716 (0%) | ||
| Ischaemia | 1/3716 (0%) | 0/3716 (0%) | ||
| Peripheral artery aneurysm | 0/3716 (0%) | 1/3716 (0%) | ||
| Peripheral artery stenosis | 1/3716 (0%) | 0/3716 (0%) | ||
| Peripheral vascular disorder | 1/3716 (0%) | 0/3716 (0%) | ||
| Phlebitis superficial | 0/3716 (0%) | 1/3716 (0%) | ||
| Shock haemorrhagic | 0/3716 (0%) | 1/3716 (0%) | ||
| Venous thrombosis limb | 0/3716 (0%) | 1/3716 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Betrixaban | Enoxaparin | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 879/3716 (23.7%) | 779/3716 (21%) | ||
| Blood and lymphatic system disorders | ||||
| Anaemia | 44/3716 (1.2%) | 29/3716 (0.8%) | ||
| Cardiac disorders | ||||
| Atrial fibrillation | 50/3716 (1.3%) | 85/3716 (2.3%) | ||
| Cardiac failure | 48/3716 (1.3%) | 32/3716 (0.9%) | ||
| Mitral valve incompetence | 41/3716 (1.1%) | 49/3716 (1.3%) | ||
| Tricuspid valve incompetence | 38/3716 (1%) | 41/3716 (1.1%) | ||
| Gastrointestinal disorders | ||||
| Constipation | 109/3716 (2.9%) | 102/3716 (2.7%) | ||
| Nausea | 67/3716 (1.8%) | 55/3716 (1.5%) | ||
| Diarrhoea | 63/3716 (1.7%) | 59/3716 (1.6%) | ||
| General disorders | ||||
| Oedema peripheral | 39/3716 (1%) | 19/3716 (0.5%) | ||
| Infections and infestations | ||||
| Urinary tract infection | 110/3716 (3%) | 78/3716 (2.1%) | ||
| Metabolism and nutrition disorders | ||||
| Hypokalaemia | 91/3716 (2.4%) | 84/3716 (2.3%) | ||
| Nervous system disorders | ||||
| Headache | 74/3716 (2%) | 59/3716 (1.6%) | ||
| Psychiatric disorders | ||||
| Insomnia | 87/3716 (2.3%) | 89/3716 (2.4%) | ||
| Renal and urinary disorders | ||||
| Renal cyst | 55/3716 (1.5%) | 47/3716 (1.3%) | ||
| Haematuria | 46/3716 (1.2%) | 23/3716 (0.6%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Chronic obstructive pulmonary disease | 53/3716 (1.4%) | 41/3716 (1.1%) | ||
| Epistaxis | 48/3716 (1.3%) | 19/3716 (0.5%) | ||
| Vascular disorders | ||||
| Hypertension | 88/3716 (2.4%) | 80/3716 (2.2%) | ||
| Deep vein thrombosis | 29/3716 (0.8%) | 58/3716 (1.6%) | ||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Due to multi centers, studies and countries this varies.
Results Point of Contact
| Name/Title | Head of Clinical Development |
|---|---|
| Organization | Portola Pharmaceuticals, Inc. |
| Phone | 650-246-7000 |
Responsible Party:
Portola Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01583218
Other Study ID Numbers:
- 11-019
First Posted:
Apr 23, 2012
Last Update Posted:
Sep 26, 2018
Last Verified:
Jun 1, 2016