EinsteinChoice: Reduced-dosed Rivaroxaban in the Long-term Prevention of Recurrent Symptomatic VTE(Venous Thromboembolism)
Study Details
Study Description
Brief Summary
This is a multicenter, randomized, double-blind, event-driven, superiority study for efficacy.
Patients with confirmed symptomatic DVT (Deep Vein Thrombosis) or PE (Pulmonary embolism) who completed 6 or 12 months of treatment of anticoagulation are eligible for this trial
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Arm 1 Rivaroxaban 10 mg once daily for 12 months |
Drug: BAY 59-7939
10 mg tablet once daily for 12 months
|
Experimental: Arm 2 Rivaroxaban 20 mg once daily for 12 months |
Drug: BAY 59-7939
20 mg tablet once daily for 12 months
|
Active Comparator: Arm 3 ASA (Acetylsalicylic Acid) 100 mg once daily for 12 months |
Drug: ASA
100 mg tablet once daily for 12 months
|
Outcome Measures
Primary Outcome Measures
- Number of Participants With the Composite of Fatal or Non-fatal Symptomatic Recurrent Venous Thromboembolism [Up to 12 months, at least 6 months]
The primary efficacy outcomes (i.e., recurrent venous thromboembolism [VTE] defined as composite of fatal or non-fatal symptomatic recurrent VTE, including unexplained death for which pulmonary embolism [PE] could not be ruled out) as confirmed by the central independent adjudication committee (CIAC) were considered up to the end of the individual intended duration of treatment. Incidence of the composite of the primary and secondary efficacy outcome and its components are based on the first occurrence to participant.
- Number of Participants With First Treatment-emergent Major Bleeding [Up to 12 months, at least 6 months]
The principal safety outcome was major bleeding which was defined according to the criteria of the International Society on Thrombosis and Hemostasis (ISTH) as clinically overt bleeding and associated with a fall in hemoglobin of 2 gram per deciliter (g/dL) or more, or leading to a transfusion of 2 or more units of packed red blood cells or whole blood, or occurring in a critical site, e.g. intracranial, intraspinal, intraocular, pericardial, intra articular, intramuscular with compartment syndrome, retroperitoneal, or contributing to death. Incidence of the composite of the primary and secondary efficacy outcome and its components are based on the first occurrence to participant.
Secondary Outcome Measures
- Number of Participants With the Composite of the Primary Efficacy Outcome, Myocardial Infarction, Ischemic Stroke or Systemic Non-CNS Embolism [Up to 12 months, at least 6 months]
The secondary efficacy outcome is the composite of the primary efficacy outcome, myocardial infarction (MI), ischemic stroke or non-central nervous system (CNS) systemic embolism. Incidence of the composite of the primary and secondary efficacy outcome and its components are based on the first occurrence to participant.
- Number of Participants With Non-major Bleeding Associated With Study Drug Interruption for > 14 Days [Up to 12 months, at least 6 months]
The secondary safety outcome was clinically relevant non-major (CRNM) bleeding, which was adjudicated by the CIAC using the ASA criteria: the bleeding was non-major and the bleeding was associated with a study medication interruption of more than 14 days.
Eligibility Criteria
Criteria
Inclusion Criteria:
- Patients with confirmed symptomatic PE and/or DVT who have been treated for 6 to 12 months and did not interrupt anticoagulation for longer than 1 week
Exclusion Criteria:
- Legal lower age limitations (country specific) Indication for therapeutic-dosed anticoagulants Indication for antiplatelet therapy or a conventional non-steroid anti-inflammatory drug (NSAID) Hepatic disease which is associated with coagulopathy leading to a clinically relevant bleeding risk Calculated creatinine clearance < 30 mL/min
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Beverly Hills | California | United States | 90211 | |
2 | La Jolla | California | United States | 92037 | |
3 | Ventura | California | United States | 93003 | |
4 | Denver | Colorado | United States | 80262 | |
5 | Jacksonville | Florida | United States | 32207 | |
6 | Columbus | Georgia | United States | 31904 | |
7 | Joliet | Illinois | United States | 60435 | |
8 | Rockport | Maine | United States | 04856 | |
9 | Boston | Massachusetts | United States | 02114-2696 | |
10 | Boston | Massachusetts | United States | 02115 | |
11 | Boston | Massachusetts | United States | 02215 | |
12 | Detroit | Michigan | United States | 48202 | |
13 | Butte | Montana | United States | 59701 | |
14 | Las Vegas | Nevada | United States | 89169 | |
15 | Raleigh | North Carolina | United States | 27607 | |
16 | Columbus | Ohio | United States | 43210-1240 | |
17 | Toledo | Ohio | United States | 43606 | |
18 | Philadelphia | Pennsylvania | United States | 19104 | |
19 | San Antonio | Texas | United States | 78229 | |
20 | Fredericksburg | Virginia | United States | 22401 | |
21 | Bellevue | Washington | United States | 98004 | |
22 | Seattle | Washington | United States | 98104 | |
23 | Spokane | Washington | United States | 99216 | |
24 | Tacoma | Washington | United States | 98405-2433 | |
25 | Garran | Australian Capital Territory | Australia | 2605 | |
26 | Concord | New South Wales | Australia | 2139 | |
27 | Kogarah | New South Wales | Australia | 2217 | |
28 | Lismore | New South Wales | Australia | 2480 | |
29 | Randwick | New South Wales | Australia | 2031 | |
30 | St Leonards | New South Wales | Australia | 2065 | |
31 | Westmead | New South Wales | Australia | 2145 | |
32 | Brisbane | Queensland | Australia | 4029 | |
33 | Clayton | Victoria | Australia | 3168 | |
34 | Box Hill | Australia | 3128 | ||
35 | Melbourne | Australia | 3004 | ||
36 | Redcliffe | Australia | 4020 | ||
37 | Graz | Steiermark | Austria | 8036 | |
38 | Innsbruck | Tirol | Austria | 6020 | |
39 | Wien | Austria | 1090 | ||
40 | Aalst | Belgium | 9300 | ||
41 | Bruxelles - Brussel | Belgium | 1070 | ||
42 | Bruxelles - Brussel | Belgium | 1200 | ||
43 | Hasselt | Belgium | 3500 | ||
44 | Leuven | Belgium | 3000 | ||
45 | Belo Horizonte | Minas Gerais | Brazil | 30150-221 | |
46 | Porto Alegre | Rio Grande Do Sul | Brazil | ||
47 | Campinas | Sao Paulo | Brazil | 13083-970 | |
48 | Santo André | Sao Paulo | Brazil | 09060-650 | |
49 | Santo André | Sao Paulo | Brazil | 09190-615 | |
50 | São Paulo | Sao Paulo | Brazil | 01323-001 | |
51 | São Paulo | Sao Paulo | Brazil | 04039-004 | |
52 | Rio de Janeiro | Brazil | |||
53 | Sao Paulo | Brazil | 05403-900 | ||
54 | Edmonton | Alberta | Canada | T6G 2B7 | |
55 | Victoria | British Columbia | Canada | V8R 4R2 | |
56 | Saint John | New Brunswick | Canada | E2L 4L2 | |
57 | Halifax | Nova Scotia | Canada | B3H 3A7 | |
58 | Hamilton | Ontario | Canada | L8L 2X2 | |
59 | Hamilton | Ontario | Canada | L8N 4A6 | |
60 | Hamilton | Ontario | Canada | L8V 1C3 | |
61 | London | Ontario | Canada | N6A 4G5 | |
62 | Ottawa | Ontario | Canada | K1H 8L6 | |
63 | Montreal | Quebec | Canada | H1T 2M4 | |
