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PRoFESS - Prevention Regimen For Effectively Avoiding Second Strokes

Sponsor
Boehringer Ingelheim (Industry)
Overall Status
Completed
CT.gov ID
NCT00153062
Collaborator
GlaxoSmithKline (Industry), Bayer (Industry)
20,332
Enrollment
667
Locations
4
Arms
30.5
Patients Per Site

Study Details

Study Description

Brief Summary

The purpose of the trial is to determine if extended-release dipyridamole + aspirin [Aggrenox, Asasa ntin] is superior to clopidogrel [Plavix], and if telmisartan [Micardis, Gliosartan, Kinzal, Kinzalm ono, Predxal, Pritor, Samertan, Telmisartan] is superior to placebo, in the presence of background antihypertensive therapy, in prevention of a second stroke in patients who have recently suffered a stroke and therefore are at high risk of suffering another one.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
20332 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
Primary Purpose:
Prevention
Official Title:
PRoFESS - Prevention Regimen For Effectively Avoiding Second Strokes: A Double-blind, Active and Placebo Controlled Study of Aggrenox vs. Clopidogrel, With and Without Micardis
Study Start Date :
Aug 1, 2003
Actual Primary Completion Date :
Apr 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Aggrenox, Clopidogrel placebo, Micardis

Aggrenox (25mg/200mg) bid, clopidogrel placebo qd, Micardis (80mg) qd

Drug: Aggrenox
25mg aspirin, 200 mg dipyridamole

Drug: Clopidogrel placebo
placebo

Drug: Micardis
80 mg micardis
Placebo Comparator: Aggrenox placebo, clopidogrel,, Micardis

Clopidogrel (75mg) qd; Aggrenox placebo bid, Micardis (80mg) qd

Drug: Micardis
80 mg micardis

Drug: Aggrenox placebo
placebo

Drug: Clopidogrel
75 mg clopidogrel
Placebo Comparator: Aggrenox, clop placebo, micardis placebo

Aggrenox (25mg/200mg) bid, clopidogrel placebo qd, Micardis placebo qd

Drug: Aggrenox
25mg aspirin, 200 mg dipyridamole

Drug: Clopidogrel placebo
placebo

Drug: Micardis placebo
placebo
Placebo Comparator: Aggrenox plcebo, clop, micardis placebo

Clopidogrel (75mg) qd, Aggrenox placebo bid, Micardis placebo qd.

Drug: Aggrenox placebo
placebo

Drug: Clopidogrel
75 mg clopidogrel

Drug: Micardis placebo
placebo

Outcome Measures

Primary Outcome Measures

  1. Number of Patients With First Recurrent Stroke of Any Type, Fatal or Nonfatal (Antiplatelet Comparison Only) [time since randomization; follow-up period is 1.5 to 4.4 years]

  2. Number of Patients With First Recurrent Stroke of Any Type, Fatal or Nonfatal (Telmisartan vs. Placebo Only) [time since randomization; follow-up period is 1.5 to 4.4 years]

Secondary Outcome Measures

  1. Composite Outcome of Stroke, Myocardial Infarction (MI), or Vascular Death (Antiplatelet Comparison Only) [time since randomization; follow-up period is 1.5 to 4.4 years]

    Number of patients with any of stroke, myocardial infarction, vascular death

  2. Composite Outcome of Stroke, Myocardial Infarction, Vascular Death, or New or Worsening Congestive Heart Failure (CHF) (Telmisartan vs. Placebo Only) [time since randomization; follow-up period is 1.5 to 4.4 years]

    Number of patients with any of stroke, myocardial infarction, vascular death, or new or worsening congestive heart failure

  3. Number of Patients With New Onset of Diabetes (Telmisartan vs. Placebo Only) [Randomization to final patient contact]

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion criteria:

Male or female subjects 55 year or older who have suffered an ischemic stroke within the past 90 days and who meet all other inclusion criteria. Include also patients of ages 50 - 54 years and/or 90 to 120 days after the qualifying stroke provided the patient has at least two of the following additional risk factors:

  • Diabetes mellitus

  • Hypertension (systolic BP ¿ 140 or diastolic BP ¿ 90)

  • Smoker at time of qualifying stroke

  • Obesity (BMI>30; BMI=weight (kg)/[height (m)]2)

  • Previous vascular disease (stroke, MI, or peripheral arterial disease prior to qualifying stroke)

  • End-organ-damage (retinopathy, LVH, or microalbuminuria)

  • Hyperlipidemia

Exclusion criteria:

hemorrhagic stroke (must be ruled out by imaging);unable to give informed consent; known brain tumor, severe renal or hepatic insufficiency, current active peptic ulcer disease, severe coronary artery disease including unstable angina pectoris or an MI within the previous 3 months,or history of a hemostatic disorder or systemic bleeding ;hyperkalemia;uncorrected volume or sodium depletion; pre-stroke history of dementia;modified Rankin score greater than 4;qualifying stroke induced by surgical or cardiovascular procedure;uncontrolled hypertension at entry above 180/110 mmHg (goal BPs are lower); SBP 120 mmHg or less for hospitalized patients; currently taking an ARB and not able or willing to switch to alternative; required or planned continuing treatment with antithrombotics or anticoagulants including heparin or warfarin or non-study platelet inhibitors; syndrome of asthma, rhinitis and nasal polyps;scheduled for major surgery, carotid endarterectomy, or carotid angioplasty (4 weeks post surgery is allowed);unlikely to be released from hospital following the qualifying stroke or presence of a severe disability likely to lead to being bedridden or demented or a non-vascular disease or condition which makes it unlikely that the patient will survive to the end of the trial; history of thrombocytopenia or neutropenia.

