LEADERĀ®: Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results
Study Details
Study Description
Brief Summary
This trial is conducted in Africa, Asia, Europe, and North and South America. The aim of this trial is to determine the long term effect of liraglutide on cardiovascular events in subjects with type 2 diabetes.
Condition or Disease | Intervention/Treatment | Phase |
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|
Phase 3 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Liraglutide
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Drug: liraglutide
Maximum dose of 1.8 mg liraglutide, injected subcutaneously (under the skin) once daily. Administered in addition to the subject's standard treatment
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Placebo Comparator: Placebo
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Drug: placebo
Maximum dose of 1.8 mg placebo, injected subcutaneously (under the skin) once daily. Administered in addition to the subject's standard treatment
|
Outcome Measures
Primary Outcome Measures
- Time From Randomisation to First Occurrence of Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke (a Composite Cardiovascular Outcome) [from randomisation (visit 3; month 0) to last contact (visit 16; up to month 60+30 days)]
Time from randomisation to first occurrence of cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke (a composite cardiovascular outcome). The percentage of subjects experiencing a first event of cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke (a composite cardiovascular outcome) is presented.
Secondary Outcome Measures
- Time From Rand. to First Occurrence of an Expanded Composite Cardiovascular Outcome Defined as Either Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke, Revascularisation, Hospitalisation for Unstable Angina or for Heart Failure. [from randomisation (visit 3; month 0) to last contact (visit 16; up to month 60+30 days)]
Time from randomisation to first occurrence of an expanded composite cardiovascular outcome defined as either cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, coronary revascularisation, hospitalisation for unstable angina or for heart failure. The percentage of subjects experiencing first occurrence of an expanded composite cardiovascular outcome defined as either cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, coronary revascularisation, hospitalisation for unstable angina or for heart failure is presented.
- Time From Randomisation to All Cause Death [from randomisation (visit 3; month 0) to last contact (visit 16; up to month 60+30 days)]
Time from randomisation to all cause death. The percentage of subjects with a death by any cause (all-cause death) is presented.
- Time From Randomisation to Each Individual Component of the Expanded Composite Cardiovascular Outcome [from randomisation (visit 3; month 0) to last contact (visit 16; up to month 60+30 days)]
Time from randomisation to each individual component of the expanded composite cardiovascular outcome. The percentage of subjects experiencing each of the individual component of the expanded composite cardiovascular outcome (defined as either cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, coronary revascularisation, hospitalisation for unstable angina or heart failure) is presented.
- Time From Randomisation to First Occurrence of a Composite Microvascular Outcome [from randomisation (visit 3; month 0) to last contact (visit 16; up to month 60+30 days)]
Time from randomisation to first occurrence of a composite microvascular outcome, defined as any one of the following: new onset of persistent macroalbuminuria persistent doubling of serum creatinine need for continuous renal replacement therapy death due to renal disease need for retinal photocoagulation or treatment with intravitreal agents vitreous haemorrhage diabetes-related blindness The percentage of subjects experiencing a first occurrence of a composite microvascular outcome is presented.
- Time From Randomisation to Each Individual Component of the Composite Microvascular Outcome and to the Retinopathy and Nephropathy Composite Outcomes Separately. [from randomisation (visit 3; month 0) to last contact (visit 16; up to month 60+30 days)]
Time from randomisation to each individual component of the composite microvascular outcome and to the retinopathy and nephropathy composite outcomes separately. The percentage of subjects experiencing each individual component of the composite microvascular outcome are presented.
Eligibility Criteria
Criteria
Inclusion Criteria: - Type 2 diabetes - Age min. 50 years at screening and concomitant cardiovascular, cerebrovascular or peripheral vascular disease or chronic renal failure or chronic heart failure OR age min. 60 years at screening and other specified risk factors of cardiovascular disease - HbA1c: 7.0% or above - Anti-diabetic drug naive or treated with one or more oral anti-diabetic drugs (OADs) or treated with human NPH insulin or long-acting insulin analogue or premixed insulin, alone or in combination with OAD(s) Exclusion Criteria: - Type 1 diabetes - Use of a glucagon-like peptide-1 (GLP-1) receptor agonist (exenatide, liraglutide or other) or pramlintide or any dipeptidyl peptidase 4 (DPP-4) inhibitor within the 3 months prior to screening (trial start) - Use of insulin other than human NPH insulin or long-acting insulin analogue or premixed insulin within 3 months prior to screening. Short-term use of other insulin during this period in connection with intercurrent illness is allowed, at Investigator's discretion
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Novo Nordisk Investigational Site | Alabaster | Alabama | United States | 35007 |
2 | Novo Nordisk Investigational Site | Birmingham | Alabama | United States | 35209 |
3 | Novo Nordisk Investigational Site | Birmingham | Alabama | United States | 35294 |
4 | Novo Nordisk Investigational Site | Huntsville | Alabama | United States | 35801 |
5 | Novo Nordisk Investigational Site | Mobile | Alabama | United States | 36608 |
6 | Novo Nordisk Investigational Site | Tempe | Arizona | United States | 85283 |
7 | Novo Nordisk Investigational Site | Little Rock | Arkansas | United States | 72205-5446 |
8 | Novo Nordisk Investigational Site | Little Rock | Arkansas | United States | 72205 |
9 | Novo Nordisk Investigational Site | Anaheim | California | United States | 92801 |
10 | Novo Nordisk Investigational Site | Cerritos | California | United States | 90703-2115 |
11 | Novo Nordisk Investigational Site | Escondido | California | United States | 92025 |
12 | Novo Nordisk Investigational Site | Fresno | California | United States | 93721-1443 |
13 | Novo Nordisk Investigational Site | Los Angeles | California | United States | 90017-4006 |
14 | Novo Nordisk Investigational Site | Los Banos | California | United States | 93635 |
15 | Novo Nordisk Investigational Site | Mission Hills | California | United States | 91345 |
16 | Novo Nordisk Investigational Site | Montclair | California | United States | 91763 |
17 | Novo Nordisk Investigational Site | San Diego | California | United States | 92111 |
18 | Novo Nordisk Investigational Site | Tustin | California | United States | 92780 |
19 | Novo Nordisk Investigational Site | Walnut Creek | California | United States | 94598 |
20 | Novo Nordisk Investigational Site | Watsonville | California | United States | 95076 |
21 | Novo Nordisk Investigational Site | Aurora | Colorado | United States | 80045-7402 |
22 | Novo Nordisk Investigational Site | Denver | Colorado | United States | 80220 |
23 | Novo Nordisk Investigational Site | Newark | Delaware | United States | 19713 |
24 | Novo Nordisk Investigational Site | Bradenton | Florida | United States | 34201 |
25 | Novo Nordisk Investigational Site | Clearwater | Florida | United States | 33756 |
26 | Novo Nordisk Investigational Site | DeLand | Florida | United States | 32724 |
27 | Novo Nordisk Investigational Site | Fort Lauderdale | Florida | United States | 33316 |
28 | Novo Nordisk Investigational Site | Kissimmee | Florida | United States | 34744 |
29 | Novo Nordisk Investigational Site | Miami | Florida | United States | 33136 |
30 | Novo Nordisk Investigational Site | Orlando | Florida | United States | 32804 |
31 | Novo Nordisk Investigational Site | Saint Petersburg | Florida | United States | 33711 |
32 | Novo Nordisk Investigational Site | Tampa | Florida | United States | 33624 |
33 | Novo Nordisk Investigational Site | West Palm Beach | Florida | United States | 33409 |
34 | Novo Nordisk Investigational Site | Lawrenceville | Georgia | United States | 30046 |
35 | Novo Nordisk Investigational Site | Roswell | Georgia | United States | 30076 |
36 | Novo Nordisk Investigational Site | Chicago | Illinois | United States | 60607 |
37 | Novo Nordisk Investigational Site | Chicago | Illinois | United States | 60612 |
38 | Novo Nordisk Investigational Site | Chicago | Illinois | United States | 60654 |
39 | Novo Nordisk Investigational Site | Crystal Lake | Illinois | United States | 60012 |
40 | Novo Nordisk Investigational Site | Indianapolis | Indiana | United States | 46260-1992 |
41 | Novo Nordisk Investigational Site | Michigan City | Indiana | United States | 46360 |
42 | Novo Nordisk Investigational Site | West Des Moines | Iowa | United States | 50265 |
43 | Novo Nordisk Investigational Site | Lexington | Kentucky | United States | 40502 |
44 | Novo Nordisk Investigational Site | Louisville | Kentucky | United States | 40202 |
45 | Novo Nordisk Investigational Site | Louisville | Kentucky | United States | 40206 |
46 | Novo Nordisk Investigational Site | Metairie | Louisiana | United States | 70006-2930 |
47 | Novo Nordisk Investigational Site | Monroe | Louisiana | United States | 71203 |
48 | Novo Nordisk Investigational Site | Natchitoches | Louisiana | United States | 71457-5881 |
49 | Novo Nordisk Investigational Site | New Orleans | Louisiana | United States | 70112 |
50 | Novo Nordisk Investigational Site | Baltimore | Maryland | United States | 21204 |
51 | Novo Nordisk Investigational Site | Baltimore | Maryland | United States | 21218-2829 |
52 | Novo Nordisk Investigational Site | Bloomfield Hills | Michigan | United States | 48302 |
53 | Novo Nordisk Investigational Site | Dearborn | Michigan | United States | 48124 |
54 | Novo Nordisk Investigational Site | Interlochen | Michigan | United States | 49643 |
55 | Novo Nordisk Investigational Site | Troy | Michigan | United States | 48085-5524 |
56 | Novo Nordisk Investigational Site | Minneapolis | Minnesota | United States | 55416 |
57 | Novo Nordisk Investigational Site | Saint Louis | Missouri | United States | 63108 |
58 | Novo Nordisk Investigational Site | Springfield | Missouri | United States | 65807 |
59 | Novo Nordisk Investigational Site | Great Falls | Montana | United States | 59405 |
60 | Novo Nordisk Investigational Site | Omaha | Nebraska | United States | 68105 |
61 | Novo Nordisk Investigational Site | Lebanon | New Hampshire | United States | 03756 |
62 | Novo Nordisk Investigational Site | Nashua | New Hampshire | United States | 03063 |
63 | Novo Nordisk Investigational Site | Mine Hill | New Jersey | United States | 07803 |
64 | Novo Nordisk Investigational Site | Neptune | New Jersey | United States | 07753-4859 |
65 | Novo Nordisk Investigational Site | Albany | New York | United States | 12208 |
66 | Novo Nordisk Investigational Site | Buffalo | New York | United States | 14221-7091 |
67 | Novo Nordisk Investigational Site | New York | New York | United States | 10032 |
68 | Novo Nordisk Investigational Site | New York | New York | United States | 10036 |
69 | Novo Nordisk Investigational Site | New York | New York | United States | 10065 |
70 | Novo Nordisk Investigational Site | Smithtown | New York | United States | 11787 |
71 | Novo Nordisk Investigational Site | Syracuse | New York | United States | 13210 |
72 | Novo Nordisk Investigational Site | Westfield | New York | United States | 14787 |
73 | Novo Nordisk Investigational Site | Asheville | North Carolina | United States | 28801 |
74 | Novo Nordisk Investigational Site | Burlington | North Carolina | United States | 27215 |
75 | Novo Nordisk Investigational Site | Chapel Hill | North Carolina | United States | 27517 |
76 | Novo Nordisk Investigational Site | Greensboro | North Carolina | United States | 27401 |
77 | Novo Nordisk Investigational Site | Greenville | North Carolina | United States | 27834 |
78 | Novo Nordisk Investigational Site | Monroe | North Carolina | United States | 28110 |
79 | Novo Nordisk Investigational Site | Mooresville | North Carolina | United States | 28117 |
80 | Novo Nordisk Investigational Site | Morehead City | North Carolina | United States | 28557 |
81 | Novo Nordisk Investigational Site | Whiteville | North Carolina | United States | 28472 |
82 | Novo Nordisk Investigational Site | Cadiz | Ohio | United States | 43907 |
83 | Novo Nordisk Investigational Site | Cincinnati | Ohio | United States | 45219 |
84 | Novo Nordisk Investigational Site | Cincinnati | Ohio | United States | 45220-2213 |
85 | Novo Nordisk Investigational Site | Cleveland | Ohio | United States | 44106 |
86 | Novo Nordisk Investigational Site | Marion | Ohio | United States | 43302 |
87 | Novo Nordisk Investigational Site | Middleburg Heights | Ohio | United States | 44310 |
88 | Novo Nordisk Investigational Site | Oklahoma City | Oklahoma | United States | 73103 |
89 | Novo Nordisk Investigational Site | Oklahoma City | Oklahoma | United States | 73104 |
90 | Novo Nordisk Investigational Site | Altoona | Pennsylvania | United States | 16602 |