64 | Montreal | Quebec | Canada | H3T 1E2 | |
65 | Montreal | Quebec | Canada | H3T 1M5 | |
66 | St. Jerome | Quebec | Canada | J7Z 5T3 | |
67 | Fuzhou | Fujian | China | 350025 | |
68 | Guangzhou | Guangdong | China | 510080 | |
69 | Guangzhou | Guangdong | China | 510120 | |
70 | Nanning | Guangxi | China | 530021 | |
71 | Shijiazhuang | Hebei | China | 050000 | |
72 | Harbin | Heilongjiang | China | ||
73 | Wuhan | Hubei | China | 430032 | |
74 | Changsha | Hunan | China | 410011 | |
75 | Changsha | Hunan | China | 410013 | |
76 | Nantong | Jiangsu | China | 226001 | |
77 | Suzhou | Jiangsu | China | 215004 | |
78 | Changchun | Jilin | China | 130000 | |
79 | Shengyang | Liaoning | China | 110004 | |
80 | Shenyang | Liaoning | China | 110001 | |
81 | Yinchuan | Ningxia | China | 750004 | |
82 | Xi'an | Shaanxi | China | 710032 | |
83 | Xi'an | Shaanxi | China | 710061 | |
84 | Jinan | Shandong | China | 250012 | |
85 | Qingdao | Shandong | China | 266000 | |
86 | Taiyuan | Shanxi | China | 030001 | |
87 | Chengdu | Sichuan | China | 610041 | |
88 | Kunming | Yunnan | China | 650032 | |
89 | Hangzhou | Zhejiang | China | 310003 | |
90 | Hangzhou | Zhejiang | China | 310016 | |
91 | Wenzhou | Zhejiang | China | 325000 | |
92 | Beijing | China | 100020 | ||
93 | Beijing | China | 100029 | ||
94 | Beijing | China | 100037 | ||
95 | Beijing | China | 100053 | ||
96 | Beijing | China | 100730 | ||
97 | Shanghai | China | 200001 | ||
98 | Shanghai | China | 200025 | ||
99 | Shanghai | China | 200032 | ||
100 | Shanghai | China | 200233 | ||
101 | Shanghai | China | 200433 | ||
102 | Tianjin | China | 300052 | ||
103 | Tianjin | China | 300121 | ||
104 | Tianjin | China | 300211 | ||
105 | Kladno | Czechia | 27259 | ||
106 | Liberec | Czechia | 46063 | ||
107 | Litomysl | Czechia | 570 14 | ||
108 | Ostrava | Czechia | 708 52 | ||
109 | Ostrava | Czechia | 728 80 | ||
110 | Prague | Czechia | 118 33 | ||
111 | Praha 1 | Czechia | 110 00 | ||
112 | Praha 5 | Czechia | 150 06 | ||
113 | Usti nad Labem | Czechia | 401 13 | ||
114 | Aarhus N | Denmark | 8200 | ||
115 | Copenhagen | Denmark | 2300 | ||
116 | Glostrup | Denmark | 2600 | ||
117 | Hellerup | Denmark | 2900 | ||
118 | Herning | Denmark | 7400 | ||
119 | København NV | Denmark | 2400 | ||
120 | Svendborg | Denmark | 5700 | ||
121 | Angers | France | 49933 | ||
122 | Arras | France | 62000 | ||
123 | Besancon | France | 25030 | ||
124 | Bois-guillaume | France | 76320 | ||
125 | BREST Cedex 9 | France | 29240 | ||
126 | Brest Cedex | France | 29609 | ||
127 | Castelnau Le Lez | France | 34170 | ||
128 | Clermont Ferrand | France | 63000 | ||
129 | Colombes Cedex | France | 92701 | ||
130 | Dijon | France | 21000 | ||
131 | Grenoble | France | 38043 | ||
132 | Le Kremlin Bicetre Cedex | France | 94275 | ||
133 | Le Mans | France | 72037 | ||
134 | Limoges Cedex | France | 87042 | ||
135 | Nice | France | 06002 | ||
136 | Paris Cedex 15 | France | 75908 | ||
137 | Paris | France | 75475 | ||
138 | Paris | France | 75674 | ||
139 | Quimper | France | 29000 | ||
140 | Saint Etienne | France | 42055 | ||
141 | Strasbourg Cedex | France | 67091 | ||
142 | Toulon | France | 83056 | ||
143 | Toulouse | France | 31403 | ||
144 | Vernon | France | 27200 | ||
145 | Heidelberg | Baden-Württemberg | Germany | 69120 | |
146 | München | Bayern | Germany | 80336 | |
147 | Darmstadt | Hessen | Germany | 64297 | |
148 | Witten | Nordrhein-Westfalen | Germany | 58448 | |
149 | Mainz | Rheinland-Pfalz | Germany | 55131 | |
150 | Magdeburg | Sachsen-Anhalt | Germany | 39112 | |
151 | Dresden | Sachsen | Germany | 01067 | |
152 | Dresden | Sachsen | Germany | 01307 | |
153 | Erfurt | Thüringen | Germany | 99089 | |
154 | Berlin | Germany | 10787 | ||
155 | Karlsbad | Germany | 76307 | ||
156 | Baja | Hungary | 6500 | ||
157 | Budapest | Hungary | 1115 | ||
158 | Debrecen | Hungary | 4032 | ||
159 | Gyula | Hungary | 5700 | ||
160 | Kecskemet | Hungary | 6000 | ||
161 | Miskolc | Hungary | 3526 | ||
162 | Pecs | Hungary | 7624 | ||
163 | Szentes | Hungary | 6600 | ||
164 | Szombathely | Hungary | 9700 | ||
165 | Zalaegerszeg | Hungary | 8900 | ||
166 | Afula | Israel | 1834111 | ||
167 | Haifa | Israel | 3109601 | ||
168 | Haifa | Israel | 3339419 | ||
169 | Holon | Israel | 5810001 | ||
170 | Kfar Saba | Israel | 4428164 | ||
171 | Nahariya | Israel | 2210001 | ||
172 | Petah Tikva | Israel | 4941492 | ||
173 | Tel-Aviv | Israel | 64239 | ||
174 | Zefat | Israel | 1311001 | ||
175 | Chieti | Abruzzo | Italy | 66013 | |
176 | Cosenza | Calabria | Italy | 87100 | |
177 | Piacenza | Emilia-Romagna | Italy | 29121 | |
178 | Reggio Emilia | Emilia-Romagna | Italy | 42100 | |
179 | Varese | Lombardia | Italy | 21100 | |
180 | Perugia | Umbria | Italy | 06156 | |
181 | Padova | Veneto | Italy | 35128 | |
182 | Treviso | Veneto | Italy | 31029 | |
183 | Treviso | Veneto | Italy | 31033 | |
184 | Donggu, | Gwangju Gwang''yeogsi | Korea, Republic of | 501-757 | |
185 | Busan | Korea, Republic of | 602-739 | ||
186 | Daegu | Korea, Republic of | 705-718 | ||
187 | Seoul | Korea, Republic of | 03080 | ||
188 | Seoul | Korea, Republic of | 120-752 | ||
189 | Seoul | Korea, Republic of | 135-710 | ||
190 | Leon | Guanajuato | Mexico | 37000 | |
191 | León | Guanajuato | Mexico | 37000 | |
192 | Guadalajara | Jalisco | Mexico | 44280 | |
193 | Guadalajara | Jalisco | Mexico | 44340 | |
194 | Monterrey | Nuevo Leon | Mexico | 64718 | |
195 | Xalapa | Veracruz | Mexico | 91020 | |
196 | Merida | Yucatán | Mexico | 97129 | |
197 | Aguascalientes | Mexico | 20230 | ||
198 | Chihuahua | Mexico | 31203 | ||
199 | Alkmaar | Netherlands | 1815 JD | ||
200 | Almere | Netherlands | 1315 RA | ||
201 | Amsterdam | Netherlands | 1105 AZ | ||
202 | Assen | Netherlands | 9401 RK | ||
203 | Dordrecht | Netherlands | 3318 AT | ||
204 | Groningen | Netherlands | 9713 GZ | ||
205 | Hoofddorp | Netherlands | 2134 TM | ||
206 | Maastricht | Netherlands | 6229 HX | ||
207 | Sittard | Netherlands | 6131 BK | ||
208 | Zwolle | Netherlands | 8025 AB | ||
209 | Auckland | New Zealand | 1023 | ||
210 | Auckland | New Zealand | 1309 | ||
211 | Auckland | New Zealand | 2024 | ||
212 | Christchurch | New Zealand | 8011 | ||
213 | Palmerston North | New Zealand | 4414 | ||
214 | Wellington | New Zealand | 6021 | ||
215 | Fredrikstad | Norway | 1603 | ||
216 | Oslo | Norway | 0450 | ||
217 | Quezon City | Philippines | NCR 1100 | ||
218 | Bialystok | Poland | 15-276 | ||
219 | Bydgoszcz | Poland | 85-681 | ||
220 | Poznan | Poland | 60-631 | ||
221 | Warszawa | Poland | 01-138 | ||
222 | Wroclaw | Poland | 51-124 | ||
223 | Barnaul | Russian Federation | 656045 | ||
224 | Moscow | Russian Federation | 111539 | ||
225 | Moscow | Russian Federation | 121552 | ||
226 | Novosibirsk | Russian Federation | 630055 | ||
227 | Novosibirsk | Russian Federation | 630087 | ||
228 | Rostov-on-Don | Russian Federation | 344022 | ||
229 | Ryazan | Russian Federation | 390026 | ||
230 | Sochi | Russian Federation | 354057 | ||