Contacts and Locations

Locations

Site City State Country Postal Code
1 9.159.1101 Boehringer Ingelheim Investigational Site Birmingham Alabama United States
2 9.159.1173 Boehringer Ingelheim Investigational Site Huntsville Alabama United States
3 9.159.1058 Boehringer Ingelheim Investigational Site Mobile Alabama United States
4 9.159.1087 Boehringer Ingelheim Investigational Site Montgomery Alabama United States
5 9.159.1081 Boehringer Ingelheim Investigational Site Northport Alabama United States
6 9.159.1022 Boehringer Ingelheim Investigational Site Phoenix Arizona United States
7 9.159.1133 Boehringer Ingelheim Investigational Site Phoenix Arizona United States
8 9.159.1149 Boehringer Ingelheim Investigational Site Phoenix Arizona United States
9 9.159.1137 Boehringer Ingelheim Investigational Site Tucson Arizona United States
10 9.159.1184 Boehringer Ingelheim Investigational Site Fayetteville Arkansas United States
11 9.159.1005 Boehringer Ingelheim Investigational Site Fort Smith Arkansas United States
12 9.159.1136 Boehringer Ingelheim Investigational Site Jonesboro Arkansas United States
13 9.159.1062 Boehringer Ingelheim Investigational Site Little Rock Arkansas United States
14 9.159.1040 Boehringer Ingelheim Investigational Site Berkeley California United States
15 9.159.1180 Boehringer Ingelheim Investigational Site Carmichael California United States
16 9.159.1114 Boehringer Ingelheim Investigational Site Irvine California United States
17 9.159.1202 Boehringer Ingelheim Investigational Site Laguna Hills California United States
18 9.159.1036 Boehringer Ingelheim Investigational Site Los Angeles California United States
19 9.159.1052 Boehringer Ingelheim Investigational Site Los Angeles California United States
20 9.159.1100 Boehringer Ingelheim Investigational Site Los Angeles California United States
21 9.159.1111 Boehringer Ingelheim Investigational Site Los Angeles California United States
22 9.159.1165 Boehringer Ingelheim Investigational Site Los Angeles California United States
23 9.159.1134 Boehringer Ingelheim Investigational Site Oceanside California United States
24 9.159.1002 Boehringer Ingelheim Investigational Site Palo Alto California United States
25 9.159.1108 Boehringer Ingelheim Investigational Site Redding California United States
26 9.159.1013 Boehringer Ingelheim Investigational Site Sacramento California United States
27 9.159.1198 Boehringer Ingelheim Investigational Site Sacramento California United States
28 9.159.1029 Boehringer Ingelheim Investigational Site San Diego California United States
29 9.159.1185 Boehringer Ingelheim Investigational Site San Francisco California United States
30 9.159.1218 Boehringer Ingelheim Investigational Site San Jose California United States
31 9.159.1179 Boehringer Ingelheim Investigational Site Santa Rosa California United States
32 9.159.1162 Boehringer Ingelheim Investigational Site Sylmar California United States
33 9.159.1183 Boehringer Ingelheim Investigational Site Torrance California United States
34 9.159.1205 Boehringer Ingelheim Investigational Site Walnut Creek California United States
35 9.159.1118 Boehringer Ingelheim Investigational Site Denver Colorado United States
36 9.159.1045 Boehringer Ingelheim Investigational Site Englewood Colorado United States
37 9.159.1038 Boehringer Ingelheim Investigational Site Danbury Connecticut United States
38 9.159.1196 Boehringer Ingelheim Investigational Site Fairfield Connecticut United States
39 9.159.1018 Boehringer Ingelheim Investigational Site Hartford Connecticut United States
40 9.159.1080 Boehringer Ingelheim Investigational Site Newark Delaware United States
41 9.159.1120 Boehringer Ingelheim Investigational Site Washington District of Columbia United States
42 9.159.1216 Boehringer Ingelheim Investigational Site Washington District of Columbia United States
43 9.159.1057 Boehringer Ingelheim Investigational Site Bay Pines Florida United States
44 9.159.1217 Boehringer Ingelheim Investigational Site Boca Raton Florida United States
45 9.159.1096 Boehringer Ingelheim Investigational Site Bradenton Florida United States
46 9.159.1144 Boehringer Ingelheim Investigational Site Clearwater Florida United States
47 9.159.1007 Boehringer Ingelheim Investigational Site Ft. Lauderdale Florida United States
48 9.159.1190 Boehringer Ingelheim Investigational Site Jacksonville Florida United States
49 9.159.1150 Boehringer Ingelheim Investigational Site Ocala Florida United States
50 9.159.1153 Boehringer Ingelheim Investigational Site Panama City Florida United States
51 9.159.1041 Boehringer Ingelheim Investigational Site Plantation Florida United States
52 9.159.1072 Boehringer Ingelheim Investigational Site Port Charlotte Florida United States
53 9.159.1063 Boehringer Ingelheim Investigational Site Sarasota Florida United States
54 9.159.1208 Boehringer Ingelheim Investigational Site Tampa Florida United States
55 9.159.1049 Boehringer Ingelheim Investigational Site Vero Beach Florida United States
56 9.159.1176 Boehringer Ingelheim Investigational Site West Palm Beach Florida United States
57 9.159.1071 Boehringer Ingelheim Investigational Site Atlanta Georgia United States
58 9.159.1079 Boehringer Ingelheim Investigational Site Augusta Georgia United States
59 9.159.1181 Boehringer Ingelheim Investigational Site Columbus Georgia United States
60 9.159.1138 Boehringer Ingelheim Investigational Site Decatur Georgia United States
61 9.159.1070 Boehringer Ingelheim Investigational Site Rome Georgia United States
62 9.159.1107 Boehringer Ingelheim Investigational Site Savannah Georgia United States
63 9.159.1189 Boehringer Ingelheim Investigational Site Boise Idaho United States
64 9.159.1026 University of Illinois Chicago Illinois United States
65 9.159.1033 Boehringer Ingelheim Investigational Site Chicago Illinois United States
66 9.159.1060 Boehringer Ingelheim Investigational Site Chicago Illinois United States
67 9.159.1044 Boehringer Ingelheim Investigational Site Maywood Illinois United States
68 9.159.1054 Boehringer Ingelheim Investigational Site Palos Heights Illinois United States
69 9.159.1068 Boehringer Ingelheim Investigational Site Park Ridge Illinois United States
70 9.159.1178 Boehringer Ingelheim Investigational Site Peoria Illinois United States
71 9.159.1156 Boehringer Ingelheim Investigational Site Elkhart Indiana United States
72 9.159.1092 Boehringer Ingelheim Investigational Site South Bend Indiana United States
73 9.159.1027 Boehringer Ingelheim Investigational Site Cedar Rapids Iowa United States
74 9.159.1119 Boehringer Ingelheim Investigational Site Des Moines Iowa United States
75 9.159.1187 Boehringer Ingelheim Investigational Site Des Moines Iowa United States
76 9.159.1059 Boehringer Ingelheim Investigational Site Iowa City Iowa United States
77 9.159.1135 Boehringer Ingelheim Investigational Site Waterloo Iowa United States
78 9.159.1090 Boehringer Ingelheim Investigational Site Kansas City Kansas United States
79 9.159.1129 Central Baptis Hospital Lexington Kentucky United States
80 9.159.1131 Boehringer Ingelheim Investigational Site Lexington Kentucky United States
81 9.159.1206 Boehringer Ingelheim Investigational Site Lexington Kentucky United States
82 9.159.1212 Boehringer Ingelheim Investigational Site Lexington Kentucky United States
83 9.159.1091 Boehringer Ingelheim Investigational Site Louisville Kentucky United States
84 9.159.1147 Boehringer Ingelheim Investigational Site Louisville Kentucky United States
85 9.159.1106 Boehringer Ingelheim Investigational Site Baton Rouge Louisiana United States
86 9.159.1194 Boehringer Ingelheim Investigational Site Marrero Louisiana United States
87 9.159.1083 Boehringer Ingelheim Investigational Site New Orleans Louisiana United States
88 9.159.1195 Boehringer Ingelheim Investigational Site Shreveport Louisiana United States
89 9.159.1024 Boehringer Ingelheim Investigational Site Baltimore Maryland United States
90 9.159.1055 Boehringer Ingelheim Investigational Site Baltimore Maryland United States
91 9.159.1139 Boehringer Ingelheim Investigational Site Baltimore Maryland United States
92 9.159.1031 Boehringer Ingelheim Investigational Site Boston Massachusetts United States
93 9.159.1066 Boehringer Ingelheim Investigational Site Boston Massachusetts United States
94 9.159.1104 Boehringer Ingelheim Investigational Site Boston Massachusetts United States
95 9.159.1166 Boehringer Ingelheim Investigational Site Boston Massachusetts United States
96 9.159.1192 Boehringer Ingelheim Investigational Site South Weymouth Massachusetts United States
97 9.159.1039 Boehringer Ingelheim Investigational Site Worchester Massachusetts United States
98 9.159.1019 Boehringer Ingelheim Investigational Site Detroit Michigan United States
99 9.159.1048 Boehringer Ingelheim Investigational Site Detroit Michigan United States
100 9.159.1089 Boehringer Ingelheim Investigational Site Detroit Michigan United States
101 9.159.1078 Boehringer Ingelheim Investigational Site East Lansing Michigan United States
102 9.159.1143 Boehringer Ingelheim Investigational Site Grand Rapids Michigan United States
103 9.159.1102 Boehringer Ingelheim Investigational Site Kalamazoo Michigan United States
104 9.159.1011 Boehringer Ingelheim Investigational Site Saginaw Michigan United States
105 9.159.1132 Boehringer Ingelheim Investigational Site Southfield Michigan United States
106 9.159.1088 Boehringer Ingelheim Investigational Site Duluth Minnesota United States
107 9.159.1158 Boehringer Ingelheim Investigational Site Duluth Minnesota United States
108 9.159.1084 Boehringer Ingelheim Investigational Site Golden Valley Minnesota United States
109 9.159.1097 Boehringer Ingelheim Investigational Site Minneapolis Minnesota United States
110 9.159.1113 Boehringer Ingelheim Investigational Site Minneapolis Minnesota United States
111 9.159.1128 St. Luke's Hospital MABSI Research Kansas City Missouri United States
112 9.159.1172 Boehringer Ingelheim Investigational Site Lees Summit Missouri United States
113 9.159.1174 Boehringer Ingelheim Investigational Site Saint Louis Missouri United States
114 9.159.1009 Boehringer Ingelheim Investigational Site Springfield Missouri United States
115 9.159.1182 Boehringer Ingelheim Investigational Site St. Louis Missouri United States
116 9.159.1191 Boehringer Ingelheim Investigational Site St. Louis Missouri United States
117 9.159.1146 Boehringer Ingelheim Investigational Site Great Falls Montana United States
118 9.159.1201 Boehringer Ingelheim Investigational Site Omaha Nebraska United States
119 9.159.1127 Boehringer Ingelheim Investigational Site Las Vegas Nevada United States
120 9.159.1188 Boehringer Ingelheim Investigational Site Reno Nevada United States
121 9.159.1204 Boehringer Ingelheim Investigational Site Camden New Jersey United States
122 9.159.1203 Boehringer Ingelheim Investigational Site Edison New Jersey United States
123 9.159.1042 Neurology Consultants of Burlington County Lumberton New Jersey United States
124 9.159.1209 Boehringer Ingelheim Investigational Site New Brunswick New Jersey United States
125 9.159.1125 Boehringer Ingelheim Investigational Site Newark New Jersey United States
126 9.159.1095 Boehringer Ingelheim Investigational Site Ridgewood New Jersey United States
127 9.159.1170 Boehringer Ingelheim Investigational Site Albuquerque New Mexico United States
128 9.159.1086 Boehringer Ingelheim Investigational Site Albany New York United States
129 9.159.1121 Boehringer Ingelheim Investigational Site Bronx New York United States
130 9.159.1130 Boehringer Ingelheim Investigational Site Bronx New York United States
131 9.159.1017 Boehringer Ingelheim Investigational Site Brooklyn New York United States
132 9.159.1064 Boehringer Ingelheim Investigational Site Brooklyn New York United States
133 9.159.1186 Boehringer Ingelheim Investigational Site Brooklyn New York United States
134 9.159.1151 Boehringer Ingelheim Investigational Site Buffalo New York United States
135 9.159.1076 North Shore University Hospital Manasset New York United States
136 9.159.1037 Boehringer Ingelheim Investigational Site Mineola New York United States
137 9.159.1220 Boehringer Ingelheim Investigational Site New Hyde Park New York United States
138 9.159.1001 Boehringer Ingelheim Investigational Site New York New York United States
139 9.159.1116 Boehringer Ingelheim Investigational Site New York New York United States
140 9.159.1142 Saint Luke's-Roosevelt Hospital New York New York United States
141 9.159.1126 Boehringer Ingelheim Investigational Site Schenectady New York United States
142 9.159.1163 Boehringer Ingelheim Investigational Site Stony Brook New York United States
143 9.159.1169 Boehringer Ingelheim Investigational Site Tonawanda New York United States
144 9.159.1065 Boehringer Ingelheim Investigational Site White Plains New York United States
145 9.159.1099 Boehringer Ingelheim Investigational Site Asheville North Carolina United States
146 9.159.1046 Boehringer Ingelheim Investigational Site Chapel Hill North Carolina United States
147 9.159.1094 Boehringer Ingelheim Investigational Site Durham North Carolina United States
148 9.159.1012 Boehringer Ingelheim Investigational Site High Point North Carolina United States
149 9.159.1115 Wilmington North Carolina United States
150 9.159.1051 Boehringer Ingelheim Investigational Site Winston-Salem North Carolina United States
151 9.159.1110 Boehringer Ingelheim Investigational Site Winston-Salem North Carolina United States
152 9.159.1215 Boehringer Ingelheim Investigational Site Bismarck North Dakota United States
153 9.159.1152 Boehringer Ingelheim Investigational Site Fargo North Dakota United States
154 9.159.1159 Boehringer Ingelheim Investigational Site Akron Ohio United States
155 9.159.1085 Boehringer Ingelheim Investigational Site Canton Ohio United States
156 9.159.1032 Boehringer Ingelheim Investigational Site Cincinnati Ohio United States
157 9.159.1025 Boehringer Ingelheim Investigational Site Cleveland Ohio United States
158 9.159.1177 Boehringer Ingelheim Investigational Site Cleveland Ohio United States
159 9.159.1008 Boehringer Ingelheim Investigational Site Columbus Ohio United States
160 9.159.1141 Boehringer Ingelheim Investigational Site Columbus Ohio United States
161 9.159.1053 Boehringer Ingelheim Investigational Site Toledo Ohio United States
162 9.159.1122 Boehringer Ingelheim Investigational Site Youngstown Ohio United States
163 9.159.1199 Boehringer Ingelheim Investigational Site Oklahoma City Oklahoma United States
164 9.159.1010 Boehringer Ingelheim Investigational Site Portland Oregon United States
165 9.159.1171 Boehringer Ingelheim Investigational Site Abington Pennsylvania United States
166 9.159.1210 Boehringer Ingelheim Investigational Site Allentown Pennsylvania United States
167 9.159.1214 Boehringer Ingelheim Investigational Site Allentown Pennsylvania United States
168 9.159.1200 Boehringer Ingelheim Investigational Site Erie Pennsylvania United States
169 9.159.1043 Boehringer Ingelheim Investigational Site Greensburg Pennsylvania United States
170 9.159.1164 Boehringer Ingelheim Investigational Site Hershey Pennsylvania United States
171 9.159.1175 Boehringer Ingelheim Investigational Site Lancaster Pennsylvania United States
172 9.159.1016 Boehringer Ingelheim Investigational Site Philadelphia Pennsylvania United States
173 9.159.1056 Boehringer Ingelheim Investigational Site Philadelphia Pennsylvania United States
174 9.159.1074 Boehringer Ingelheim Investigational Site Philadelphia Pennsylvania United States
175 9.159.1112 Boehringer Ingelheim Investigational Site Pittsburgh Pennsylvania United States
176 9.159.1148 Boehringer Ingelheim Investigational Site Upland Pennsylvania United States
177 9.159.1123 Boehringer Ingelheim Investigational Site Providence Rhode Island United States
178 9.159.1140 Boehringer Ingelheim Investigational Site Columbia South Carolina United States
179 9.159.1207 Boehringer Ingelheim Investigational Site Greenville South Carolina United States
180 9.159.1004 Boehringer Ingelheim Investigational Site Spartanberg South Carolina United States
181 9.159.1006 Boehringer Ingelheim Investigational Site Bristol Tennessee United States
182 9.159.1154 Boehringer Ingelheim Investigational Site Knoxville Tennessee United States
183 9.159.1213 Boehringer Ingelheim Investigational Site Memphis Tennessee United States
184 9.159.1075 Boehringer Ingelheim Investigational Site Nashville Tennessee United States
185 9.159.1219 Boehringer Ingelheim Investigational Site Brownwood Texas United States
186 9.159.1155 Boehringer Ingelheim Investigational Site Dallas Texas United States
187 9.159.1197 Boehringer Ingelheim Investigational Site Dallas Texas United States
188 9.159.1020 Boehringer Ingelheim Investigational Site Houston Texas United States
189 9.159.1023 Boehringer Ingelheim Investigational Site Houston Texas United States
190 9.159.1082 Boehringer Ingelheim Investigational Site Houston Texas United States
191 9.159.1160 Boehringer Ingelheim Investigational Site Houston Texas United States
192 9.159.1047 Boehringer Ingelheim Investigational Site San Antonio Texas United States
193 9.159.1069 Boehringer Ingelheim Investigational Site Tyler Texas United States
194 9.159.1003 Boehringer Ingelheim Investigational Site Bountiful Utah United States
195 9.159.1077 Boehringer Ingelheim Investigational Site Newport News Virginia United States
196 9.159.1021 Boehringer Ingelheim Investigational Site Richmond Virginia United States
197 9.159.1061 Boehringer Ingelheim Investigational Site Salem Virginia United States
198 9.159.1014 Boehringer Ingelheim Investigational Site Seattle Washington United States
199 9.159.1145 Boehringer Ingelheim Investigational Site Spokane Washington United States
200 9.159.1211 Boehringer Ingelheim Investigational Site Charleston West Virginia United States
201 9.159.1035 Boehringer Ingelheim Investigational Site Morgantown West Virginia United States
202 9.159.1030 Boehringer Ingelheim Investigational Site Marshfield Wisconsin United States
203 9.159.1117 Boehringer Ingelheim Investigational Site Milwaukee Wisconsin United States
204 9.159.1098 Community Healthcare Clinic Westhill Medical Specialists Wausau Wisconsin United States
205 9.159.1331 Boehringer Ingelheim Investigational Site Capital Federal Argentina
206 9.159.1333 Boehringer Ingelheim Investigational Site Capital Federal Argentina
207 9.159.1334 Boehringer Ingelheim Investigational Site Capital Federal Argentina
208 9.159.1335 Boehringer Ingelheim Investigational Site Capital Federal Argentina
209 9.159.1336 Boehringer Ingelheim Investigational Site Capital Federal Argentina
210 9.159.1332 Boehringer Ingelheim Investigational Site Rosario, Sta. Fe Argentina
211 9.159.1342 Boehringer Ingelheim Investigational Site Santa Fe Argentina
212 9.159.2444 Boehringer Ingelheim Investigational Site Gosford New South Wales Australia
213 9.159.2449 Boehringer Ingelheim Investigational Site New Lambton New South Wales Australia
214 9.159.2448 Boehringer Ingelheim Investigational Site Westmead New South Wales Australia
215 9.159.2450 Boehringer Ingelheim Investigational Site Herston Queensland Australia
216 9.159.2452 Boehringer Ingelheim Investigational Site Southport Queensland Australia
217 9.159.2451 Boehringer Ingelheim Investigational Site Bedford Park South Australia Australia
218 9.159.2443 Boehringer Ingelheim Investigational Site Box Hill Victoria Australia
219 9.159.2447 Boehringer Ingelheim Investigational Site Melbourne Victoria Australia
220 9.159.2445 Boehringer Ingelheim Investigational Site Parkville Victoria Australia
221 9.159.2446 Boehringer Ingelheim Investigational Site West Heidelberg Victoria Australia
222 9.159.1515 Boehringer Ingelheim Investigational Site Graz Austria
223 9.159.1519 Boehringer Ingelheim Investigational Site Graz Austria
224 9.159.1517 Boehringer Ingelheim Investigational Site Innsbruck Austria
225 9.159.1516 Boehringer Ingelheim Investigational Site Linz Austria
226 9.159.1518 Boehringer Ingelheim Investigational Site Ma.Gugging/Klosterneuburg Austria
227 9.159.1520 Boehringer Ingelheim Investigational Site St. Pölten Austria
228 9.159.1521 Boehringer Ingelheim Investigational Site Wien Austria
229 9.159.1553 Boehringer Ingelheim Investigational Site Aalst Belgium
230 9.159.1543 Boehringer Ingelheim Investigational Site Anderlecht Belgium
231 9.159.1552 Boehringer Ingelheim Investigational Site Antwerpen Belgium
232 9.159.1546 Boehringer Ingelheim Investigational Site Bonheiden Belgium
233 9.159.1547 Boehringer Ingelheim Investigational Site Brugge Belgium
234 9.159.1550 Boehringer Ingelheim Investigational Site Bruxelles Belgium
235 9.159.1549 Boehringer Ingelheim Investigational Site Hasselt Belgium
236 9.159.1555 Boehringer Ingelheim Investigational Site Kortrijk Belgium
237 9.159.1554 Boehringer Ingelheim Investigational Site La Louvière Belgium
238 9.159.1544 Boehringer Ingelheim Investigational Site Leuven Belgium
239 9.159.1548 Boehringer Ingelheim Investigational Site Montegnée Belgium
240 9.159.1556 Boehringer Ingelheim Investigational Site Ottignies Belgium
241 9.159.1545 Boehringer Ingelheim Investigational Site Wilrijk Belgium
242 9.159.1551 Boehringer Ingelheim Investigational Site Yvoir Belgium
243 9.159.2869 Complexo Hospitalar Universitario Prof Edgard Santos Salvador Brazil
244 9.159.2853 Boehringer Ingelheim Investigational Site São Paulo Brazil
245 9.159.1397 Foothills Medical Centre Calgary Alberta Canada
246 9.159.1382 Boehringer Ingelheim Investigational Site Edmonton Alberta Canada
247 9.159.1390 Boehringer Ingelheim Investigational Site Lethbridge Alberta Canada
248 9.159.1370 Boehringer Ingelheim Investigational Site Kamloops British Columbia Canada
249 9.159.1368 Boehringer Ingelheim Investigational Site New Westminster British Columbia Canada
250 9.159.1376 Boehringer Ingelheim Investigational Site Penticton British Columbia Canada
251 9.159.1387 Boehringer Ingelheim Investigational Site Vancouver British Columbia Canada
252 9.159.1377 Boehringer Ingelheim Investigational Site Victoria British Columbia Canada
253 9.159.1355 Boehringer Ingelheim Investigational Site Winnipeg Manitoba Canada
254 9.159.1394 Boehringer Ingelheim Investigational Site Winnipeg Manitoba Canada
255 9.159.1356 Boehringer Ingelheim Investigational Site Saint John New Brunswick Canada
256 9.159.1392 Boehringer Ingelheim Investigational Site Corner Brook Newfoundland and Labrador Canada
257 9.159.1385 Boehringer Ingelheim Investigational Site St. John's Newfoundland and Labrador Canada
258 9.159.1373 Boehringer Ingelheim Investigational Site Sydney Nova Scotia Canada
259 9.159.1393 Boehringer Ingelheim Investigational Site Barrie Ontario Canada
260 9.159.1395 Boehringer Ingelheim Investigational Site Hamilton Ontario Canada
261 9.159.1360 Boehringer Ingelheim Investigational Site Kingston Ontario Canada
262 9.159.1367 Boehringer Ingelheim Investigational Site London Ontario Canada
263 9.159.1384 Boehringer Ingelheim Investigational Site London Ontario Canada
264 9.159.1380 Boehringer Ingelheim Investigational Site Mississauga Ontario Canada
265 9.159.1378 Boehringer Ingelheim Investigational Site Ottawa Ontario Canada
266 9.159.1381 Ottawa Hospital General Campus Ottawa Ontario Canada
267 9.159.1366 Boehringer Ingelheim Investigational Site Richmond Hill Ontario Canada
268 9.159.1365 Boehringer Ingelheim Investigational Site Scarborough Ontario Canada
269 9.159.1375 Boehringer Ingelheim Investigational Site Scarborough Ontario Canada
270 9.159.1391 Boehringer Ingelheim Investigational Site Tecumseh Ontario Canada
271 9.159.1369 Boehringer Ingelheim Investigational Site Thunder Bay Ontario Canada
272 9.159.1357 Boehringer Ingelheim Investigational Site Toronto Ontario Canada
273 9.159.1379 Boehringer Ingelheim Investigational Site Toronto Ontario Canada
274 9.159.1383 Boehringer Ingelheim Investigational Site Toronto Ontario Canada
275 9.159.1363 Boehringer Ingelheim Investigational Site Windsor Ontario Canada
276 9.159.1359 Boehringer Ingelheim Investigational Site Greenfield Park Quebec Canada
277 9.159.1361 Boehringer Ingelheim Investigational Site Montreal Quebec Canada
278 9.159.1362 Boehringer Ingelheim Investigational Site Montreal Quebec Canada
279 9.159.1371 Boehringer Ingelheim Investigational Site Montreal Quebec Canada
280 9.159.1374 Boehringer Ingelheim Investigational Site Montreal Quebec Canada
281 9.159.1388 Boehringer Ingelheim Investigational Site Montreal Quebec Canada
282 9.159.1372 Boehringer Ingelheim Investigational Site Quebec City Quebec Canada
283 9.159.1358 Boehringer Ingelheim Investigational Site Saguenay Quebec Canada
284 9.159.1364 Boehringer Ingelheim Investigational Site St. Jerome Quebec Canada
285 9.159.1389 Boehringer Ingelheim Investigational Site Regina Saskatchewan Canada
286 9.159.1396 Boehringer Ingelheim Investigational Site Saskatoon Saskatchewan Canada
287 9.159.2490 Boehringer Ingelheim Investigational Site Beijing China
288 9.159.2491 Boehringer Ingelheim Investigational Site Beijing China
289 9.159.2492 Boehringer Ingelheim Investigational Site Beijing China
290 9.159.2493 Boehringer Ingelheim Investigational Site Beijing China
291 9.159.2494 Boehringer Ingelheim Investigational Site Beijing China
292 9.159.2495 Boehringer Ingelheim Investigational Site Beijing China
293 9.159.2496 Boehringer Ingelheim Investigational Site Beijing China
294 9.159.2503 Boehringer Ingelheim Investigational Site Changchun, Jilin Province China
295 9.159.2500 Boehringer Ingelheim Investigational Site Changsha, Hunan Province China
296 9.159.2513 Boehringer Ingelheim Investigational Site Chengdu, Sichuan Province China
297 9.159.2512 Boehringer Ingelheim Investigational Site Chongqing China
298 9.159.2507 Boehringer Ingelheim Investigational Site Guangzhou, Guangdong Province China
299 9.159.2510 Boehringer Ingelheim Investigational Site Guangzhou, Guangdong Province China
300 9.159.2509 Boehringer Ingelheim Investigational Site Guangzhou China
301 9.159.2518 Boehringer Ingelheim Investigational Site Guangzhou China
302 9.159.2521 Boehringer Ingelheim Investigational Site Guangzhou China
303 9.159.2502 Boehringer Ingelheim Investigational Site Hangzhou, Zhejiang Province China
304 9.159.2504 Boehringer Ingelheim Investigational Site Harbin, Heilongjiang Province China
305 9.159.2505 Boehringer Ingelheim Investigational Site Jinan, Shandong Province China
306 9.159.2506 Boehringer Ingelheim Investigational Site Jinan, Shangdong Province China
307 9.159.2517 Boehringer Ingelheim Investigational Site Nanjing, Jiangsu Province China
308 9.159.2519 Boehringer Ingelheim Investigational Site Nanjing, Jiangsu Province China