91 | Novo Nordisk Investigational Site | Beaver | Pennsylvania | United States | 15009-1957 |
92 | Novo Nordisk Investigational Site | Hatfield | Pennsylvania | United States | 19440 |
93 | Novo Nordisk Investigational Site | Philadelphia | Pennsylvania | United States | 19104 |
94 | Novo Nordisk Investigational Site | Philadelphia | Pennsylvania | United States | 19107 |
95 | Novo Nordisk Investigational Site | Pittsburgh | Pennsylvania | United States | 15243 |
96 | Novo Nordisk Investigational Site | Uniontown | Pennsylvania | United States | 15401 |
97 | Novo Nordisk Investigational Site | Charleston | South Carolina | United States | 29455 |
98 | Novo Nordisk Investigational Site | Columbia | South Carolina | United States | 29203 |
99 | Novo Nordisk Investigational Site | Greenville | South Carolina | United States | 29607 |
100 | Novo Nordisk Investigational Site | Greer | South Carolina | United States | 29651 |
101 | Novo Nordisk Investigational Site | Murrells Inlet | South Carolina | United States | 29576 |
102 | Novo Nordisk Investigational Site | Myrtle Beach | South Carolina | United States | 29572 |
103 | Novo Nordisk Investigational Site | Bartlett | Tennessee | United States | 38133 |
104 | Novo Nordisk Investigational Site | Kingsport | Tennessee | United States | 37660 |
105 | Novo Nordisk Investigational Site | Memphis | Tennessee | United States | 38163 |
106 | Novo Nordisk Investigational Site | Nashville | Tennessee | United States | 37212 |
107 | Novo Nordisk Investigational Site | Arlington | Texas | United States | 76014 |
108 | Novo Nordisk Investigational Site | Corpus Christi | Texas | United States | 78404 |
109 | Novo Nordisk Investigational Site | Dallas | Texas | United States | 75230 |
110 | Novo Nordisk Investigational Site | Dallas | Texas | United States | 75231 |
111 | Novo Nordisk Investigational Site | Dallas | Texas | United States | 75246 |
112 | Novo Nordisk Investigational Site | Dallas | Texas | United States | 75390 |
113 | Novo Nordisk Investigational Site | Houston | Texas | United States | 77070 |
114 | Novo Nordisk Investigational Site | Houston | Texas | United States | 77095 |
115 | Novo Nordisk Investigational Site | Longview | Texas | United States | 75605 |
116 | Novo Nordisk Investigational Site | Lubbock | Texas | United States | 79423 |
117 | Novo Nordisk Investigational Site | Odessa | Texas | United States | 79761 |
118 | Novo Nordisk Investigational Site | San Antonio | Texas | United States | 78228-3419 |
119 | Novo Nordisk Investigational Site | San Antonio | Texas | United States | 78229 |
120 | Novo Nordisk Investigational Site | Schertz | Texas | United States | 78154 |
121 | Novo Nordisk Investigational Site | Tomball | Texas | United States | 77375 |
122 | Novo Nordisk Investigational Site | Salt Lake City | Utah | United States | 84102 |
123 | Novo Nordisk Investigational Site | South Burlington | Vermont | United States | 05403 |
124 | Novo Nordisk Investigational Site | Spokane | Washington | United States | 99210 |
125 | Novo Nordisk Investigational Site | Madison | Wisconsin | United States | 53717 |
126 | Novo Nordisk Investigational Site | Blacktown | New South Wales | Australia | 2148 |
127 | Novo Nordisk Investigational Site | Douglas | Queensland | Australia | 4814 |
128 | Novo Nordisk Investigational Site | Herston | Queensland | Australia | 4029 |
129 | Novo Nordisk Investigational Site | Meadowbrook | Queensland | Australia | 4131 |
130 | Novo Nordisk Investigational Site | Keswick | South Australia | Australia | 5035 |
131 | Novo Nordisk Investigational Site | Oaklands Park | South Australia | Australia | 5046 |
132 | Novo Nordisk Investigational Site | Hobart | Tasmania | Australia | 7000 |
133 | Novo Nordisk Investigational Site | Box Hill | Victoria | Australia | 3128 |
134 | Novo Nordisk Investigational Site | Fitzroy | Victoria | Australia | 3065 |
135 | Novo Nordisk Investigational Site | Fremantle | Western Australia | Australia | 6160 |
136 | Novo Nordisk Investigational Site | Graz | Austria | 8036 | |
137 | Novo Nordisk Investigational Site | Wien | Austria | 1030 | |
138 | Novo Nordisk Investigational Site | Wien | Austria | 1090 | |
139 | Novo Nordisk Investigational Site | Wien | Austria | 1130 | |
140 | Novo Nordisk Investigational Site | Wien | Austria | 1140 | |
141 | Novo Nordisk Investigational Site | Edegem | Belgium | 2650 | |
142 | Novo Nordisk Investigational Site | Gent | Belgium | 9000 | |
143 | Novo Nordisk Investigational Site | Leuven | Belgium | 3000 | |
144 | Novo Nordisk Investigational Site | LiĆØge | Belgium | 4000 | |
145 | Novo Nordisk Investigational Site | Fortaleza | Ceara | Brazil | 60115-282 |
146 | Novo Nordisk Investigational Site | Fortaleza | Ceara | Brazil | 60170-001 |
147 | Novo Nordisk Investigational Site | Fortaleza | Ceara | Brazil | 60192-340 |
148 | Novo Nordisk Investigational Site | Aparecida de Goiania | Goias | Brazil | 74935-530 |
149 | Novo Nordisk Investigational Site | Curitiba | Parana | Brazil | 80010-030 |
150 | Novo Nordisk Investigational Site | Curitiba | Parana | Brazil | 80030-110 |
151 | Novo Nordisk Investigational Site | Curitiba | Parana | Brazil | 80810-040 |
152 | Novo Nordisk Investigational Site | BelƩm | Para | Brazil | 66073-000 |
153 | Novo Nordisk Investigational Site | Caxias Do Sul | Rio Grande Do Sul | Brazil | 95070-560 |
154 | Novo Nordisk Investigational Site | Porto Alegre | Rio Grande Do Sul | Brazil | 90035-001 |
155 | Novo Nordisk Investigational Site | Campinas | Sao Paulo | Brazil | 13059-740 |
156 | Novo Nordisk Investigational Site | Campinas | Sao Paulo | Brazil | 13073-350 |
157 | Novo Nordisk Investigational Site | Mogi das Cruzes | Sao Paulo | Brazil | 08780-090 |
158 | Novo Nordisk Investigational Site | SĆ£o Paulo | Sao Paulo | Brazil | 01223-001 |
159 | Novo Nordisk Investigational Site | SĆ£o Paulo | Sao Paulo | Brazil | 01228-000 |
160 | Novo Nordisk Investigational Site | SĆ£o Paulo | Sao Paulo | Brazil | 01228-200 |
161 | Novo Nordisk Investigational Site | SĆ£o Paulo | Sao Paulo | Brazil | 04012-909 |
162 | Novo Nordisk Investigational Site | SĆ£o Paulo | Sao Paulo | Brazil | 04020-041 |
163 | Novo Nordisk Investigational Site | SĆ£o Paulo | Sao Paulo | Brazil | 05403-000 |
164 | Novo Nordisk Investigational Site | AracajĆŗ | Brazil | 49020-270 | |
165 | Novo Nordisk Investigational Site | Belo Horizonte | Brazil | 30150-221 | |
166 | Novo Nordisk Investigational Site | Campinas | Brazil | 13084-971 | |
167 | Novo Nordisk Investigational Site | Curitiba | Brazil | 80420-011 | |
168 | Novo Nordisk Investigational Site | Fortaleza | Brazil | 60430-350 | |
169 | Novo Nordisk Investigational Site | GoiĆ¢nia | Brazil | 74110-120 | |
170 | Novo Nordisk Investigational Site | Joinville | Brazil | 05001-100 | |
171 | Novo Nordisk Investigational Site | MarĆlia | Brazil | 17519-000 | |
172 | Novo Nordisk Investigational Site | Porto Alegre | Brazil | 90035-170 | |
173 | Novo Nordisk Investigational Site | Recife | Brazil | 52020-010 | |
174 | Novo Nordisk Investigational Site | Rio de Janeiro | Brazil | 20211-340 | |
175 | Novo Nordisk Investigational Site | Rio de Janeiro | Brazil | 20551-030 | |
176 | Novo Nordisk Investigational Site | Santos | Brazil | 11045-904 | |
177 | Novo Nordisk Investigational Site | Sao Paulo | Brazil | 01323-001 | |
178 | Novo Nordisk Investigational Site | Sao Paulo | Brazil | 04011-030 | |
179 | Novo Nordisk Investigational Site | SĆ£o Paulo | Brazil | 05403-000 | |
180 | Novo Nordisk Investigational Site | Edmonton | Alberta | Canada | T5J 3N4 |
181 | Novo Nordisk Investigational Site | Vancouver | British Columbia | Canada | V6H 3X8 |
182 | Novo Nordisk Investigational Site | Winnipeg | Manitoba | Canada | R3E 3P4 |
183 | Novo Nordisk Investigational Site | St.John's | Newfoundland and Labrador | Canada | A1B 3V6 |
184 | Novo Nordisk Investigational Site | Halifax | Nova Scotia | Canada | B3H 2Y9 |
185 | Novo Nordisk Investigational Site | Cambridge | Ontario | Canada | N1R 7L6 |
186 | Novo Nordisk Investigational Site | Cornwall | Ontario | Canada | K6H 4M4 |
187 | Novo Nordisk Investigational Site | London | Ontario | Canada | N6A 4V2 |
188 | Novo Nordisk Investigational Site | London | Ontario | Canada | N6G 2M1 |
189 | Novo Nordisk Investigational Site | Mississauga | Ontario | Canada | L5M 2V8 |
190 | Novo Nordisk Investigational Site | Scarborough | Ontario | Canada | M1E 5E9 |
191 | Novo Nordisk Investigational Site | Smiths Falls | Ontario | Canada | K7A 4W8 |
192 | Novo Nordisk Investigational Site | Thunder Bay | Ontario | Canada | P7A 4V7 |
193 | Novo Nordisk Investigational Site | Toronto | Ontario | Canada | M5C 2T2 |
194 | Novo Nordisk Investigational Site | Toronto | Ontario | Canada | M5T 3L9 |
195 | Novo Nordisk Investigational Site | Montreal | Quebec | Canada | H2W 1R7 |
196 | Novo Nordisk Investigational Site | Quebec | Canada | G1V 4G2 | |
197 | Novo Nordisk Investigational Site | Quebec | Canada | G1V 4G5 | |
198 | Novo Nordisk Investigational Site | Beijing | Beijing | China | 100044 |
199 | Novo Nordisk Investigational Site | Beijing | Beijing | China | 100730 |
200 | Novo Nordisk Investigational Site | Beijing | Beijing | China | 100853 |
201 | Novo Nordisk Investigational Site | Xiamen | Fujian | China | 361003 |
202 | Novo Nordisk Investigational Site | Guangzhou | Guangdong | China | 510120 |
203 | Novo Nordisk Investigational Site | Zhenjiang | Jiangsu | China | 212001 |
204 | Novo Nordisk Investigational Site | Qingdao | Shandong | China | 266003 |
205 | Novo Nordisk Investigational Site | Shanghai | Shanghai | China | 200003 |
206 | Novo Nordisk Investigational Site | Plzen | Czechia | 304 60 | |
207 | Novo Nordisk Investigational Site | Praha | Czechia | 128 08 | |
208 | Novo Nordisk Investigational Site | Aalborg | Denmark | 9100 | |
209 | Novo Nordisk Investigational Site | Esbjerg | Denmark | 6700 | |
210 | Novo Nordisk Investigational Site | Gentofte | Denmark | 2820 | |
211 | Novo Nordisk Investigational Site | Hvidovre | Denmark | 2650 | |
212 | Novo Nordisk Investigational Site | Odense | Denmark | 5000 | |
213 | Novo Nordisk Investigational Site | Ć rhus C | Denmark | 8000 | |
214 | Novo Nordisk Investigational Site | Kuopio | Finland | 70210 | |
215 | Novo Nordisk Investigational Site | Lahti | Finland | 15110 | |
216 | Novo Nordisk Investigational Site | Oulu | Finland | 90220 | |
217 | Novo Nordisk Investigational Site | Tampere | Finland | 33520 | |
218 | Novo Nordisk Investigational Site | Vantaa | Finland | FIN-01600 | |
219 | Novo Nordisk Investigational Site | Corbeil Essonnes | France | 91106 | |
220 | Novo Nordisk Investigational Site | Jarny | France | 54800 | |
221 | Novo Nordisk Investigational Site | Nimes | France | 30006 | |
222 | Novo Nordisk Investigational Site | Paris | France | 75877 | |
223 | Novo Nordisk Investigational Site | AngermĆ¼nde/OT Wolletz | Germany | 16278 | |
224 | Novo Nordisk Investigational Site | Aschaffenburg | Germany | 63739 | |
225 | Novo Nordisk Investigational Site | Berlin | Germany | 12163 | |
226 | Novo Nordisk Investigational Site | Berlin | Germany | 13055 | |
227 | Novo Nordisk Investigational Site | Dillingen | Germany | 89407 | |
228 | Novo Nordisk Investigational Site | Dresden | Germany | 01219 | |
229 | Novo Nordisk Investigational Site | Elsterwerda | Germany | 04910 | |
230 | Novo Nordisk Investigational Site | Essen | Germany | 45219 | |
231 | Novo Nordisk Investigational Site | Falkensee | Germany | 14612 | |
232 | Novo Nordisk Investigational Site | Gifhorn | Germany | 38518 | |
233 | Novo Nordisk Investigational Site | Hamburg | Germany | 22587 | |
234 | Novo Nordisk Investigational Site | Karlsbad | Germany | 76307 | |
235 | Novo Nordisk Investigational Site | Leipzig | Germany | 04103 | |
236 | Novo Nordisk Investigational Site | Leipzig | Germany | 04275 | |
237 | Novo Nordisk Investigational Site | Ludwigshafen | Germany | 67059 | |
238 | Novo Nordisk Investigational Site | Mannheim | Germany | 68163 | |
239 | Novo Nordisk Investigational Site | MĆ¼nchen | Germany | 80336 | |
240 | Novo Nordisk Investigational Site | Oldenburg | Germany | 23758 | |
241 | Novo Nordisk Investigational Site | Saint Ingbert-OberwĆ¼rzbach | Germany | 66386 | |
242 | Novo Nordisk Investigational Site | Schkeuditz | Germany | 04435 | |
243 | Novo Nordisk Investigational Site | Schweinfurt | Germany | 97421 | |
244 | Novo Nordisk Investigational Site | Ulm | Germany | 89081 | |
245 | Novo Nordisk Investigational Site | Villingen-Schwenningen | Germany | 78048 | |
246 | Novo Nordisk Investigational Site | Wangen | Germany | 88239 | |
247 | Novo Nordisk Investigational Site | Athens | Greece | GR-10552 | |
248 | Novo Nordisk Investigational Site | Athens | Greece | GR-11527 | |
249 | Novo Nordisk Investigational Site | Crete | Greece | 71001 | |
250 | Novo Nordisk Investigational Site | Thessaloniki | Greece | GR-57001 | |
251 | Novo Nordisk Investigational Site | Hyderabad | Andhra Pradesh | India | 500034 |
252 | Novo Nordisk Investigational Site | Hyderbad | Andhra Pradesh | India | 500 012 |
253 | Novo Nordisk Investigational Site | Guwahati | Assam | India | 781007 |
254 | Novo Nordisk Investigational Site | Karnal | Haryana | India | 132001 |
255 | Novo Nordisk Investigational Site | Bangalore | Karnataka | India | 560 003 |
256 | Novo Nordisk Investigational Site | Bangalore | Karnataka | India | 560043 |
257 | Novo Nordisk Investigational Site | Bangalore | Karnataka | India | 560052 |
258 | Novo Nordisk Investigational Site | Manipal | Karnataka | India | 576104 |
259 | Novo Nordisk Investigational Site | Kochi | Kerala | India | 682041 |
260 | Novo Nordisk Investigational Site | Indore | Madhya Pradesh | India | 452010 |