231 | St. Petersburg | Russian Federation | 197022 | ||
232 | St. Petersburg | Russian Federation | |||
233 | Tver | Russian Federation | 170036 | ||
234 | Johannesburg | Gauteng | South Africa | 2132 | |
235 | Johannesburg | Gauteng | South Africa | 2191 | |
236 | Pretoria West | Gauteng | South Africa | 0082 | |
237 | Pretoria | Gauteng | South Africa | 0181 | |
238 | Roodepoort | Gauteng | South Africa | 1724 | |
239 | Worcester | Western Cape | South Africa | 6850 | |
240 | Bloemfontein | South Africa | 9301 | ||
241 | Torrevieja | Alicante | Spain | 03186 | |
242 | L'Hospitalet de Llobregat | Barcelona | Spain | 08907 | |
243 | San Sebastián de los Reyes | Madrid | Spain | 28702 | |
244 | Girona | Spain | 17007 | ||
245 | Madrid | Spain | 28007 | ||
246 | Göteborg | Sweden | 416 85 | ||
247 | Kristianstad | Sweden | 29185 | ||
248 | Basel | Basel-Stadt | Switzerland | 4031 | |
249 | Lausanne | Vaud | Switzerland | 1011 | |
250 | Bern | Switzerland | 3010 | ||
251 | Fribourg | Switzerland | 1700 | ||
252 | Genève | Switzerland | 1205 | ||
253 | Luzern | Switzerland | 6000 | ||
254 | New Taipei City | Taiwan | 220 | ||
255 | Taichung | Taiwan | 40447 | ||
256 | Taipei | Taiwan | 11217 | ||
257 | Bangkok | Thailand | 10400 | ||
258 | Khon Kaen | Thailand | 40002 | ||
259 | Istanbul | Turkey | 34-300 | ||
260 | Istanbul | Turkey | 34760 | ||
261 | Plymouth | Devon | United Kingdom | PL6 8DH | |
262 | Hull | Humberside | United Kingdom | HU3 2JZ | |
263 | Newcastle Upon Tyne | Tyne And Wear | United Kingdom | NE1 4LP | |
264 | Cardiff | United Kingdom | CF14 4XW | ||
265 | London | United Kingdom | SE1 7EH | ||
266 | Ha Noi | Vietnam | |||
267 | Ho Chi Minh | Vietnam | 70000 |
Sponsors and Collaborators
- Bayer
- Janssen Scientific Affairs, LLC
Investigators
- Study Director: Bayer Study Director, Bayer
Study Documents (Full-Text)
None provided.More Information
Publications
- 16416
- 2013-000619-26
Study Results
Participant Flow
Recruitment Details | In total 3439 participants were screened at 244 sites in 31 countries from 05-Mar-2014 (First Patient First Visit) to 15-Mar-2016 (Last Patient First Visit). |
---|---|
Pre-assignment Detail | Of the 3439 participants screened 43 did not complete screening. Thus, 3396 participants were randomly assigned to treatment, 31 of the randomized participants never received study medication because either withdrew consent or were withdrawn from the study based on protocol violations. |
Arm/Group Title | Rivaroxaban (Xarelto, BAY59-7939) 10 mg, OD | Rivaroxaban (Xarelto, BAY59-7939) 20 mg, OD | Acetylsalicylic (ASA) 100 mg, OD |
---|---|---|---|
Arm/Group Description | Participants were randomized, stratified by country and by index event, to receive rivaroxaban 10 mg tablet or matching placebo once daily (OD) with food for 12, or 9 to less than 12, or 6 months depending on the date of randomization. Treatment of all participants stopped 6 months after the last participant was randomized. | Participants were randomized, stratified by country and by index event, to receive rivaroxaban 20 mg tablet or matching placebo OD with food for 12, or 9 to less than 12, or 6 months depending on the date of randomization. Treatment of all participants stopped 6 months after the last participant was randomized. | Participants were randomized, stratified by country and by index event, to receive ASA 100 mg tablet or matching placebo OD with food for 12, or 9 to less than 12, or 6 months depending on the date of randomization. Treatment of all participants stopped 6 months after the last participant was randomized. |
Period Title: Overall Study | |||
STARTED | 1127 | 1107 | 1131 |
COMPLETED | 984 | 969 | 949 |
NOT COMPLETED | 143 | 138 | 182 |
Baseline Characteristics
Arm/Group Title | Rivaroxaban (Xarelto, BAY59-7939) 10 mg, OD | Rivaroxaban (Xarelto, BAY59-7939) 20 mg, OD | Acetylsalicylic (ASA) 100 mg, OD | Total |
---|---|---|---|---|
Arm/Group Description | Participants were randomized, stratified by country and by index event, to receive rivaroxaban 10 mg tablet or matching placebo once daily (OD) with food for 12, or 9 to less than 12, or 6 months depending on the date of randomization. Treatment of all participants stopped 6 months after the last participant was randomized. | Participants were randomized, stratified by country and by index event, to receive rivaroxaban 20 mg tablet or matching placebo OD with food for 12, or 9 to less than 12, or 6 months depending on the date of randomization. Treatment of all participants stopped 6 months after the last participant was randomized. | Participants were randomized, stratified by country and by index event, to receive ASA 100 mg tablet or matching placebo OD with food for 12, or 9 to less than 12, or 6 months depending on the date of randomization. Treatment of all participants stopped 6 months after the last participant was randomized. | Total of all reporting groups |
Overall Participants | 1127 | 1107 | 1131 | 3365 |
Age (years) [Mean (Standard Deviation) ] | ||||
Mean (Standard Deviation) [years] |
58.8
(14.7)
|
57.9
(14.7)
|
58.8
(14.7)
|
58.5
(14.7)
|
Sex: Female, Male (Count of Participants) | ||||
Female |
507
45%
|
505
45.6%
|
488
43.1%
|
1500
44.6%
|
Male |
620
55%
|
602
54.4%
|
643
56.9%
|
1865
55.4%
|
Ethnicity (NIH/OMB) (Count of Participants) | ||||
Hispanic or Latino |
31
2.8%
|
31
2.8%
|
30
2.7%
|
92
2.7%
|
Not Hispanic or Latino |
892
79.1%
|
899
81.2%
|
889
78.6%
|
2680
79.6%
|
Unknown or Not Reported |
204
18.1%
|
177
16%
|
212
18.7%
|
593
17.6%
|
Race (NIH/OMB) (Count of Participants) | ||||
American Indian or Alaska Native |
2
0.2%
|
0
0%
|
2
0.2%
|
4
0.1%
|
Asian |
161
14.3%
|
159
14.4%
|
159
14.1%
|
479
14.2%
|
Native Hawaiian or Other Pacific Islander |
1
0.1%
|
1
0.1%
|
2
0.2%
|
4
0.1%
|
Black or African American |
41
3.6%
|
49
4.4%
|
36
3.2%
|
126
3.7%
|
White |
786
69.7%
|
772
69.7%
|
786
69.5%
|
2344
69.7%
|
More than one race |
1
0.1%
|
0
0%
|
5
0.4%
|
6
0.2%
|
Unknown or Not Reported |
135
12%
|
126
11.4%
|
141
12.5%
|
402
11.9%
|
Outcome Measures
Title | Number of Participants With the Composite of Fatal or Non-fatal Symptomatic Recurrent Venous Thromboembolism |
---|---|
Description | The primary efficacy outcomes (i.e., recurrent venous thromboembolism [VTE] defined as composite of fatal or non-fatal symptomatic recurrent VTE, including unexplained death for which pulmonary embolism [PE] could not be ruled out) as confirmed by the central independent adjudication committee (CIAC) were considered up to the end of the individual intended duration of treatment. Incidence of the composite of the primary and secondary efficacy outcome and its components are based on the first occurrence to participant. |
Time Frame | Up to 12 months, at least 6 months |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Rivaroxaban (Xarelto, BAY59-7939) 10 mg, OD | Rivaroxaban (Xarelto, BAY59-7939) 20 mg, OD | Acetylsalicylic (ASA) 100 mg, OD |
---|---|---|---|