309 9.159.2520 Boehringer Ingelheim Investigational Site Nanjing, Jiangsu Province China
310 9.159.2483 Boehringer Ingelheim Investigational Site Shanghai China
311 9.159.2484 Boehringer Ingelheim Investigational Site Shanghai China
312 9.159.2485 Boehringer Ingelheim Investigational Site Shanghai China
313 9.159.2486 Boehringer Ingelheim Investigational Site Shanghai China
314 9.159.2487 Boehringer Ingelheim Investigational Site Shanghai China
315 9.159.2488 Boehringer Ingelheim Investigational Site Shanghai China
316 9.159.2489 Boehringer Ingelheim Investigational Site Shanghai China
317 9.159.2516 Boehringer Ingelheim Investigational Site Suzhou, Jiangsu Province China
318 9.159.2497 Boehringer Ingelheim Investigational Site Tianjin China
319 9.159.2501 Boehringer Ingelheim Investigational Site Wenzhou, Zhejiang Province China
320 9.159.2498 Boehringer Ingelheim Investigational Site Wuhan, Hubei Province China
321 9.159.2499 Boehringer Ingelheim Investigational Site Wuhan, Hubei Province China
322 9.159.2515 Boehringer Ingelheim Investigational Site Xian, Shanxi Province China
323 9.159.2514 Boehringer Ingelheim Investigational Site Xian, Shanxi China
324 9.159.2511 Boehringer Ingelheim Investigational Site Xian China
325 9.159.1636 Boehringer Ingelheim Investigational Site Aarhuc C Denmark
326 9.159.1635 Boehringer Ingelheim Investigational Site Aarhus C Denmark
327 9.159.1639 Boehringer Ingelheim Investigational Site Esbjerg Denmark
328 9.159.1634 Boehringer Ingelheim Investigational Site Frederiksberg Denmark
329 9.159.1637 Boehringer Ingelheim Investigational Site Glostrup Denmark
330 9.159.1640 Boehringer Ingelheim Investigational Site Hellerup Denmark
331 9.159.1638 Boehringer Ingelheim Investigational Site Hvidovre Denmark
332 9.159.1633 Boehringer Ingelheim Investigational Site København NV Denmark
333 9.159.1631 Boehringer Ingelheim Investigational Site København Ø Denmark
334 9.159.1632 Boehringer Ingelheim Investigational Site Odense Denmark
335 9.159.2181 Boehringer Ingelheim Investigational Site Oviedo El Salvador
336 9.159.1655 Boehringer Ingelheim Investigational Site Helsinki Finland
337 9.159.1658 Boehringer Ingelheim Investigational Site Kuopio Finland
338 9.159.1659 Boehringer Ingelheim Investigational Site Lappeenranta Finland
339 9.159.1656 Boehringer Ingelheim Investigational Site Oulu Finland
340 9.159.1657 Boehringer Ingelheim Investigational Site Seinäjoki Finland
341 9.159.1680 Boehringer Ingelheim Investigational Site Lille cedex France
342 9.159.1683 Boehringer Ingelheim Investigational Site Limoges cedex 1 France
343 9.159.1681 Boehringer Ingelheim Investigational Site Marseille cedex 05 France
344 9.159.1679 Boehringer Ingelheim Investigational Site Nancy France
345 9.159.1685 Boehringer Ingelheim Investigational Site Paris cedex 19 France
346 9.159.1682 Boehringer Ingelheim Investigational Site Poitiers cedex France
347 9.159.1684 Boehringer Ingelheim Investigational Site Tours cedex 9 France
348 9.159.1713 Boehringer Ingelheim Investigational Site Bad Neustadt/Saale Germany
349 9.159.1736 Boehringer Ingelheim Investigational Site Berlin Germany
350 9.159.1732 Boehringer Ingelheim Investigational Site Braunschweig Germany
351 9.159.1726 Boehringer Ingelheim Investigational Site Cloppenburg Germany
352 9.159.1723 Boehringer Ingelheim Investigational Site Dresden Germany
353 9.159.1728 Boehringer Ingelheim Investigational Site Düsseldorf Germany
354 9.159.1707 Boehringer Ingelheim Investigational Site Essen Germany
355 9.159.1738 Boehringer Ingelheim Investigational Site Freiburg Germany
356 9.159.1720 Boehringer Ingelheim Investigational Site Gießen Germany
357 9.159.1722 Boehringer Ingelheim Investigational Site Hamburg Germany
358 9.159.1739 Boehringer Ingelheim Investigational Site Hamburg Germany
359 9.159.1724 Boehringer Ingelheim Investigational Site Heidelberg Germany
360 9.159.1734 Boehringer Ingelheim Investigational Site Jena Germany
361 9.159.1730 Boehringer Ingelheim Investigational Site Kaiserslautern Germany
362 9.159.1737 Boehringer Ingelheim Investigational Site Köln Germany
363 9.159.1717 Boehringer Ingelheim Investigational Site Leipzig Germany
364 9.159.1735 Boehringer Ingelheim Investigational Site Ludwigshafen am Rhein Germany
365 9.159.1712 Boehringer Ingelheim Investigational Site Magdeburg Germany
366 9.159.1710 Boehringer Ingelheim Investigational Site Mainz Germany
367 9.159.1709 Boehringer Ingelheim Investigational Site Minden Germany
368 9.159.1716 Boehringer Ingelheim Investigational Site Mönchengladbach Germany
369 9.159.1718 Boehringer Ingelheim Investigational Site München Germany
370 9.159.1725 Boehringer Ingelheim Investigational Site München Germany
371 9.159.1729 Boehringer Ingelheim Investigational Site München Germany
372 9.159.1727 Boehringer Ingelheim Investigational Site Münster Germany
373 9.159.1711 Boehringer Ingelheim Investigational Site Nürnberg Germany
374 9.159.1719 Boehringer Ingelheim Investigational Site Regensburg Germany
375 9.159.1731 Boehringer Ingelheim Investigational Site Remscheid Germany
376 9.159.1708 Boehringer Ingelheim Investigational Site Rostock Germany
377 9.159.1715 Boehringer Ingelheim Investigational Site Saarbrücken Germany
378 9.159.1714 Boehringer Ingelheim Investigational Site Siegen Germany
379 9.159.1733 Boehringer Ingelheim Investigational Site Stuttgart Germany
380 9.159.1721 Boehringer Ingelheim Investigational Site Weimar Germany
381 9.159.1826 Boehringer Ingelheim Investigational Site Alexandroupolis Greece
382 9.159.1819 Boehringer Ingelheim Investigational Site Athens Greece
383 9.159.1820 Boehringer Ingelheim Investigational Site Athens Greece
384 9.159.1821 Boehringer Ingelheim Investigational Site Athens Greece
385 9.159.1825 Boehringer Ingelheim Investigational Site Ioannina Greece
386 9.159.1824 Boehringer Ingelheim Investigational Site Patras Greece
387 9.159.2713 Boehringer Ingelheim Investigational Site Hong KoNG Hong Kong
388 9.159.2714 Boehringer Ingelheim Investigational Site Hong Kong Hong Kong
389 9.159.2605 Boehringer Ingelheim Investigational Site Annamalainagar India
390 9.159.2603 Boehringer Ingelheim Investigational Site Bangalore India
391 9.159.2620 Boehringer Ingelheim Investigational Site Bangalore India
392 9.159.2616 Boehringer Ingelheim Investigational Site Bikaner India
393 9.159.2618 Boehringer Ingelheim Investigational Site Calicut India
394 9.159.2604 Boehringer Ingelheim Investigational Site Chennai India
395 9.159.2619 Boehringer Ingelheim Investigational Site Chennai India
396 9.159.2625 Boehringer Ingelheim Investigational Site Chennai India
397 9.159.2606 Boehringer Ingelheim Investigational Site Cochin India
398 9.159.2607 Boehringer Ingelheim Investigational Site Hyderabad India
399 9.159.2624 Boehringer Ingelheim Investigational Site Hyderabad India
400 9.159.2630 Boehringer Ingelheim Investigational Site Hyderabad India
401 9.159.2632 Boehringer Ingelheim Investigational Site Hyderabad India
402 9.159.2610 Boehringer Ingelheim Investigational Site Indore India
403 9.159.2615 Boehringer Ingelheim Investigational Site Jaipur India
404 9.159.2617 Boehringer Ingelheim Investigational Site Jaipur India
405 9.159.2612 Boehringer Ingelheim Investigational Site Jodhpur India
406 9.159.2621 Boehringer Ingelheim Investigational Site Kottayam India
407 9.159.2613 Boehringer Ingelheim Investigational Site Lucknow India
408 9.159.2614 Boehringer Ingelheim Investigational Site Ludhiana India
409 9.159.2611 Boehringer Ingelheim Investigational Site Mumbai India
410 9.159.2628 Boehringer Ingelheim Investigational Site New Delhi India
411 9.159.2629 Boehringer Ingelheim Investigational Site New Delhi India
412 9.159.2623 Boehringer Ingelheim Investigational Site Patiala India
413 9.159.2609 Boehringer Ingelheim Investigational Site Pune India
414 9.159.2622 Boehringer Ingelheim Investigational Site Pune India
415 9.159.2627 Boehringer Ingelheim Investigational Site Secunderabad India
416 9.159.2626 Boehringer Ingelheim Investigational Site Trichy India
417 9.159.2631 Boehringer Ingelheim Investigational Site Visakhapatnam India
418 9.159.2608 Boehringer Ingelheim Investigational Site Wardha India
419 9.159.1851 Boehringer Ingelheim Investigational Site Cork Ireland
420 9.159.1852 Boehringer Ingelheim Investigational Site Dublin 7 Ireland
421 9.159.2729 Barzilai Medical Center Ashkelon Israel
422 9.159.2721 Neurology Unit Haifa Israel
423 9.159.2724 Rambam Medical Center, Tel-Aviv Medical Haifa Israel
424 9.159.2723 Boehringer Ingelheim Investigational Site Israel Israel
425 9.159.2727 Western Galilee Hospital Naharia Israel
426 9.159.2722 Neurology Unit Petach Tikva Israel
427 9.159.2726 Sheba Medical Center Tel Hashomer Israel
428 9.159.2725 Tel Aviv Medical Center Tel-Aviv Israel
429 9.159.1875 Università degli Studi di Ancona Ancona Italy
430 9.159.1882 Ospedale Brotzu Cagliari Italy
431 9.159.1883 Azienda Ospedaliera S. Anna Como Italy
432 9.159.1871 Azienda Ospedaliera "Careggi" Firenze Italy
433 9.159.1869 Università degli Studi di Genova Genova Italy
434 9.159.1870 ASL No. 5 di Jesi Jesi (ancona) Italy
435 9.159.1865 Ospedale Regionale "S. Salvatore" L'aquila Italy
436 9.159.1866 Ospedale S. Raffaele Milano Italy
437 9.159.1873 Istituto Scientifico "S. Luca" Milano Italy
438 9.159.1884 Ospedale S. Carlo Borromeo" Milano Italy
439 9.159.1868 Ospedale "S. Maria di Loreto Mare" Napoli Italy
440 9.159.1876 Azienda Ospedaliera di Padova -Policlinico Universitario Padova Italy
441 9.159.1874 Ospedale Civico - ARNAS Palermo Italy
442 9.159.1872 Neuromed IRCCS Pozzilli (IS) Italy
443 9.159.1879 Policlinico S. Andrea Roma Italy
444 9.159.1881 Università "La Sapienza" Roma Italy
445 9.159.1877 Azienda Ospedaliera Umberto I Siracusa Italy
446 9.159.1878 Azienda Ospedaliera "Santo Maria" Terni Italy
447 9.159.1864 Azienda Ospedaliera "S. Giovanni Battista" Torino Italy
448 9.159.1863 Ospedale di Cattinara Trieste Italy
449 9.159.1867 Presidio Ospedaliero G.Jazzolino Vibo Valentia Italy
450 9.159.1880 Ospedale Civile Vicenza Italy
451 9.159.2964 Boehringer Ingelheim Investigational Site Adachi-ku, Tokyo Japan
452 9.159.2958 Boehringer Ingelheim Investigational Site Akashi, Hyogo Japan
453 9.159.2970 Boehringer Ingelheim Investigational Site Akashi, Hyogo Japan
454 9.159.2965 Boehringer Ingelheim Investigational Site Ako, Hyogo Japan
455 9.159.2968 Boehringer Ingelheim Investigational Site Aoba-ku, Yokohama, Kanagawa Japan
456 9.159.2951 Boehringer Ingelheim Investigational Site Azumino, Nagano Japan
457 9.159.2959 Boehringer Ingelheim Investigational Site Chitose, Hokkaido Japan
458 9.159.2944 Boehringer Ingelheim Investigational Site Chuo-ku, Kobe, Hyogo Japan
459 9.159.2947 Boehringer Ingelheim Investigational Site Chuo-Ku, Sapporo, Hokkaido Japan
460 9.159.2954 Boehringer Ingelheim Investigational Site Fushimi-ku, Kyoto, Kyoto Japan
461 9.159.2942 Boehringer Ingelheim Investigational Site Habikino, Osaka Japan
462 9.159.2948 Boehringer Ingelheim Investigational Site Higashi-ku, Sapporo, Hokkaido Japan
463 9.159.2957 Boehringer Ingelheim Investigational Site Higashi-osaka, Osaka Japan
464 9.159.2940 Boehringer Ingelheim Investigational Site Higashinari-ku, Osaka, Osaka Japan
465 9.159.2973 Boehringer Ingelheim Investigational Site Higashiyodogawa-ku, Osaka, Osaka Japan
466 9.159.2949 Boehringer Ingelheim Investigational Site Hitachinaka, Ibaraki Japan
467 9.159.2953 Boehringer Ingelheim Investigational Site Iida, Nagano Japan
468 9.159.2943 Boehringer Ingelheim Investigational Site Izumisano, Osaka Japan
469 9.159.2963 Boehringer Ingelheim Investigational Site Jyonan-ku, Fukuoka, Fukuoka Japan
470 9.159.2933 Boehringer Ingelheim Investigational Site Kasama, Ibaraki Japan
471 9.159.2955 Boehringer Ingelheim Investigational Site Kasuga, Fukuoka Japan
472 9.159.2938 Boehringer Ingelheim Investigational Site Kita-ku, Osaka, Osaka Japan
473 9.159.2967 Boehringer Ingelheim Investigational Site Koriyama, Fukushima Japan
474 9.159.2969 Boehringer Ingelheim Investigational Site Kushiro, Hokkaido Japan
475 9.159.2952 Boehringer Ingelheim Investigational Site Matsumoto, Nagano Japan
476 9.159.2961 Boehringer Ingelheim Investigational Site Midori-ku, Yokohama, Kanagawa Japan
477 9.159.2934 Boehringer Ingelheim Investigational Site Moriya, Ibaraki Japan
478 9.159.2971 Boehringer Ingelheim Investigational Site Musashino, Tokyo Japan
479 9.159.2962 Boehringer Ingelheim Investigational Site Nakagawa-ku, Nagoya, Aichi Japan
480 9.159.2939 Boehringer Ingelheim Investigational Site Nishi-yodogawa-ku, Osaka, Osaka Japan
481 9.159.2956 Boehringer Ingelheim Investigational Site Ohnojo, Fukuoka Japan
482 9.159.2941 Boehringer Ingelheim Investigational Site Sakai-ku, Sakai, Osaka Japan
483 9.159.2945 Boehringer Ingelheim Investigational Site Sawara-ku, Fukuoka, Fukuoka Japan
484 9.159.2937 Boehringer Ingelheim Investigational Site Shimogyo-ku, Kyoto, Kyoto Japan
485 9.159.2966 Boehringer Ingelheim Investigational Site Shiroishi, Miyagi Japan
486 9.159.2936 Boehringer Ingelheim Investigational Site Suwa, Nagano Japan
487 9.159.2946 Boehringer Ingelheim Investigational Site Takikawa, Hokkaido Japan
488 9.159.2935 Boehringer Ingelheim Investigational Site Tatebayashi, Gunma Japan
489 9.159.2950 Boehringer Ingelheim Investigational Site Tsuchiura, Ibaraki Japan
490 9.159.2972 Boehringer Ingelheim Investigational Site Yao, Osaka Japan
491 9.159.1593 Boehringer Ingelheim Investigational Site Gwangju Korea, Republic of
492 9.159.1595 Boehringer Ingelheim Investigational Site Incheon Korea, Republic of
493 9.159.1592 Boehringer Ingelheim Investigational Site Kyunggi-do Korea, Republic of
494 9.159.1591 Boehringer Ingelheim Investigational Site Seoul Korea, Republic of
495 9.159.1594 Boehringer Ingelheim Investigational Site Seoul Korea, Republic of
496 9.159.1597 Boehringer Ingelheim Investigational Site Seoul Korea, Republic of
497 9.159.1596 Boehringer Ingelheim Investigational Site Suwon Korea, Republic of
498 9.159.2707 Boehringer Ingelheim Investigational Site Kelantan Darul Naim Malaysia
499 9.159.2706 Boehringer Ingelheim Investigational Site Kuala Lumpur Malaysia
500 9.159.2765 Boehringer Ingelheim Investigational Site Metepec Mexico
501 9.159.1960 Jeroen Bosch Ziekenhuis 's-Hertogenbosch Netherlands
502 9.159.1945 Medisch Centrum Alkmaar Alkmaar Netherlands
503 9.159.1963 Polikliniek Neurologie Assen Netherlands
504 9.159.1949 Ziekenhuis Gooi-Noord Blaricum Netherlands
505 9.159.1962 Locatie Molengracht Breda Netherlands
506 9.159.1950 HagaZiekenhuis Den Haag Netherlands
507 9.159.1959 Catharina Ziekenhuis Eindhoven Netherlands
508 9.159.1946 Scheper Ziekenhuis Emmen Netherlands
509 9.159.1958 Medisch Spectrum Twente Enschede Netherlands
510 9.159.1943 Umcg Groningen Netherlands
511 9.159.1961 Lokatie Van Swieten Groningen Netherlands
512 9.159.1953 Atrium Medisch Centrum Heerlen Netherlands
513 9.159.1955 Elkerliek Ziekenhuis Helmond Netherlands
514 9.159.1951 Ziekenhuisgroep Twente Hengelo Netherlands
515 9.159.1948 Medisch Centrum Leeuwarden Leeuwarden Netherlands
516 9.159.1952 Rijnland Ziekenhuis Leiderdorp Netherlands
517 9.159.1947 Sint Antonius Ziekenhuis Nieuwegein Netherlands
518 9.159.1964 Canisius-Wilhelmina ziekenhuis Nijmegen Netherlands
519 9.159.1956 TweeSteden Ziekenhuis Tilburg Tilburg Netherlands
520 9.159.1957 Sint Elisabeth Ziekenhuis Tilburg Netherlands
521 9.159.1944 Máxima Medisch Centrum Veldhoven Netherlands
522 9.159.1954 St. Jans Gasthuis Weert Netherlands
523 9.159.2029 Boehringer Ingelheim Investigational Site Bergen Norway
524 9.159.2028 Boehringer Ingelheim Investigational Site Oslo Norway
525 9.159.2027 Boehringer Ingelheim Investigational Site Trondheim Norway
526 9.159.2040 Hospital Fernando Fonseca Amadora Portugal
527 9.159.2039 Centro Hospitalar e Universitário de Coimbra, EPE Coimbra Portugal
528 9.159.2041 Centro Hospitalar de Lisboa Norte Lisboa Portugal
529 9.159.2042 Centro Hospitalar do Porto Porto Portugal
530 9.159.2114 Boehringer Ingelheim Investigational Site Ekaterinburg Russian Federation
531 9.159.2102 Boehringer Ingelheim Investigational Site Kazan Russian Federation
532 9.159.2117 Boehringer Ingelheim Investigational Site Kemerovo Russian Federation
533 9.159.2107 Boehringer Ingelheim Investigational Site Kirov Russian Federation
534 9.159.2116 Boehringer Ingelheim Investigational Site Krasnoyarsk Russian Federation
535 9.159.2079 Boehringer Ingelheim Investigational Site Moscow Russian Federation
536 9.159.2080 Boehringer Ingelheim Investigational Site Moscow Russian Federation
537 9.159.2081 Boehringer Ingelheim Investigational Site Moscow Russian Federation
538 9.159.2082 Boehringer Ingelheim Investigational Site Moscow Russian Federation
539 9.159.2083 Boehringer Ingelheim Investigational Site Moscow Russian Federation
540 9.159.2084 Boehringer Ingelheim Investigational Site Moscow Russian Federation
541 9.159.2085 Boehringer Ingelheim Investigational Site Moscow Russian Federation
542 9.159.2087 Boehringer Ingelheim Investigational Site Moscow Russian Federation
543 9.159.2088 Boehringer Ingelheim Investigational Site Moscow Russian Federation
544 9.159.2089 Boehringer Ingelheim Investigational Site Moscow Russian Federation
545 9.159.2090 Boehringer Ingelheim Investigational Site Moscow Russian Federation
546 9.159.2091 Boehringer Ingelheim Investigational Site Moscow Russian Federation
547 9.159.2092 Boehringer Ingelheim Investigational Site Moscow Russian Federation
548 9.159.2093 Boehringer Ingelheim Investigational Site Moscow Russian Federation
549 9.159.2095 Boehringer Ingelheim Investigational Site Moscow Russian Federation
550 9.159.2098 Boehringer Ingelheim Investigational Site Moscow Russian Federation
551 9.159.2101 Boehringer Ingelheim Investigational Site Moscow Russian Federation
552 9.159.2105 Boehringer Ingelheim Investigational Site Nizhnyi Novgorod Russian Federation
553 9.159.2115 Boehringer Ingelheim Investigational Site Novosibirsk Russian Federation
554 9.159.2119 Boehringer Ingelheim Investigational Site Omsk Russian Federation
555 9.159.2111 Boehringer Ingelheim Investigational Site Orel Russian Federation
556 9.159.2106 Boehringer Ingelheim Investigational Site Rostov-na-Donu Russian Federation
557 9.159.2108 Boehringer Ingelheim Investigational Site Samara Russian Federation
558 9.159.2109 Boehringer Ingelheim Investigational Site Saratov Russian Federation
559 9.159.2110 Boehringer Ingelheim Investigational Site Saratov Russian Federation
560 9.159.2118 Boehringer Ingelheim Investigational Site Seversk Russian Federation
561 9.159.2086 Boehringer Ingelheim Investigational Site Smolensk Russian Federation
562 9.159.2094 Boehringer Ingelheim Investigational Site St. Petersburg Russian Federation
563 9.159.2097 Boehringer Ingelheim Investigational Site St. Petersburg Russian Federation
564 9.159.2099 Boehringer Ingelheim Investigational Site St. Petersburg Russian Federation
565 9.159.2100 Boehringer Ingelheim Investigational Site St. Petersburg Russian Federation
566 9.159.2120 Boehringer Ingelheim Investigational Site Ufa Russian Federation
567 9.159.2112 Boehringer Ingelheim Investigational Site Volgograd Russian Federation
568 9.159.2113 Boehringer Ingelheim Investigational Site Volgograd Russian Federation
569 9.159.2104 Boehringer Ingelheim Investigational Site Voronezh Russian Federation
570 9.159.2103 Boehringer Ingelheim Investigational Site Yaroslavl Russian Federation
571 9.159.2703 Boehringer Ingelheim Investigational Site Singapore Singapore
572 9.159.2704 Boehringer Ingelheim Investigational Site Singapore Singapore
573 9.159.2705 Boehringer Ingelheim Investigational Site Singapore Singapore
574 9.159.2060 Boehringer Ingelheim Investigational Site Bloemfontein South Africa
575 9.159.2056 Boehringer Ingelheim Investigational Site Cape Town South Africa
576 9.159.2057 Boehringer Ingelheim Investigational Site Durban South Africa
577 9.159.2055 Boehringer Ingelheim Investigational Site Johannesburg South Africa
578 9.159.2061 Boehringer Ingelheim Investigational Site Johannesburg South Africa
579 9.159.2058 Boehringer Ingelheim Investigational Site Pretoria South Africa
580 9.159.2059 Boehringer Ingelheim Investigational Site Sunninghill South Africa
581 9.159.2179 Boehringer Ingelheim Investigational Site Alicante Spain
582 9.159.2177 Boehringer Ingelheim Investigational Site Barcelona Spain
583 9.159.2178 Boehringer Ingelheim Investigational Site Hospitalet de Llobregat (Barcelona) Spain
584 9.159.2175 Boehringer Ingelheim Investigational Site Madrid Spain
585 9.159.2176 Boehringer Ingelheim Investigational Site Madrid Spain
586 9.159.2180 Boehringer Ingelheim Investigational Site Pamplona Spain
587 9.159.2223 Boehringer Ingelheim Investigational Site Borås Sweden
588 9.159.2209 Boehringer Ingelheim Investigational Site Eskilstuna Sweden
589 9.159.2204 Boehringer Ingelheim Investigational Site Göteborg Sweden
590 9.159.2205 Boehringer Ingelheim Investigational Site Göteborg Sweden
591 9.159.2728 Neurology Unit Holon Sweden
592 9.159.2210 Boehringer Ingelheim Investigational Site Jönköping Sweden
593 9.159.2206 Boehringer Ingelheim Investigational Site Lund Sweden
594 9.159.2211 Boehringer Ingelheim Investigational Site Mora Sweden
595 9.159.2216 Boehringer Ingelheim Investigational Site Skellefteå Sweden
596 9.159.2215 Boehringer Ingelheim Investigational Site Skövde Sweden
597 9.159.2203 Boehringer Ingelheim Investigational Site Stockholm Sweden
598 9.159.2212 Boehringer Ingelheim Investigational Site Stockholm Sweden
599 9.159.2213 Boehringer Ingelheim Investigational Site Stockholm Sweden
600 9.159.2222 Boehringer Ingelheim Investigational Site Stockholm Sweden
601 9.159.2225 Boehringer Ingelheim Investigational Site Stockholm Sweden
602 9.159.2207 Boehringer Ingelheim Investigational Site Umeå Sweden
603 9.159.2214 Boehringer Ingelheim Investigational Site Värnamo Sweden
604 9.159.2224 Boehringer Ingelheim Investigational Site Västervik Sweden
605 9.159.2208 Boehringer Ingelheim Investigational Site Örebro Sweden
606 9.159.2250 Boehringer Ingelheim Investigational Site Kaohsiung Taiwan
607 9.159.2253 Boehringer Ingelheim Investigational Site Kaohsiung Taiwan
608 9.159.2248 Boehringer Ingelheim Investigational Site Taichung Taiwan
609 9.159.2249 Boehringer Ingelheim Investigational Site Taichung Taiwan
610 9.159.2251 Boehringer Ingelheim Investigational Site Tainan Taiwan
611 9.159.2244 Boehringer Ingelheim Investigational Site Taipei Taiwan
612 9.159.2245 Boehringer Ingelheim Investigational Site Taipei Taiwan
613 9.159.2246 Boehringer Ingelheim Investigational Site Taipei Taiwan
614 9.159.2247 Boehringer Ingelheim Investigational Site Taipei Taiwan
615 9.159.2252 Boehringer Ingelheim Investigational Site Taipei Taiwan
616 9.159.2254 Boehringer Ingelheim Investigational Site Taipei Taiwan
617 9.159.2243 Boehringer Ingelheim Investigational Site Taoyuan Taiwan
618 9.159.2797 Boehringer Ingelheim Investigational Site Bangkok Thailand
619 9.159.2798 Boehringer Ingelheim Investigational Site Bangkok Thailand
620 9.159.2799 Boehringer Ingelheim Investigational Site Bangkok Thailand
621 9.159.2800 Boehringer Ingelheim Investigational Site Bangkok Thailand
622 9.159.2801 Boehringer Ingelheim Investigational Site Chiang Mai Thailand
623 9.159.2830 Boehringer Ingelheim Investigational Site Ankara Turkey
624 9.159.2829 Boehringer Ingelheim Investigational Site Antalya Turkey
625 9.159.2831 Boehringer Ingelheim Investigational Site Bursa Turkey
626 9.159.2827 Boehringer Ingelheim Investigational Site Eskisehir Turkey
627 9.159.2825 Boehringer Ingelheim Investigational Site Istanbul Turkey
628 9.159.2826 Boehringer Ingelheim Investigational Site Istanbul Turkey
629 9.159.2828 Dkuz Eylul Universitesi Tip Fakultesi Noroloji A.B.D. Izmir Turkey
630 9.159.2387 Boehringer Ingelheim Investigational Site Dnepropetrovsk Ukraine
631 9.159.2384 Boehringer Ingelheim Investigational Site Kharkiv Ukraine
632 9.159.2385 Boehringer Ingelheim Investigational Site Kharkiv Ukraine
633 9.159.2386 Boehringer Ingelheim Investigational Site Kharkiv Ukraine
634 9.159.2392 Boehringer Ingelheim Investigational Site Kharkiv Ukraine
635 9.159.2379 Boehringer Ingelheim Investigational Site Kyiv Ukraine
636 9.159.2380 Boehringer Ingelheim Investigational Site Kyiv Ukraine
637 9.159.2382 Boehringer Ingelheim Investigational Site Kyiv Ukraine
638 9.159.2389 Boehringer Ingelheim Investigational Site Odesa Ukraine
639 9.159.2390 Boehringer Ingelheim Investigational Site Odesa Ukraine
640 9.159.2391 Boehringer Ingelheim Investigational Site Vinnytzya Ukraine
641 9.159.2388 Boehringer Ingelheim Investigational Site Zaporizhzhya Ukraine
642 9.159.2304 Boehringer Ingelheim Investigational Site Belfast United Kingdom
643 9.159.2297 Boehringer Ingelheim Investigational Site Birmingham United Kingdom
644 9.159.2299 Boehringer Ingelheim Investigational Site Bournemouth United Kingdom
645 9.159.2301 Boehringer Ingelheim Investigational Site Bristol United Kingdom
646 9.159.2298 Boehringer Ingelheim Investigational Site Dundee United Kingdom
647 9.159.2307 Boehringer Ingelheim Investigational Site Exeter United Kingdom
648 9.159.2296 Boehringer Ingelheim Investigational Site Glasgow United Kingdom
649 9.159.2300 Boehringer Ingelheim Investigational Site Glasgow United Kingdom
650 9.159.2287 Boehringer Ingelheim Investigational Site Harrow United Kingdom
651 9.159.2303 Boehringer Ingelheim Investigational Site Henshingham, Whitehaven United Kingdom
652 9.159.2308 Boehringer Ingelheim Investigational Site Leicester United Kingdom
653 9.159.2295 Boehringer Ingelheim Investigational Site Liverpool United Kingdom
654 9.159.2286 Boehringer Ingelheim Investigational Site London United Kingdom
655 9.159.2293 Boehringer Ingelheim Investigational Site London United Kingdom
656 9.159.2294 Boehringer Ingelheim Investigational Site London United Kingdom
657 9.159.2305 Boehringer Ingelheim Investigational Site Mansfield United Kingdom
658 9.159.2290 Boehringer Ingelheim Investigational Site Newcastle Upon Tyne United Kingdom
659 9.159.2288 Boehringer Ingelheim Investigational Site North Shields United Kingdom
660 9.159.2285 Boehringer Ingelheim Investigational Site Northampton United Kingdom
661 9.159.2284 Boehringer Ingelheim Investigational Site Nottingham United Kingdom
662 9.159.2283 Boehringer Ingelheim Investigational Site Poole United Kingdom
663 9.159.2302 Boehringer Ingelheim Investigational Site Rotherham United Kingdom
664 9.159.2292 Boehringer Ingelheim Investigational Site Sheffield United Kingdom
665 9.159.2289 Boehringer Ingelheim Investigational Site Southampton United Kingdom
666 9.159.2306 Boehringer Ingelheim Investigational Site Stoke on Trent United Kingdom
667 9.159.2291 Boehringer Ingelheim Investigational Site Sunderland United Kingdom