261 | Novo Nordisk Investigational Site | Mumbai | Maharashtra | India | 400012 |
262 | Novo Nordisk Investigational Site | Chandigarh | Punjab | India | 160012 |
263 | Novo Nordisk Investigational Site | Chennai | Tamil Nadu | India | 600029 |
264 | Novo Nordisk Investigational Site | Chennai | Tamil Nadu | India | 600086 |
265 | Novo Nordisk Investigational Site | Madurai | Tamil Nadu | India | 625 020 |
266 | Novo Nordisk Investigational Site | Vellore | Tamil Nadu | India | 632004 |
267 | Novo Nordisk Investigational Site | Kolkata | West Bengal | India | 700054 |
268 | Novo Nordisk Investigational Site | Thriruvananthapuram | India | 695 032 | |
269 | Novo Nordisk Investigational Site | Dublin 9 | Ireland | ||
270 | Novo Nordisk Investigational Site | Dublin | Ireland | DUBLIN 4 | |
271 | Novo Nordisk Investigational Site | Haifa | Israel | 31096 | |
272 | Novo Nordisk Investigational Site | Haifa | Israel | 35152 | |
273 | Novo Nordisk Investigational Site | Jerusalem | Israel | 91120 | |
274 | Novo Nordisk Investigational Site | Petah-Tikva | Israel | 49372 | |
275 | Novo Nordisk Investigational Site | Tel Hashomer | Israel | 52621 | |
276 | Novo Nordisk Investigational Site | Bologna | Italy | 40138 | |
277 | Novo Nordisk Investigational Site | Catanzaro | Italy | 88100 | |
278 | Novo Nordisk Investigational Site | Chieti | Italy | 66100 | |
279 | Novo Nordisk Investigational Site | Firenze | Italy | 50141 | |
280 | Novo Nordisk Investigational Site | Latina | Italy | 04100 | |
281 | Novo Nordisk Investigational Site | Lucca | Italy | 55100 | |
282 | Novo Nordisk Investigational Site | Milano | Italy | 20132 | |
283 | Novo Nordisk Investigational Site | Padova | Italy | 35128 | |
284 | Novo Nordisk Investigational Site | Palermo | Italy | 90127 | |
285 | Novo Nordisk Investigational Site | Roma | Italy | 00133 | |
286 | Novo Nordisk Investigational Site | Roma | Italy | 00161 | |
287 | Novo Nordisk Investigational Site | Goyang | Korea, Republic of | 410-719 | |
288 | Novo Nordisk Investigational Site | Seongnam-si | Korea, Republic of | 463-707 | |
289 | Novo Nordisk Investigational Site | Seoul | Korea, Republic of | 02447 | |
290 | Novo Nordisk Investigational Site | Seoul | Korea, Republic of | 137-701 | |
291 | Novo Nordisk Investigational Site | Seoul | Korea, Republic of | 139-827 | |
292 | Novo Nordisk Investigational Site | Tijuana | Baja California Norte | Mexico | 22010 |
293 | Novo Nordisk Investigational Site | Guadalajara | Jalisco | Mexico | 44600 |
294 | Novo Nordisk Investigational Site | Guadalajara | Jalisco | Mexico | 44650 |
295 | Novo Nordisk Investigational Site | Aguascalientes | Mexico | 20230 | |
296 | Novo Nordisk Investigational Site | Durango | Mexico | 34000 | |
297 | Novo Nordisk Investigational Site | Durango | Mexico | 34080 | |
298 | Novo Nordisk Investigational Site | Monterrey | Mexico | 64460 | |
299 | Novo Nordisk Investigational Site | San Luis Potosi | Mexico | 78200 | |
300 | Novo Nordisk Investigational Site | Amsterdam | Netherlands | 1066 EC | |
301 | Novo Nordisk Investigational Site | Eindhoven | Netherlands | 5631 BM | |
302 | Novo Nordisk Investigational Site | Etten-Leur | Netherlands | 4872 LP | |
303 | Novo Nordisk Investigational Site | Goes | Netherlands | 4461 LT | |
304 | Novo Nordisk Investigational Site | Groningen | Netherlands | 9728 NT | |
305 | Novo Nordisk Investigational Site | Hoogeveen | Netherlands | 7909 AA | |
306 | Novo Nordisk Investigational Site | Maastricht | Netherlands | 6229 HX | |
307 | Novo Nordisk Investigational Site | Nijmegen | Netherlands | 6525 GA | |
308 | Novo Nordisk Investigational Site | Utrecht | Netherlands | 3584 CX | |
309 | Novo Nordisk Investigational Site | Oslo | Norway | 0407 | |
310 | Novo Nordisk Investigational Site | Oslo | Norway | 0586 | |
311 | Novo Nordisk Investigational Site | Stavanger | Norway | 4011 | |
312 | Novo Nordisk Investigational Site | Trondheim | Norway | 7030 | |
313 | Novo Nordisk Investigational Site | TĆønsberg | Norway | 3117 | |
314 | Novo Nordisk Investigational Site | Bialystok | Poland | 15-435 | |
315 | Novo Nordisk Investigational Site | Bydgoszcz | Poland | 85-822 | |
316 | Novo Nordisk Investigational Site | Katowice | Poland | 40-084 | |
317 | Novo Nordisk Investigational Site | Krakow | Poland | 31-261 | |
318 | Novo Nordisk Investigational Site | Krakow | Poland | 31-271 | |
319 | Novo Nordisk Investigational Site | Krakow | Poland | 31-501 | |
320 | Novo Nordisk Investigational Site | Lodz | Poland | 93-338 | |
321 | Novo Nordisk Investigational Site | Poznan | Poland | 60-569 | |
322 | Novo Nordisk Investigational Site | Pulawy | Poland | 24-100 | |
323 | Novo Nordisk Investigational Site | Ruda Slaska | Poland | 41-709 | |
324 | Novo Nordisk Investigational Site | Warszawa | Poland | 01-192 | |
325 | Novo Nordisk Investigational Site | Warszawa | Poland | 02-507 | |
326 | Novo Nordisk Investigational Site | Wroclaw | Poland | 50-381 | |
327 | Novo Nordisk Investigational Site | Bayamon | Puerto Rico | 00961 | |
328 | Novo Nordisk Investigational Site | Caguas | Puerto Rico | 00725 | |
329 | Novo Nordisk Investigational Site | Craiova | Dolj | Romania | 200642 |
330 | Novo Nordisk Investigational Site | Targu Mures | Mures | Romania | 540098 |
331 | Novo Nordisk Investigational Site | Timisoara | Timis | Romania | 300736 |
332 | Novo Nordisk Investigational Site | Bacau | Romania | 600114 | |
333 | Novo Nordisk Investigational Site | Bucharest | Romania | 020475 | |
334 | Novo Nordisk Investigational Site | Constanta | Romania | 900591 | |
335 | Novo Nordisk Investigational Site | Deva | Romania | 330084 | |
336 | Novo Nordisk Investigational Site | Iasi | Romania | 700547 | |
337 | Novo Nordisk Investigational Site | Satu Mare | Romania | 440055 | |
338 | Novo Nordisk Investigational Site | Sibiu | Romania | 550245 | |
339 | Novo Nordisk Investigational Site | Arkhangelsk | Russian Federation | 163001 | |
340 | Novo Nordisk Investigational Site | Arkhangelsk | Russian Federation | 163045 | |
341 | Novo Nordisk Investigational Site | Barnaul | Russian Federation | 656045 | |
342 | Novo Nordisk Investigational Site | Kazan | Russian Federation | 420043 | |
343 | Novo Nordisk Investigational Site | Moscow | Russian Federation | 117036 | |
344 | Novo Nordisk Investigational Site | Moscow | Russian Federation | 119435 | |
345 | Novo Nordisk Investigational Site | Moscow | Russian Federation | 125367 | |
346 | Novo Nordisk Investigational Site | Moscow | Russian Federation | 127486 | |
347 | Novo Nordisk Investigational Site | Nizhniy Novgorod | Russian Federation | 603126 | |
348 | Novo Nordisk Investigational Site | Penza | Russian Federation | 440026 | |
349 | Novo Nordisk Investigational Site | Saratov | Russian Federation | 410053 | |
350 | Novo Nordisk Investigational Site | Smolensk | Russian Federation | 214019 | |
351 | Novo Nordisk Investigational Site | Tumen | Russian Federation | 625023 | |
352 | Novo Nordisk Investigational Site | Yaroslavl | Russian Federation | 150062 | |
353 | Novo Nordisk Investigational Site | Belgrade | Serbia | 11000 | |
354 | Novo Nordisk Investigational Site | Bloemfontein | Free State | South Africa | 9301 |
355 | Novo Nordisk Investigational Site | Johannesburg | Gauteng | South Africa | 1829 |
356 | Novo Nordisk Investigational Site | Johannesburg | Gauteng | South Africa | 2013 |
357 | Novo Nordisk Investigational Site | Lenasia | Gauteng | South Africa | 1827 |
358 | Novo Nordisk Investigational Site | Midrand | Gauteng | South Africa | 1685 |
359 | Novo Nordisk Investigational Site | Pretoria | Gauteng | South Africa | 0001 |
360 | Novo Nordisk Investigational Site | Pretoria | Gauteng | South Africa | 0083 |
361 | Novo Nordisk Investigational Site | Pretoria | Gauteng | South Africa | 0181 |
362 | Novo Nordisk Investigational Site | Durban | KwaZulu-Natal | South Africa | 4091 |
363 | Novo Nordisk Investigational Site | Durban | KwaZulu-Natal | South Africa | 4126 |
364 | Novo Nordisk Investigational Site | Durban | KwaZulu-Natal | South Africa | 4320 |
365 | Novo Nordisk Investigational Site | Tongaat | KwaZulu-Natal | South Africa | 4400 |
366 | Novo Nordisk Investigational Site | Cape Town | Western Cape | South Africa | |
367 | Novo Nordisk Investigational Site | Somerset West | Western Cape | South Africa | 7130 |
368 | Novo Nordisk Investigational Site | Alberton | South Africa | 1449 | |
369 | Novo Nordisk Investigational Site | Cape Town | South Africa | 7530 | |
370 | Novo Nordisk Investigational Site | AlmerĆa | Spain | 04001 | |
371 | Novo Nordisk Investigational Site | Barcelona | Spain | 08036 | |
372 | Novo Nordisk Investigational Site | La CoruƱa | Spain | 15006 | |
373 | Novo Nordisk Investigational Site | Madrid | Spain | 28040 | |
374 | Novo Nordisk Investigational Site | Mora De Ebre | Spain | 43740 | |
375 | Novo Nordisk Investigational Site | Mostoles - Madrid - | Spain | 28935 | |
376 | Novo Nordisk Investigational Site | Palma de Mallorca | Spain | 07198 | |
377 | Novo Nordisk Investigational Site | Pozuelo de Alarcon | Spain | 28223 | |
378 | Novo Nordisk Investigational Site | Sevilla | Spain | 41003 | |
379 | Novo Nordisk Investigational Site | Sevilla | Spain | 41014 | |
380 | Novo Nordisk Investigational Site | Valladolid | Spain | 47005 | |
381 | Novo Nordisk Investigational Site | Gƶteborg | Sweden | 413 45 | |
382 | Novo Nordisk Investigational Site | Malmƶ | Sweden | 205 02 | |
383 | Novo Nordisk Investigational Site | Stockholm | Sweden | 111 57 | |
384 | Novo Nordisk Investigational Site | Stockholm | Sweden | 113 24 | |
385 | Novo Nordisk Investigational Site | Stockholm | Sweden | 141 86 | |
386 | Novo Nordisk Investigational Site | Ćrebro | Sweden | 701 85 | |
387 | Novo Nordisk Investigational Site | Changhua City | Taiwan | 500 | |
388 | Novo Nordisk Investigational Site | Kaoshiung | Taiwan | 807 | |
389 | Novo Nordisk Investigational Site | Tainan city | Taiwan | 710 | |
390 | Novo Nordisk Investigational Site | Taoyuan | Taiwan | 333 | |
391 | Novo Nordisk Investigational Site | Ankara | Turkey | 06100 | |
392 | Novo Nordisk Investigational Site | Ankara | Turkey | 06500 | |
393 | Novo Nordisk Investigational Site | Antalya | Turkey | 07058 | |
394 | Novo Nordisk Investigational Site | Bursa | Turkey | 16059 | |
395 | Novo Nordisk Investigational Site | Gaziantep | Turkey | 27070 | |
396 | Novo Nordisk Investigational Site | Istanbul | Turkey | 34096 | |
397 | Novo Nordisk Investigational Site | Istanbul | Turkey | 34098 | |
398 | Novo Nordisk Investigational Site | Istanbul | Turkey | 34360 | |
399 | Novo Nordisk Investigational Site | Istanbul | Turkey | 34371 | |
400 | Novo Nordisk Investigational Site | Istanbul | Turkey | 34390 | |
401 | Novo Nordisk Investigational Site | Istanbul | Turkey | 34722 | |
402 | Novo Nordisk Investigational Site | Istanbul | Turkey | 34890 | |
403 | Novo Nordisk Investigational Site | Istanbul | Turkey | ||
404 | Novo Nordisk Investigational Site | Izmir | Turkey | 35100 | |
405 | Novo Nordisk Investigational Site | Izmir | Turkey | 35340 | |
406 | Novo Nordisk Investigational Site | Kayseri | Turkey | 38039 | |
407 | Novo Nordisk Investigational Site | Dubai | United Arab Emirates | 4545 | |
408 | Novo Nordisk Investigational Site | Dubai | United Arab Emirates | 7272 | |
409 | Novo Nordisk Investigational Site | Aberdeen | United Kingdom | AB25 1LD | |
410 | Novo Nordisk Investigational Site | Birmingham | United Kingdom | B9 5SS | |
411 | Novo Nordisk Investigational Site | Bristol | United Kingdom | BS10 5NB | |
412 | Novo Nordisk Investigational Site | Coventry | United Kingdom | CV2 2DX | |
413 | Novo Nordisk Investigational Site | Devon | United Kingdom | EX2 5DW | |
414 | Novo Nordisk Investigational Site | Dundee | United Kingdom | DD1 9SY | |
415 | Novo Nordisk Investigational Site | Edinburgh | United Kingdom | EH16 4SA | |
416 | Novo Nordisk Investigational Site | Glasgow | United Kingdom | G31 2ER | |
417 | Novo Nordisk Investigational Site | Guildford | United Kingdom | GU2 7XX | |
418 | Novo Nordisk Investigational Site | Hull | United Kingdom | HU3 2RW | |
419 | Novo Nordisk Investigational Site | Livington | United Kingdom | EH54 6PP | |
420 | Novo Nordisk Investigational Site | London | United Kingdom | W2 1NY | |
421 | Novo Nordisk Investigational Site | Manchester | United Kingdom | M6 8HD | |
422 | Novo Nordisk Investigational Site | Norwich | United Kingdom | NR4 7TJ | |
423 | Novo Nordisk Investigational Site | Nuneaton | United Kingdom | CV10 7DJ | |
424 | Novo Nordisk Investigational Site | Plymouth | United Kingdom | PL6 8BQ | |
425 | Novo Nordisk Investigational Site | St Helens | United Kingdom | WA9 3DA | |
426 | Novo Nordisk Investigational Site | Swansea | United Kingdom | SA6 6NL | |
427 | Novo Nordisk Investigational Site | Torquay | United Kingdom | TQ2 7AA | |
428 | Novo Nordisk Investigational Site | West Midlands | United Kingdom | B71 4HJ |
Sponsors and Collaborators
- Novo Nordisk A/S
Investigators
- Study Director: Global Clinical Registry (GCR, 1452), Novo Nordisk A/S
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- Hinton W, Feher M, Munro N, Walker M, de Lusignan S. Real-world prevalence of the inclusion criteria for the LEADER trial: Data from a national general practice network. Diabetes Obes Metab. 2019 Jul;21(7):1661-1667. doi: 10.1111/dom.13710. Epub 2019 Apr 11.
- Verma S, Bain SC, Monk Fries T, Mazer CD, Nauck MA, Pratley RE, Rasmussen S, Saevereid HA, Zinman B, Buse JB. Duration of diabetes and cardiorenal efficacy of liraglutide and semaglutide: A post hoc analysis of the LEADER and SUSTAIN 6 clinical trials. Diabetes Obes Metab. 2019 Jul;21(7):1745-1751. doi: 10.1111/dom.13698. Epub 2019 Apr 2.