Arm/Group Description | Participants were randomized, stratified by country and by index event, to receive rivaroxaban 10 mg tablet or matching placebo once daily (OD) with food for 12, or 9 to less than 12, or 6 months depending on the date of randomization. Treatment of all participants stopped 6 months after the last participant was randomized. | Participants were randomized, stratified by country and by index event, to receive rivaroxaban 20 mg tablet or matching placebo OD with food for 12, or 9 to less than 12, or 6 months depending on the date of randomization. Treatment of all participants stopped 6 months after the last participant was randomized. | Participants were randomized, stratified by country and by index event, to receive ASA 100 mg tablet or matching placebo OD with food for 12, or 9 to less than 12, or 6 months depending on the date of randomization. Treatment of all participants stopped 6 months after the last participant was randomized. |
Measure Participants | 1127 | 1107 | 1131 |
Composite |
13
1.2%
|
17
1.5%
|
50
4.4%
|
Symptomatic recurrent Deep vein thrombosis (DVT) |
8
0.7%
|
9
0.8%
|
29
2.6%
|
Symptomatic recurrent PE |
5
0.4%
|
6
0.5%
|
19
1.7%
|
Death (PE) |
0
0%
|
0
0%
|
1
0.1%
|
Death (unexplained and PE cannot be ruled out) |
0
0%
|
2
0.2%
|
1
0.1%
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Rivaroxaban (Xarelto, BAY59-7939) 20 mg, OD, Acetylsalicylic (ASA) 100 mg, OD |
---|---|---|
Comments | Statistical analysis was performed on the first occurrence of the composite outcome. | |
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.0001 |
Comments | P-value and hazard ratio estimates based on stratified proportional hazards model, with stratification based index event (DVT or PE with or without DVT). | |
Method | Wald test | |
Comments | ||
Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
Estimated Value | 0.34 | |
Confidence Interval |
(2-Sided) 95% 0.20 to 0.59 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | Rivaroxaban (Xarelto, BAY59-7939) 10 mg, OD, Acetylsalicylic (ASA) 100 mg, OD |
---|---|---|
Comments | Statistical analysis was performed on the first occurrence of the composite outcome. | |
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | <0.0001 |
Comments | P-value and hazard ratio estimates based on stratified proportional hazards model, with stratification based index event (DVT or PE with or without DVT). | |
Method | Wald test | |
Comments | ||
Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
Estimated Value | 0.26 | |
Confidence Interval |
(2-Sided) 98% 0.14 to 0.47 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | Rivaroxaban (Xarelto, BAY59-7939) 10 mg, OD, Rivaroxaban (Xarelto, BAY59-7939) 20 mg, OD |
---|---|---|
Comments | Statistical analysis was performed on the first occurrence of the composite outcome. | |
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.4328 |
Comments | P-value and hazard ratio estimates based on stratified proportional hazards model, with stratification based index event (DVT or PE with or without DVT). | |
Method | Wald test | |
Comments | ||
Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
Estimated Value | 1.34 | |
Confidence Interval |
(2-Sided) 95% 0.65 to 2.75 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Title | Number of Participants With First Treatment-emergent Major Bleeding |
---|---|
Description | The principal safety outcome was major bleeding which was defined according to the criteria of the International Society on Thrombosis and Hemostasis (ISTH) as clinically overt bleeding and associated with a fall in hemoglobin of 2 gram per deciliter (g/dL) or more, or leading to a transfusion of 2 or more units of packed red blood cells or whole blood, or occurring in a critical site, e.g. intracranial, intraspinal, intraocular, pericardial, intra articular, intramuscular with compartment syndrome, retroperitoneal, or contributing to death. Incidence of the composite of the primary and secondary efficacy outcome and its components are based on the first occurrence to participant. |
Time Frame | Up to 12 months, at least 6 months |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Rivaroxaban (Xarelto, BAY59-7939) 10 mg, OD | Rivaroxaban (Xarelto, BAY59-7939) 20 mg, OD | Acetylsalicylic (ASA) 100 mg, OD |
---|---|---|---|
Arm/Group Description | Participants were randomized, stratified by country and by index event, to receive rivaroxaban 10 mg tablet or matching placebo once daily (OD) with food for 12, or 9 to less than 12, or 6 months depending on the date of randomization. Treatment of all participants stopped 6 months after the last participant was randomized. | Participants were randomized, stratified by country and by index event, to receive rivaroxaban 20 mg tablet or matching placebo OD with food for 12, or 9 to less than 12, or 6 months depending on the date of randomization. Treatment of all participants stopped 6 months after the last participant was randomized. | Participants were randomized, stratified by country and by index event, to receive ASA 100 mg tablet or matching placebo OD with food for 12, or 9 to less than 12, or 6 months depending on the date of randomization. Treatment of all participants stopped 6 months after the last participant was randomized. |
Measure Participants | 1127 | 1107 | 1131 |
Any major bleeding |
5
0.4%
|
6
0.5%
|
3
0.3%
|
Fatal bleeding |
0
0%
|
1
0.1%
|
1
0.1%
|
Non-fatal critical organ bleed |
2
0.2%
|
4
0.4%
|
1
0.1%
|
Non-fatal non-critical organ bleeding |
3
0.3%
|
1
0.1%
|
1
0.1%
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Rivaroxaban (Xarelto, BAY59-7939) 20 mg, OD, Acetylsalicylic (ASA) 100 mg, OD |
---|---|---|
Comments | Statistical analysis was performed on the first occurrence of the composite outcome. | |
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.3235 |
Comments | P-value and hazard ratio estimates based on stratified proportional hazards model, with stratification based index event (DVT or PE with or without DVT). | |
Method | Wald test | |
Comments | ||
Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
Estimated Value | 2.01 | |
Confidence Interval |
(2-Sided) 95% 0.50 to 8.04 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | Rivaroxaban (Xarelto, BAY59-7939) 10 mg, OD, Acetylsalicylic (ASA) 100 mg, OD |
---|---|---|
Comments | Statistical analysis was performed on the first occurrence of the composite outcome. | |
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.5005 |
Comments | P-value and hazard ratio estimates based on stratified proportional hazards model, with stratification based index event (DVT or PE with or without DVT). | |
Method | Wald test | |
Comments | ||
Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
Estimated Value | 1.64 | |
Confidence Interval |
(2-Sided) 95% 0.39 to 6.84 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | Rivaroxaban (Xarelto, BAY59-7939) 10 mg, OD, Rivaroxaban (Xarelto, BAY59-7939) 20 mg, OD |
---|---|---|
Comments | Statistical analysis was performed on the first occurrence of the composite outcome. | |