Sponsors and Collaborators

  • Boehringer Ingelheim
  • GlaxoSmithKline
  • Bayer

Investigators

  • Study Chair: Boehringer Ingelheim, Boehringer Ingelheim

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00153062
Other Study ID Numbers:
  • 9.159
First Posted:
Sep 12, 2005
Last Update Posted:
May 13, 2014
Last Verified:
Apr 1, 2014
Additional relevant MeSH terms:
Stroke
Telmisartan
Clopidogrel
Aspirin, Dipyridamole Drug Combination

Study Results

Participant Flow

Recruitment Details Sept 2003 - July 2006; 695 centres in 35 countries
Pre-assignment Detail No screening period
Arm/Group Title Aspirin + Extended Release Dipyridamole / Telmisartan Aspirin + Extended Release Dipyridamole / Placebo Clopidogrel / Telmisartan Clopidogrel / Placebo
Arm/Group Description 25 milligrams (mg) aspirin + 200 mg extended-release dipyridamole, twice daily, capsule / telmisartan 80 mg, once daily, tablet 25 mg aspirin + 200 mg extended-release dipyridamole, twice daily, capsule / placebo tablet clopidogrel 75 mg, once daily, tablet / telmisartan 80 mg, once daily, tablet clopidogrel 75 mg, once daily, tablet / placebo tablet
Period Title: Overall Study
STARTED 5086 5095 5060 5091
COMPLETED 4699 4689 4645 4680
NOT COMPLETED 387 406 415 411

Baseline Characteristics

Arm/Group Title Aspirin + Extended Release Dipyridamole / Telmisartan Aspirin + Extended Release Dipyridamole / Placebo Clopidogrel / Telmisartan Clopidogrel / Placebo Total
Arm/Group Description 25 milligrams (mg) aspirin + 200 mg extended-release dipyridamole, twice daily, capsule / telmisartan 80 mg, once daily, tablet 25 mg aspirin + 200 mg extended-release dipyridamole, twice daily, capsule / placebo tablet clopidogrel 75 mg, once daily, tablet / telmisartan 80 mg, once daily, tablet clopidogrel 75 mg, once daily, tablet / placebo tablet Total of all reporting groups
Overall Participants 5086 5095 5060 5091 20332
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
66.0
(8.5)
66.2
(8.6)
66.2
(8.6)
66.2
(8.5)
66.1
(8.6)
Sex: Female, Male (Count of Participants)
Female
1802
35.4%
1851
36.3%
1817
35.9%
1840
36.1%
7310.0
36%
Male
3284
64.6%
3244
63.7%
3243
64.1%
3251
63.9%
13022.0
64%

Outcome Measures

1. Primary Outcome
Title Number of Patients With First Recurrent Stroke of Any Type, Fatal or Nonfatal (Antiplatelet Comparison Only)
Description
Time Frame time since randomization; follow-up period is 1.5 to 4.4 years

Outcome Measure Data

Analysis Population Description
Patients were analyzed as randomized and were included in the analysis until final patient contact regardless of whether they were still on treatment.
Arm/Group Title Aspirin + Extended Release Dipyridamole Clopidogrel
Arm/Group Description Consists of patients in the two treatment groups: ASA+ERDP + telmisartan and ASA+ERDP + placebo Consists of patients in the two treatment groups: Clopidogrel + telmisartan and Clopidogrel + placebo
Measure Participants 10181 10151
Number [Participants]
916
18%
898
17.6%
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Aspirin + Extended Release Dipyridamole, Clopidogrel
Comments ASA+ER-DP vs clopidogrel
Type of Statistical Test Non-Inferiority or Equivalence
Comments The pre-defined non-inferiority margin of 1.075
Statistical Test of Hypothesis p-Value 0.7830
Comments
Method Cox Proportional Hazard model
Comments Cox proportional hazards model with age, baseline diabetes status, baseline ACE-I use, and baseline modified Rankin score as covariates
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.01
Confidence Interval (2-Sided) 95%
0.92 to 1.11
Parameter Dispersion Type:
Value:
Estimation Comments
2. Secondary Outcome
Title Composite Outcome of Stroke, Myocardial Infarction (MI), or Vascular Death (Antiplatelet Comparison Only)
Description Number of patients with any of stroke, myocardial infarction, vascular death
Time Frame time since randomization; follow-up period is 1.5 to 4.4 years

Outcome Measure Data

Analysis Population Description
Patients were analyzed as randomized and were included in the analysis until final patient contact regardless of whether they were still on treatment.
Arm/Group Title Aspirin + Extended Release Dipyridamole Clopidogrel
Arm/Group Description Consists of patients in the two treatment groups: ASA+ERDP + telmisartan and ASA+ERDP + placebo Consists of patients in the two treatment groups: Clopidogrel + telmisartan and Clopidogrel + placebo
Measure Participants 10181 10151
Number [Participants]
1333
26.2%
1333
26.2%
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Aspirin + Extended Release Dipyridamole, Clopidogrel
Comments ASA+ER-DP vs Clopidogrel
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.8292
Comments
Method Cox Proportional Hazard model
Comments Cox proportional hazards model with age, baseline diabetes status, baseline ACE-I use, and baseline modified Rankin score as covariates
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.99
Confidence Interval (2-Sided) 95%
0.92 to 1.07
Parameter Dispersion Type:
Value:
Estimation Comments
3. Secondary Outcome
Title Composite Outcome of Stroke, Myocardial Infarction, Vascular Death, or New or Worsening Congestive Heart Failure (CHF) (Telmisartan vs. Placebo Only)
Description Number of patients with any of stroke, myocardial infarction, vascular death, or new or worsening congestive heart failure
Time Frame time since randomization; follow-up period is 1.5 to 4.4 years

Outcome Measure Data

Analysis Population Description
Patients were analyzed as randomized and were included in the analysis until final patient contact regardless of whether they were still on treatment.
Arm/Group Title Telmisartan Placebo
Arm/Group Description Consists of patients in the two treatment groups: ASA+ERDP + telmisartan and Clopidogrel + telmisartan Consists of patients in the two treatment groups: ASA+ERDP + placebo and Clopidogrel + placebo
Measure Participants 10146 10186
Number [Participants]
1367
26.9%
1463
28.7%
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Aspirin + Extended Release Dipyridamole, Clopidogrel
Comments Telmisartan vs Placebo
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.1073
Comments
Method Cox Proportional Hazard model
Comments Cox proportional hazards model with age, baseline diabetes status, baseline ACE-I use, and baseline modified Rankin score as covariates.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.94
Confidence Interval (2-Sided) 95%
0.87 to 1.01
Parameter Dispersion Type:
Value:
Estimation Comments
4. Secondary Outcome
Title Number of Patients With New Onset of Diabetes (Telmisartan vs. Placebo Only)
Description
Time Frame Randomization to final patient contact

Outcome Measure Data

Analysis Population Description
Patients who did not have diabetes mellitus at baseline were analyzed as randomized and were included in the analysis until final patient contact regardless of whether they were still on treatment.
Arm/Group Title Telmisartan Placebo
Arm/Group Description Consists of patients in the two treatment groups: ASA+ERDP + telmisartan and Clopidogrel + telmisartan Consists of patients in the two treatment groups: ASA+ERDP + placebo and Clopidogrel + placebo
Measure Participants 7306 7283
Number [Participants]
125
2.5%
151
3%
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Aspirin + Extended Release Dipyridamole, Clopidogrel
Comments Telmisartan vs Placebo
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.1007
Comments
Method Cox Proportional Hazard model
Comments Cox proportional hazards model with age, baseline ACE-I use, and baseline modified Rankin score as covariates
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.82
Confidence Interval (2-Sided) 95%
0.65 to 1.04
Parameter Dispersion Type:
Value:
Estimation Comments
5. Primary Outcome
Title Number of Patients With First Recurrent Stroke of Any Type, Fatal or Nonfatal (Telmisartan vs. Placebo Only)
Description
Time Frame time since randomization; follow-up period is 1.5 to 4.4 years

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Telmisartan Placebo
Arm/Group Description Consists of patients in the two treatment groups: ASA+ERDP + telmisartan and Clopidogrel + telmisartan Consists of patients in the two treatment groups: ASA+ERDP + placebo and Clopidogrel + placebo
Measure Participants 10146 10186
Number [Participants]
880
17.3%
934
18.3%
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Aspirin + Extended Release Dipyridamole, Clopidogrel
Comments Telmisartan vs placebo
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.2312
Comments
Method Cox Proportional Hazard model
Comments Cox proportional hazards model with age, baseline diabetes status, baseline ACE-I use, and baseline Modified Rankin score as covariates
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.95
Confidence Interval (2-Sided) 95%
0.86 to 1.04
Parameter Dispersion Type:
Value:
Estimation Comments