- EX2211-3748
- 2009-012201-19
- U1111-1113-7090
- CTR20130003
Study Results
Participant Flow
Recruitment Details | 410 sites in 32 countries across the 4 regions recruited subjects. Number of sites that recruited subjects is given in parenthesis. Europe (143), North America (135) (US, Canada) , Asia (33) (China, Taiwan, Korea, India) and Rest of the world (99) (Brazil, Mexico, Australia, South Africa, Turkey, Russian Federation, United Arab Emirates). |
---|---|
Pre-assignment Detail | All subjects received placebo (0.6 mg/day) during the open labeled run-in period of 2-3 weeks and were instructed on how to administer the trial product. During this period the subjects demonstrated that they could adhere to the injection regimen in the trial. |
Arm/Group Title | Liraglutide | Placebo |
---|---|---|
Arm/Group Description | Subjects received liraglutide once daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Liraglutide was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months. | Subjects received placebo (matched to liraglutide) daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Placebo was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months. |
Period Title: Overall Study | ||
STARTED | 4668 | 4672 |
COMPLETED | 4529 | 4513 |
NOT COMPLETED | 139 | 159 |
Baseline Characteristics
Arm/Group Title | Liraglutide | Placebo | Total |
---|---|---|---|
Arm/Group Description | Subjects received liraglutide once daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Liraglutide was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months. | Subjects received placebo (matched to liraglutide) daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Placebo was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months. | Total of all reporting groups |
Overall Participants | 4668 | 4672 | 9340 |
Age (years) [Mean (Standard Deviation) ] | |||
Mean (Standard Deviation) [years] |
64.2
(7.2)
|
64.4
(7.2)
|
64.3
(7.2)
|
Age, Customized (Number) [Number] | |||
Between 18 and 64 years |
2512
53.8%
|
2499
53.5%
|
5011
53.7%
|
Between 65 to 84 years |
2139
45.8%
|
2148
46%
|
4287
45.9%
|
85 years and over |
17
0.4%
|
25
0.5%
|
42
0.4%
|
Sex: Female, Male (Count of Participants) | |||
Female |
1657
35.5%
|
1680
36%
|
3337
35.7%
|
Male |
3011
64.5%
|
2992
64%
|
6003
64.3%
|
Outcome Measures
Title | Time From Randomisation to First Occurrence of Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke (a Composite Cardiovascular Outcome) |
---|---|
Description | Time from randomisation to first occurrence of cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke (a composite cardiovascular outcome). The percentage of subjects experiencing a first event of cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke (a composite cardiovascular outcome) is presented. |
Time Frame | from randomisation (visit 3; month 0) to last contact (visit 16; up to month 60+30 days) |
Outcome Measure Data
Analysis Population Description |
---|
All randomised subjects. |
Arm/Group Title | Liraglutide | Placebo |
---|---|---|
Arm/Group Description | Subjects received liraglutide once daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Liraglutide was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months. | Subjects received placebo (matched to liraglutide) daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Placebo was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months. |
Measure Participants | 4668 | 4672 |
Number [percentage of subjects] |
13.0
|
14.9
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Liraglutide, Placebo |
---|---|---|
Comments | The primary endpoint was evaluated using the Cox regression model to estimate the hazard ratio (HR) (liraglutide/placebo) and the 2-sided 95% confidence interval (CI) including treatment group as factor. Non-inferiority of liraglutide versus placebo was considered confirmed, if the upper limit of the two-sided 95% CI for the hazard ratio was below 1.3 or if the p-value for the one-sided test of H0: HR >=1.3 against Ha: HR <1.3 was less than 2.5% (or equivalent to 5% in two-sided test). | |
Type of Statistical Test | Non-Inferiority or Equivalence | |
Comments | Non-inferiority of liraglutide versus placebo was considered confirmed, if the upper limit of the two-sided 95% CI for the hazard ratio was below 1.3 or if the p-value for the one-sided test of H0: HR >=1.3 against Ha: HR <1.3 was less than 2.5% (or equivalent to 5% in two-sided test). If non-inferiority was established for the primary outcome, a test for superiority was to be performed. | |
Statistical Test of Hypothesis | p-Value | <0.001 |
Comments | p-value is reported for one-sided (Ī±-level 0.025) test for non-inferiority (hazard ratio >=1.3). | |
Method | Regression, Cox | |
Comments | ||
Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
Estimated Value | 0.868 | |
Confidence Interval |
(2-Sided) 95% 0.778 to 0.968 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | Liraglutide, Placebo |
---|---|---|
Comments | If non-inferiority was established for the primary outcome, a test for superiority was performed. Superiority of liraglutide versus placebo was considered confirmed, if the upper limit of the two-sided 95% CI for the hazard ratio was below 1.0 or equivalent if the p-value for the one-sided test of H0: HR >=1.0 against Ha: HR <1.0 was less than 2.5% (or equivalent to 5% in two-sided test). | |
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.005 |
Comments | p-value is reported for one-sided (Ī±-level 0.025) test for superiority (hazard ratio>=1.0). | |
Method | Regression, Cox | |
Comments | ||
Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
Estimated Value | 0.868 | |
Confidence Interval |
(2-Sided) 95% 0.778 to 0.968 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Title | Time From Rand. to First Occurrence of an Expanded Composite Cardiovascular Outcome Defined as Either Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke, Revascularisation, Hospitalisation for Unstable Angina or for Heart Failure. |
---|---|
Description | Time from randomisation to first occurrence of an expanded composite cardiovascular outcome defined as either cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, coronary revascularisation, hospitalisation for unstable angina or for heart failure. The percentage of subjects experiencing first occurrence of an expanded composite cardiovascular outcome defined as either cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, coronary revascularisation, hospitalisation for unstable angina or for heart failure is presented. |
Time Frame | from randomisation (visit 3; month 0) to last contact (visit 16; up to month 60+30 days) |
Outcome Measure Data
Analysis Population Description |
---|
All randomised subjects. |
Arm/Group Title | Liraglutide | Placebo |
---|---|---|
Arm/Group Description | Subjects received liraglutide once daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Liraglutide was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months. | Subjects received placebo (matched to liraglutide) daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Placebo was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months. |
Measure Participants | 4668 | 4672 |
Number [percentage of subjects] |
20.3
|
22.7
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Liraglutide, Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
Estimated Value | 0.881 | |
Confidence Interval |
(2-Sided) 95% 0.807 to 0.962 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Title | Time From Randomisation to All Cause Death |
---|---|
Description | Time from randomisation to all cause death. The percentage of subjects with a death by any cause (all-cause death) is presented. |
Time Frame | from randomisation (visit 3; month 0) to last contact (visit 16; up to month 60+30 days) |
Outcome Measure Data
Analysis Population Description |
---|
All randomised subjects |
Arm/Group Title | Liraglutide | Placebo |
---|---|---|
Arm/Group Description | Subjects received liraglutide once daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Liraglutide was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months. | Subjects received placebo (matched to liraglutide) daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Placebo was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months. |
Measure Participants | 4668 | 4672 |
Number [percentage of subjects] |
8.2
|
9.6
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Liraglutide, Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
Estimated Value | 0.847 | |
Confidence Interval |
(2-Sided) 95% 0.739 to 0.971 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Title | Time From Randomisation to Each Individual Component of the Expanded Composite Cardiovascular Outcome |
---|---|
Description | Time from randomisation to each individual component of the expanded composite cardiovascular outcome. The percentage of subjects experiencing each of the individual component of the expanded composite cardiovascular outcome (defined as either cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, coronary revascularisation, hospitalisation for unstable angina or heart failure) is presented. |
Time Frame | from randomisation (visit 3; month 0) to last contact (visit 16; up to month 60+30 days) |
Outcome Measure Data
Analysis Population Description |
---|
All the randomised subjects. |
Arm/Group Title | Liraglutide | Placebo |
---|---|---|
Arm/Group Description | Subjects received liraglutide once daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Liraglutide was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months. | Subjects received placebo (matched to liraglutide) daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Placebo was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months. |
Measure Participants | 4668 | 4672 |
Cardiovascular death |
4.7
|
6.0
|
Non-fatal stroke |
3.4
|
3.8
|
Non-fatal myocardial infarction |
6.0
|
6.8
|
Unstable angina pectoris (hospitalisation) |
2.6
|
2.7
|
Coronary revascularisation |
8.7
|
9.4
|
Heart failure (hospitalisation) |
4.7
|
5.3
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Liraglutide, Placebo |
---|---|---|
Comments | Analysis for percentage of subjects experiencing cardiovascular death was done by Cox regression model with treatment as fixed factor. | |
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
Estimated Value | 0.783 | |
Confidence Interval |
(2-Sided) 95% 0.656 to 0.934 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | Liraglutide, Placebo |
---|---|---|
Comments | Analysis for percentage of subjects experiencing non-fatal stroke was done by Cox regression model with treatment as fixed factor | |
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
Estimated Value | 0.894 | |
Confidence Interval |
(2-Sided) 95% 0.721 to 1.107 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | Liraglutide, Placebo |
---|---|---|
Comments | Analysis for percentage of subjects experiencing non-fatal myocardial infarction was done by Cox regression model with treatment as fixed factor | |
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
Estimated Value | 0.878 | |
Confidence Interval |
(2-Sided) 95% 0.747 to 1.031 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Statistical Analysis 4
Statistical Analysis Overview | Comparison Group Selection | Liraglutide, Placebo |
---|---|---|
Comments | Analysis for percentage of subjects experiencing hospitalisation for unstable angina pectoris was done by Cox regression model with treatment as fixed factor | |
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
Estimated Value | 0.980 | |
Confidence Interval |
(2-Sided) 95% 0.763 to 1.258 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Statistical Analysis 5
Statistical Analysis Overview | Comparison Group Selection | Liraglutide, Placebo |
---|---|---|
Comments | Analysis for percentage of subjects experiencing coronary revascularisation was done by Cox regression model with treatment as fixed factor | |
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
Estimated Value | 0.912 | |
Confidence Interval |
(2-Sided) 95% 0.797 to 1.044 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Statistical Analysis 6
Statistical Analysis Overview | Comparison Group Selection | Liraglutide, Placebo |
---|---|---|
Comments | Analysis for percentage of subjects experiencing hospitalisation for heart failure was done by Cox regression model with treatment as fixed factor | |
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
Estimated Value | 0.872 | |
Confidence Interval |
(2-Sided) 95% 0.727 to 1.046 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Title | Time From Randomisation to First Occurrence of a Composite Microvascular Outcome |
---|---|
Description | Time from randomisation to first occurrence of a composite microvascular outcome, defined as any one of the following: new onset of persistent macroalbuminuria persistent doubling of serum creatinine need for continuous renal replacement therapy death due to renal disease need for retinal photocoagulation or treatment with intravitreal agents vitreous haemorrhage diabetes-related blindness The percentage of subjects experiencing a first occurrence of a composite microvascular outcome is presented. |
Time Frame | from randomisation (visit 3; month 0) to last contact (visit 16; up to month 60+30 days) |
Outcome Measure Data
Analysis Population Description |
---|
All randomised subjects. |
Arm/Group Title | Liraglutide | Placebo |
---|---|---|
Arm/Group Description | Subjects received liraglutide once daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Liraglutide was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months. | Subjects received placebo (matched to liraglutide) daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Placebo was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months. |
Measure Participants | 4668 | 4672 |
Number [Percentage of subjects] |
7.6
|
8.9
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Liraglutide, Placebo |
---|---|---|
Comments | Analysis for percentage of subjects experiencing a first microvascular event was done by Cox regression model with treatment as fixed factor. | |
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
Estimated Value | 0.841 | |
Confidence Interval |
(2-Sided) 95% 0.730 to 0.969 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Title | Time From Randomisation to Each Individual Component of the Composite Microvascular Outcome and to the Retinopathy and Nephropathy Composite Outcomes Separately. |
---|---|
Description | Time from randomisation to each individual component of the composite microvascular outcome and to the retinopathy and nephropathy composite outcomes separately. The percentage of subjects experiencing each individual component of the composite microvascular outcome are presented. |
Time Frame | from randomisation (visit 3; month 0) to last contact (visit 16; up to month 60+30 days) |
Outcome Measure Data
Analysis Population Description |
---|
All randomised subjects |
Arm/Group Title | Liraglutide | Placebo |
---|---|---|
Arm/Group Description | Subjects received liraglutide once daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Liraglutide was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months. | Subjects received placebo (matched to liraglutide) daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Placebo was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months. |
Measure Participants | 4668 | 4672 |
Nephropathy composite |
5.7
|
7.2
|
New onset of persistent macroalbuminuria |
3.4
|
4.6
|
Persistent doubling of serum creatinine |
1.9
|
2.1
|
Need for continuous renal-replacement therapy |
1.2
|
1.4
|
Death due to renal disease |
0.2
|
0.1
|
Retinopathy composite |
2.3
|
2.0
|
Treatment with photocoagulation/intravitreal agent |
2.1
|
1.8
|