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.7337 |
Comments | P-value and hazard ratio estimates based on stratified proportional hazards model, with stratification based index event (DVT or PE with or without DVT). | |
Method | Wald test | |
Comments | ||
Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
Estimated Value | 1.23 | |
Confidence Interval |
(2-Sided) 95% 0.37 to 4.03 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Title | Number of Participants With the Composite of the Primary Efficacy Outcome, Myocardial Infarction, Ischemic Stroke or Systemic Non-CNS Embolism |
---|---|
Description | The secondary efficacy outcome is the composite of the primary efficacy outcome, myocardial infarction (MI), ischemic stroke or non-central nervous system (CNS) systemic embolism. Incidence of the composite of the primary and secondary efficacy outcome and its components are based on the first occurrence to participant. |
Time Frame | Up to 12 months, at least 6 months |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Rivaroxaban (Xarelto, BAY59-7939) 10 mg, OD | Rivaroxaban (Xarelto, BAY59-7939) 20 mg, OD | Acetylsalicylic (ASA) 100 mg, OD |
---|---|---|---|
Arm/Group Description | Participants were randomized, stratified by country and by index event, to receive rivaroxaban 10 mg tablet or matching placebo once daily (OD) with food for 12, or 9 to less than 12, or 6 months depending on the date of randomization. Treatment of all participants stopped 6 months after the last participant was randomized. | Participants were randomized, stratified by country and by index event, to receive rivaroxaban 20 mg tablet or matching placebo OD with food for 12, or 9 to less than 12, or 6 months depending on the date of randomization. Treatment of all participants stopped 6 months after the last participant was randomized. | Participants were randomized, stratified by country and by index event, to receive ASA 100 mg tablet or matching placebo OD with food for 12, or 9 to less than 12, or 6 months depending on the date of randomization. Treatment of all participants stopped 6 months after the last participant was randomized. |
Measure Participants | 1127 | 1107 | 1131 |
Composite |
18
1.6%
|
19
1.7%
|
56
5%
|
Ischemic stroke |
4
0.4%
|
2
0.2%
|
2
0.2%
|
Non-CNS systemic embolism |
1
0.1%
|
0
0%
|
1
0.1%
|
Myocardial infarction |
0
0%
|
1
0.1%
|
4
0.4%
|
Symptomatic recurrent DVT |
8
0.7%
|
9
0.8%
|
29
2.6%
|
Symptomatic recurrent PE |
5
0.4%
|
6
0.5%
|
18
1.6%
|
Death (PE) |
0
0%
|
0
0%
|
1
0.1%
|
Death (unexplained and PE cannot be ruled out) |
0
0%
|
1
0.1%
|
1
0.1%
|
Death (cardiovascular: myocardial infarction) |
0
0%
|
0
0%
|
0
0%
|
Death (cardiovascular: ischemic stroke) |
0
0%
|
0
0%
|
0
0%
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Rivaroxaban (Xarelto, BAY59-7939) 20 mg, OD, Acetylsalicylic (ASA) 100 mg, OD |
---|---|---|
Comments | Statistical analysis was performed on the first occurrence of the composite outcome. | |
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | <0.0001 |
Comments | P-value and hazard ratio estimates based on stratified proportional hazards model, with stratification based index event (DVT or PE with or without DVT). | |
Method | Wald test | |
Comments | ||
Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
Estimated Value | 0.34 | |
Confidence Interval |
(2-Sided) 95% 0.20 to 0.57 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | Rivaroxaban (Xarelto, BAY59-7939) 10 mg, OD, Acetylsalicylic (ASA) 100 mg, OD |
---|---|---|
Comments | Statistical analysis was performed on the first occurrence of the composite outcome. | |
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | <0.0001 |
Comments | P-value and hazard ratio estimates based on stratified proportional hazards model, with stratification based index event (DVT or PE with or without DVT). | |
Method | Wald test | |
Comments | ||
Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
Estimated Value | 0.32 | |
Confidence Interval |
(2-Sided) 95% 0.19 to 0.54 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | Rivaroxaban (Xarelto, BAY59-7939) 10 mg, OD, Rivaroxaban (Xarelto, BAY59-7939) 20 mg, OD |
---|---|---|
Comments | Statistical analysis was performed on the first occurrence of the composite outcome. | |
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.8172 |
Comments | P-value and hazard ratio estimates based on stratified proportional hazards model, with stratification based index event (DVT or PE with or without DVT). | |
Method | Wald test | |
Comments | ||
Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
Estimated Value | 1.08 | |
Confidence Interval |
(2-Sided) 95% 0.57 to 2.06 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Title | Number of Participants With Non-major Bleeding Associated With Study Drug Interruption for > 14 Days |
---|---|
Description | The secondary safety outcome was clinically relevant non-major (CRNM) bleeding, which was adjudicated by the CIAC using the ASA criteria: the bleeding was non-major and the bleeding was associated with a study medication interruption of more than 14 days. |
Time Frame | Up to 12 months, at least 6 months |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Rivaroxaban (Xarelto, BAY59-7939) 10 mg, OD | Rivaroxaban (Xarelto, BAY59-7939) 20 mg, OD | Acetylsalicylic (ASA) 100 mg, OD |
---|---|---|---|
Arm/Group Description | Participants were randomized, stratified by country and by index event, to receive rivaroxaban 10 mg tablet or matching placebo once daily (OD) with food for 12, or 9 to less than 12, or 6 months depending on the date of randomization. Treatment of all participants stopped 6 months after the last participant was randomized. | Participants were randomized, stratified by country and by index event, to receive rivaroxaban 20 mg tablet or matching placebo OD with food for 12, or 9 to less than 12, or 6 months depending on the date of randomization. Treatment of all participants stopped 6 months after the last participant was randomized. | Participants were randomized, stratified by country and by index event, to receive ASA 100 mg tablet or matching placebo OD with food for 12, or 9 to less than 12, or 6 months depending on the date of randomization. Treatment of all participants stopped 6 months after the last participant was randomized. |
Measure Participants | 1127 | 1107 | 1131 |
Number [participants] |
12
1.1%
|
17
1.5%
|
12
1.1%
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Rivaroxaban (Xarelto, BAY59-7939) 20 mg, OD, Acetylsalicylic (ASA) 100 mg, OD |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.3318 |
Comments | P-value and hazard ratio estimates based on stratified proportional hazards model, with stratification based index event (DVT or PE with or without DVT). | |
Method | Wald test | |
Comments | ||
Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
Estimated Value | 1.44 | |
Confidence Interval |