Adverse Events

Time Frame From day of first dose until 28 days after last dose
Adverse Event Reporting Description Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
Arm/Group Title Aspirin + Extended Release Dipyridamole / Telmisartan Aspirin + Extended Release Dipyridamole / Placebo Clopidogrel / Telmisartan Clopidogrel / Placebo
Arm/Group Description 25 milligrams (mg) aspirin + 200 mg extended-release dipyridamole, twice daily, capsule / telmisartan 80 mg, once daily, tablet 25 mg aspirin + 200 mg extended-release dipyridamole, twice daily, capsule / placebo tablet clopidogrel 75 mg, once daily, tablet / telmisartan 80 mg, once daily, tablet clopidogrel 75 mg, once daily, tablet / placebo tablet
All Cause Mortality
Aspirin + Extended Release Dipyridamole / Telmisartan Aspirin + Extended Release Dipyridamole / Placebo Clopidogrel / Telmisartan Clopidogrel / Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total / (NaN) / (NaN) / (NaN) / (NaN)
Serious Adverse Events
Aspirin + Extended Release Dipyridamole / Telmisartan Aspirin + Extended Release Dipyridamole / Placebo Clopidogrel / Telmisartan Clopidogrel / Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 1145/ (NaN) 1124/ (NaN) 1225/ (NaN) 1163/ (NaN)
Blood and lymphatic system disorders
Agranulocytosis 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Anaemia 21/5013 (0.4%) 25/5024 (0.5%) 21/5000 (0.4%) 10/5023 (0.2%)
Anaemia folate deficiency 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Anaemia megaloblastic 1/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Anaemia of malignant disease 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Anaemia vitamin B12 deficiency 0/5013 (0%) 2/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Aplastic anaemia 1/5013 (0%) 1/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Eosinophilia 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Febrile neutropenia 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Haemolytic anaemia 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Idiopathic thrombocytopenic purpura 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Iron deficiency anaemia 1/5013 (0%) 0/5024 (0%) 3/5000 (0.1%) 1/5023 (0%)
Leukocytosis 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Leukopenia 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Lymphadenopathy 0/5013 (0%) 0/5024 (0%) 3/5000 (0.1%) 0/5023 (0%)
Microcytic anaemia 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Nephrogenic anaemia 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Normochromic normocytic anaemia 1/5013 (0%) 1/5024 (0%) 2/5000 (0%) 0/5023 (0%)
Pancytopenia 5/5013 (0.1%) 0/5024 (0%) 1/5000 (0%) 2/5023 (0%)
Polycythaemia 1/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Splenic infarction 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Thrombocythaemia 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Thrombocytopenia 1/5013 (0%) 1/5024 (0%) 0/5000 (0%) 3/5023 (0.1%)
Cardiac disorders
AV dissociation 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Acute coronary syndrome 3/5013 (0.1%) 3/5024 (0.1%) 3/5000 (0.1%) 2/5023 (0%)
Adams-Stokes syndrome 1/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Angina pectoris 25/5013 (0.5%) 18/5024 (0.4%) 25/5000 (0.5%) 20/5023 (0.4%)
Angina unstable 41/5013 (0.8%) 47/5024 (0.9%) 46/5000 (0.9%) 30/5023 (0.6%)
Aortic valve incompetence 0/5013 (0%) 2/5024 (0%) 1/5000 (0%) 1/5023 (0%)
Aortic valve stenosis 4/5013 (0.1%) 0/5024 (0%) 3/5000 (0.1%) 1/5023 (0%)
Arrhythmia 3/5013 (0.1%) 8/5024 (0.2%) 5/5000 (0.1%) 4/5023 (0.1%)
Arrhythmia supraventricular 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Arteriosclerosis coronary artery 1/5013 (0%) 2/5024 (0%) 2/5000 (0%) 1/5023 (0%)
Atrial fibrillation 42/5013 (0.8%) 38/5024 (0.8%) 54/5000 (1.1%) 47/5023 (0.9%)
Atrial flutter 2/5013 (0%) 3/5024 (0.1%) 4/5000 (0.1%) 1/5023 (0%)
Atrial tachycardia 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Atrioventricular block 0/5013 (0%) 1/5024 (0%) 1/5000 (0%) 2/5023 (0%)
Atrioventricular block complete 4/5013 (0.1%) 3/5024 (0.1%) 1/5000 (0%) 4/5023 (0.1%)
Atrioventricular block first degree 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Atrioventricular block second degree 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 3/5023 (0.1%)
Bradyarrhythmia 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Bradycardia 8/5013 (0.2%) 4/5024 (0.1%) 4/5000 (0.1%) 8/5023 (0.2%)
Cardiac aneurysm 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Cardiac arrest 14/5013 (0.3%) 5/5024 (0.1%) 19/5000 (0.4%) 8/5023 (0.2%)
Cardiac disorder 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Cardiac failure 3/5013 (0.1%) 5/5024 (0.1%) 1/5000 (0%) 2/5023 (0%)
Cardiac failure acute 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 2/5023 (0%)
Cardiac failure congestive 0/5013 (0%) 0/5024 (0%) 2/5000 (0%) 0/5023 (0%)
Cardiac fibrillation 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Cardiac hypertrophy 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Cardiac tamponade 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Cardiac valve disease 0/5013 (0%) 1/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Cardio-respiratory arrest 2/5013 (0%) 9/5024 (0.2%) 5/5000 (0.1%) 7/5023 (0.1%)
Cardiogenic shock 1/5013 (0%) 0/5024 (0%) 3/5000 (0.1%) 0/5023 (0%)
Cardiomyopathy 1/5013 (0%) 1/5024 (0%) 1/5000 (0%) 3/5023 (0.1%)
Cardiopulmonary failure 0/5013 (0%) 0/5024 (0%) 3/5000 (0.1%) 1/5023 (0%)
Cardiovascular disorder 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 2/5023 (0%)
Conduction disorder 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Congestive cardiomyopathy 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 1/5023 (0%)
Cor pulmonale 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Cor pulmonale acute 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Coronary artery disease 14/5013 (0.3%) 33/5024 (0.7%) 21/5000 (0.4%) 31/5023 (0.6%)
Coronary artery dissection 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Coronary artery occlusion 1/5013 (0%) 0/5024 (0%) 2/5000 (0%) 2/5023 (0%)
Coronary artery restenosis 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Coronary artery stenosis 9/5013 (0.2%) 4/5024 (0.1%) 9/5000 (0.2%) 5/5023 (0.1%)
Electromechanical dissociation 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 1/5023 (0%)
Extrasystoles 0/5013 (0%) 1/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Haemorrhage coronary artery 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Hypertensive heart disease 0/5013 (0%) 1/5024 (0%) 3/5000 (0.1%) 0/5023 (0%)
Hypertrophic cardiomyopathy 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
In-stent coronary artery restenosis 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Intracardiac thrombus 2/5013 (0%) 1/5024 (0%) 0/5000 (0%) 2/5023 (0%)
Left ventricular dysfunction 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Left ventricular failure 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Left ventricular hypertrophy 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Mitral valve calcification 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Mitral valve incompetence 2/5013 (0%) 0/5024 (0%) 2/5000 (0%) 0/5023 (0%)
Mitral valve prolapse 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Mitral valve stenosis 0/5013 (0%) 1/5024 (0%) 2/5000 (0%) 0/5023 (0%)
Myocardial infarction 0/5013 (0%) 1/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Myocardial ischaemia 4/5013 (0.1%) 8/5024 (0.2%) 2/5000 (0%) 5/5023 (0.1%)
Myopericarditis 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Palpitations 3/5013 (0.1%) 3/5024 (0.1%) 5/5000 (0.1%) 1/5023 (0%)
Pericardial effusion 0/5013 (0%) 2/5024 (0%) 2/5000 (0%) 0/5023 (0%)
Pericarditis 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Sick sinus syndrome 3/5013 (0.1%) 2/5024 (0%) 3/5000 (0.1%) 2/5023 (0%)
Sinus arrest 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Sinus bradycardia 1/5013 (0%) 0/5024 (0%) 1/5000 (0%) 2/5023 (0%)
Sinus tachycardia 0/5013 (0%) 0/5024 (0%) 2/5000 (0%) 0/5023 (0%)
Supraventricular extrasystoles 0/5013 (0%) 1/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Supraventricular tachycardia 5/5013 (0.1%) 5/5024 (0.1%) 3/5000 (0.1%) 0/5023 (0%)
Tachyarrhythmia 1/5013 (0%) 0/5024 (0%) 3/5000 (0.1%) 1/5023 (0%)
Tachycardia 0/5013 (0%) 0/5024 (0%) 3/5000 (0.1%) 4/5023 (0.1%)
Tachycardia paroxysmal 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Ventricular arrhythmia 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Ventricular extrasystoles 2/5013 (0%) 0/5024 (0%) 3/5000 (0.1%) 2/5023 (0%)
Ventricular fibrillation 1/5013 (0%) 0/5024 (0%) 3/5000 (0.1%) 1/5023 (0%)
Ventricular tachycardia 0/5013 (0%) 2/5024 (0%) 3/5000 (0.1%) 3/5023 (0.1%)
Congenital, familial and genetic disorders
Adenomatous polyposis coli 0/5013 (0%) 1/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Atrial septal defect 1/5013 (0%) 2/5024 (0%) 2/5000 (0%) 3/5023 (0.1%)
Cerebrovascular arteriovenous malformation 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Congenital coronary artery malformation 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Corneal dystrophy 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Gastrointestinal angiodysplasia 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Hydrocele 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Hypospadias 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Spondylolisthesis 0/5013 (0%) 3/5024 (0.1%) 1/5000 (0%) 0/5023 (0%)
Ear and labyrinth disorders
Conductive deafness 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Deafness 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Deafness unilateral 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Ear haemorrhage 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Ear pain 1/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Hypoacusis 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Meniere's disease 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Neurosensory hypoacusis 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Sudden hearing loss 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Tympanic membrane perforation 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Vertigo 13/5013 (0.3%) 12/5024 (0.2%) 20/5000 (0.4%) 10/5023 (0.2%)
Vertigo labyrinthine 0/5013 (0%) 0/5024 (0%) 2/5000 (0%) 0/5023 (0%)
Vertigo positional 2/5013 (0%) 2/5024 (0%) 5/5000 (0.1%) 2/5023 (0%)
Vestibular disorder 2/5013 (0%) 2/5024 (0%) 1/5000 (0%) 2/5023 (0%)
Vestibular neuronitis 2/5013 (0%) 3/5024 (0.1%) 0/5000 (0%) 0/5023 (0%)
Endocrine disorders
Basedow's disease 0/5013 (0%) 2/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Euthyroid sick syndrome 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Goitre 6/5013 (0.1%) 0/5024 (0%) 1/5000 (0%) 2/5023 (0%)
Hyperaldosteronism 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Hyperparathyroidism 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Hyperthyroidism 3/5013 (0.1%) 2/5024 (0%) 1/5000 (0%) 1/5023 (0%)
Hypothyroidism 1/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Inappropriate antidiuretic hormone secretion 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 2/5023 (0%)
Parathyroid gland enlargement 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Thyrotoxic crisis 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Eye disorders
Angle closure glaucoma 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Cataract 12/5013 (0.2%) 15/5024 (0.3%) 9/5000 (0.2%) 8/5023 (0.2%)
Dacryostenosis acquired 2/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Diabetic retinopathy 1/5013 (0%) 2/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Diplopia 1/5013 (0%) 0/5024 (0%) 1/5000 (0%) 1/5023 (0%)
Eyelid ptosis 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Glaucoma 2/5013 (0%) 1/5024 (0%) 2/5000 (0%) 1/5023 (0%)
Keratitis 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 1/5023 (0%)
Maculopathy 0/5013 (0%) 1/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Open angle glaucoma 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Retinal detachment 0/5013 (0%) 2/5024 (0%) 2/5000 (0%) 2/5023 (0%)
Retinal haemorrhage 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Retinal tear 1/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Retinal vein occlusion 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Strabismus 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Ulcerative keratitis 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 2/5023 (0%)
Uveitis 1/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Vision blurred 0/5013 (0%) 0/5024 (0%) 2/5000 (0%) 0/5023 (0%)
Visual acuity reduced 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Visual disturbance 0/5013 (0%) 1/5024 (0%) 2/5000 (0%) 1/5023 (0%)
Gastrointestinal disorders
Abdominal discomfort 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 2/5023 (0%)
Abdominal distension 0/5013 (0%) 0/5024 (0%) 2/5000 (0%) 2/5023 (0%)
Abdominal hernia 2/5013 (0%) 1/5024 (0%) 0/5000 (0%) 2/5023 (0%)
Abdominal mass 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Abdominal pain 10/5013 (0.2%) 12/5024 (0.2%) 13/5000 (0.3%) 7/5023 (0.1%)
Abdominal pain lower 1/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Abdominal pain upper 6/5013 (0.1%) 2/5024 (0%) 2/5000 (0%) 6/5023 (0.1%)
Abdominal strangulated hernia 0/5013 (0%) 1/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Acute abdomen 2/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Anal fissure 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Anal fistula 1/5013 (0%) 1/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Anal prolapse 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Anal ulcer 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Aphagia 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Appendicitis perforated 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 1/5023 (0%)
Ascites 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Barrett's oesophagus 1/5013 (0%) 0/5024 (0%) 1/5000 (0%) 2/5023 (0%)
Colitis 1/5013 (0%) 0/5024 (0%) 2/5000 (0%) 2/5023 (0%)
Colitis ischaemic 2/5013 (0%) 2/5024 (0%) 1/5000 (0%) 1/5023 (0%)
Colitis ulcerative 1/5013 (0%) 1/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Colonic obstruction 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Colonic polyp 7/5013 (0.1%) 6/5024 (0.1%) 3/5000 (0.1%) 2/5023 (0%)
Constipation 3/5013 (0.1%) 2/5024 (0%) 1/5000 (0%) 5/5023 (0.1%)
Crohn's disease 0/5013 (0%) 1/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Diabetic gastroparesis 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Diarrhoea 18/5013 (0.4%) 18/5024 (0.4%) 18/5000 (0.4%) 10/5023 (0.2%)
Diverticulum 2/5013 (0%) 2/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Diverticulum intestinal 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Duodenal ulcer 10/5013 (0.2%) 4/5024 (0.1%) 9/5000 (0.2%) 12/5023 (0.2%)
Duodenal ulcer perforation 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Duodenitis 4/5013 (0.1%) 1/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Dyspepsia 2/5013 (0%) 1/5024 (0%) 0/5000 (0%) 2/5023 (0%)
Dysphagia 2/5013 (0%) 3/5024 (0.1%) 5/5000 (0.1%) 4/5023 (0.1%)
Enteritis 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Enterocolitis 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Erosive oesophagitis 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Faecaloma 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Femoral hernia 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Femoral hernia, obstructive 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Gastric polyps 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Gastric ulcer 13/5013 (0.3%) 8/5024 (0.2%) 10/5000 (0.2%) 8/5023 (0.2%)
Gastric ulcer haemorrhage 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Gastric ulcer perforation 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Gastritis 7/5013 (0.1%) 8/5024 (0.2%) 5/5000 (0.1%) 7/5023 (0.1%)
Gastritis erosive 4/5013 (0.1%) 4/5024 (0.1%) 2/5000 (0%) 1/5023 (0%)
Gastroduodenal ulcer 2/5013 (0%) 2/5024 (0%) 0/5000 (0%) 2/5023 (0%)
Gastroduodenitis 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Gastrointestinal disorder 1/5013 (0%) 1/5024 (0%) 1/5000 (0%) 1/5023 (0%)
Gastrointestinal dysplasia 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Gastrointestinal haemorrhage 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Gastrointestinal necrosis 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Gastrooesophageal reflux disease 1/5013 (0%) 4/5024 (0.1%) 5/5000 (0.1%) 2/5023 (0%)
Gastrooesophagitis 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Gingivitis 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Haemorrhoids 1/5013 (0%) 2/5024 (0%) 1/5000 (0%) 1/5023 (0%)
Hiatus hernia 2/5013 (0%) 1/5024 (0%) 2/5000 (0%) 0/5023 (0%)
Ileitis 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Ileus 2/5013 (0%) 1/5024 (0%) 3/5000 (0.1%) 1/5023 (0%)
Ileus paralytic 1/5013 (0%) 1/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Inguinal hernia 6/5013 (0.1%) 17/5024 (0.3%) 10/5000 (0.2%) 17/5023 (0.3%)
Inguinal hernia strangulated 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Intestinal ischaemia 1/5013 (0%) 0/5024 (0%) 1/5000 (0%) 1/5023 (0%)
Intestinal obstruction 4/5013 (0.1%) 3/5024 (0.1%) 4/5000 (0.1%) 6/5023 (0.1%)
Intestinal perforation 0/5013 (0%) 2/5024 (0%) 2/5000 (0%) 0/5023 (0%)
Irritable bowel syndrome 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Mallory-Weiss syndrome 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Mechanical ileus 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Megacolon 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Mesenteric arteriosclerosis 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Mesenteric artery stenosis 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Mouth ulceration 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Nausea 13/5013 (0.3%) 10/5024 (0.2%) 8/5000 (0.2%) 4/5023 (0.1%)
Oedematous pancreatitis 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Oesophageal polyp 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Oesophageal stenosis 0/5013 (0%) 1/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Oesophageal ulcer 0/5013 (0%) 1/5024 (0%) 3/5000 (0.1%) 0/5023 (0%)
Oesophagitis 2/5013 (0%) 2/5024 (0%) 0/5000 (0%) 2/5023 (0%)
Oesophagitis ulcerative 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Oral disorder 1/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Oral mucosal blistering 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Pancreatic mass 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Pancreatic necrosis 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Pancreatitis 6/5013 (0.1%) 5/5024 (0.1%) 4/5000 (0.1%) 7/5023 (0.1%)
Pancreatitis acute 2/5013 (0%) 3/5024 (0.1%) 7/5000 (0.1%) 1/5023 (0%)
Pancreatitis chronic 2/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Paraesthesia oral 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Peptic ulcer 1/5013 (0%) 3/5024 (0.1%) 0/5000 (0%) 1/5023 (0%)
Periodontitis 1/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Peritonitis 1/5013 (0%) 2/5024 (0%) 1/5000 (0%) 1/5023 (0%)
Proctalgia 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Proctitis 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Proctocolitis 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 1/5023 (0%)
Rectal polyp 2/5013 (0%) 0/5024 (0%) 2/5000 (0%) 0/5023 (0%)
Rectal prolapse 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Rectal stenosis 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Rectal ulcer 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Reflux oesophagitis 1/5013 (0%) 2/5024 (0%) 2/5000 (0%) 2/5023 (0%)
Small intestinal obstruction 7/5013 (0.1%) 2/5024 (0%) 1/5000 (0%) 3/5023 (0.1%)
Stomach mass 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Tongue oedema 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Tooth disorder 0/5013 (0%) 1/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Umbilical hernia 1/5013 (0%) 2/5024 (0%) 2/5000 (0%) 0/5023 (0%)
Varices oesophageal 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Volvulus 1/5013 (0%) 0/5024 (0%) 1/5000 (0%) 1/5023 (0%)
Vomiting 23/5013 (0.5%) 18/5024 (0.4%) 13/5000 (0.3%) 15/5023 (0.3%)
General disorders
Adverse drug reaction 0/5013 (0%) 7/5024 (0.1%) 4/5000 (0.1%) 4/5023 (0.1%)
Asthenia 5/5013 (0.1%) 7/5024 (0.1%) 11/5000 (0.2%) 7/5023 (0.1%)
Calcinosis 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Cardiac death 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Catheter site haemorrhage 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Chest discomfort 4/5013 (0.1%) 1/5024 (0%) 3/5000 (0.1%) 2/5023 (0%)
Chest pain 44/5013 (0.9%) 33/5024 (0.7%) 21/5000 (0.4%) 30/5023 (0.6%)
Chills 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Death 39/5013 (0.8%) 37/5024 (0.7%) 39/5000 (0.8%) 34/5023 (0.7%)
Drowning 3/5013 (0.1%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Drug withdrawal syndrome 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Dysplasia 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Effusion 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Face oedema 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Facial pain 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Fatigue 4/5013 (0.1%) 4/5024 (0.1%) 3/5000 (0.1%) 1/5023 (0%)
Feeling abnormal 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Fibrosis 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Gait disturbance 5/5013 (0.1%) 3/5024 (0.1%) 5/5000 (0.1%) 1/5023 (0%)
General physical health deterioration 3/5013 (0.1%) 3/5024 (0.1%) 1/5000 (0%) 1/5023 (0%)
Generalised oedema 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Granuloma 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Hernia 0/5013 (0%) 0/5024 (0%) 3/5000 (0.1%) 0/5023 (0%)
Hyperthermia 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Hyperthermia malignant 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Hypothermia 0/5013 (0%) 2/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Impaired healing 1/5013 (0%) 0/5024 (0%) 1/5000 (0%) 4/5023 (0.1%)
Influenza like illness 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Malaise 5/5013 (0.1%) 2/5024 (0%) 1/5000 (0%) 3/5023 (0.1%)
Multi-organ disorder 1/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Multi-organ failure 1/5013 (0%) 2/5024 (0%) 3/5000 (0.1%) 1/5023 (0%)
Non-cardiac chest pain 3/5013 (0.1%) 4/5024 (0.1%) 1/5000 (0%) 1/5023 (0%)
Oedema 0/5013 (0%) 0/5024 (0%) 2/5000 (0%) 1/5023 (0%)
Oedema peripheral 4/5013 (0.1%) 1/5024 (0%) 1/5000 (0%) 3/5023 (0.1%)
Pain 0/5013 (0%) 0/5024 (0%) 2/5000 (0%) 4/5023 (0.1%)
Polyp 2/5013 (0%) 2/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Pyrexia 15/5013 (0.3%) 11/5024 (0.2%) 12/5000 (0.2%) 12/5023 (0.2%)
Sudden cardiac death 4/5013 (0.1%) 0/5024 (0%) 1/5000 (0%) 1/5023 (0%)
Sudden death 5/5013 (0.1%) 3/5024 (0.1%) 4/5000 (0.1%) 5/5023 (0.1%)
Systemic inflammatory response syndrome 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Tenderness 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Ulcer 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 1/5023 (0%)
Vestibulitis 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Hepatobiliary disorders
Acute hepatic failure 0/5013 (0%) 0/5024 (0%) 2/5000 (0%) 1/5023 (0%)
Bile duct obstruction 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 2/5023 (0%)
Bile duct stone 3/5013 (0.1%) 4/5024 (0.1%) 3/5000 (0.1%) 3/5023 (0.1%)
Biliary colic 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 2/5023 (0%)
Cholangitis 4/5013 (0.1%) 2/5024 (0%) 1/5000 (0%) 4/5023 (0.1%)
Cholangitis acute 2/5013 (0%) 1/5024 (0%) 0/5000 (0%) 2/5023 (0%)
Cholecystitis 5/5013 (0.1%) 5/5024 (0.1%) 3/5000 (0.1%) 6/5023 (0.1%)
Cholecystitis acute 2/5013 (0%) 10/5024 (0.2%) 9/5000 (0.2%) 5/5023 (0.1%)
Cholecystitis chronic 2/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Cholelithiasis 10/5013 (0.2%) 8/5024 (0.2%) 9/5000 (0.2%) 9/5023 (0.2%)
Gallbladder disorder 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Gallbladder necrosis 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Gallbladder pain 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Gallbladder polyp 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Hepatic cirrhosis 0/5013 (0%) 2/5024 (0%) 0/5000 (0%) 2/5023 (0%)
Hepatic failure 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 3/5023 (0.1%)
Hepatic function abnormal 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 1/5023 (0%)
Hepatic steatosis 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Hepatitis 1/5013 (0%) 0/5024 (0%) 1/5000 (0%) 1/5023 (0%)
Hepatitis acute 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Hepatitis toxic 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Hepatomegaly 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Hyperbilirubinaemia 1/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Jaundice 2/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Jaundice cholestatic 2/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Liver disorder 0/5013 (0%) 1/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Post cholecystectomy syndrome 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Immune system disorders
Allergic oedema 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Anaphylactic reaction 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Anaphylactic shock 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Drug hypersensitivity 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 2/5023 (0%)
Food allergy 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Hypersensitivity 0/5013 (0%) 3/5024 (0.1%) 1/5000 (0%) 5/5023 (0.1%)
Sarcoidosis 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Infections and infestations
Abdominal abscess 1/5013 (0%) 0/5024 (0%) 1/5000 (0%) 1/5023 (0%)
Abdominal wall abscess 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 1/5023 (0%)
Abscess 1/5013 (0%) 1/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Abscess intestinal 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Abscess limb 1/5013 (0%) 0/5024 (0%) 2/5000 (0%) 2/5023 (0%)