Development of diabetes-related blindness |
0.0
|
0.02
|
Vitreous haemorrhage |
0.7
|
0.5
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Liraglutide, Placebo |
---|---|---|
Comments | Analysis for percentage of subjects experiencing a composite nephropathy event was done by Cox regression model with treatment as fixed factor. | |
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
Estimated Value | 0.782 | |
Confidence Interval |
(2-Sided) 95% 0.666 to 0.918 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | Liraglutide, Placebo |
---|---|---|
Comments | Analysis for percentage of subjects experiencing a new onset of persistant macroalbuminaria event was done by Cox regression model with treatment as fixed factor. | |
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
Estimated Value | 0.738 | |
Confidence Interval |
(2-Sided) 95% 0.602 to 0.905 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | Liraglutide, Placebo |
---|---|---|
Comments | Analysis for percentage of subjects experiencing persistent doubling of serum creatinine was done by Cox regression model with treatment as fixed factor. | |
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
Estimated Value | 0.890 | |
Confidence Interval |
(2-Sided) 95% 0.667 to 1.189 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Statistical Analysis 4
Statistical Analysis Overview | Comparison Group Selection | Liraglutide, Placebo |
---|---|---|
Comments | Analysis for percentage of subjects experiencing a need for continuous renal-replacement therapy was done by Cox regression model with treatment as fixed factor. | |
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
Estimated Value | 0.869 | |
Confidence Interval |
(2-Sided) 95% 0.607 to 1.244 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Statistical Analysis 5
Statistical Analysis Overview | Comparison Group Selection | Liraglutide, Placebo |
---|---|---|
Comments | Analysis for percentage of subjects experiencing death due to renal disease was done by Cox regression model with treatment as fixed factor. | |
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
Estimated Value | 1.593 | |
Confidence Interval |
(2-Sided) 95% 0.521 to 4.869 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Statistical Analysis 6
Statistical Analysis Overview | Comparison Group Selection | Liraglutide, Placebo |
---|---|---|
Comments | Analysis for percentage of subjects experiencing composite retinopathy was done by Cox regression model with treatment as fixed factor. | |
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
Estimated Value | 1.149 | |
Confidence Interval |
(2-Sided) 95% 0.869 to 1.519 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Statistical Analysis 7
Statistical Analysis Overview | Comparison Group Selection | Liraglutide, Placebo |
---|---|---|
Comments | Analysis for percentage of subjects experiencing treatment with photocoagulation or intravitreal agents was done by Cox regression model with treatment as fixed factor. | |
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
Estimated Value | 1.159 | |
Confidence Interval |
(2-Sided) 95% 0.869 to 1.546 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Statistical Analysis 8
Statistical Analysis Overview | Comparison Group Selection | Liraglutide, Placebo |
---|---|---|
Comments | Analysis for percentage of subjects experiencing development of diabetes-related blindness was done by Cox regression model with treatment as fixed factor. | |
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
Estimated Value | 0.335 | |
Confidence Interval |
(2-Sided) 95% 0.004 to 30.847 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Statistical Analysis 9
Statistical Analysis Overview | Comparison Group Selection | Liraglutide, Placebo |
---|---|---|
Comments | Analysis for percentage of subjects experiencing vitreous haemorrhage was done by Cox regression model with treatment as fixed factor. | |
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
Estimated Value | 1.454 | |
Confidence Interval |
(2-Sided) 95% 0.845 to 2.502 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Adverse Events
Time Frame | Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up). | |||
---|---|---|---|---|
Adverse Event Reporting Description | Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events. | |||
Arm/Group Title | Liraglutide | Placebo | ||
Arm/Group Description | Subjects received liraglutide once daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Liraglutide was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months. | Subjects received placebo (matched to liraglutide) daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Placebo was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months. | ||
All Cause Mortality |
||||
Liraglutide | Placebo | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
Liraglutide | Placebo | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 2320/4668 (49.7%) | 2354/4672 (50.4%) | ||
Blood and lymphatic system disorders | ||||
Anaemia | 31/4668 (0.7%) | 32 | 21/4672 (0.4%) | 22 |
Anaemia macrocytic | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Anaemia megaloblastic | 2/4668 (0%) | 2 | 1/4672 (0%) | 1 |
Anaemia vitamin B12 deficiency | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Coagulopathy | 1/4668 (0%) | 1 | 1/4672 (0%) | 1 |
Haemolytic anaemia | 1/4668 (0%) | 1 | 1/4672 (0%) | 1 |
Haemorrhagic anaemia | 1/4668 (0%) | 1 | 4/4672 (0.1%) | 5 |
Hypochromic anaemia | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Immune thrombocytopenic purpura | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Iron deficiency anaemia | 9/4668 (0.2%) | 9 | 13/4672 (0.3%) | 13 |
Leukocytosis | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Leukopenia | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Lymphadenopathy | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Microcytic anaemia | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Neutropenia | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Normochromic normocytic anaemia | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Pancytopenia | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Paratracheal lymphadenopathy | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Polycythaemia | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Splenic embolism | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Splenic infarction | 2/4668 (0%) | 2 | 1/4672 (0%) | 1 |
Splenomegaly | 2/4668 (0%) | 2 | 0/4672 (0%) | 0 |
Thrombocytopenia | 1/4668 (0%) | 1 | 1/4672 (0%) | 1 |
Cardiac disorders | ||||
Acute coronary syndrome | 37/4668 (0.8%) | 41 | 54/4672 (1.2%) | 59 |
Acute left ventricular failure | 2/4668 (0%) | 2 | 7/4672 (0.1%) | 7 |
Acute myocardial infarction | 155/4668 (3.3%) | 176 | 187/4672 (4%) | 211 |
Adams-Stokes syndrome | 2/4668 (0%) | 2 | 0/4672 (0%) | 0 |
Angina pectoris | 93/4668 (2%) | 105 | 93/4672 (2%) | 106 |
Angina unstable | 144/4668 (3.1%) | 179 | 151/4672 (3.2%) | 180 |
Aortic valve calcification | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Aortic valve incompetence | 0/4668 (0%) | 0 | 2/4672 (0%) | 2 |
Aortic valve sclerosis | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Aortic valve stenosis | 6/4668 (0.1%) | 6 | 10/4672 (0.2%) | 10 |
Arrhythmia | 10/4668 (0.2%) | 11 | 5/4672 (0.1%) | 5 |
Arrhythmia supraventricular | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Arteriosclerosis coronary artery | 7/4668 (0.1%) | 7 | 12/4672 (0.3%) | 12 |
Atrial fibrillation | 89/4668 (1.9%) | 113 | 97/4672 (2.1%) | 112 |
Atrial flutter | 17/4668 (0.4%) | 20 | 16/4672 (0.3%) | 18 |
Atrial tachycardia | 1/4668 (0%) | 1 | 4/4672 (0.1%) | 4 |
Atrioventricular block | 1/4668 (0%) | 1 | 4/4672 (0.1%) | 4 |
Atrioventricular block complete | 10/4668 (0.2%) | 10 | 9/4672 (0.2%) | 9 |
Atrioventricular block first degree | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Atrioventricular block second degree | 5/4668 (0.1%) | 5 | 4/4672 (0.1%) | 4 |
Atrioventricular dissociation | 1/4668 (0%) | 1 | 1/4672 (0%) | 1 |
Bradyarrhythmia | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Bradycardia | 11/4668 (0.2%) | 11 | 11/4672 (0.2%) | 11 |
Bundle branch block left | 2/4668 (0%) | 2 | 2/4672 (0%) | 2 |
Bundle branch block right | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Cardiac aneurysm | 1/4668 (0%) | 1 | 1/4672 (0%) | 1 |
Cardiac arrest | 20/4668 (0.4%) | 20 | 31/4672 (0.7%) | 31 |
Cardiac discomfort | 1/4668 (0%) | 1 | 1/4672 (0%) | 1 |
Cardiac disorder | 1/4668 (0%) | 2 | 1/4672 (0%) | 1 |
Cardiac failure | 115/4668 (2.5%) | 138 | 137/4672 (2.9%) | 201 |
Cardiac failure acute | 9/4668 (0.2%) | 11 | 11/4672 (0.2%) | 12 |
Cardiac failure chronic | 28/4668 (0.6%) | 28 | 25/4672 (0.5%) | 29 |
Cardiac failure congestive | 121/4668 (2.6%) | 180 | 129/4672 (2.8%) | 176 |
Cardiac valve disease | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Cardiac ventricular thrombosis | 2/4668 (0%) | 2 | 3/4672 (0.1%) | 3 |
Cardio-respiratory arrest | 15/4668 (0.3%) | 15 | 13/4672 (0.3%) | 15 |
Cardiogenic shock | 4/4668 (0.1%) | 4 | 11/4672 (0.2%) | 11 |
Cardiomegaly | 0/4668 (0%) | 0 | 2/4672 (0%) | 2 |
Cardiomyopathy | 2/4668 (0%) | 2 | 3/4672 (0.1%) | 4 |
Cardiopulmonary failure | 3/4668 (0.1%) | 3 | 6/4672 (0.1%) | 6 |
Cardiorenal syndrome | 0/4668 (0%) | 0 | 2/4672 (0%) | 2 |
Cardiovascular disorder | 1/4668 (0%) | 1 | 2/4672 (0%) | 2 |
Cardiovascular insufficiency | 2/4668 (0%) | 2 | 0/4672 (0%) | 0 |
Chordae tendinae rupture | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Congestive cardiomyopathy | 2/4668 (0%) | 2 | 3/4672 (0.1%) | 3 |
Cor pulmonale | 0/4668 (0%) | 0 | 1/4672 (0%) | 2 |
Cor pulmonale acute | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Cor pulmonale chronic | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Coronary artery disease | 73/4668 (1.6%) | 77 | 87/4672 (1.9%) | 89 |
Coronary artery insufficiency | 2/4668 (0%) | 2 | 2/4672 (0%) | 2 |
Coronary artery occlusion | 16/4668 (0.3%) | 16 | 10/4672 (0.2%) | 10 |
Coronary artery stenosis | 20/4668 (0.4%) | 20 | 35/4672 (0.7%) | 36 |
Coronary ostial stenosis | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Dilatation atrial | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Extrasystoles | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Hypertensive cardiomyopathy | 2/4668 (0%) | 2 | 0/4672 (0%) | 0 |
Hypertensive heart disease | 2/4668 (0%) | 2 | 3/4672 (0.1%) | 3 |
Ischaemic cardiomyopathy | 3/4668 (0.1%) | 3 | 9/4672 (0.2%) | 9 |
Left ventricular dysfunction | 5/4668 (0.1%) | 5 | 10/4672 (0.2%) | 10 |
Left ventricular failure | 3/4668 (0.1%) | 3 | 7/4672 (0.1%) | 7 |
Left ventricular hypertrophy | 3/4668 (0.1%) | 3 | 3/4672 (0.1%) | 3 |
Microvascular coronary artery disease | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Mitral valve calcification | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Mitral valve incompetence | 3/4668 (0.1%) | 3 | 10/4672 (0.2%) | 10 |
Mitral valve stenosis | 1/4668 (0%) | 1 | 1/4672 (0%) | 1 |
Myocardial fibrosis | 2/4668 (0%) | 2 | 0/4672 (0%) | 0 |
Myocardial infarction | 68/4668 (1.5%) | 71 | 84/4672 (1.8%) | 89 |
Myocardial ischaemia | 27/4668 (0.6%) | 27 | 33/4672 (0.7%) | 35 |
Myocarditis | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Nodal rhythm | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Palpitations | 3/4668 (0.1%) | 3 | 4/4672 (0.1%) | 4 |
Pericardial cyst | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Pericardial effusion | 1/4668 (0%) | 1 | 3/4672 (0.1%) | 3 |
Pericardial haemorrhage | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Pericarditis | 1/4668 (0%) | 1 | 5/4672 (0.1%) | 5 |
Pericarditis uraemic | 1/4668 (0%) | 1 | 1/4672 (0%) | 1 |
Pneumopericardium | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Postural orthostatic tachycardia syndrome | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Rhythm idioventricular | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Right ventricular failure | 0/4668 (0%) | 0 | 2/4672 (0%) | 2 |
Silent myocardial infarction | 1/4668 (0%) | 1 | 1/4672 (0%) | 1 |
Sinus arrest | 2/4668 (0%) | 2 | 0/4672 (0%) | 0 |
Sinus bradycardia | 0/4668 (0%) | 0 | 6/4672 (0.1%) | 6 |
Sinus node dysfunction | 10/4668 (0.2%) | 10 | 9/4672 (0.2%) | 9 |
Sinus tachycardia | 2/4668 (0%) | 2 | 1/4672 (0%) | 1 |
Stress cardiomyopathy | 0/4668 (0%) | 0 | 2/4672 (0%) | 2 |
Supraventricular extrasystoles | 1/4668 (0%) | 1 | 1/4672 (0%) | 1 |
Supraventricular tachycardia | 9/4668 (0.2%) | 9 | 7/4672 (0.1%) | 9 |
Systolic dysfunction | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Tachyarrhythmia | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Tachycardia | 4/4668 (0.1%) | 4 | 3/4672 (0.1%) | 3 |
Tricuspid valve incompetence | 0/4668 (0%) | 0 | 4/4672 (0.1%) | 4 |
Ventricular arrhythmia | 3/4668 (0.1%) | 3 | 0/4672 (0%) | 0 |
Ventricular dyssynchrony | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Ventricular extrasystoles | 5/4668 (0.1%) | 5 | 3/4672 (0.1%) | 3 |
Ventricular fibrillation | 4/4668 (0.1%) | 4 | 6/4672 (0.1%) | 6 |
Ventricular hypokinesia | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Ventricular tachyarrhythmia | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Ventricular tachycardia | 18/4668 (0.4%) | 29 | 8/4672 (0.2%) | 11 |
Wolff-Parkinson-White syndrome | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Congenital, familial and genetic disorders | ||||
Arteriovenous malformation | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Atrial septal defect | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Buried penis syndrome | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Coarctation of the aorta | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Congenital cystic kidney disease | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Dermoid cyst | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Hamartoma | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Hydrocele | 1/4668 (0%) | 1 | 1/4672 (0%) | 1 |
Hypertrophic cardiomyopathy | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Intracranial lipoma | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Pancreas divisum | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Phimosis | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Tracheo-oesophageal fistula | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Ear and labyrinth disorders | ||||
Aural polyp | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Deafness bilateral | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Deafness unilateral | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Eustachian tube dysfunction | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Hypoacusis | 2/4668 (0%) | 2 | 0/4672 (0%) | 0 |
Sudden hearing loss | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Vertigo | 6/4668 (0.1%) | 6 | 10/4672 (0.2%) | 10 |
Vertigo positional | 3/4668 (0.1%) | 3 | 1/4672 (0%) | 1 |
Vestibular disorder | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Endocrine disorders | ||||
Autoimmune thyroiditis | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Cushing's syndrome | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Goitre | 8/4668 (0.2%) | 8 | 5/4672 (0.1%) | 5 |
Hypercorticoidism | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Hyperparathyroidism primary | 1/4668 (0%) | 1 | 1/4672 (0%) | 1 |
Hyperthyroidism | 2/4668 (0%) | 2 | 1/4672 (0%) | 1 |
Hypoaldosteronism | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Hypothyroidism | 6/4668 (0.1%) | 6 | 0/4672 (0%) | 0 |
Thyroid C-cell hyperplasia | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Thyroiditis | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Thyroiditis subacute | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Toxic nodular goitre | 1/4668 (0%) | 1 | 1/4672 (0%) | 1 |
Eye disorders | ||||
Amaurosis | 2/4668 (0%) | 2 | 0/4672 (0%) | 0 |