(2-Sided) 95% 0.69 to 3.02 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | Rivaroxaban (Xarelto, BAY59-7939) 10 mg, OD, Acetylsalicylic (ASA) 100 mg, OD |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.9726 |
Comments | P-value and hazard ratio estimates based on stratified proportional hazards model, with stratification based index event (DVT or PE with or without DVT). | |
Method | Wald test | |
Comments | ||
Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
Estimated Value | 0.99 | |
Confidence Interval |
(2-Sided) 95% 0.44 to 2.20 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | Rivaroxaban (Xarelto, BAY59-7939) 10 mg, OD, Rivaroxaban (Xarelto, BAY59-7939) 20 mg, OD |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.3137 |
Comments | P-value and hazard ratio estimates based on stratified proportional hazards model, with stratification based index event (DVT or PE with or without DVT). | |
Method | Wald test | |
Comments | ||
Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
Estimated Value | 1.46 | |
Confidence Interval |
(2-Sided) 95% 0.70 to 3.06 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Adverse Events
Time Frame | From after start of study medication but not more than 2 days after stop of study medication. | |||||
---|---|---|---|---|---|---|
Adverse Event Reporting Description | ||||||
Arm/Group Title | Rivaroxaban (Xarelto, BAY59-7939) 10 mg, OD | Rivaroxaban (Xarelto, BAY59-7939) 20 mg, OD | Acetylsalicylic (ASA) 100 mg, OD | |||
Arm/Group Description | Participants were randomized, stratified by country and by index event, to receive rivaroxaban 10 mg tablet or matching placebo once daily (OD) with food for 12, or 9 to less than 12, or 6 months depending on the date of randomization. Treatment of all participants stopped 6 months after the last participant was randomized. | Participants were randomized, stratified by country and by index event, to receive rivaroxaban 20 mg tablet or matching placebo OD with food for 12, or 9 to less than 12, or 6 months depending on the date of randomization. Treatment of all participants stopped 6 months after the last participant was randomized. | Participants were randomized, stratified by country and by index event, to receive ASA 100 mg tablet or matching placebo OD with food for 12, or 9 to less than 12, or 6 months depending on the date of randomization. Treatment of all participants stopped 6 months after the last participant was randomized. | |||
All Cause Mortality |
||||||
Rivaroxaban (Xarelto, BAY59-7939) 10 mg, OD | Rivaroxaban (Xarelto, BAY59-7939) 20 mg, OD | Acetylsalicylic (ASA) 100 mg, OD | ||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | / (NaN) | / (NaN) | / (NaN) | |||
Serious Adverse Events |
||||||
Rivaroxaban (Xarelto, BAY59-7939) 10 mg, OD | Rivaroxaban (Xarelto, BAY59-7939) 20 mg, OD | Acetylsalicylic (ASA) 100 mg, OD | ||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 78/1127 (6.9%) | 82/1107 (7.4%) | 79/1131 (7%) | |||
Blood and lymphatic system disorders | ||||||
Anaemia | 0/1127 (0%) | 0 | 2/1107 (0.2%) | 2 | 0/1131 (0%) | 0 |
Iron deficiency anaemia | 0/1127 (0%) | 0 | 2/1107 (0.2%) | 2 | 0/1131 (0%) | 0 |
Thrombocytopenia | 0/1127 (0%) | 0 | 1/1107 (0.1%) | 1 | 0/1131 (0%) | 0 |
Cardiac disorders | ||||||
Arteriosclerosis coronary artery | 0/1127 (0%) | 0 | 1/1107 (0.1%) | 1 | 0/1131 (0%) | 0 |
Atrial fibrillation | 1/1127 (0.1%) | 1 | 3/1107 (0.3%) | 3 | 1/1131 (0.1%) | 1 |
Atrial flutter | 1/1127 (0.1%) | 1 | 0/1107 (0%) | 0 | 0/1131 (0%) | 0 |
Atrioventricular block second degree | 1/1127 (0.1%) | 1 | 0/1107 (0%) | 0 | 0/1131 (0%) | 0 |
Bradycardia | 0/1127 (0%) | 0 | 1/1107 (0.1%) | 1 | 0/1131 (0%) | 0 |
Cardiac failure | 1/1127 (0.1%) | 1 | 0/1107 (0%) | 0 | 1/1131 (0.1%) | 1 |
Cardiac failure chronic | 0/1127 (0%) | 0 | 1/1107 (0.1%) | 1 | 0/1131 (0%) | 0 |
Cardiac failure congestive | 0/1127 (0%) | 0 | 0/1107 (0%) | 0 | 1/1131 (0.1%) | 1 |
Coronary artery disease | 0/1127 (0%) | 0 | 0/1107 (0%) | 0 | 2/1131 (0.2%) | 2 |
Mitral valve incompetence | 0/1127 (0%) | 0 | 1/1107 (0.1%) | 1 | 0/1131 (0%) | 0 |
Myocardial ischaemia | 0/1127 (0%) | 0 | 1/1107 (0.1%) | 1 | 0/1131 (0%) | 0 |
Pericarditis | 0/1127 (0%) | 0 | 0/1107 (0%) | 0 | 1/1131 (0.1%) | 1 |
Pericarditis constrictive | 0/1127 (0%) | 0 | 1/1107 (0.1%) | 1 | 0/1131 (0%) | 0 |
Tachycardia | 0/1127 (0%) | 0 | 1/1107 (0.1%) | 1 | 0/1131 (0%) | 0 |
Ear and labyrinth disorders | ||||||
Vertigo | 0/1127 (0%) | 0 | 1/1107 (0.1%) | 1 | 1/1131 (0.1%) | 1 |
Vestibular disorder | 0/1127 (0%) | 0 | 1/1107 (0.1%) | 1 | 0/1131 (0%) | 0 |
Sudden hearing loss | 0/1127 (0%) | 0 | 0/1107 (0%) | 0 | 1/1131 (0.1%) | 1 |
Endocrine disorders | ||||||
Cushing's syndrome | 0/1127 (0%) | 0 | 0/1107 (0%) | 0 | 1/1131 (0.1%) | 1 |
Eye disorders | ||||||
Corneal degeneration | 1/1127 (0.1%) | 1 | 0/1107 (0%) | 0 | 0/1131 (0%) | 0 |
Gastrointestinal disorders | ||||||
Ascites | 0/1127 (0%) | 0 | 1/1107 (0.1%) | 1 | 0/1131 (0%) | 0 |
Diverticulum | 1/1127 (0.1%) | 1 | 0/1107 (0%) | 0 | 0/1131 (0%) | 0 |
Diverticulum intestinal | 0/1127 (0%) | 0 | 1/1107 (0.1%) | 1 | 0/1131 (0%) | 0 |
Gastritis | 1/1127 (0.1%) | 1 | 1/1107 (0.1%) | 1 | 0/1131 (0%) | 0 |
Haemorrhoids | 0/1127 (0%) | 0 | 1/1107 (0.1%) | 1 | 0/1131 (0%) | 0 |
Inguinal hernia | 1/1127 (0.1%) | 1 | 2/1107 (0.2%) | 2 | 0/1131 (0%) | 0 |
Intestinal obstruction | 0/1127 (0%) | 0 | 1/1107 (0.1%) | 1 | 0/1131 (0%) | 0 |
Pancreatitis acute | 0/1127 (0%) | 0 | 0/1107 (0%) | 0 | 1/1131 (0.1%) | 1 |
Pancreatitis relapsing | 0/1127 (0%) | 0 | 0/1107 (0%) | 0 | 1/1131 (0.1%) | 1 |
Umbilical hernia | 0/1127 (0%) | 0 | 0/1107 (0%) | 0 | 1/1131 (0.1%) | 1 |
Subileus | 0/1127 (0%) | 0 | 1/1107 (0.1%) | 1 | 0/1131 (0%) | 0 |
Hypertrophic anal papilla | 1/1127 (0.1%) | 1 | 0/1107 (0%) | 0 | 0/1131 (0%) | 0 |
Abdominal hernia | 1/1127 (0.1%) | 1 | 0/1107 (0%) | 0 | 1/1131 (0.1%) | 1 |
Eosinophilic oesophagitis | 1/1127 (0.1%) | 1 | 0/1107 (0%) | 0 | 0/1131 (0%) | 0 |
Colon dysplasia | 1/1127 (0.1%) | 1 | 0/1107 (0%) | 0 | 0/1131 (0%) | 0 |
General disorders | ||||||
Chest pain | 0/1127 (0%) | 0 | 0/1107 (0%) | 0 | 1/1131 (0.1%) | 1 |
Hepatobiliary disorders | ||||||
Bile duct stone | 0/1127 (0%) | 0 | 0/1107 (0%) | 0 | 1/1131 (0.1%) | 1 |
Biliary colic | 0/1127 (0%) | 0 | 0/1107 (0%) | 0 | 1/1131 (0.1%) | 1 |
Cholecystitis | 0/1127 (0%) | 0 | 1/1107 (0.1%) | 1 | 0/1131 (0%) | 0 |
Cholecystitis acute | 0/1127 (0%) | 0 | 1/1107 (0.1%) | 1 | 2/1131 (0.2%) | 2 |
Cholelithiasis | 1/1127 (0.1%) | 2 | 0/1107 (0%) | 0 | 0/1131 (0%) | 0 |
Immune system disorders | ||||||
Overlap syndrome | 0/1127 (0%) | 0 | 1/1107 (0.1%) | 1 | 0/1131 (0%) | 0 |
Infections and infestations | ||||||
Appendicitis | 1/1127 (0.1%) | 1 | 0/1107 (0%) | 0 | 0/1131 (0%) | 0 |
Cellulitis | 1/1127 (0.1%) | 1 | 2/1107 (0.2%) | 2 | 1/1131 (0.1%) | 1 |
Clostridium difficile colitis | 0/1127 (0%) | 0 | 1/1107 (0.1%) | 1 | 0/1131 (0%) | 0 |
Diarrhoea infectious | 0/1127 (0%) | 0 | 0/1107 (0%) | 0 | 1/1131 (0.1%) | 1 |
Diverticulitis | 1/1127 (0.1%) | 1 | 0/1107 (0%) | 0 | 0/1131 (0%) | 0 |
Erysipelas | 2/1127 (0.2%) | 2 | 0/1107 (0%) | 0 | 2/1131 (0.2%) | 2 |