Abscess oral 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Acute tonsillitis 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Anal abscess 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Anogenital warts 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Appendicitis 5/5013 (0.1%) 5/5024 (0.1%) 5/5000 (0.1%) 8/5023 (0.2%)
Arthritis bacterial 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Arthritis infective 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Aspergillosis 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Bacteraemia 1/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Bacterial sepsis 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Bone tuberculosis 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Borrelia infection 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Breast abscess 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Bronchiectasis 0/5013 (0%) 0/5024 (0%) 2/5000 (0%) 1/5023 (0%)
Bronchitis 11/5013 (0.2%) 5/5024 (0.1%) 6/5000 (0.1%) 7/5023 (0.1%)
Bronchopneumonia 4/5013 (0.1%) 2/5024 (0%) 2/5000 (0%) 5/5023 (0.1%)
Bronchopulmonary aspergillosis 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Burn infection 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Bursitis infective 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Campylobacter intestinal infection 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Carbuncle 1/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Catheter related infection 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Catheter sepsis 1/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Catheter site infection 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Cellulitis 9/5013 (0.2%) 5/5024 (0.1%) 11/5000 (0.2%) 8/5023 (0.2%)
Cellulitis pharyngeal 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Cellulitis staphylococcal 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Cholecystitis infective 0/5013 (0%) 2/5024 (0%) 1/5000 (0%) 1/5023 (0%)
Chronic sinusitis 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Clostridial infection 1/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Clostridium difficile colitis 2/5013 (0%) 1/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Cystitis 2/5013 (0%) 1/5024 (0%) 6/5000 (0.1%) 1/5023 (0%)
Dengue fever 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Device related infection 0/5013 (0%) 1/5024 (0%) 2/5000 (0%) 0/5023 (0%)
Diabetic gangrene 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 1/5023 (0%)
Diarrhoea infectious 0/5013 (0%) 1/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Disseminated tuberculosis 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Diverticulitis 3/5013 (0.1%) 5/5024 (0.1%) 5/5000 (0.1%) 1/5023 (0%)
Dysentery 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Empyema 2/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Encephalitis viral 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Endocarditis 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 2/5023 (0%)
Endocarditis bacterial 0/5013 (0%) 1/5024 (0%) 2/5000 (0%) 0/5023 (0%)
Endocarditis enterococcal 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Endometritis 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Enteritis infectious 0/5013 (0%) 0/5024 (0%) 2/5000 (0%) 0/5023 (0%)
Enterococcal sepsis 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 1/5023 (0%)
Epidemic vomiting syndrome 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 2/5023 (0%)
Epiglottitis 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Erysipelas 1/5013 (0%) 1/5024 (0%) 1/5000 (0%) 4/5023 (0.1%)
Escherichia infection 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Escherichia sepsis 0/5013 (0%) 1/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Escherichia urinary tract infection 2/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Febrile infection 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Fungal infection 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Gangrene 2/5013 (0%) 1/5024 (0%) 1/5000 (0%) 4/5023 (0.1%)
Gastritis viral 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Gastroenteritis 17/5013 (0.3%) 8/5024 (0.2%) 14/5000 (0.3%) 10/5023 (0.2%)
Gastroenteritis viral 1/5013 (0%) 0/5024 (0%) 1/5000 (0%) 1/5023 (0%)
Gastrointestinal infection 2/5013 (0%) 0/5024 (0%) 2/5000 (0%) 0/5023 (0%)
Genitourinary tract infection 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Graft infection 2/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Helicobacter gastritis 1/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Hepatitis A 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Hepatitis B 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Hepatitis C 0/5013 (0%) 1/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Hepatitis E 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Hepatitis viral 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Herpes zoster 1/5013 (0%) 1/5024 (0%) 3/5000 (0.1%) 4/5023 (0.1%)
Incision site abscess 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Infected epidermal cyst 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Infected skin ulcer 0/5013 (0%) 1/5024 (0%) 3/5000 (0.1%) 0/5023 (0%)
Infection 1/5013 (0%) 1/5024 (0%) 1/5000 (0%) 1/5023 (0%)
Infective exacerbation of chronic obstructive airways disease 1/5013 (0%) 0/5024 (0%) 5/5000 (0.1%) 1/5023 (0%)
Influenza 0/5013 (0%) 1/5024 (0%) 2/5000 (0%) 1/5023 (0%)
Joint abscess 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Kidney infection 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Klebsiella bacteraemia 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Klebsiella infection 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Labyrinthitis 1/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Liver abscess 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Lobar pneumonia 2/5013 (0%) 3/5024 (0.1%) 5/5000 (0.1%) 4/5023 (0.1%)
Localised infection 5/5013 (0.1%) 1/5024 (0%) 2/5000 (0%) 5/5023 (0.1%)
Lower respiratory tract infection 4/5013 (0.1%) 2/5024 (0%) 5/5000 (0.1%) 4/5023 (0.1%)
Lung abscess 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Lung infection 6/5013 (0.1%) 4/5024 (0.1%) 3/5000 (0.1%) 3/5023 (0.1%)
Lymph node tuberculosis 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Malaria 0/5013 (0%) 1/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Mastoiditis 1/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Meningitis 1/5013 (0%) 1/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Meningitis bacterial 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Meningitis tuberculous 1/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Nasopharyngitis 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Necrotising fasciitis 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Oropharyngeal candidiasis 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Osteomyelitis 3/5013 (0.1%) 1/5024 (0%) 1/5000 (0%) 1/5023 (0%)
Osteomyelitis acute 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Osteomyelitis chronic 1/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Otitis externa 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Otitis media 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Otitis media acute 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Paronychia 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Parotitis 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Perianal abscess 0/5013 (0%) 1/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Pericarditis tuberculous 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Perineal abscess 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Perinephric abscess 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Perirectal abscess 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Peritonsillar abscess 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Plasmodium falciparum infection 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Pneumococcal bacteraemia 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Pneumonia 62/5013 (1.2%) 60/5024 (1.2%) 72/5000 (1.4%) 73/5023 (1.5%)
Pneumonia pneumococcal 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Pneumonia primary atypical 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Pneumonia streptococcal 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Post procedural infection 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Postoperative wound infection 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Pseudomembranous colitis 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Pulmonary sepsis 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Pulmonary tuberculosis 3/5013 (0.1%) 1/5024 (0%) 1/5000 (0%) 2/5023 (0%)
Purulence 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Purulent discharge 0/5013 (0%) 1/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Pyelonephritis 1/5013 (0%) 3/5024 (0.1%) 5/5000 (0.1%) 3/5023 (0.1%)
Pyelonephritis acute 1/5013 (0%) 4/5024 (0.1%) 1/5000 (0%) 0/5023 (0%)
Pyelonephritis chronic 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Pyothorax 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Rectal abscess 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Respiratory tract infection 3/5013 (0.1%) 2/5024 (0%) 3/5000 (0.1%) 3/5023 (0.1%)
Respiratory tract infection viral 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Salmonella sepsis 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Salmonellosis 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Scrotal abscess 1/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Sepsis 17/5013 (0.3%) 11/5024 (0.2%) 17/5000 (0.3%) 14/5023 (0.3%)
Septic embolus 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Septic shock 3/5013 (0.1%) 6/5024 (0.1%) 7/5000 (0.1%) 2/5023 (0%)
Sialoadenitis 1/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Sinusitis 2/5013 (0%) 4/5024 (0.1%) 0/5000 (0%) 0/5023 (0%)
Staphylococcal infection 1/5013 (0%) 1/5024 (0%) 1/5000 (0%) 1/5023 (0%)
Stitch abscess 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Streptococcal sepsis 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Subcutaneous abscess 1/5013 (0%) 1/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Sweat gland infection 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Tonsillitis 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 1/5023 (0%)
Tooth infection 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Toxic shock syndrome 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Tracheobronchitis 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Tuberculosis 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Tuberculous pleurisy 0/5013 (0%) 2/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Typhoid fever 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Upper respiratory tract infection 3/5013 (0.1%) 5/5024 (0.1%) 3/5000 (0.1%) 1/5023 (0%)
Urinary bladder abscess 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Urinary tract infection 32/5013 (0.6%) 22/5024 (0.4%) 40/5000 (0.8%) 38/5023 (0.8%)
Urinary tract infection enterococcal 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Urosepsis 2/5013 (0%) 3/5024 (0.1%) 9/5000 (0.2%) 6/5023 (0.1%)
Viral infection 1/5013 (0%) 3/5024 (0.1%) 2/5000 (0%) 1/5023 (0%)
Viral myocarditis 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Viral pharyngitis 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Viral upper respiratory tract infection 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
West Nile viral infection 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Wound infection 1/5013 (0%) 2/5024 (0%) 1/5000 (0%) 2/5023 (0%)
Injury, poisoning and procedural complications
Accident 0/5013 (0%) 1/5024 (0%) 1/5000 (0%) 1/5023 (0%)
Accident at work 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Accidental overdose 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Acetabulum fracture 0/5013 (0%) 2/5024 (0%) 1/5000 (0%) 1/5023 (0%)
Alcohol poisoning 3/5013 (0.1%) 0/5024 (0%) 1/5000 (0%) 4/5023 (0.1%)
Anaemia postoperative 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Animal bite 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Ankle fracture 3/5013 (0.1%) 4/5024 (0.1%) 4/5000 (0.1%) 1/5023 (0%)
Arthropod bite 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Avulsion fracture 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Back injury 0/5013 (0%) 2/5024 (0%) 2/5000 (0%) 1/5023 (0%)
Brain contusion 3/5013 (0.1%) 0/5024 (0%) 0/5000 (0%) 2/5023 (0%)
Burns second degree 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Burns third degree 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Carbon monoxide poisoning 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Cardiac pacemaker malfunction 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Cerebral haemorrhage traumatic 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Cervical vertebral fracture 2/5013 (0%) 1/5024 (0%) 1/5000 (0%) 1/5023 (0%)
Chemical poisoning 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Clavicle fracture 1/5013 (0%) 1/5024 (0%) 1/5000 (0%) 1/5023 (0%)
Collapse of lung 1/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Comminuted fracture 0/5013 (0%) 1/5024 (0%) 1/5000 (0%) 1/5023 (0%)
Compression fracture 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Concussion 2/5013 (0%) 3/5024 (0.1%) 0/5000 (0%) 4/5023 (0.1%)
Contusion 3/5013 (0.1%) 3/5024 (0.1%) 1/5000 (0%) 4/5023 (0.1%)
Device failure 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Drug toxicity 2/5013 (0%) 3/5024 (0.1%) 0/5000 (0%) 2/5023 (0%)
Eschar 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Excoriation 0/5013 (0%) 1/5024 (0%) 1/5000 (0%) 1/5023 (0%)
Exposure to toxic agent 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Extradural haematoma 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 1/5023 (0%)
Eye injury 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 2/5023 (0%)
Eye penetration 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Face injury 0/5013 (0%) 2/5024 (0%) 1/5000 (0%) 1/5023 (0%)
Facial bones fracture 2/5013 (0%) 2/5024 (0%) 0/5000 (0%) 2/5023 (0%)
Fall 39/5013 (0.8%) 53/5024 (1.1%) 40/5000 (0.8%) 49/5023 (1%)
Femoral neck fracture 9/5013 (0.2%) 13/5024 (0.3%) 12/5000 (0.2%) 9/5023 (0.2%)
Femur fracture 11/5013 (0.2%) 12/5024 (0.2%) 13/5000 (0.3%) 12/5023 (0.2%)
Fibula fracture 2/5013 (0%) 0/5024 (0%) 2/5000 (0%) 0/5023 (0%)
Foot fracture 0/5013 (0%) 1/5024 (0%) 2/5000 (0%) 1/5023 (0%)
Forearm fracture 1/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Foreign body in eye 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Foreign body trauma 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Fracture 4/5013 (0.1%) 1/5024 (0%) 1/5000 (0%) 2/5023 (0%)
Fracture displacement 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Fractured coccyx 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Gastrointestinal injury 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Hand fracture 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 3/5023 (0.1%)
Head injury 9/5013 (0.2%) 9/5024 (0.2%) 9/5000 (0.2%) 12/5023 (0.2%)
Heat exhaustion 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Heat stroke 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 1/5023 (0%)
Hip fracture 14/5013 (0.3%) 15/5024 (0.3%) 12/5000 (0.2%) 12/5023 (0.2%)
Humerus fracture 4/5013 (0.1%) 5/5024 (0.1%) 10/5000 (0.2%) 5/5023 (0.1%)
Ilium fracture 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Incisional hernia 2/5013 (0%) 1/5024 (0%) 2/5000 (0%) 0/5023 (0%)
Injury 3/5013 (0.1%) 2/5024 (0%) 3/5000 (0.1%) 3/5023 (0.1%)
Jaw fracture 0/5013 (0%) 1/5024 (0%) 1/5000 (0%) 1/5023 (0%)
Joint dislocation 3/5013 (0.1%) 2/5024 (0%) 5/5000 (0.1%) 2/5023 (0%)
Joint injury 0/5013 (0%) 2/5024 (0%) 2/5000 (0%) 1/5023 (0%)
Joint sprain 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 2/5023 (0%)
Limb injury 0/5013 (0%) 0/5024 (0%) 2/5000 (0%) 1/5023 (0%)
Lower limb fracture 0/5013 (0%) 4/5024 (0.1%) 1/5000 (0%) 0/5023 (0%)
Lumbar vertebral fracture 1/5013 (0%) 2/5024 (0%) 0/5000 (0%) 3/5023 (0.1%)
Medical device pain 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Medication error 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Meniscus lesion 1/5013 (0%) 4/5024 (0.1%) 0/5000 (0%) 1/5023 (0%)
Multiple drug overdose 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Multiple fractures 1/5013 (0%) 1/5024 (0%) 2/5000 (0%) 1/5023 (0%)
Multiple injuries 0/5013 (0%) 0/5024 (0%) 2/5000 (0%) 2/5023 (0%)
Muscle injury 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Muscle strain 1/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Neck injury 0/5013 (0%) 1/5024 (0%) 2/5000 (0%) 1/5023 (0%)
Nerve injury 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Open wound 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Overdose 2/5013 (0%) 0/5024 (0%) 2/5000 (0%) 0/5023 (0%)
Pacemaker complication 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Patella fracture 1/5013 (0%) 1/5024 (0%) 3/5000 (0.1%) 0/5023 (0%)
Pelvic fracture 5/5013 (0.1%) 2/5024 (0%) 3/5000 (0.1%) 4/5023 (0.1%)
Periorbital haematoma 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Pneumothorax traumatic 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Post procedural fistula 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Postoperative fever 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Postoperative ileus 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Postpericardiotomy syndrome 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Procedural pain 1/5013 (0%) 1/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Procedural site reaction 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Pubic rami fracture 3/5013 (0.1%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Radiation pneumonitis 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Radius fracture 3/5013 (0.1%) 0/5024 (0%) 1/5000 (0%) 2/5023 (0%)
Respiratory fume inhalation disorder 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Rib fracture 3/5013 (0.1%) 5/5024 (0.1%) 4/5000 (0.1%) 4/5023 (0.1%)
Road traffic accident 10/5013 (0.2%) 9/5024 (0.2%) 7/5000 (0.1%) 12/5023 (0.2%)
Scapula fracture 1/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Scratch 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Shunt aneurysm 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Skeletal injury 2/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Skin laceration 4/5013 (0.1%) 2/5024 (0%) 4/5000 (0.1%) 1/5023 (0%)
Skull fracture 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Snake bite 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Spinal compression fracture 5/5013 (0.1%) 1/5024 (0%) 6/5000 (0.1%) 6/5023 (0.1%)
Spinal cord injury 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Spinal cord injury thoracic 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Spinal fracture 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Splenic rupture 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Sports injury 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Stent occlusion 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Sternal fracture 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Subcutaneous haematoma 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Subdural haematoma 3/5013 (0.1%) 3/5024 (0.1%) 4/5000 (0.1%) 8/5023 (0.2%)
Subdural haemorrhage 2/5013 (0%) 1/5024 (0%) 3/5000 (0.1%) 2/5023 (0%)
Synovial rupture 0/5013 (0%) 1/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Tendon rupture 1/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Therapeutic agent toxicity 1/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Thermal burn 2/5013 (0%) 0/5024 (0%) 1/5000 (0%) 1/5023 (0%)
Thoracic vertebral fracture 1/5013 (0%) 1/5024 (0%) 1/5000 (0%) 2/5023 (0%)
Tibia fracture 2/5013 (0%) 1/5024 (0%) 2/5000 (0%) 1/5023 (0%)
Traumatic arthritis 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Traumatic arthropathy 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Traumatic brain injury 2/5013 (0%) 1/5024 (0%) 0/5000 (0%) 2/5023 (0%)
Traumatic fracture 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 1/5023 (0%)
Traumatic intracranial haemorrhage 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Traumatic ulcer 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Ulna fracture 1/5013 (0%) 2/5024 (0%) 2/5000 (0%) 2/5023 (0%)
Upper limb fracture 7/5013 (0.1%) 1/5024 (0%) 5/5000 (0.1%) 3/5023 (0.1%)
Vaccination complication 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Vascular graft occlusion 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Wound 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 1/5023 (0%)
Wound dehiscence 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Wrist fracture 2/5013 (0%) 3/5024 (0.1%) 2/5000 (0%) 1/5023 (0%)
Investigations
Acid base balance abnormal 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Alanine aminotransferase increased 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Allergy test 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Arteriogram coronary 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Aspartate aminotransferase increased 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Aspiration bronchial 1/5013 (0%) 1/5024 (0%) 3/5000 (0.1%) 0/5023 (0%)
Biopsy lymph gland 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Blood creatine phosphokinase increased 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 3/5023 (0.1%)
Blood creatinine increased 1/5013 (0%) 4/5024 (0.1%) 6/5000 (0.1%) 3/5023 (0.1%)
Blood glucose abnormal 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Blood glucose decreased 1/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Blood glucose increased 0/5013 (0%) 3/5024 (0.1%) 2/5000 (0%) 0/5023 (0%)
Blood lactate dehydrogenase increased 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Blood potassium decreased 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Blood potassium increased 0/5013 (0%) 0/5024 (0%) 2/5000 (0%) 0/5023 (0%)
Blood pressure decreased 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Blood pressure increased 4/5013 (0.1%) 3/5024 (0.1%) 2/5000 (0%) 1/5023 (0%)
Blood pressure systolic increased 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Blood sodium decreased 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Blood test abnormal 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Blood urea increased 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Body temperature increased 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Cardiac enzymes increased 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Creatinine renal clearance decreased 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Endoscopic retrograde cholangiopancreatography 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Haematocrit decreased 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Haemoglobin decreased 3/5013 (0.1%) 1/5024 (0%) 1/5000 (0%) 2/5023 (0%)
Heart rate decreased 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Heart rate irregular 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Hepatic enzyme increased 2/5013 (0%) 0/5024 (0%) 1/5000 (0%) 1/5023 (0%)
International normalised ratio increased 1/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Liver function test abnormal 0/5013 (0%) 0/5024 (0%) 2/5000 (0%) 0/5023 (0%)
Myoglobin blood increased 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
QRS axis abnormal 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Renal function test abnormal 1/5013 (0%) 1/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Transaminases increased 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Troponin increased 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Urine output decreased 0/5013 (0%) 2/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Weight decreased 4/5013 (0.1%) 1/5024 (0%) 1/5000 (0%) 3/5023 (0.1%)
Metabolism and nutrition disorders
Anorexia 2/5013 (0%) 3/5024 (0.1%) 1/5000 (0%) 1/5023 (0%)
Cachexia 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Decreased appetite 2/5013 (0%) 0/5024 (0%) 1/5000 (0%) 1/5023 (0%)
Dehydration 27/5013 (0.5%) 22/5024 (0.4%) 12/5000 (0.2%) 7/5023 (0.1%)
Diabetes mellitus 3/5013 (0.1%) 6/5024 (0.1%) 4/5000 (0.1%) 3/5023 (0.1%)
Diabetes mellitus inadequate control 6/5013 (0.1%) 6/5024 (0.1%) 6/5000 (0.1%) 6/5023 (0.1%)
Diabetic complication 1/5013 (0%) 1/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Diabetic foot 2/5013 (0%) 4/5024 (0.1%) 2/5000 (0%) 2/5023 (0%)
Diabetic ketoacidosis 3/5013 (0.1%) 1/5024 (0%) 2/5000 (0%) 0/5023 (0%)
Electrolyte imbalance 2/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Failure to thrive 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Fluid overload 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Gout 1/5013 (0%) 2/5024 (0%) 1/5000 (0%) 4/5023 (0.1%)
Hypercalcaemia 1/5013 (0%) 0/5024 (0%) 1/5000 (0%) 3/5023 (0.1%)
Hyperglycaemia 2/5013 (0%) 2/5024 (0%) 8/5000 (0.2%) 4/5023 (0.1%)
Hyperkalaemia 8/5013 (0.2%) 0/5024 (0%) 5/5000 (0.1%) 4/5023 (0.1%)
Hyperuricaemia 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Hypoalbuminaemia 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Hypochloraemia 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Hypoglycaemia 13/5013 (0.3%) 11/5024 (0.2%) 18/5000 (0.4%) 10/5023 (0.2%)
Hypokalaemia 3/5013 (0.1%) 5/5024 (0.1%) 4/5000 (0.1%) 7/5023 (0.1%)
Hyponatraemia 13/5013 (0.3%) 18/5024 (0.4%) 19/5000 (0.4%) 11/5023 (0.2%)
Hyponatraemic syndrome 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Hypovolaemia 0/5013 (0%) 2/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Ketosis 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Lactic acidosis 0/5013 (0%) 1/5024 (0%) 1/5000 (0%) 1/5023 (0%)
Malnutrition 1/5013 (0%) 1/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Metabolic acidosis 2/5013 (0%) 1/5024 (0%) 1/5000 (0%) 1/5023 (0%)
Metabolic alkalosis 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Obesity 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Oral intake reduced 1/5013 (0%) 1/5024 (0%) 1/5000 (0%) 1/5023 (0%)
Overweight 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Shock hypoglycaemic 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Type 2 diabetes mellitus 1/5013 (0%) 0/5024 (0%) 1/5000 (0%) 1/5023 (0%)