Angle closure glaucoma | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Aphakia | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Autoimmune uveitis | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Blepharitis | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Blindness unilateral | 2/4668 (0%) | 2 | 0/4672 (0%) | 0 |
Cataract | 24/4668 (0.5%) | 29 | 32/4672 (0.7%) | 35 |
Corneal erosion | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Diabetic blindness | 1/4668 (0%) | 1 | 1/4672 (0%) | 1 |
Diabetic retinal oedema | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Diabetic retinopathy | 9/4668 (0.2%) | 9 | 15/4672 (0.3%) | 15 |
Diplopia | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Eye haemorrhage | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Eyelid ptosis | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Glaucoma | 1/4668 (0%) | 1 | 3/4672 (0.1%) | 3 |
Iridocyclitis | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Iritis | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Macular fibrosis | 2/4668 (0%) | 2 | 4/4672 (0.1%) | 4 |
Macular oedema | 1/4668 (0%) | 1 | 1/4672 (0%) | 1 |
Macular rupture | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Open angle glaucoma | 1/4668 (0%) | 1 | 1/4672 (0%) | 1 |
Optic ischaemic neuropathy | 1/4668 (0%) | 1 | 3/4672 (0.1%) | 3 |
Optic nerve infarction | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Papilloedema | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Retinal aneurysm | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Retinal artery embolism | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Retinal artery occlusion | 2/4668 (0%) | 2 | 1/4672 (0%) | 1 |
Retinal degeneration | 1/4668 (0%) | 1 | 1/4672 (0%) | 1 |
Retinal detachment | 2/4668 (0%) | 2 | 0/4672 (0%) | 0 |
Retinal haemorrhage | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Retinal infarction | 2/4668 (0%) | 2 | 0/4672 (0%) | 0 |
Retinal vascular occlusion | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Retinal vein occlusion | 3/4668 (0.1%) | 4 | 0/4672 (0%) | 0 |
Retinal vein thrombosis | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Retinopathy | 2/4668 (0%) | 2 | 4/4672 (0.1%) | 5 |
Retinopathy haemorrhagic | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Retinopathy proliferative | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Ulcerative keratitis | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Vision blurred | 1/4668 (0%) | 1 | 3/4672 (0.1%) | 3 |
Visual impairment | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Vitreous adhesions | 2/4668 (0%) | 2 | 0/4672 (0%) | 0 |
Vitreous haemorrhage | 6/4668 (0.1%) | 6 | 5/4672 (0.1%) | 5 |
Gastrointestinal disorders | ||||
Abdominal discomfort | 2/4668 (0%) | 2 | 0/4672 (0%) | 0 |
Abdominal distension | 0/4668 (0%) | 0 | 3/4672 (0.1%) | 3 |
Abdominal hernia | 2/4668 (0%) | 2 | 5/4672 (0.1%) | 5 |
Abdominal incarcerated hernia | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Abdominal mass | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Abdominal pain | 20/4668 (0.4%) | 20 | 15/4672 (0.3%) | 16 |
Abdominal pain lower | 2/4668 (0%) | 2 | 2/4672 (0%) | 2 |
Abdominal pain upper | 5/4668 (0.1%) | 6 | 4/4672 (0.1%) | 4 |
Abdominal strangulated hernia | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Acid peptic disease | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Acquired oesophageal web | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Anal fistula | 1/4668 (0%) | 1 | 2/4672 (0%) | 2 |
Anal skin tags | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Ascites | 2/4668 (0%) | 2 | 1/4672 (0%) | 1 |
Barrett's oesophagus | 2/4668 (0%) | 2 | 5/4672 (0.1%) | 5 |
Cardiospasm | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Change of bowel habit | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Chronic gastritis | 0/4668 (0%) | 0 | 4/4672 (0.1%) | 4 |
Colitis | 9/4668 (0.2%) | 9 | 4/4672 (0.1%) | 4 |
Colitis ischaemic | 1/4668 (0%) | 1 | 1/4672 (0%) | 1 |
Colitis ulcerative | 2/4668 (0%) | 2 | 1/4672 (0%) | 1 |
Colonic pseudo-obstruction | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Constipation | 11/4668 (0.2%) | 11 | 7/4672 (0.1%) | 7 |
Crohn's disease | 1/4668 (0%) | 1 | 1/4672 (0%) | 1 |
Diarrhoea | 14/4668 (0.3%) | 14 | 11/4672 (0.2%) | 11 |
Diverticular perforation | 2/4668 (0%) | 2 | 4/4672 (0.1%) | 4 |
Diverticulitis intestinal haemorrhagic | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Diverticulum | 2/4668 (0%) | 2 | 7/4672 (0.1%) | 7 |
Diverticulum intestinal | 3/4668 (0.1%) | 3 | 1/4672 (0%) | 1 |
Diverticulum intestinal haemorrhagic | 2/4668 (0%) | 2 | 1/4672 (0%) | 2 |
Duodenal perforation | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Duodenal polyp | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Duodenal ulcer | 8/4668 (0.2%) | 8 | 6/4672 (0.1%) | 6 |
Duodenal ulcer haemorrhage | 3/4668 (0.1%) | 3 | 5/4672 (0.1%) | 5 |
Duodenal ulcer perforation | 2/4668 (0%) | 2 | 0/4672 (0%) | 0 |
Duodenitis | 4/4668 (0.1%) | 4 | 2/4672 (0%) | 2 |
Dyspepsia | 1/4668 (0%) | 1 | 3/4672 (0.1%) | 3 |
Dysphagia | 1/4668 (0%) | 1 | 2/4672 (0%) | 2 |
Enteritis | 1/4668 (0%) | 1 | 3/4672 (0.1%) | 3 |
Enterocolitis | 2/4668 (0%) | 2 | 2/4672 (0%) | 2 |
Enterocutaneous fistula | 1/4668 (0%) | 1 | 1/4672 (0%) | 1 |
Enterovesical fistula | 1/4668 (0%) | 1 | 1/4672 (0%) | 1 |
Epigastric discomfort | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Erosive oesophagitis | 2/4668 (0%) | 2 | 1/4672 (0%) | 1 |
Faecal incontinence | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Faecalith | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Faecaloma | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Food poisoning | 1/4668 (0%) | 1 | 1/4672 (0%) | 1 |
Gastric antral vascular ectasia | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Gastric haemorrhage | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Gastric polyps | 2/4668 (0%) | 2 | 3/4672 (0.1%) | 3 |
Gastric ulcer | 4/4668 (0.1%) | 4 | 6/4672 (0.1%) | 6 |
Gastric ulcer haemorrhage | 5/4668 (0.1%) | 5 | 0/4672 (0%) | 0 |
Gastric ulcer perforation | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Gastritis | 15/4668 (0.3%) | 16 | 13/4672 (0.3%) | 14 |
Gastritis erosive | 4/4668 (0.1%) | 4 | 10/4672 (0.2%) | 10 |
Gastritis haemorrhagic | 2/4668 (0%) | 3 | 0/4672 (0%) | 0 |
Gastroduodenitis | 1/4668 (0%) | 3 | 0/4672 (0%) | 0 |
Gastrointestinal angiodysplasia | 0/4668 (0%) | 0 | 2/4672 (0%) | 3 |
Gastrointestinal disorder | 1/4668 (0%) | 1 | 1/4672 (0%) | 1 |
Gastrointestinal haemorrhage | 14/4668 (0.3%) | 17 | 21/4672 (0.4%) | 27 |
Gastrointestinal hypomotility | 1/4668 (0%) | 3 | 0/4672 (0%) | 0 |
Gastrointestinal necrosis | 1/4668 (0%) | 1 | 1/4672 (0%) | 1 |
Gastrointestinal polyp haemorrhage | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Gastrointestinal ulcer haemorrhage | 2/4668 (0%) | 2 | 0/4672 (0%) | 0 |
Gastrooesophageal reflux disease | 11/4668 (0.2%) | 11 | 12/4672 (0.3%) | 12 |
Haematemesis | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Haematochezia | 1/4668 (0%) | 1 | 5/4672 (0.1%) | 5 |
Haemorrhoidal haemorrhage | 2/4668 (0%) | 2 | 1/4672 (0%) | 1 |
Haemorrhoids | 3/4668 (0.1%) | 3 | 4/4672 (0.1%) | 4 |
Hiatus hernia | 0/4668 (0%) | 0 | 6/4672 (0.1%) | 6 |
Ileus | 4/4668 (0.1%) | 4 | 7/4672 (0.1%) | 7 |
Ileus paralytic | 1/4668 (0%) | 1 | 2/4672 (0%) | 2 |
Impaired gastric emptying | 5/4668 (0.1%) | 6 | 1/4672 (0%) | 1 |
Incarcerated hiatus hernia | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Incarcerated inguinal hernia | 0/4668 (0%) | 0 | 2/4672 (0%) | 2 |
Incarcerated umbilical hernia | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Inflammatory bowel disease | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Inguinal hernia | 12/4668 (0.3%) | 15 | 14/4672 (0.3%) | 14 |
Intestinal infarction | 1/4668 (0%) | 1 | 1/4672 (0%) | 1 |
Intestinal ischaemia | 3/4668 (0.1%) | 3 | 2/4672 (0%) | 2 |
Intestinal obstruction | 2/4668 (0%) | 2 | 7/4672 (0.1%) | 9 |
Intestinal polyp | 0/4668 (0%) | 0 | 2/4672 (0%) | 2 |
Irritable bowel syndrome | 0/4668 (0%) | 0 | 2/4672 (0%) | 3 |
Large intestinal ulcer | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Large intestine perforation | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Large intestine polyp | 16/4668 (0.3%) | 16 | 13/4672 (0.3%) | 18 |
Lower gastrointestinal haemorrhage | 3/4668 (0.1%) | 3 | 1/4672 (0%) | 1 |
Mallory-Weiss syndrome | 2/4668 (0%) | 2 | 1/4672 (0%) | 1 |
Mechanical ileus | 0/4668 (0%) | 0 | 2/4672 (0%) | 2 |
Melaena | 1/4668 (0%) | 1 | 1/4672 (0%) | 1 |
Mesenteric artery embolism | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Nausea | 8/4668 (0.2%) | 9 | 9/4672 (0.2%) | 9 |
Obstruction gastric | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Oedematous pancreatitis | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Oesophageal achalasia | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Oesophageal varices haemorrhage | 2/4668 (0%) | 2 | 0/4672 (0%) | 0 |
Oesophagitis | 1/4668 (0%) | 1 | 1/4672 (0%) | 1 |
Oesophagitis ulcerative | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Pancreatic cyst | 2/4668 (0%) | 2 | 2/4672 (0%) | 2 |
Pancreatic disorder | 1/4668 (0%) | 1 | 2/4672 (0%) | 2 |
Pancreatic mass | 2/4668 (0%) | 2 | 0/4672 (0%) | 0 |
Pancreatic pseudocyst | 1/4668 (0%) | 3 | 0/4672 (0%) | 0 |
Pancreatitis | 18/4668 (0.4%) | 20 | 10/4672 (0.2%) | 11 |
Pancreatitis acute | 14/4668 (0.3%) | 14 | 19/4672 (0.4%) | 22 |
Pancreatitis chronic | 2/4668 (0%) | 2 | 2/4672 (0%) | 2 |
Pancreatitis relapsing | 1/4668 (0%) | 1 | 1/4672 (0%) | 1 |
Peptic ulcer | 3/4668 (0.1%) | 3 | 4/4672 (0.1%) | 4 |
Peritoneal adhesions | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Peritoneal haematoma | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Proctitis ulcerative | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Reactive gastropathy | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Rectal haemorrhage | 6/4668 (0.1%) | 7 | 5/4672 (0.1%) | 6 |
Rectal polyp | 3/4668 (0.1%) | 3 | 2/4672 (0%) | 2 |
Rectal prolapse | 1/4668 (0%) | 1 | 1/4672 (0%) | 1 |
Reflux gastritis | 2/4668 (0%) | 2 | 0/4672 (0%) | 0 |
Retroperitoneal haematoma | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Retroperitoneal haemorrhage | 1/4668 (0%) | 1 | 1/4672 (0%) | 1 |
Retroperitoneal mass | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Salivary gland mass | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Short-bowel syndrome | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Small intestinal obstruction | 10/4668 (0.2%) | 12 | 5/4672 (0.1%) | 23 |
Swollen tongue | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Tooth socket haemorrhage | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Umbilical hernia | 6/4668 (0.1%) | 6 | 4/4672 (0.1%) | 4 |
Upper gastrointestinal haemorrhage | 6/4668 (0.1%) | 6 | 8/4672 (0.2%) | 8 |
Volvulus | 1/4668 (0%) | 8 | 0/4672 (0%) | 0 |
Vomiting | 17/4668 (0.4%) | 20 | 11/4672 (0.2%) | 11 |
General disorders | ||||
Adhesion | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Adverse drug reaction | 1/4668 (0%) | 1 | 1/4672 (0%) | 1 |
Asthenia | 9/4668 (0.2%) | 10 | 4/4672 (0.1%) | 4 |
Cardiac death | 4/4668 (0.1%) | 4 | 6/4672 (0.1%) | 6 |
Catheter site haemorrhage | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Chest discomfort | 3/4668 (0.1%) | 3 | 6/4672 (0.1%) | 6 |
Chest pain | 53/4668 (1.1%) | 56 | 49/4672 (1%) | 52 |
Chills | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Cyst | 1/4668 (0%) | 1 | 1/4672 (0%) | 1 |
Death | 55/4668 (1.2%) | 55 | 47/4672 (1%) | 47 |
Decreased activity | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Device battery issue | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Device dislocation | 2/4668 (0%) | 3 | 4/4672 (0.1%) | 5 |
Device leakage | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Device malfunction | 2/4668 (0%) | 2 | 5/4672 (0.1%) | 5 |
Device occlusion | 2/4668 (0%) | 3 | 3/4672 (0.1%) | 3 |
Drowning | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Drug interaction | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Drug withdrawal syndrome | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Fatigue | 2/4668 (0%) | 2 | 1/4672 (0%) | 1 |
Gait disturbance | 0/4668 (0%) | 0 | 2/4672 (0%) | 2 |
General physical health deterioration | 1/4668 (0%) | 1 | 3/4672 (0.1%) | 3 |
Generalised oedema | 2/4668 (0%) | 2 | 2/4672 (0%) | 2 |
Granuloma | 1/4668 (0%) | 1 | 1/4672 (0%) | 1 |
Hernia | 2/4668 (0%) | 2 | 0/4672 (0%) | 0 |
Hypothermia | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Ill-defined disorder | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Impaired healing | 4/4668 (0.1%) | 4 | 2/4672 (0%) | 2 |
Incarcerated hernia | 2/4668 (0%) | 2 | 1/4672 (0%) | 1 |
Inflammation | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Local swelling | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Malaise | 0/4668 (0%) | 0 | 3/4672 (0.1%) | 3 |
Mass | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Medical device complication | 2/4668 (0%) | 2 | 0/4672 (0%) | 0 |
Metaplasia | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Mucosal inflammation | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Multi-organ failure | 7/4668 (0.1%) | 7 | 9/4672 (0.2%) | 9 |
Necrosis | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Non-cardiac chest pain | 45/4668 (1%) | 52 | 63/4672 (1.3%) | 73 |
Oedema | 2/4668 (0%) | 2 | 0/4672 (0%) | 0 |
Oedema peripheral | 6/4668 (0.1%) | 6 | 9/4672 (0.2%) | 10 |
Pain | 2/4668 (0%) | 2 | 3/4672 (0.1%) | 3 |
Peripheral swelling | 0/4668 (0%) | 0 | 3/4672 (0.1%) | 3 |
Polyp | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Pyrexia | 5/4668 (0.1%) | 6 | 6/4672 (0.1%) | 6 |
Stent-graft endoleak | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Sudden cardiac death | 4/4668 (0.1%) | 4 | 6/4672 (0.1%) | 6 |
Sudden death | 11/4668 (0.2%) | 11 | 17/4672 (0.4%) | 17 |
Systemic inflammatory response syndrome | 2/4668 (0%) | 2 | 2/4672 (0%) | 2 |
Thrombosis in device | 1/4668 (0%) | 2 | 1/4672 (0%) | 1 |
Hepatobiliary disorders | ||||
Autoimmune hepatitis | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Bile duct stenosis | 0/4668 (0%) | 0 | 1/4672 (0%) | 5 |
Bile duct stone | 3/4668 (0.1%) | 3 | 1/4672 (0%) | 2 |
Biliary cirrhosis | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Biliary colic | 5/4668 (0.1%) | 5 | 2/4672 (0%) | 3 |
Biliary fistula | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Cholangitis | 2/4668 (0%) | 3 | 4/4672 (0.1%) | 4 |
Cholangitis acute | 4/4668 (0.1%) | 4 | 0/4672 (0%) | 0 |
Cholecystitis | 11/4668 (0.2%) | 11 | 12/4672 (0.3%) | 12 |
Cholecystitis acute | 35/4668 (0.7%) | 35 | 18/4672 (0.4%) | 19 |
Cholecystitis chronic | 8/4668 (0.2%) | 8 | 5/4672 (0.1%) | 5 |
Cholelithiasis | 44/4668 (0.9%) | 45 | 30/4672 (0.6%) | 30 |
Cholestasis | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Chronic hepatic failure | 0/4668 (0%) | 0 | 2/4672 (0%) | 2 |
Chronic hepatitis | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Cirrhosis alcoholic | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Cryptogenic cirrhosis | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Drug-induced liver injury | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Gallbladder disorder | 1/4668 (0%) | 1 | 1/4672 (0%) | 2 |
Gallbladder perforation | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Gallbladder polyp | 2/4668 (0%) | 2 | 1/4672 (0%) | 1 |
Hepatic cirrhosis | 4/4668 (0.1%) | 4 | 6/4672 (0.1%) | 6 |
Hepatic cyst | 1/4668 (0%) | 1 | 1/4672 (0%) | 1 |
Hepatic failure | 2/4668 (0%) | 2 | 0/4672 (0%) | 0 |
Hepatic lesion | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Hepatic steatosis | 3/4668 (0.1%) | 3 | 0/4672 (0%) | 0 |