Gastroenteritis | 2/1127 (0.2%) | 2 | 1/1107 (0.1%) | 1 | 1/1131 (0.1%) | 1 |
Influenza | 0/1127 (0%) | 0 | 1/1107 (0.1%) | 1 | 0/1131 (0%) | 0 |
Nasopharyngitis | 0/1127 (0%) | 0 | 1/1107 (0.1%) | 1 | 0/1131 (0%) | 0 |
Orchitis | 1/1127 (0.1%) | 1 | 0/1107 (0%) | 0 | 0/1131 (0%) | 0 |
Peritonitis | 0/1127 (0%) | 0 | 1/1107 (0.1%) | 1 | 0/1131 (0%) | 0 |
Plasmodium falciparum infection | 1/1127 (0.1%) | 1 | 0/1107 (0%) | 0 | 0/1131 (0%) | 0 |
Pneumonia | 2/1127 (0.2%) | 2 | 5/1107 (0.5%) | 6 | 3/1131 (0.3%) | 3 |
Pseudomembranous colitis | 1/1127 (0.1%) | 1 | 0/1107 (0%) | 0 | 0/1131 (0%) | 0 |
Pyelitis | 0/1127 (0%) | 0 | 0/1107 (0%) | 0 | 1/1131 (0.1%) | 1 |
Pyelonephritis acute | 0/1127 (0%) | 0 | 0/1107 (0%) | 0 | 1/1131 (0.1%) | 1 |
Sepsis | 1/1127 (0.1%) | 1 | 3/1107 (0.3%) | 3 | 2/1131 (0.2%) | 2 |
Septic shock | 0/1127 (0%) | 0 | 1/1107 (0.1%) | 1 | 0/1131 (0%) | 0 |
Urethral abscess | 0/1127 (0%) | 0 | 1/1107 (0.1%) | 1 | 0/1131 (0%) | 0 |
Urinary tract infection | 2/1127 (0.2%) | 2 | 4/1107 (0.4%) | 6 | 0/1131 (0%) | 0 |
Wound infection | 0/1127 (0%) | 0 | 1/1107 (0.1%) | 1 | 0/1131 (0%) | 0 |
Urosepsis | 1/1127 (0.1%) | 1 | 0/1107 (0%) | 0 | 0/1131 (0%) | 0 |
Abscess limb | 0/1127 (0%) | 0 | 1/1107 (0.1%) | 1 | 0/1131 (0%) | 0 |
Arthritis bacterial | 0/1127 (0%) | 0 | 2/1107 (0.2%) | 3 | 0/1131 (0%) | 0 |
Infective exacerbation of chronic obstructive airways disease | 0/1127 (0%) | 0 | 1/1107 (0.1%) | 1 | 0/1131 (0%) | 0 |
Pseudomonal sepsis | 0/1127 (0%) | 0 | 1/1107 (0.1%) | 1 | 0/1131 (0%) | 0 |
Pneumonia bacterial | 0/1127 (0%) | 0 | 1/1107 (0.1%) | 1 | 0/1131 (0%) | 0 |
Lung infection | 0/1127 (0%) | 0 | 1/1107 (0.1%) | 1 | 0/1131 (0%) | 0 |
Borrelia infection | 1/1127 (0.1%) | 1 | 0/1107 (0%) | 0 | 0/1131 (0%) | 0 |
Post procedural infection | 0/1127 (0%) | 0 | 1/1107 (0.1%) | 1 | 0/1131 (0%) | 0 |
Injury, poisoning and procedural complications | ||||||
Ankle fracture | 1/1127 (0.1%) | 1 | 0/1107 (0%) | 0 | 0/1131 (0%) | 0 |
Clavicle fracture | 1/1127 (0.1%) | 1 | 0/1107 (0%) | 0 | 0/1131 (0%) | 0 |
Fall | 1/1127 (0.1%) | 1 | 0/1107 (0%) | 0 | 3/1131 (0.3%) | 3 |
Femoral neck fracture | 1/1127 (0.1%) | 1 | 0/1107 (0%) | 0 | 0/1131 (0%) | 0 |
Femur fracture | 0/1127 (0%) | 0 | 0/1107 (0%) | 0 | 3/1131 (0.3%) | 3 |
Fibula fracture | 0/1127 (0%) | 0 | 1/1107 (0.1%) | 1 | 0/1131 (0%) | 0 |
Head injury | 1/1127 (0.1%) | 1 | 0/1107 (0%) | 0 | 0/1131 (0%) | 0 |
Humerus fracture | 2/1127 (0.2%) | 2 | 0/1107 (0%) | 0 | 1/1131 (0.1%) | 1 |
Injury | 0/1127 (0%) | 0 | 0/1107 (0%) | 0 | 1/1131 (0.1%) | 1 |
Joint dislocation | 1/1127 (0.1%) | 1 | 0/1107 (0%) | 0 | 0/1131 (0%) | 0 |
Overdose | 1/1127 (0.1%) | 1 | 0/1107 (0%) | 0 | 0/1131 (0%) | 0 |
Radius fracture | 0/1127 (0%) | 0 | 1/1107 (0.1%) | 1 | 0/1131 (0%) | 0 |
Road traffic accident | 0/1127 (0%) | 0 | 0/1107 (0%) | 0 | 1/1131 (0.1%) | 1 |
Spinal compression fracture | 0/1127 (0%) | 0 | 0/1107 (0%) | 0 | 1/1131 (0.1%) | 1 |
Tendon rupture | 0/1127 (0%) | 0 | 1/1107 (0.1%) | 1 | 0/1131 (0%) | 0 |
Tibia fracture | 1/1127 (0.1%) | 1 | 1/1107 (0.1%) | 1 | 0/1131 (0%) | 0 |
Cervical vertebral fracture | 0/1127 (0%) | 0 | 0/1107 (0%) | 0 | 1/1131 (0.1%) | 1 |
Lumbar vertebral fracture | 0/1127 (0%) | 0 | 0/1107 (0%) | 0 | 1/1131 (0.1%) | 1 |
Lower limb fracture | 1/1127 (0.1%) | 1 | 0/1107 (0%) | 0 | 0/1131 (0%) | 0 |
Stomal hernia | 0/1127 (0%) | 0 | 0/1107 (0%) | 0 | 1/1131 (0.1%) | 1 |
Pubis fracture | 0/1127 (0%) | 0 | 1/1107 (0.1%) | 1 | 0/1131 (0%) | 0 |
Craniocerebral injury | 0/1127 (0%) | 0 | 0/1107 (0%) | 0 | 1/1131 (0.1%) | 1 |
Investigations | ||||||
Cystoscopy | 1/1127 (0.1%) | 1 | 0/1107 (0%) | 0 | 0/1131 (0%) | 0 |
Haemoglobin decreased | 1/1127 (0.1%) | 1 | 0/1107 (0%) | 0 | 0/1131 (0%) | 0 |
White blood cell count decreased | 1/1127 (0.1%) | 1 | 0/1107 (0%) | 0 | 0/1131 (0%) | 0 |
B-lymphocyte count increased | 0/1127 (0%) | 0 | 1/1107 (0.1%) | 1 | 0/1131 (0%) | 0 |
Metabolism and nutrition disorders | ||||||
Diabetes mellitus inadequate control | 0/1127 (0%) | 0 | 1/1107 (0.1%) | 1 | 0/1131 (0%) | 0 |
Obesity | 0/1127 (0%) | 0 | 1/1107 (0.1%) | 1 | 0/1131 (0%) | 0 |
Type 2 diabetes mellitus | 2/1127 (0.2%) | 2 | 0/1107 (0%) | 0 | 0/1131 (0%) | 0 |
Musculoskeletal and connective tissue disorders | ||||||
Joint ankylosis | 0/1127 (0%) | 0 | 0/1107 (0%) | 0 | 1/1131 (0.1%) | 1 |
Osteitis | 0/1127 (0%) | 0 | 0/1107 (0%) | 0 | 1/1131 (0.1%) | 2 |
Osteoarthritis | 3/1127 (0.3%) | 3 | 0/1107 (0%) | 0 | 5/1131 (0.4%) | 6 |
Pain in extremity | 1/1127 (0.1%) | 1 | 0/1107 (0%) | 0 | 0/1131 (0%) | 0 |
Rheumatoid arthritis | 0/1127 (0%) | 0 | 1/1107 (0.1%) | 1 | 0/1131 (0%) | 0 |
Spinal column stenosis | 0/1127 (0%) | 0 | 2/1107 (0.2%) | 2 | 1/1131 (0.1%) | 1 |
Mobility decreased | 1/1127 (0.1%) | 1 | 0/1107 (0%) | 0 | 0/1131 (0%) | 0 |
Intervertebral disc protrusion | 1/1127 (0.1%) | 1 | 0/1107 (0%) | 0 | 1/1131 (0.1%) | 1 |
Musculoskeletal chest pain | 0/1127 (0%) | 0 | 1/1107 (0.1%) | 1 | 0/1131 (0%) | 0 |
Meniscal degeneration | 0/1127 (0%) | 0 | 1/1107 (0.1%) | 1 | 0/1131 (0%) | 0 |
Spinal pain | 0/1127 (0%) | 0 | 1/1107 (0.1%) | 2 | 0/1131 (0%) | 0 |
Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||
Adenocarcinoma of colon | 1/1127 (0.1%) | 1 | 1/1107 (0.1%) | 1 | 0/1131 (0%) | 0 |
Basal cell carcinoma | 0/1127 (0%) | 0 | 1/1107 (0.1%) | 1 | 1/1131 (0.1%) | 1 |
Benign gastric neoplasm | 0/1127 (0%) | 0 | 0/1107 (0%) | 0 | 1/1131 (0.1%) | 1 |
Bladder cancer | 1/1127 (0.1%) | 1 | 0/1107 (0%) | 0 | 0/1131 (0%) | 0 |
Bladder cancer recurrent | 0/1127 (0%) | 0 | 0/1107 (0%) | 0 | 1/1131 (0.1%) | 1 |
Bladder transitional cell carcinoma | 0/1127 (0%) | 0 | 0/1107 (0%) | 0 | 1/1131 (0.1%) | 1 |
Breast cancer | 0/1127 (0%) | 0 | 0/1107 (0%) | 0 | 1/1131 (0.1%) | 1 |
Cervix carcinoma | 0/1127 (0%) | 0 | 0/1107 (0%) | 0 | 1/1131 (0.1%) | 1 |
Cervix carcinoma recurrent | 1/1127 (0.1%) | 1 | 0/1107 (0%) | 0 | 0/1131 (0%) | 0 |
Endometrial cancer | 0/1127 (0%) | 0 | 1/1107 (0.1%) | 1 | 0/1131 (0%) | 0 |
Gastric cancer | 1/1127 (0.1%) | 1 | 0/1107 (0%) | 0 | 0/1131 (0%) | 0 |
Leiomyosarcoma | 0/1127 (0%) | 0 | 0/1107 (0%) | 0 | 1/1131 (0.1%) | 1 |
Lung carcinoma cell type unspecified stage IV | 1/1127 (0.1%) | 1 | 0/1107 (0%) | 0 | 0/1131 (0%) | 0 |
Malignant melanoma stage I | 0/1127 (0%) | 0 | 1/1107 (0.1%) | 1 | 0/1131 (0%) | 0 |
Malignant melanoma stage IV | 0/1127 (0%) | 0 | 0/1107 (0%) | 0 | 1/1131 (0.1%) | 1 |
Meningioma | 0/1127 (0%) | 0 | 1/1107 (0.1%) | 1 | 0/1131 (0%) | 0 |
Metastases to lung | 0/1127 (0%) | 0 | 1/1107 (0.1%) | 1 | 0/1131 (0%) | 0 |
Metastases to lymph nodes | 1/1127 (0.1%) | 1 | 1/1107 (0.1%) | 1 | 0/1131 (0%) | 0 |
Oesophageal carcinoma | 0/1127 (0%) | 0 | 1/1107 (0.1%) | 1 | 0/1131 (0%) | 0 |
Oesophageal carcinoma stage 0 | 0/1127 (0%) | 0 | 0/1107 (0%) | 0 | 1/1131 (0.1%) | 1 |
Plasma cell myeloma | 1/1127 (0.1%) | 1 | 0/1107 (0%) | 0 | 0/1131 (0%) | 0 |
Rectal cancer recurrent | 1/1127 (0.1%) | 1 | 1/1107 (0.1%) | 1 | 0/1131 (0%) | 0 |
Ureteric cancer | 0/1127 (0%) | 0 | 1/1107 (0.1%) | 1 | 0/1131 (0%) | 0 |