Vitamin B12 deficiency 3/5013 (0.1%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Musculoskeletal and connective tissue disorders
Arthralgia 3/5013 (0.1%) 4/5024 (0.1%) 4/5000 (0.1%) 7/5023 (0.1%)
Arthritis 0/5013 (0%) 2/5024 (0%) 4/5000 (0.1%) 0/5023 (0%)
Arthropathy 0/5013 (0%) 0/5024 (0%) 2/5000 (0%) 0/5023 (0%)
Back disorder 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Back pain 12/5013 (0.2%) 9/5024 (0.2%) 10/5000 (0.2%) 15/5023 (0.3%)
Bone cyst 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Bone infarction 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Bone pain 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Bursitis 0/5013 (0%) 2/5024 (0%) 1/5000 (0%) 1/5023 (0%)
Cervical spinal stenosis 1/5013 (0%) 2/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Chondropathy 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Dupuytren's contracture 0/5013 (0%) 1/5024 (0%) 4/5000 (0.1%) 0/5023 (0%)
Exostosis 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Fibromyalgia 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Fistula 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Fistula discharge 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Flank pain 1/5013 (0%) 1/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Foot deformity 0/5013 (0%) 0/5024 (0%) 2/5000 (0%) 1/5023 (0%)
Gouty arthritis 0/5013 (0%) 1/5024 (0%) 3/5000 (0.1%) 1/5023 (0%)
Groin pain 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Haemarthrosis 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Intervertebral disc compression 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Intervertebral disc degeneration 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Intervertebral disc disorder 0/5013 (0%) 2/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Intervertebral disc protrusion 8/5013 (0.2%) 2/5024 (0%) 10/5000 (0.2%) 9/5023 (0.2%)
Joint effusion 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Joint range of motion decreased 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Joint swelling 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Knee deformity 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Ligament disorder 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Lumbar spinal stenosis 2/5013 (0%) 2/5024 (0%) 3/5000 (0.1%) 1/5023 (0%)
Mobility decreased 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Monarthritis 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Muscle haemorrhage 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Muscle spasms 1/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Muscular weakness 3/5013 (0.1%) 2/5024 (0%) 5/5000 (0.1%) 4/5023 (0.1%)
Musculoskeletal chest pain 3/5013 (0.1%) 1/5024 (0%) 0/5000 (0%) 2/5023 (0%)
Musculoskeletal pain 1/5013 (0%) 0/5024 (0%) 3/5000 (0.1%) 2/5023 (0%)
Myalgia 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Myofascial pain syndrome 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Myopathy 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Myositis 2/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Neck mass 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Neck pain 1/5013 (0%) 0/5024 (0%) 2/5000 (0%) 4/5023 (0.1%)
Osteitis 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Osteoarthritis 28/5013 (0.6%) 23/5024 (0.5%) 30/5000 (0.6%) 34/5023 (0.7%)
Osteochondrosis 1/5013 (0%) 1/5024 (0%) 0/5000 (0%) 2/5023 (0%)
Osteolysis 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 1/5023 (0%)
Osteonecrosis 0/5013 (0%) 2/5024 (0%) 1/5000 (0%) 2/5023 (0%)
Osteoporosis 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Osteoporotic fracture 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 1/5023 (0%)
Pain in extremity 7/5013 (0.1%) 1/5024 (0%) 4/5000 (0.1%) 2/5023 (0%)
Pain in jaw 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Pathological fracture 1/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Periarthritis 1/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Polyarthritis 2/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Polymyalgia rheumatica 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Pseudarthrosis 0/5013 (0%) 1/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Rhabdomyolysis 2/5013 (0%) 1/5024 (0%) 2/5000 (0%) 2/5023 (0%)
Rheumatoid arthritis 1/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Rotator cuff syndrome 3/5013 (0.1%) 3/5024 (0.1%) 1/5000 (0%) 2/5023 (0%)
Spinal column stenosis 2/5013 (0%) 3/5024 (0.1%) 3/5000 (0.1%) 2/5023 (0%)
Spinal disorder 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Spinal osteoarthritis 3/5013 (0.1%) 2/5024 (0%) 3/5000 (0.1%) 6/5023 (0.1%)
Spondylitis 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Synovial cyst 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Tendon disorder 1/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Tenosynovitis stenosans 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Trismus 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acoustic neuroma 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Acute leukaemia 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Acute megakaryocytic leukaemia 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Adenocarcinoma 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 2/5023 (0%)
Adenocarcinoma pancreas 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Adrenal adenoma 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Anal cancer 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Anal cancer recurrent 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Angiosarcoma metastatic 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Astrocytoma 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
B-cell lymphoma 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Basal cell carcinoma 2/5013 (0%) 1/5024 (0%) 6/5000 (0.1%) 2/5023 (0%)
Benign gastric neoplasm 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Benign gastrointestinal neoplasm 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Benign muscle neoplasm 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Benign neoplasm of bladder 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Benign neoplasm of eye 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Benign neoplasm of spinal cord 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Bile duct cancer 1/5013 (0%) 0/5024 (0%) 1/5000 (0%) 1/5023 (0%)
Biliary cancer metastatic 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Bladder cancer 3/5013 (0.1%) 5/5024 (0.1%) 5/5000 (0.1%) 6/5023 (0.1%)
Bladder cancer recurrent 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 4/5023 (0.1%)
Bladder neoplasm 1/5013 (0%) 2/5024 (0%) 0/5000 (0%) 3/5023 (0.1%)
Bladder papilloma 2/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Bladder transitional cell carcinoma 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Bone neoplasm malignant 1/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Brain cancer metastatic 1/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Brain neoplasm 6/5013 (0.1%) 5/5024 (0.1%) 2/5000 (0%) 4/5023 (0.1%)
Brain neoplasm malignant 1/5013 (0%) 1/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Breast cancer 6/5013 (0.1%) 5/5024 (0.1%) 9/5000 (0.2%) 6/5023 (0.1%)
Breast cancer in situ 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Breast cancer metastatic 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Breast cancer recurrent 1/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Bronchial carcinoma 1/5013 (0%) 2/5024 (0%) 2/5000 (0%) 1/5023 (0%)
Bronchial neoplasm 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Buccal cavity papilloma 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Carcinoid tumour of the appendix 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Cardiac myxoma 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Cerebellar tumour 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Cervix carcinoma 0/5013 (0%) 1/5024 (0%) 1/5000 (0%) 1/5023 (0%)
Cervix neoplasm 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Chronic lymphocytic leukaemia 0/5013 (0%) 1/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Colon adenoma 2/5013 (0%) 1/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Colon cancer 13/5013 (0.3%) 11/5024 (0.2%) 4/5000 (0.1%) 14/5023 (0.3%)
Colon cancer metastatic 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 2/5023 (0%)
Colon cancer stage 0 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Colon neoplasm 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Colorectal cancer 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 2/5023 (0%)
Colorectal cancer metastatic 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Endometrial cancer 1/5013 (0%) 1/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Gallbladder cancer 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Gastric cancer 6/5013 (0.1%) 4/5024 (0.1%) 2/5000 (0%) 5/5023 (0.1%)
Gastrointestinal carcinoma 0/5013 (0%) 2/5024 (0%) 1/5000 (0%) 2/5023 (0%)
Gastrointestinal tract adenoma 1/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Gastrooesophageal cancer 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Genital neoplasm malignant female 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Glioblastoma 1/5013 (0%) 1/5024 (0%) 1/5000 (0%) 1/5023 (0%)
Glioblastoma multiforme 0/5013 (0%) 3/5024 (0.1%) 3/5000 (0.1%) 0/5023 (0%)
Glioma 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Haemangioma 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Haemangioma of liver 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Hepatic cancer metastatic 1/5013 (0%) 1/5024 (0%) 1/5000 (0%) 2/5023 (0%)
Hepatic neoplasm 0/5013 (0%) 1/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Hepatic neoplasm malignant 3/5013 (0.1%) 4/5024 (0.1%) 3/5000 (0.1%) 5/5023 (0.1%)
Hepatic neoplasm malignant recurrent 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Hodgkin's disease 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Intraocular melanoma 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Large intestine carcinoma 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Laryngeal cancer 0/5013 (0%) 1/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Laryngeal neoplasm 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Leukaemia 2/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Leukaemia plasmacytic 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Lip and/or oral cavity cancer 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Lipoma 1/5013 (0%) 1/5024 (0%) 2/5000 (0%) 0/5023 (0%)
Lung adenocarcinoma 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Lung adenocarcinoma metastatic 1/5013 (0%) 1/5024 (0%) 2/5000 (0%) 0/5023 (0%)
Lung cancer metastatic 2/5013 (0%) 3/5024 (0.1%) 2/5000 (0%) 6/5023 (0.1%)
Lung carcinoma cell type unspecified stage IV 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Lung neoplasm 1/5013 (0%) 1/5024 (0%) 3/5000 (0.1%) 0/5023 (0%)
Lung neoplasm malignant 14/5013 (0.3%) 13/5024 (0.3%) 21/5000 (0.4%) 10/5023 (0.2%)
Lymphangiosis carcinomatosa 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Lymphocytic leukaemia 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Lymphoma 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 4/5023 (0.1%)
Malignant ascites 0/5013 (0%) 2/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Malignant melanoma 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 2/5023 (0%)
Malignant neoplasm of eye 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Malignant neoplasm of eyelid 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Malignant nervous system neoplasm 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Malignant palate neoplasm 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Malignant pleural effusion 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Maxillofacial sinus neoplasm 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Meningioma 0/5013 (0%) 1/5024 (0%) 1/5000 (0%) 1/5023 (0%)
Metastases to abdominal cavity 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Metastases to abdominal wall 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Metastases to adrenals 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Metastases to bone 3/5013 (0.1%) 1/5024 (0%) 4/5000 (0.1%) 1/5023 (0%)
Metastases to central nervous system 6/5013 (0.1%) 3/5024 (0.1%) 3/5000 (0.1%) 1/5023 (0%)
Metastases to chest wall 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Metastases to liver 6/5013 (0.1%) 5/5024 (0.1%) 6/5000 (0.1%) 6/5023 (0.1%)
Metastases to lung 3/5013 (0.1%) 2/5024 (0%) 2/5000 (0%) 5/5023 (0.1%)
Metastases to lymph nodes 5/5013 (0.1%) 1/5024 (0%) 2/5000 (0%) 2/5023 (0%)
Metastases to neck 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Metastases to pancreas 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Metastases to peritoneum 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Metastases to spine 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 1/5023 (0%)
Metastases to spleen 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Metastasis 1/5013 (0%) 1/5024 (0%) 1/5000 (0%) 1/5023 (0%)
Metastatic bronchial carcinoma 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Metastatic neoplasm 1/5013 (0%) 2/5024 (0%) 0/5000 (0%) 3/5023 (0.1%)
Metastatic renal cell carcinoma 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 1/5023 (0%)
Metastatic squamous cell carcinoma 1/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Multiple myeloma 1/5013 (0%) 2/5024 (0%) 1/5000 (0%) 1/5023 (0%)
Mycosis fungoides 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Myelodysplastic syndrome 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Myeloproliferative disorder 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Nasal neoplasm 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Neoplasm malignant 2/5013 (0%) 0/5024 (0%) 1/5000 (0%) 4/5023 (0.1%)
Neuroma 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Non-Hodgkin's lymphoma 2/5013 (0%) 2/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Non-Hodgkin's lymphoma recurrent 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Non-small cell lung cancer 2/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Non-small cell lung cancer metastatic 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 2/5023 (0%)
Oesophageal adenocarcinoma 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Oesophageal cancer metastatic 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Oesophageal carcinoma 0/5013 (0%) 1/5024 (0%) 4/5000 (0.1%) 4/5023 (0.1%)
Oral neoplasm 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Oropharyngeal cancer stage unspecified 0/5013 (0%) 1/5024 (0%) 1/5000 (0%) 1/5023 (0%)
Ovarian cancer 1/5013 (0%) 1/5024 (0%) 0/5000 (0%) 2/5023 (0%)
Ovarian cancer metastatic 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Ovarian epithelial cancer metastatic 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Ovarian neoplasm 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Pancreatic carcinoma 3/5013 (0.1%) 8/5024 (0.2%) 2/5000 (0%) 3/5023 (0.1%)
Pancreatic carcinoma metastatic 0/5013 (0%) 0/5024 (0%) 2/5000 (0%) 1/5023 (0%)
Pancreatic neoplasm 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Papillary thyroid cancer 2/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Parathyroid tumour 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Parathyroid tumour benign 0/5013 (0%) 1/5024 (0%) 2/5000 (0%) 0/5023 (0%)
Peritoneal carcinoma 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Pharyngeal cancer stage unspecified 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Pituitary tumour 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Pituitary tumour benign 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Pleura carcinoma 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Pleural neoplasm 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Prostate cancer 12/5013 (0.2%) 15/5024 (0.3%) 16/5000 (0.3%) 12/5023 (0.2%)
Prostate cancer metastatic 1/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Prostate cancer stage IV 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Prostatic adenoma 0/5013 (0%) 0/5024 (0%) 2/5000 (0%) 3/5023 (0.1%)
Pseudomyxoma peritonei 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Rectal cancer 1/5013 (0%) 3/5024 (0.1%) 3/5000 (0.1%) 4/5023 (0.1%)
Rectal neoplasm 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 2/5023 (0%)
Renal cancer metastatic 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Renal cell carcinoma stage unspecified 1/5013 (0%) 1/5024 (0%) 2/5000 (0%) 1/5023 (0%)
Renal neoplasm 2/5013 (0%) 2/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Retroperitoneal neoplasm 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Rhabdomyoma 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Salivary gland adenoma 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Salivary gland cancer 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Seborrhoeic keratosis 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Skin cancer 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Small cell lung cancer metastatic 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Small cell lung cancer stage unspecified 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 2/5023 (0%)
Small intestine carcinoma metastatic 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Squamous cell carcinoma 1/5013 (0%) 0/5024 (0%) 4/5000 (0.1%) 2/5023 (0%)
Squamous cell carcinoma of skin 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
T-cell lymphoma 0/5013 (0%) 1/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Thyroid adenoma 1/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Tongue neoplasm 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Tongue neoplasm malignant stage unspecified 1/5013 (0%) 1/5024 (0%) 1/5000 (0%) 1/5023 (0%)
Tonsil cancer 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Tonsillar neoplasm benign 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Transitional cell carcinoma 0/5013 (0%) 1/5024 (0%) 2/5000 (0%) 0/5023 (0%)
Tumour invasion 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Ureteral neoplasm 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Uterine cancer 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Uterine leiomyoma 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Nervous system disorders
Altered state of consciousness 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Amnesia 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 2/5023 (0%)
Amyotrophic lateral sclerosis 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Anoxic encephalopathy 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Aphasia 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Ataxia 0/5013 (0%) 2/5024 (0%) 2/5000 (0%) 1/5023 (0%)
Autonomic nervous system imbalance 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Balance disorder 3/5013 (0.1%) 1/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Basilar artery stenosis 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Bradykinesia 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Brain mass 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Brain oedema 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Bulbar palsy 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Carotid arteriosclerosis 1/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Carotid artery aneurysm 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Carotid artery disease 1/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Carotid artery occlusion 1/5013 (0%) 2/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Carotid artery stenosis 26/5013 (0.5%) 19/5024 (0.4%) 27/5000 (0.5%) 20/5023 (0.4%)
Carotid artery thrombosis 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Carpal tunnel syndrome 1/5013 (0%) 3/5024 (0.1%) 1/5000 (0%) 3/5023 (0.1%)
Central nervous system lesion 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Central pain syndrome 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Cerebellar infarction 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Cerebral arteriosclerosis 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Cerebral artery embolism 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Cerebral artery stenosis 0/5013 (0%) 1/5024 (0%) 1/5000 (0%) 1/5023 (0%)
Cerebral disorder 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Cerebral haemorrhage 3/5013 (0.1%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Cerebral infarction 1/5013 (0%) 3/5024 (0.1%) 2/5000 (0%) 2/5023 (0%)
Cerebral ischaemia 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Cerebrovascular accident 4/5013 (0.1%) 7/5024 (0.1%) 4/5000 (0.1%) 6/5023 (0.1%)
Cerebrovascular disorder 0/5013 (0%) 2/5024 (0%) 3/5000 (0.1%) 2/5023 (0%)
Cerebrovascular insufficiency 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Cervical myelopathy 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 1/5023 (0%)
Chorea 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Clonic convulsion 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Clonus 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Cognitive disorder 1/5013 (0%) 1/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Coma 1/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Complex partial seizures 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Consciousness fluctuating 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Convulsion 27/5013 (0.5%) 18/5024 (0.4%) 23/5000 (0.5%) 26/5023 (0.5%)
Coordination abnormal 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Cubital tunnel syndrome 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Dementia 2/5013 (0%) 3/5024 (0.1%) 1/5000 (0%) 3/5023 (0.1%)
Dementia Alzheimer's type 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 1/5023 (0%)
Demyelination 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Depressed level of consciousness 0/5013 (0%) 1/5024 (0%) 2/5000 (0%) 1/5023 (0%)
Diabetic coma 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Diabetic hyperosmolar coma 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 2/5023 (0%)
Diabetic neuropathy 2/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Dizziness 16/5013 (0.3%) 19/5024 (0.4%) 12/5000 (0.2%) 15/5023 (0.3%)
Dizziness postural 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Drug withdrawal convulsions 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Dysarthria 2/5013 (0%) 0/5024 (0%) 1/5000 (0%) 3/5023 (0.1%)
Dyskinesia 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Dysphasia 1/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Dysstasia 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Dystonia 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Encephalitis 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Encephalopathy 5/5013 (0.1%) 2/5024 (0%) 2/5000 (0%) 2/5023 (0%)
Epilepsy 18/5013 (0.4%) 14/5024 (0.3%) 16/5000 (0.3%) 7/5023 (0.1%)
Facial palsy 3/5013 (0.1%) 4/5024 (0.1%) 0/5000 (0%) 1/5023 (0%)
Facial paresis 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Global amnesia 0/5013 (0%) 1/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Grand mal convulsion 2/5013 (0%) 4/5024 (0.1%) 1/5000 (0%) 5/5023 (0.1%)
Guillain-Barre syndrome 1/5013 (0%) 1/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Haemorrhage intracranial 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Haemorrhagic transformation stroke 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Head discomfort 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Headache 21/5013 (0.4%) 18/5024 (0.4%) 16/5000 (0.3%) 8/5023 (0.2%)
Hemiparesis 6/5013 (0.1%) 1/5024 (0%) 1/5000 (0%) 3/5023 (0.1%)
Hepatic encephalopathy 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Hyperaesthesia 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Hypersomnia 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Hypertensive encephalopathy 1/5013 (0%) 1/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Hypoaesthesia 1/5013 (0%) 3/5024 (0.1%) 4/5000 (0.1%) 2/5023 (0%)
Hypoglycaemic coma 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Hypoxic encephalopathy 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
IIIrd nerve paralysis 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 1/5023 (0%)
IVth nerve paralysis 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Intracranial aneurysm 0/5013 (0%) 1/5024 (0%) 1/5000 (0%) 2/5023 (0%)
Intracranial hypotension 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Intracranial pressure increased 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Intraventricular haemorrhage 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Ischaemic neuropathy 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Ischaemic stroke 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Lateral medullary syndrome 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Lethargy 1/5013 (0%) 2/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Loss of consciousness 5/5013 (0.1%) 1/5024 (0%) 3/5000 (0.1%) 3/5023 (0.1%)
Lumbar radiculopathy 2/5013 (0%) 1/5024 (0%) 2/5000 (0%) 0/5023 (0%)
Memory impairment 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Mental impairment 1/5013 (0%) 0/5024 (0%) 2/5000 (0%) 0/5023 (0%)
Metabolic encephalopathy 2/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Migraine 0/5013 (0%) 2/5024 (0%) 1/5000 (0%) 1/5023 (0%)
Monoparesis 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Motor neurone disease 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Multiple system atrophy 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Muscle spasticity 1/5013 (0%) 1/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Myasthenia gravis 1/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Myelitis 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Myelopathy 0/5013 (0%) 1/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Myoclonus 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Nerve compression 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Nerve root compression 0/5013 (0%) 0/5024 (0%) 2/5000 (0%) 0/5023 (0%)