Hepatitis acute | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Hepatomegaly | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Hepatorenal syndrome | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Ischaemic hepatitis | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Jaundice | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Jaundice cholestatic | 1/4668 (0%) | 1 | 2/4672 (0%) | 2 |
Liver disorder | 1/4668 (0%) | 1 | 1/4672 (0%) | 1 |
Portal hypertension | 1/4668 (0%) | 1 | 1/4672 (0%) | 1 |
Portal vein thrombosis | 2/4668 (0%) | 2 | 1/4672 (0%) | 1 |
Immune system disorders | ||||
Amyloidosis | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Anaphylactic reaction | 2/4668 (0%) | 2 | 1/4672 (0%) | 1 |
Contrast media allergy | 3/4668 (0.1%) | 3 | 0/4672 (0%) | 0 |
Drug hypersensitivity | 4/4668 (0.1%) | 4 | 1/4672 (0%) | 1 |
Hypersensitivity | 1/4668 (0%) | 1 | 2/4672 (0%) | 2 |
Sarcoidosis | 2/4668 (0%) | 2 | 0/4672 (0%) | 0 |
Infections and infestations | ||||
Abdominal abscess | 2/4668 (0%) | 2 | 0/4672 (0%) | 0 |
Abdominal wall abscess | 1/4668 (0%) | 2 | 4/4672 (0.1%) | 5 |
Abscess | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Abscess limb | 5/4668 (0.1%) | 5 | 6/4672 (0.1%) | 6 |
Abscess neck | 1/4668 (0%) | 2 | 2/4672 (0%) | 2 |
Abscess of salivary gland | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Acute hepatitis B | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Acute sinusitis | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Anal abscess | 1/4668 (0%) | 1 | 1/4672 (0%) | 1 |
Appendicitis | 8/4668 (0.2%) | 8 | 11/4672 (0.2%) | 11 |
Appendicitis perforated | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Arteriosclerotic gangrene | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Arthritis bacterial | 2/4668 (0%) | 2 | 3/4672 (0.1%) | 4 |
Arthritis infective | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Atypical pneumonia | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Bacteraemia | 5/4668 (0.1%) | 5 | 6/4672 (0.1%) | 6 |
Bacterial food poisoning | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Bacterial infection | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Bacterial sepsis | 1/4668 (0%) | 1 | 2/4672 (0%) | 2 |
Biliary sepsis | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Biliary tract infection | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Breast abscess | 0/4668 (0%) | 0 | 2/4672 (0%) | 3 |
Bronchiolitis | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Bronchitis | 15/4668 (0.3%) | 15 | 24/4672 (0.5%) | 25 |
Bronchopneumonia | 11/4668 (0.2%) | 13 | 19/4672 (0.4%) | 21 |
Campylobacter gastroenteritis | 1/4668 (0%) | 1 | 1/4672 (0%) | 1 |
Carbuncle | 2/4668 (0%) | 2 | 0/4672 (0%) | 0 |
Cardiac valve abscess | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Cellulitis | 37/4668 (0.8%) | 50 | 54/4672 (1.2%) | 61 |
Cellulitis gangrenous | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Cellulitis of male external genital organ | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Cervicitis | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Cholecystitis infective | 3/4668 (0.1%) | 3 | 1/4672 (0%) | 1 |
Cholera | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Citrobacter sepsis | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Clostridium colitis | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Clostridium difficile colitis | 6/4668 (0.1%) | 6 | 3/4672 (0.1%) | 3 |
Clostridium difficile infection | 1/4668 (0%) | 1 | 1/4672 (0%) | 1 |
Cystitis | 7/4668 (0.1%) | 7 | 1/4672 (0%) | 1 |
Dacryocystitis | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Dengue fever | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Device related infection | 5/4668 (0.1%) | 5 | 3/4672 (0.1%) | 5 |
Device related sepsis | 1/4668 (0%) | 1 | 1/4672 (0%) | 1 |
Diabetic foot infection | 11/4668 (0.2%) | 12 | 9/4672 (0.2%) | 11 |
Diabetic gangrene | 1/4668 (0%) | 1 | 2/4672 (0%) | 2 |
Diarrhoea infectious | 2/4668 (0%) | 2 | 0/4672 (0%) | 0 |
Diverticulitis | 7/4668 (0.1%) | 8 | 13/4672 (0.3%) | 13 |
Dysentery | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Ear infection | 1/4668 (0%) | 1 | 1/4672 (0%) | 1 |
Endocarditis | 3/4668 (0.1%) | 3 | 4/4672 (0.1%) | 4 |
Endocarditis enterococcal | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Endocarditis staphylococcal | 0/4668 (0%) | 0 | 2/4672 (0%) | 2 |
Endophthalmitis | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Enterobacter pneumonia | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Enterococcal infection | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Epididymitis | 1/4668 (0%) | 1 | 1/4672 (0%) | 1 |
Epididymitis ureaplasmal | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Erysipelas | 10/4668 (0.2%) | 11 | 14/4672 (0.3%) | 16 |
Escherichia bacteraemia | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Escherichia pyelonephritis | 1/4668 (0%) | 1 | 1/4672 (0%) | 1 |
Escherichia urinary tract infection | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Extradural abscess | 2/4668 (0%) | 2 | 1/4672 (0%) | 1 |
Eye infection | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Gallbladder abscess | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Gallbladder empyema | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Gangrene | 10/4668 (0.2%) | 13 | 12/4672 (0.3%) | 14 |
Gas gangrene | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Gastritis bacterial | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Gastroenteritis | 33/4668 (0.7%) | 34 | 31/4672 (0.7%) | 31 |
Gastroenteritis bacterial | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Gastroenteritis norovirus | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Gastroenteritis salmonella | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Gastroenteritis viral | 9/4668 (0.2%) | 9 | 4/4672 (0.1%) | 4 |
Gastrointestinal viral infection | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Gingivitis | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Groin abscess | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Haematoma infection | 1/4668 (0%) | 2 | 0/4672 (0%) | 0 |
Helicobacter gastritis | 3/4668 (0.1%) | 3 | 1/4672 (0%) | 1 |
Helicobacter infection | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Herpes virus infection | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Herpes zoster | 1/4668 (0%) | 1 | 2/4672 (0%) | 2 |
Human ehrlichiosis | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Ileal gangrene | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Incision site infection | 1/4668 (0%) | 1 | 1/4672 (0%) | 1 |
Infected bites | 1/4668 (0%) | 1 | 2/4672 (0%) | 2 |
Infected dermal cyst | 1/4668 (0%) | 1 | 1/4672 (0%) | 1 |
Infected skin ulcer | 0/4668 (0%) | 0 | 4/4672 (0.1%) | 5 |
Infection | 2/4668 (0%) | 2 | 7/4672 (0.1%) | 7 |
Infectious colitis | 1/4668 (0%) | 1 | 1/4672 (0%) | 1 |
Infectious pleural effusion | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Infective exacerbation of bronchiectasis | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Infective exacerbation of chronic obstructive airways disease | 2/4668 (0%) | 4 | 1/4672 (0%) | 1 |
Influenza | 3/4668 (0.1%) | 3 | 8/4672 (0.2%) | 8 |
Intervertebral discitis | 2/4668 (0%) | 2 | 0/4672 (0%) | 0 |
Kidney infection | 2/4668 (0%) | 2 | 0/4672 (0%) | 0 |
Klebsiella bacteraemia | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Klebsiella sepsis | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Laryngitis | 1/4668 (0%) | 1 | 1/4672 (0%) | 1 |
Legionella infection | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Liver abscess | 2/4668 (0%) | 2 | 2/4672 (0%) | 2 |
Lobar pneumonia | 15/4668 (0.3%) | 16 | 15/4672 (0.3%) | 15 |
Localised infection | 7/4668 (0.1%) | 9 | 8/4672 (0.2%) | 8 |
Lower respiratory tract infection | 15/4668 (0.3%) | 16 | 15/4672 (0.3%) | 15 |
Lung infection | 2/4668 (0%) | 2 | 5/4672 (0.1%) | 5 |
Mastitis | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Mastoiditis | 1/4668 (0%) | 1 | 1/4672 (0%) | 1 |
Mediastinitis | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Meningitis | 1/4668 (0%) | 1 | 2/4672 (0%) | 2 |
Meningitis pneumococcal | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Metapneumovirus infection | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Nasopharyngitis | 1/4668 (0%) | 2 | 0/4672 (0%) | 0 |
Necrotising fasciitis | 4/4668 (0.1%) | 4 | 0/4672 (0%) | 0 |
Neutropenic sepsis | 1/4668 (0%) | 2 | 0/4672 (0%) | 0 |
Oesophageal candidiasis | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Oral candidiasis | 1/4668 (0%) | 1 | 1/4672 (0%) | 1 |
Orchitis | 2/4668 (0%) | 2 | 2/4672 (0%) | 2 |
Osteomyelitis | 21/4668 (0.4%) | 27 | 23/4672 (0.5%) | 30 |
Osteomyelitis acute | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Osteomyelitis chronic | 0/4668 (0%) | 0 | 2/4672 (0%) | 3 |
Otitis externa | 1/4668 (0%) | 1 | 1/4672 (0%) | 1 |
Otitis media | 2/4668 (0%) | 2 | 0/4672 (0%) | 0 |
Otitis media chronic | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Pancreas infection | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Parainfluenzae virus infection | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Parotitis | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Penile infection | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Perichondritis | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Peritonitis | 5/4668 (0.1%) | 6 | 6/4672 (0.1%) | 9 |
Peritonitis bacterial | 3/4668 (0.1%) | 3 | 1/4672 (0%) | 1 |
Peritonsillar abscess | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Pharyngitis | 1/4668 (0%) | 1 | 1/4672 (0%) | 1 |
Pilonidal cyst | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Plasmodium falciparum infection | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Pneumococcal sepsis | 1/4668 (0%) | 1 | 2/4672 (0%) | 2 |
Pneumonia | 133/4668 (2.8%) | 154 | 141/4672 (3%) | 157 |
Pneumonia bacterial | 1/4668 (0%) | 1 | 3/4672 (0.1%) | 3 |
Pneumonia influenzal | 2/4668 (0%) | 2 | 1/4672 (0%) | 1 |
Pneumonia legionella | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Pneumonia pneumococcal | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Pneumonia pseudomonal | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Pneumonia staphylococcal | 1/4668 (0%) | 1 | 2/4672 (0%) | 2 |
Pneumonia viral | 2/4668 (0%) | 2 | 0/4672 (0%) | 0 |
Post procedural cellulitis | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Post procedural infection | 6/4668 (0.1%) | 6 | 3/4672 (0.1%) | 3 |
Post procedural sepsis | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Postoperative abscess | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Postoperative wound infection | 9/4668 (0.2%) | 9 | 6/4672 (0.1%) | 6 |
Prostatic abscess | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Pseudomembranous colitis | 0/4668 (0%) | 0 | 2/4672 (0%) | 2 |
Psoas abscess | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Pulmonary mycosis | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Pulmonary sepsis | 2/4668 (0%) | 2 | 3/4672 (0.1%) | 3 |
Pulmonary tuberculosis | 1/4668 (0%) | 1 | 1/4672 (0%) | 1 |
Pyelonephritis | 9/4668 (0.2%) | 9 | 10/4672 (0.2%) | 12 |
Pyelonephritis acute | 6/4668 (0.1%) | 9 | 6/4672 (0.1%) | 6 |
Pyuria | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Rectal abscess | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Respiratory syncytial virus infection | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Respiratory tract infection | 2/4668 (0%) | 2 | 7/4672 (0.1%) | 10 |
Respiratory tract infection viral | 1/4668 (0%) | 1 | 1/4672 (0%) | 1 |
Salmonella sepsis | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Salmonellosis | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Scrotal abscess | 3/4668 (0.1%) | 3 | 0/4672 (0%) | 0 |
Sepsis | 48/4668 (1%) | 50 | 34/4672 (0.7%) | 36 |
Sepsis syndrome | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Septic shock | 8/4668 (0.2%) | 9 | 13/4672 (0.3%) | 13 |
Sinusitis | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Soft tissue infection | 3/4668 (0.1%) | 3 | 0/4672 (0%) | 0 |
Staphylococcal bacteraemia | 1/4668 (0%) | 1 | 1/4672 (0%) | 1 |
Staphylococcal infection | 2/4668 (0%) | 2 | 5/4672 (0.1%) | 5 |
Staphylococcal sepsis | 4/4668 (0.1%) | 4 | 0/4672 (0%) | 0 |
Staphylococcal skin infection | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Streptococcal bacteraemia | 2/4668 (0%) | 2 | 0/4672 (0%) | 0 |
Streptococcal infection | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Subcutaneous abscess | 2/4668 (0%) | 2 | 0/4672 (0%) | 0 |
Testicular abscess | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Tonsillitis | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Tooth abscess | 0/4668 (0%) | 0 | 5/4672 (0.1%) | 5 |
Tooth infection | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Tracheitis | 0/4668 (0%) | 0 | 2/4672 (0%) | 3 |
Tracheobronchitis | 0/4668 (0%) | 0 | 3/4672 (0.1%) | 4 |
Tuberculosis | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Tuberculosis of genitourinary system | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Upper respiratory tract infection | 4/4668 (0.1%) | 4 | 3/4672 (0.1%) | 3 |
Urinary tract infection | 47/4668 (1%) | 51 | 71/4672 (1.5%) | 79 |
Urinary tract infection bacterial | 0/4668 (0%) | 0 | 3/4672 (0.1%) | 3 |
Urosepsis | 8/4668 (0.2%) | 8 | 17/4672 (0.4%) | 19 |
Vaginal abscess | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Vestibular neuronitis | 1/4668 (0%) | 1 | 3/4672 (0.1%) | 3 |
Viral infection | 5/4668 (0.1%) | 5 | 2/4672 (0%) | 2 |
Viral myocarditis | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Viral pharyngitis | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Viral sinusitis | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Viral upper respiratory tract infection | 2/4668 (0%) | 2 | 0/4672 (0%) | 0 |
Wound infection | 6/4668 (0.1%) | 6 | 0/4672 (0%) | 0 |
Wound infection staphylococcal | 1/4668 (0%) | 1 | 1/4672 (0%) | 1 |
Wound sepsis | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Zygomycosis | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Injury, poisoning and procedural complications | ||||
Abdominal wound dehiscence | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Accident | 2/4668 (0%) | 2 | 0/4672 (0%) | 0 |
Accidental overdose | 5/4668 (0.1%) | 5 | 1/4672 (0%) | 1 |
Acetabulum fracture | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Afferent loop syndrome | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Anaemia postoperative | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Anastomotic ulcer | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Ankle fracture | 2/4668 (0%) | 2 | 5/4672 (0.1%) | 6 |
Arterial restenosis | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Arteriovenous fistula site complication | 1/4668 (0%) | 1 | 1/4672 (0%) | 4 |
Arteriovenous fistula thrombosis | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Asbestosis | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Bladder injury | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Brain herniation | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Burns second degree | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Carbon monoxide poisoning | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Cardiac valve replacement complication | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Cardiac valve rupture | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Carotid artery restenosis | 0/4668 (0%) | 0 | 2/4672 (0%) | 2 |
Cataract operation complication | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Cataract traumatic | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Cervical vertebral fracture | 1/4668 (0%) | 1 | 1/4672 (0%) | 1 |
Chest injury | 1/4668 (0%) | 1 | 1/4672 (0%) | 1 |
Complications of transplanted kidney | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Concussion | 1/4668 (0%) | 1 | 5/4672 (0.1%) | 5 |
Contusion | 2/4668 (0%) | 2 | 2/4672 (0%) | 2 |