Uterine cancer | 0/1127 (0%) | 0 | 0/1107 (0%) | 0 | 1/1131 (0.1%) | 1 |
Uterine leiomyoma | 1/1127 (0.1%) | 1 | 1/1107 (0.1%) | 1 | 0/1131 (0%) | 0 |
Colon cancer metastatic | 1/1127 (0.1%) | 1 | 0/1107 (0%) | 0 | 0/1131 (0%) | 0 |
Prostate cancer | 3/1127 (0.3%) | 3 | 1/1107 (0.1%) | 1 | 1/1131 (0.1%) | 1 |
Cervix warts | 0/1127 (0%) | 0 | 0/1107 (0%) | 0 | 1/1131 (0.1%) | 1 |
Malignant glioma | 1/1127 (0.1%) | 1 | 0/1107 (0%) | 0 | 0/1131 (0%) | 0 |
Ovarian cancer stage IV | 0/1127 (0%) | 0 | 0/1107 (0%) | 0 | 1/1131 (0.1%) | 1 |
Nervous system disorders | ||||||
Axonal neuropathy | 1/1127 (0.1%) | 1 | 0/1107 (0%) | 0 | 0/1131 (0%) | 0 |
Dizziness | 1/1127 (0.1%) | 2 | 0/1107 (0%) | 0 | 0/1131 (0%) | 0 |
Dyskinesia | 2/1127 (0.2%) | 2 | 0/1107 (0%) | 0 | 0/1131 (0%) | 0 |
Headache | 0/1127 (0%) | 0 | 1/1107 (0.1%) | 1 | 0/1131 (0%) | 0 |
Migraine | 0/1127 (0%) | 0 | 0/1107 (0%) | 0 | 1/1131 (0.1%) | 1 |
Presyncope | 0/1127 (0%) | 0 | 1/1107 (0.1%) | 1 | 0/1131 (0%) | 0 |
Sciatica | 0/1127 (0%) | 0 | 0/1107 (0%) | 0 | 1/1131 (0.1%) | 1 |
Seizure | 1/1127 (0.1%) | 1 | 0/1107 (0%) | 0 | 0/1131 (0%) | 0 |
Syncope | 0/1127 (0%) | 0 | 1/1107 (0.1%) | 1 | 2/1131 (0.2%) | 2 |
Facial paresis | 0/1127 (0%) | 0 | 0/1107 (0%) | 0 | 1/1131 (0.1%) | 1 |
Pregnancy, puerperium and perinatal conditions | ||||||
Abortion spontaneous | 0/1127 (0%) | 0 | 1/1107 (0.1%) | 1 | 0/1131 (0%) | 0 |
Psychiatric disorders | ||||||
Adjustment disorder with depressed mood | 0/1127 (0%) | 0 | 1/1107 (0.1%) | 1 | 0/1131 (0%) | 0 |
Alcohol abuse | 1/1127 (0.1%) | 1 | 0/1107 (0%) | 0 | 1/1131 (0.1%) | 2 |
Alcoholism | 0/1127 (0%) | 0 | 0/1107 (0%) | 0 | 1/1131 (0.1%) | 2 |
Anxiety | 1/1127 (0.1%) | 1 | 0/1107 (0%) | 0 | 0/1131 (0%) | 0 |
Depression | 0/1127 (0%) | 0 | 1/1107 (0.1%) | 1 | 2/1131 (0.2%) | 2 |
Paranoia | 0/1127 (0%) | 0 | 0/1107 (0%) | 0 | 1/1131 (0.1%) | 1 |
Suicide attempt | 3/1127 (0.3%) | 3 | 0/1107 (0%) | 0 | 0/1131 (0%) | 0 |
Renal and urinary disorders | ||||||
Nephrolithiasis | 2/1127 (0.2%) | 2 | 1/1107 (0.1%) | 1 | 0/1131 (0%) | 0 |
Neurogenic bladder | 1/1127 (0.1%) | 1 | 0/1107 (0%) | 0 | 0/1131 (0%) | 0 |
Renal colic | 0/1127 (0%) | 0 | 1/1107 (0.1%) | 1 | 1/1131 (0.1%) | 1 |
Renal failure | 0/1127 (0%) | 0 | 1/1107 (0.1%) | 1 | 0/1131 (0%) | 0 |
Urinary retention | 0/1127 (0%) | 0 | 1/1107 (0.1%) | 1 | 1/1131 (0.1%) | 1 |
Tubulointerstitial nephritis | 0/1127 (0%) | 0 | 1/1107 (0.1%) | 1 | 0/1131 (0%) | 0 |
Urethral stenosis | 1/1127 (0.1%) | 1 | 0/1107 (0%) | 0 | 0/1131 (0%) | 0 |
Acute kidney injury | 0/1127 (0%) | 0 | 0/1107 (0%) | 0 | 2/1131 (0.2%) | 2 |
End stage renal disease | 0/1127 (0%) | 0 | 0/1107 (0%) | 0 | 1/1131 (0.1%) | 1 |
Ureterolithiasis | 0/1127 (0%) | 0 | 1/1107 (0.1%) | 1 | 0/1131 (0%) | 0 |
Reproductive system and breast disorders | ||||||
Prostatitis | 1/1127 (0.1%) | 1 | 0/1107 (0%) | 0 | 0/1131 (0%) | 0 |
Respiratory, thoracic and mediastinal disorders | ||||||
Acute pulmonary oedema | 0/1127 (0%) | 0 | 0/1107 (0%) | 0 | 1/1131 (0.1%) | 1 |
Asthma | 1/1127 (0.1%) | 1 | 1/1107 (0.1%) | 1 | 0/1131 (0%) | 0 |
Chronic obstructive pulmonary disease | 1/1127 (0.1%) | 1 | 3/1107 (0.3%) | 4 | 3/1131 (0.3%) | 3 |
Dyspnoea | 1/1127 (0.1%) | 1 | 2/1107 (0.2%) | 4 | 1/1131 (0.1%) | 1 |
Interstitial lung disease | 0/1127 (0%) | 0 | 1/1107 (0.1%) | 1 | 0/1131 (0%) | 0 |
Nasal polyps | 0/1127 (0%) | 0 | 1/1107 (0.1%) | 1 | 0/1131 (0%) | 0 |
Pleural effusion | 0/1127 (0%) | 0 | 1/1107 (0.1%) | 2 | 0/1131 (0%) | 0 |
Pleurisy | 0/1127 (0%) | 0 | 0/1107 (0%) | 0 | 1/1131 (0.1%) | 1 |
Pulmonary hypertension | 1/1127 (0.1%) | 1 | 0/1107 (0%) | 0 | 1/1131 (0.1%) | 1 |
Respiratory failure | 1/1127 (0.1%) | 1 | 0/1107 (0%) | 0 | 0/1131 (0%) | 0 |
Pulmonary mass | 0/1127 (0%) | 0 | 0/1107 (0%) | 0 | 1/1131 (0.1%) | 1 |
Organising pneumonia | 0/1127 (0%) | 0 | 0/1107 (0%) | 0 | 1/1131 (0.1%) | 1 |
Skin and subcutaneous tissue disorders | ||||||
Rash | 0/1127 (0%) | 0 | 0/1107 (0%) | 0 | 1/1131 (0.1%) | 1 |
Seborrhoea | 0/1127 (0%) | 0 | 0/1107 (0%) | 0 | 1/1131 (0.1%) | 1 |
Urticaria | 1/1127 (0.1%) | 1 | 0/1107 (0%) | 0 | 0/1131 (0%) | 0 |
Pruritus generalised | 0/1127 (0%) | 0 | 1/1107 (0.1%) | 1 | 0/1131 (0%) | 0 |
Cutaneous lupus erythematosus | 0/1127 (0%) | 0 | 0/1107 (0%) | 0 | 1/1131 (0.1%) | 1 |
Surgical and medical procedures | ||||||
Hysterectomy | 0/1127 (0%) | 0 | 1/1107 (0.1%) | 1 | 0/1131 (0%) | 0 |
Meningioma surgery | 1/1127 (0.1%) | 1 | 0/1107 (0%) | 0 | 0/1131 (0%) | 0 |
Vascular disorders | ||||||
Aortic aneurysm | 0/1127 (0%) | 0 | 0/1107 (0%) | 0 | 1/1131 (0.1%) | 1 |
Aortic dissection | 0/1127 (0%) | 0 | 1/1107 (0.1%) | 1 | 0/1131 (0%) | 0 |
Aortic stenosis | 0/1127 (0%) | 0 | 1/1107 (0.1%) | 1 | 0/1131 (0%) | 0 |
Hypertension | 0/1127 (0%) | 0 | 0/1107 (0%) | 0 | 1/1131 (0.1%) | 1 |
Hypertensive crisis | 0/1127 (0%) | 0 | 0/1107 (0%) | 0 | 1/1131 (0.1%) | 1 |
Thrombophlebitis | 0/1127 (0%) | 0 | 0/1107 (0%) | 0 | 1/1131 (0.1%) | 1 |
Peripheral arterial occlusive disease | 1/1127 (0.1%) | 1 | 0/1107 (0%) | 0 | 0/1131 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||||
Rivaroxaban (Xarelto, BAY59-7939) 10 mg, OD | Rivaroxaban (Xarelto, BAY59-7939) 20 mg, OD | Acetylsalicylic (ASA) 100 mg, OD | ||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 40/1127 (3.5%) | 35/1107 (3.2%) | 38/1131 (3.4%) | |||
Cardiac disorders | ||||||
Atrial fibrillation | 6/1127 (0.5%) | 6 | 2/1107 (0.2%) | 2 | 3/1131 (0.3%) | 3 |
Gastrointestinal disorders | ||||||
Abdominal pain upper | 2/1127 (0.2%) | 3 | 2/1107 (0.2%) | 2 | 5/1131 (0.4%) | 5 |
Constipation | 2/1127 (0.2%) | 2 | 0/1107 (0%) | 0 | 7/1131 (0.6%) | 8 |
Diarrhoea | 4/1127 (0.4%) | 4 | 4/1107 (0.4%) | 5 | 1/1131 (0.1%) | 1 |
Dyspepsia | 1/1127 (0.1%) | 1 | 3/1107 (0.3%) | 3 | 4/1131 (0.4%) | 4 |
Gastrooesophageal reflux disease | 1/1127 (0.1%) | 1 | 5/1107 (0.5%) | 5 | 6/1131 (0.5%) | 6 |
Vomiting | 0/1127 (0%) | 0 | 4/1107 (0.4%) | 4 | 2/1131 (0.2%) | 2 |
Infections and infestations | ||||||
Nasopharyngitis | 4/1127 (0.4%) | 4 | 2/1107 (0.2%) | 2 | 0/1131 (0%) | 0 |
Upper respiratory tract infection | 1/1127 (0.1%) | 1 | 4/1107 (0.4%) | 6 | 3/1131 (0.3%) | 4 |
Musculoskeletal and connective tissue disorders | ||||||
Back pain | 3/1127 (0.3%) | 3 | 3/1107 (0.3%) | 3 | 4/1131 (0.4%) | 4 |
Myalgia | 2/1127 (0.2%) | 2 | 2/1107 (0.2%) | 2 | 4/1131 (0.4%) | 4 |
Nervous system disorders | ||||||
Dizziness | 4/1127 (0.4%) | 5 | 4/1107 (0.4%) | 4 | 3/1131 (0.3%) | 3 |
Skin and subcutaneous tissue disorders | ||||||
Pruritus | 8/1127 (0.7%) | 8 | 3/1107 (0.3%) | 3 | 3/1131 (0.3%) | 3 |
Rash | 5/1127 (0.4%) | 5 | 3/1107 (0.3%) | 3 | 3/1131 (0.3%) | 3 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The steering committee will be responsible for the publication and presentation strategy. All publications will be based on data released or agreed by Bayer, verified by the steering committee.
Results Point of Contact
Name/Title | Therapeutic Area Head |
---|---|
Organization | Bayer AG |
Phone | |
clinical-trials-contact@bayer.com |
- 16416
- 2013-000619-26