Nervous system disorder 2/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Neuralgia 1/5013 (0%) 1/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Neurological symptom 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Neuromyelitis optica 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Neuropathy 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Neuropathy peripheral 0/5013 (0%) 2/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Normal pressure hydrocephalus 1/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Paraesthesia 2/5013 (0%) 2/5024 (0%) 3/5000 (0.1%) 1/5023 (0%)
Paraparesis 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Paresis 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Parkinson's disease 2/5013 (0%) 1/5024 (0%) 3/5000 (0.1%) 2/5023 (0%)
Parkinsonism 1/5013 (0%) 2/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Partial seizures 3/5013 (0.1%) 3/5024 (0.1%) 0/5000 (0%) 6/5023 (0.1%)
Peroneal nerve palsy 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Pneumocephalus 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Polyneuropathy 0/5013 (0%) 0/5024 (0%) 3/5000 (0.1%) 2/5023 (0%)
Presyncope 2/5013 (0%) 3/5024 (0.1%) 10/5000 (0.2%) 4/5023 (0.1%)
Radial nerve palsy 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Radicular pain 0/5013 (0%) 2/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Radiculitis lumbosacral 2/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Radiculopathy 1/5013 (0%) 0/5024 (0%) 2/5000 (0%) 0/5023 (0%)
Restless legs syndrome 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Sciatica 2/5013 (0%) 1/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Senile dementia 0/5013 (0%) 1/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Sensory disturbance 0/5013 (0%) 0/5024 (0%) 2/5000 (0%) 0/5023 (0%)
Sensory loss 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Simple partial seizures 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Somnolence 1/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Speech disorder 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Spinal cord disorder 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Status epilepticus 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 3/5023 (0.1%)
Subarachnoid haemorrhage 2/5013 (0%) 3/5024 (0.1%) 3/5000 (0.1%) 5/5023 (0.1%)
Syncope 25/5013 (0.5%) 20/5024 (0.4%) 31/5000 (0.6%) 24/5023 (0.5%)
Syncope vasovagal 3/5013 (0.1%) 5/5024 (0.1%) 7/5000 (0.1%) 3/5023 (0.1%)
Temporal lobe epilepsy 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Tension headache 0/5013 (0%) 0/5024 (0%) 2/5000 (0%) 0/5023 (0%)
Tonic convulsion 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Toxic encephalopathy 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Transient ischaemic attack 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Tremor 1/5013 (0%) 2/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Trigeminal neuralgia 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Ulnar nerve palsy 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Uraemic encephalopathy 1/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
VIth nerve paralysis 0/5013 (0%) 2/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Vascular dementia 2/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Vasculitis cerebral 1/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Vertebral artery stenosis 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Vertebrobasilar insufficiency 0/5013 (0%) 1/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Wernicke-Korsakoff syndrome 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Psychiatric disorders
Abnormal behaviour 0/5013 (0%) 1/5024 (0%) 1/5000 (0%) 1/5023 (0%)
Acute stress disorder 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Adjustment disorder 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Adjustment disorder with depressed mood 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Aggression 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Agitation 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Alcohol abuse 3/5013 (0.1%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Alcohol withdrawal syndrome 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Alcoholism 2/5013 (0%) 3/5024 (0.1%) 0/5000 (0%) 0/5023 (0%)
Anxiety 4/5013 (0.1%) 6/5024 (0.1%) 9/5000 (0.2%) 2/5023 (0%)
Anxiety disorder 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Bipolar disorder 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Completed suicide 1/5013 (0%) 2/5024 (0%) 3/5000 (0.1%) 2/5023 (0%)
Confusional state 2/5013 (0%) 6/5024 (0.1%) 6/5000 (0.1%) 7/5023 (0.1%)
Conversion disorder 0/5013 (0%) 0/5024 (0%) 2/5000 (0%) 0/5023 (0%)
Delirium 4/5013 (0.1%) 4/5024 (0.1%) 1/5000 (0%) 0/5023 (0%)
Delirium tremens 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Delusion 2/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Delusional disorder, persecutory type 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Depressed mood 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Depression 16/5013 (0.3%) 19/5024 (0.4%) 11/5000 (0.2%) 7/5023 (0.1%)
Depression suicidal 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Disorientation 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Eating disorder 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Generalised anxiety disorder 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Hallucination, visual 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Homicidal ideation 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Hypomania 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Impaired self-care 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Intentional self-injury 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Major depression 2/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Mania 1/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Mental disorder 0/5013 (0%) 2/5024 (0%) 1/5000 (0%) 1/5023 (0%)
Mental status changes 9/5013 (0.2%) 3/5024 (0.1%) 5/5000 (0.1%) 4/5023 (0.1%)
Nervousness 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Panic attack 2/5013 (0%) 2/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Psychiatric symptom 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Psychotic disorder 1/5013 (0%) 0/5024 (0%) 1/5000 (0%) 1/5023 (0%)
Sleep disorder 1/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Somatisation disorder 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Somatoform disorder 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Stress 1/5013 (0%) 1/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Substance abuse 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Suicidal behaviour 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Suicidal ideation 3/5013 (0.1%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Suicide attempt 2/5013 (0%) 3/5024 (0.1%) 1/5000 (0%) 0/5023 (0%)
Transient psychosis 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Renal and urinary disorders
Acute prerenal failure 1/5013 (0%) 1/5024 (0%) 1/5000 (0%) 1/5023 (0%)
Anuria 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Azotaemia 2/5013 (0%) 1/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Bladder spasm 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Calculus bladder 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 1/5023 (0%)
Calculus ureteric 1/5013 (0%) 3/5024 (0.1%) 6/5000 (0.1%) 1/5023 (0%)
Calculus urethral 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Calculus urinary 0/5013 (0%) 2/5024 (0%) 2/5000 (0%) 2/5023 (0%)
Cystitis haemorrhagic 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Diabetic cystopathy 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Diabetic nephropathy 1/5013 (0%) 1/5024 (0%) 0/5000 (0%) 2/5023 (0%)
Dysuria 1/5013 (0%) 0/5024 (0%) 1/5000 (0%) 1/5023 (0%)
Glomerulonephritis chronic 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Glomerulonephritis rapidly progressive 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Haematuria 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Hydronephrosis 3/5013 (0.1%) 4/5024 (0.1%) 3/5000 (0.1%) 0/5023 (0%)
Hydroureter 1/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Incontinence 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Kidney enlargement 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Micturition disorder 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Nephritis autoimmune 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Nephritis interstitial 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Nephrolithiasis 4/5013 (0.1%) 9/5024 (0.2%) 5/5000 (0.1%) 4/5023 (0.1%)
Nephropathy 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Nephropathy toxic 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Nephrotic syndrome 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Neurogenic bladder 1/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Obstructive uropathy 0/5013 (0%) 2/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Perinephric effusion 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Pollakiuria 1/5013 (0%) 1/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Proteinuria 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 2/5023 (0%)
Pyelectasia 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Pyuria 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Renal artery stenosis 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Renal colic 1/5013 (0%) 3/5024 (0.1%) 2/5000 (0%) 1/5023 (0%)
Renal cyst 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Renal embolism 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Renal failure 8/5013 (0.2%) 9/5024 (0.2%) 11/5000 (0.2%) 7/5023 (0.1%)
Renal failure acute 33/5013 (0.7%) 24/5024 (0.5%) 32/5000 (0.6%) 12/5023 (0.2%)
Renal failure chronic 2/5013 (0%) 6/5024 (0.1%) 4/5000 (0.1%) 2/5023 (0%)
Renal impairment 2/5013 (0%) 3/5024 (0.1%) 4/5000 (0.1%) 3/5023 (0.1%)
Renal mass 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Residual urine 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Single functional kidney 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Stress urinary incontinence 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Tubulointerstitial nephritis 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Ureteric obstruction 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 1/5023 (0%)
Ureteric stenosis 2/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Urethral disorder 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Urethral meatus stenosis 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Urethral polyp 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Urethral stenosis 1/5013 (0%) 1/5024 (0%) 0/5000 (0%) 2/5023 (0%)
Urinary bladder polyp 2/5013 (0%) 0/5024 (0%) 0/5000 (0%) 2/5023 (0%)
Urinary incontinence 1/5013 (0%) 0/5024 (0%) 1/5000 (0%) 1/5023 (0%)
Urinary retention 6/5013 (0.1%) 4/5024 (0.1%) 8/5000 (0.2%) 4/5023 (0.1%)
Urinary tract disorder 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Urinary tract obstruction 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Urine flow decreased 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Reproductive system and breast disorders
Balanitis 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Bartholin's cyst 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Benign prostatic hyperplasia 9/5013 (0.2%) 9/5024 (0.2%) 17/5000 (0.3%) 13/5023 (0.3%)
Breast mass 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Breast microcalcification 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Cervical dysplasia 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Cystocele 0/5013 (0%) 0/5024 (0%) 2/5000 (0%) 1/5023 (0%)
Epididymitis 2/5013 (0%) 2/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Genital prolapse 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Genital ulceration 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Ovarian cyst 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Pelvic pain 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Prostatic obstruction 1/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Prostatism 2/5013 (0%) 1/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Prostatitis 1/5013 (0%) 3/5024 (0.1%) 0/5000 (0%) 3/5023 (0.1%)
Prostatomegaly 1/5013 (0%) 4/5024 (0.1%) 2/5000 (0%) 0/5023 (0%)
Rectocele 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Uterine cyst 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Uterine prolapse 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 2/5023 (0%)
Uterovaginal prolapse 0/5013 (0%) 1/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Vaginal prolapse 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Varicocele 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema 0/5013 (0%) 1/5024 (0%) 2/5000 (0%) 2/5023 (0%)
Acute respiratory distress syndrome 3/5013 (0.1%) 0/5024 (0%) 1/5000 (0%) 1/5023 (0%)
Acute respiratory failure 1/5013 (0%) 1/5024 (0%) 1/5000 (0%) 2/5023 (0%)
Apnoea 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Asphyxia 3/5013 (0.1%) 1/5024 (0%) 1/5000 (0%) 1/5023 (0%)
Aspiration 0/5013 (0%) 0/5024 (0%) 2/5000 (0%) 0/5023 (0%)
Asthma 2/5013 (0%) 2/5024 (0%) 2/5000 (0%) 5/5023 (0.1%)
Atelectasis 2/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Bronchitis chronic 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Bronchopleural fistula 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Bronchospasm 1/5013 (0%) 1/5024 (0%) 1/5000 (0%) 2/5023 (0%)
Bullous lung disease 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Choking 0/5013 (0%) 0/5024 (0%) 2/5000 (0%) 1/5023 (0%)
Chronic obstructive pulmonary disease 14/5013 (0.3%) 13/5024 (0.3%) 21/5000 (0.4%) 17/5023 (0.3%)
Chronic respiratory failure 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Cough 2/5013 (0%) 0/5024 (0%) 0/5000 (0%) 3/5023 (0.1%)
Diaphragmatic hernia 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Dysphonia 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Dyspnoea 14/5013 (0.3%) 8/5024 (0.2%) 14/5000 (0.3%) 13/5023 (0.3%)
Dyspnoea exertional 0/5013 (0%) 1/5024 (0%) 1/5000 (0%) 1/5023 (0%)
Dyspnoea paroxysmal nocturnal 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Emphysema 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Epistaxis 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Foreign body aspiration 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Haemoptysis 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 2/5023 (0%)
Hiccups 1/5013 (0%) 1/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Hydropneumothorax 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Hyperventilation 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Hypopnoea 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Hypoxia 2/5013 (0%) 1/5024 (0%) 2/5000 (0%) 2/5023 (0%)
Idiopathic pulmonary fibrosis 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Interstitial lung disease 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Laryngeal leukoplakia 0/5013 (0%) 2/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Laryngospasm 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Lung consolidation 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Lung disorder 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Lung infiltration 1/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Nasal congestion 1/5013 (0%) 1/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Nasal polyps 1/5013 (0%) 0/5024 (0%) 1/5000 (0%) 1/5023 (0%)
Nasal septum deviation 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Nasal turbinate hypertrophy 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Obstructive airways disorder 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Orthopnoea 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Pharyngolaryngeal pain 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Pleural effusion 5/5013 (0.1%) 5/5024 (0.1%) 5/5000 (0.1%) 5/5023 (0.1%)
Pleurisy 2/5013 (0%) 1/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Pleuritic pain 1/5013 (0%) 2/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Pneumonia aspiration 12/5013 (0.2%) 10/5024 (0.2%) 7/5000 (0.1%) 5/5023 (0.1%)
Pneumonitis 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 1/5023 (0%)
Pneumothorax 2/5013 (0%) 4/5024 (0.1%) 0/5000 (0%) 0/5023 (0%)
Pulmonary fibrosis 1/5013 (0%) 2/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Pulmonary hilum mass 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Pulmonary hypertension 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Pulmonary mass 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Pulmonary oedema 1/5013 (0%) 2/5024 (0%) 1/5000 (0%) 1/5023 (0%)
Pulmonary sarcoidosis 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Respiratory arrest 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 1/5023 (0%)
Respiratory disorder 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Respiratory distress 1/5013 (0%) 1/5024 (0%) 2/5000 (0%) 1/5023 (0%)
Respiratory failure 8/5013 (0.2%) 7/5024 (0.1%) 10/5000 (0.2%) 9/5023 (0.2%)
Rhinitis hypertrophic 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Sleep apnoea syndrome 4/5013 (0.1%) 0/5024 (0%) 2/5000 (0%) 4/5023 (0.1%)
Skin and subcutaneous tissue disorders
Angioedema 1/5013 (0%) 1/5024 (0%) 3/5000 (0.1%) 1/5023 (0%)
Blister 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Decubitus ulcer 1/5013 (0%) 1/5024 (0%) 3/5000 (0.1%) 0/5023 (0%)
Dermal cyst 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Dermatitis allergic 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Diabetic neuropathic ulcer 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Ecchymosis 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Eczema 1/5013 (0%) 0/5024 (0%) 2/5000 (0%) 1/5023 (0%)
Erythema multiforme 1/5013 (0%) 1/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Erythema nodosum 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Hyperhidrosis 1/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Hypoaesthesia facial 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Ingrowing nail 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Nail dystrophy 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Night sweats 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Pruritus 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Psoriasis 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Purpura 0/5013 (0%) 1/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Rash 1/5013 (0%) 3/5024 (0.1%) 0/5000 (0%) 0/5023 (0%)
Rash erythematous 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Rash maculo-papular 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Scar 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 3/5023 (0.1%)
Segmented hyalinising vasculitis 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Skin discolouration 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Skin oedema 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Skin ulcer 3/5013 (0.1%) 5/5024 (0.1%) 1/5000 (0%) 5/5023 (0.1%)
Subcutaneous emphysema 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Toxic skin eruption 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 1/5023 (0%)
Urticaria 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Social circumstances
Cardiac assistance device user 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Elderly 1/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Social problem 0/5013 (0%) 1/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Social stay hospitalisation 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Surgical and medical procedures
Alcohol detoxification 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Angioplasty 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Bile duct stent insertion 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Blepharoplasty 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Carotid endarterectomy 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Cataract operation 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Cholecystectomy 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Coronary angioplasty 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 1/5023 (0%)
Finger amputation 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Plasmapheresis 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Removal of internal fixation 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Splenectomy 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Vascular disorders
Accelerated hypertension 1/5013 (0%) 3/5024 (0.1%) 2/5000 (0%) 1/5023 (0%)
Aneurysm 1/5013 (0%) 1/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Angiopathy 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Aortic aneurysm 5/5013 (0.1%) 8/5024 (0.2%) 8/5000 (0.2%) 4/5023 (0.1%)
Aortic aneurysm rupture 0/5013 (0%) 0/5024 (0%) 2/5000 (0%) 2/5023 (0%)
Aortic arteriosclerosis 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Aortic dissection 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Aortic embolus 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Aortic rupture 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Aortic stenosis 1/5013 (0%) 1/5024 (0%) 0/5000 (0%) 3/5023 (0.1%)
Arterial occlusive disease 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Arterial restenosis 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Arterial rupture 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Arterial stenosis 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Arteriosclerosis 2/5013 (0%) 3/5024 (0.1%) 4/5000 (0.1%) 3/5023 (0.1%)
Arteriosclerosis obliterans 0/5013 (0%) 1/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Arteritis 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Blood pressure inadequately controlled 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Cardiovascular insufficiency 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Circulatory collapse 2/5013 (0%) 0/5024 (0%) 1/5000 (0%) 1/5023 (0%)
Deep vein thrombosis 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Diabetic macroangiopathy 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 1/5023 (0%)
Diabetic vascular disorder 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Embolism 1/5013 (0%) 0/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Essential hypertension 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 2/5023 (0%)
Extremity necrosis 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Femoral arterial stenosis 1/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Femoral artery occlusion 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Fibromuscular dysplasia 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Haematoma 2/5013 (0%) 1/5024 (0%) 1/5000 (0%) 1/5023 (0%)
Haemorrhage 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Hypertension 14/5013 (0.3%) 15/5024 (0.3%) 19/5000 (0.4%) 20/5023 (0.4%)
Hypertensive crisis 7/5013 (0.1%) 3/5024 (0.1%) 7/5000 (0.1%) 12/5023 (0.2%)
Hypertensive emergency 2/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Hypotension 19/5013 (0.4%) 8/5024 (0.2%) 26/5000 (0.5%) 9/5023 (0.2%)
Hypovolaemic shock 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Iliac artery stenosis 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Intermittent claudication 2/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Ischaemia 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Lymphoedema 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Malignant hypertension 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Orthostatic hypotension 3/5013 (0.1%) 6/5024 (0.1%) 7/5000 (0.1%) 7/5023 (0.1%)
Peripheral arterial occlusive disease 0/5013 (0%) 1/5024 (0%) 1/5000 (0%) 1/5023 (0%)
Peripheral artery aneurysm 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Peripheral ischaemia 1/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Peripheral vascular disorder 1/5013 (0%) 5/5024 (0.1%) 0/5000 (0%) 1/5023 (0%)
Phlebitis 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Post thrombotic syndrome 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Shock 0/5013 (0%) 1/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Subclavian artery stenosis 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 1/5023 (0%)
Superior vena caval occlusion 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Temporal arteritis 1/5013 (0%) 4/5024 (0.1%) 0/5000 (0%) 0/5023 (0%)
Thrombophlebitis 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Thrombophlebitis superficial 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Thrombosis 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Varicose vein 0/5013 (0%) 1/5024 (0%) 1/5000 (0%) 2/5023 (0%)
Vascular pseudoaneurysm 1/5013 (0%) 0/5024 (0%) 2/5000 (0%) 0/5023 (0%)
Vasculitis 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Venous stasis 0/5013 (0%) 0/5024 (0%) 0/5000 (0%) 1/5023 (0%)
Venous thrombosis 0/5013 (0%) 0/5024 (0%) 1/5000 (0%) 0/5023 (0%)
Venous thrombosis limb 0/5013 (0%) 1/5024 (0%) 0/5000 (0%) 0/5023 (0%)
Other (Not Including Serious) Adverse Events
Aspirin + Extended Release Dipyridamole / Telmisartan Aspirin + Extended Release Dipyridamole / Placebo Clopidogrel / Telmisartan Clopidogrel / Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 1856/ (NaN) 1810/ (NaN) 866/ (NaN) 810/ (NaN)
Nervous system disorders
Headache (leading to permanent discont. of study medication) 318/5013 (6.3%) 280/5024 (5.6%) 42/5000 (0.8%) 50/5023 (1%)
Dizziness or lightheadedness (Solicited question at Day 7) 768/5086 (15.1%) 597/5095 (11.7%) 510/5060 (10.1%) 398/5091 (7.8%)
Headache (Solicited question at Day 7) 1515/5086 (29.8%) 1556/5095 (30.5%) 491/5060 (9.7%) 546/5091 (10.7%)

Limitations/Caveats

All SAEs and AEs that led to temporary or permanent trial drug discontinuation were reported, except in Japan, where all AEs were collected. Protocol-defined outcome events were not reported as AEs, but were recorded on the appropriate form

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.

Results Point of Contact

Name/Title Boehringer Ingelheim Call Center
Organization Boehringer Ingelheim Pharmaceuticals
Phone 1-800-243-0127
Email clintriage.rdg@boehringer-ingelheim.com
Responsible Party:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00153062
Other Study ID Numbers:
  • 9.159
First Posted:
Sep 12, 2005
Last Update Posted:
May 13, 2014
Last Verified:
Apr 1, 2014