Coronary artery reocclusion | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Coronary artery restenosis | 5/4668 (0.1%) | 5 | 10/4672 (0.2%) | 10 |
Coronary vascular graft occlusion | 1/4668 (0%) | 1 | 3/4672 (0.1%) | 3 |
Craniocerebral injury | 1/4668 (0%) | 1 | 1/4672 (0%) | 1 |
Delayed recovery from anaesthesia | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Dialysis related complication | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Electric shock | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Facial bones fracture | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Fall | 84/4668 (1.8%) | 94 | 81/4672 (1.7%) | 83 |
Fat embolism | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Femoral neck fracture | 3/4668 (0.1%) | 3 | 4/4672 (0.1%) | 4 |
Femur fracture | 6/4668 (0.1%) | 6 | 6/4672 (0.1%) | 6 |
Fibula fracture | 2/4668 (0%) | 2 | 1/4672 (0%) | 1 |
Foot fracture | 1/4668 (0%) | 1 | 4/4672 (0.1%) | 4 |
Forearm fracture | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Fracture displacement | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Frostbite | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Gun shot wound | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Hand fracture | 1/4668 (0%) | 1 | 1/4672 (0%) | 1 |
Head injury | 4/4668 (0.1%) | 4 | 4/4672 (0.1%) | 4 |
Heat exhaustion | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Hip fracture | 5/4668 (0.1%) | 6 | 4/4672 (0.1%) | 4 |
Human bite | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Humerus fracture | 1/4668 (0%) | 1 | 3/4672 (0.1%) | 4 |
Incisional hernia | 4/4668 (0.1%) | 4 | 3/4672 (0.1%) | 3 |
Incorrect dose administered | 2/4668 (0%) | 2 | 1/4672 (0%) | 1 |
Inflammation of wound | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Injury | 1/4668 (0%) | 1 | 2/4672 (0%) | 2 |
Intentional overdose | 2/4668 (0%) | 2 | 0/4672 (0%) | 0 |
Jaw fracture | 0/4668 (0%) | 0 | 2/4672 (0%) | 2 |
Joint dislocation | 4/4668 (0.1%) | 5 | 2/4672 (0%) | 6 |
Joint injury | 2/4668 (0%) | 2 | 2/4672 (0%) | 3 |
Laceration | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Ligament rupture | 2/4668 (0%) | 2 | 1/4672 (0%) | 1 |
Ligament sprain | 2/4668 (0%) | 2 | 0/4672 (0%) | 0 |
Limb injury | 1/4668 (0%) | 1 | 1/4672 (0%) | 1 |
Limb traumatic amputation | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Lower limb fracture | 1/4668 (0%) | 1 | 3/4672 (0.1%) | 3 |
Lumbar vertebral fracture | 1/4668 (0%) | 1 | 1/4672 (0%) | 1 |
Meniscus injury | 3/4668 (0.1%) | 3 | 4/4672 (0.1%) | 4 |
Multiple fractures | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Muscle rupture | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Muscle strain | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Overdose | 2/4668 (0%) | 2 | 0/4672 (0%) | 0 |
Peripheral arterial reocclusion | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Peripheral artery restenosis | 0/4668 (0%) | 0 | 3/4672 (0.1%) | 4 |
Post laminectomy syndrome | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Post procedural fistula | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Post procedural haematoma | 3/4668 (0.1%) | 3 | 0/4672 (0%) | 0 |
Post procedural haematuria | 1/4668 (0%) | 1 | 1/4672 (0%) | 1 |
Post procedural haemorrhage | 2/4668 (0%) | 2 | 3/4672 (0.1%) | 4 |
Post procedural hypothyroidism | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Post procedural myocardial infarction | 0/4668 (0%) | 0 | 6/4672 (0.1%) | 6 |
Post procedural pulmonary embolism | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Post procedural stroke | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Post-traumatic pain | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Postoperative fever | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Postoperative hernia | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Postoperative respiratory failure | 2/4668 (0%) | 2 | 1/4672 (0%) | 1 |
Postoperative thoracic procedure complication | 2/4668 (0%) | 3 | 0/4672 (0%) | 0 |
Postoperative thrombosis | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Postoperative wound complication | 3/4668 (0.1%) | 3 | 1/4672 (0%) | 1 |
Procedural haemorrhage | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Procedural hypotension | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Procedural intestinal perforation | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Procedural pain | 2/4668 (0%) | 2 | 1/4672 (0%) | 1 |
Radiation pneumonitis | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Radius fracture | 0/4668 (0%) | 0 | 2/4672 (0%) | 2 |
Respiratory fume inhalation disorder | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Rib fracture | 2/4668 (0%) | 2 | 4/4672 (0.1%) | 4 |
Road traffic accident | 20/4668 (0.4%) | 23 | 16/4672 (0.3%) | 16 |
Scapula fracture | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Seroma | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Shunt occlusion | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Skeletal injury | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Soft tissue injury | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Spinal compression fracture | 0/4668 (0%) | 0 | 3/4672 (0.1%) | 3 |
Spinal cord injury thoracic | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Spinal fracture | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Splenic rupture | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Stab wound | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Sternal fracture | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Subcutaneous haematoma | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Subdural haematoma | 5/4668 (0.1%) | 6 | 10/4672 (0.2%) | 10 |
Subdural haemorrhage | 1/4668 (0%) | 2 | 0/4672 (0%) | 0 |
Tendon rupture | 3/4668 (0.1%) | 3 | 4/4672 (0.1%) | 4 |
Thermal burn | 2/4668 (0%) | 2 | 0/4672 (0%) | 0 |
Tibia fracture | 1/4668 (0%) | 1 | 2/4672 (0%) | 2 |
Toxicity to various agents | 4/4668 (0.1%) | 4 | 1/4672 (0%) | 1 |
Tracheostomy malfunction | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Traumatic arthritis | 1/4668 (0%) | 1 | 1/4672 (0%) | 1 |
Traumatic arthrosis | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Traumatic haematoma | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Traumatic intracranial haemorrhage | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Traumatic ulcer | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Ulna fracture | 2/4668 (0%) | 2 | 1/4672 (0%) | 1 |
Urinary retention postoperative | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Vascular graft occlusion | 3/4668 (0.1%) | 3 | 6/4672 (0.1%) | 7 |
Vascular graft thrombosis | 2/4668 (0%) | 3 | 2/4672 (0%) | 2 |
Vascular pseudoaneurysm | 1/4668 (0%) | 1 | 1/4672 (0%) | 1 |
Wound | 1/4668 (0%) | 4 | 2/4672 (0%) | 2 |
Wound decomposition | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Wound dehiscence | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Wound haemorrhage | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Wound necrosis | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Wrist fracture | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Wrong drug administered | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Investigations | ||||
Ammonia increased | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Amylase increased | 5/4668 (0.1%) | 5 | 2/4672 (0%) | 2 |
Angiogram peripheral | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Arteriogram coronary | 0/4668 (0%) | 0 | 7/4672 (0.1%) | 7 |
Blood alcohol increased | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Blood calcitonin increased | 0/4668 (0%) | 0 | 3/4672 (0.1%) | 3 |
Blood creatine phosphokinase increased | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Blood creatinine increased | 6/4668 (0.1%) | 6 | 3/4672 (0.1%) | 3 |
Blood glucose fluctuation | 1/4668 (0%) | 1 | 1/4672 (0%) | 1 |
Blood glucose increased | 8/4668 (0.2%) | 8 | 8/4672 (0.2%) | 11 |
Blood iron decreased | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Blood magnesium decreased | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Blood potassium decreased | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Blood potassium increased | 2/4668 (0%) | 2 | 1/4672 (0%) | 1 |
Blood pressure decreased | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Blood pressure increased | 1/4668 (0%) | 1 | 3/4672 (0.1%) | 3 |
Blood pressure systolic increased | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Blood urea increased | 1/4668 (0%) | 1 | 1/4672 (0%) | 1 |
Blood urine present | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Cardiac murmur | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Cardiac stress test abnormal | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Cardiovascular evaluation | 2/4668 (0%) | 2 | 2/4672 (0%) | 2 |
Catheterisation cardiac | 2/4668 (0%) | 2 | 2/4672 (0%) | 2 |
Colonoscopy | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Colonoscopy normal | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Culture urine positive | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
ECG signs of myocardial ischaemia | 1/4668 (0%) | 1 | 1/4672 (0%) | 1 |
Ejection fraction decreased | 1/4668 (0%) | 1 | 2/4672 (0%) | 2 |
Electrocardiogram QT prolonged | 1/4668 (0%) | 1 | 3/4672 (0.1%) | 3 |
Gamma-glutamyltransferase increased | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Glomerular filtration rate decreased | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Glycosylated haemoglobin increased | 1/4668 (0%) | 1 | 1/4672 (0%) | 1 |
Haemoglobin decreased | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Heart rate decreased | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Heart rate increased | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Hepatic enzyme increased | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Imaging procedure | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Inflammatory marker increased | 0/4668 (0%) | 0 | 2/4672 (0%) | 2 |
International normalised ratio decreased | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
International normalised ratio increased | 3/4668 (0.1%) | 3 | 6/4672 (0.1%) | 6 |
Left ventricular end-diastolic pressure increased | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Lipase increased | 11/4668 (0.2%) | 11 | 3/4672 (0.1%) | 3 |
Liver function test abnormal | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Myocardial necrosis marker increased | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Pancreatic enzymes increased | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Prostatic specific antigen increased | 1/4668 (0%) | 1 | 1/4672 (0%) | 1 |
Red blood cell sedimentation rate increased | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Renal function test | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Serum ferritin decreased | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Transplant evaluation | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Troponin increased | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Urine albumin/creatinine ratio increased | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Weight decreased | 1/4668 (0%) | 1 | 3/4672 (0.1%) | 3 |
Weight increased | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Metabolism and nutrition disorders | ||||
Cachexia | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Cell death | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Decreased appetite | 4/4668 (0.1%) | 4 | 1/4672 (0%) | 1 |
Dehydration | 30/4668 (0.6%) | 30 | 22/4672 (0.5%) | 22 |
Diabetes mellitus | 3/4668 (0.1%) | 3 | 11/4672 (0.2%) | 12 |
Diabetes mellitus inadequate control | 25/4668 (0.5%) | 28 | 43/4672 (0.9%) | 47 |
Diabetic complication | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Diabetic ketoacidosis | 11/4668 (0.2%) | 12 | 7/4672 (0.1%) | 8 |
Dyslipidaemia | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Electrolyte imbalance | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Failure to thrive | 3/4668 (0.1%) | 4 | 0/4672 (0%) | 0 |
Fluid overload | 8/4668 (0.2%) | 8 | 4/4672 (0.1%) | 6 |
Fluid retention | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Gout | 4/4668 (0.1%) | 8 | 6/4672 (0.1%) | 6 |
Hypercalcaemia | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Hyperglycaemia | 34/4668 (0.7%) | 35 | 49/4672 (1%) | 52 |
Hyperkalaemia | 9/4668 (0.2%) | 10 | 15/4672 (0.3%) | 15 |
Hyperlipidaemia | 0/4668 (0%) | 0 | 2/4672 (0%) | 2 |
Hyperosmolar hyperglycaemic state | 3/4668 (0.1%) | 3 | 6/4672 (0.1%) | 6 |
Hypervolaemia | 2/4668 (0%) | 2 | 0/4672 (0%) | 0 |
Hypocalcaemia | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Hypoglycaemia | 44/4668 (0.9%) | 60 | 75/4672 (1.6%) | 92 |
Hypokalaemia | 7/4668 (0.1%) | 8 | 7/4672 (0.1%) | 7 |
Hypomagnesaemia | 0/4668 (0%) | 0 | 2/4672 (0%) | 2 |
Hyponatraemia | 4/4668 (0.1%) | 4 | 6/4672 (0.1%) | 6 |
Hypovolaemia | 1/4668 (0%) | 1 | 3/4672 (0.1%) | 3 |
Insulin-requiring type 2 diabetes mellitus | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Iron deficiency | 1/4668 (0%) | 1 | 3/4672 (0.1%) | 3 |
Ketoacidosis | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Lactic acidosis | 2/4668 (0%) | 2 | 0/4672 (0%) | 0 |
Malnutrition | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Metabolic acidosis | 1/4668 (0%) | 1 | 2/4672 (0%) | 2 |
Metabolic disorder | 1/4668 (0%) | 1 | 1/4672 (0%) | 1 |
Metabolic syndrome | 0/4668 (0%) | 0 | 1/4672 (0%) | 3 |
Obesity | 8/4668 (0.2%) | 8 | 11/4672 (0.2%) | 11 |
Type 2 diabetes mellitus | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Vitamin B12 deficiency | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Musculoskeletal and connective tissue disorders | ||||
Acquired claw toe | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Arthralgia | 10/4668 (0.2%) | 10 | 13/4672 (0.3%) | 14 |
Arthritis | 16/4668 (0.3%) | 17 | 5/4672 (0.1%) | 5 |
Arthritis reactive | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Arthropathy | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Back disorder | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Back pain | 14/4668 (0.3%) | 14 | 20/4672 (0.4%) | 21 |
Bursitis | 3/4668 (0.1%) | 3 | 1/4672 (0%) | 1 |
Cervical spinal stenosis | 2/4668 (0%) | 2 | 3/4672 (0.1%) | 3 |
Compartment syndrome | 0/4668 (0%) | 0 | 2/4672 (0%) | 2 |
Costochondritis | 2/4668 (0%) | 2 | 1/4672 (0%) | 1 |
Diastasis recti abdominis | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Dupuytren's contracture | 4/4668 (0.1%) | 4 | 0/4672 (0%) | 0 |
Fibromyalgia | 3/4668 (0.1%) | 3 | 0/4672 (0%) | 0 |
Foot deformity | 1/4668 (0%) | 1 | 2/4672 (0%) | 2 |
Fracture nonunion | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Gouty arthritis | 2/4668 (0%) | 2 | 1/4672 (0%) | 1 |
Groin pain | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Haemarthrosis | 1/4668 (0%) | 1 | 1/4672 (0%) | 1 |
Intervertebral disc degeneration | 4/4668 (0.1%) | 4 | 4/4672 (0.1%) | 4 |
Intervertebral disc disorder | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Intervertebral disc displacement | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Intervertebral disc protrusion | 13/4668 (0.3%) | 14 | 23/4672 (0.5%) | 27 |
Joint swelling | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Lumbar spinal stenosis | 11/4668 (0.2%) | 12 | 9/4672 (0.2%) | 9 |
Meniscal degeneration | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Mobility decreased | 1/4668 (0%) | 1 | 1/4672 (0%) | 1 |
Muscle haemorrhage | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Muscle spasms | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Muscular weakness | 2/4668 (0%) | 2 | 1/4672 (0%) | 1 |
Musculoskeletal chest pain | 7/4668 (0.1%) | 7 | 9/4672 (0.2%) | 9 |
Musculoskeletal pain | 5/4668 (0.1%) | 5 | 2/4672 (0%) | 2 |
Myositis | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Neck pain | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Neuropathic arthropathy | 1/4668 (0%) | 1 | 1/4672 (0%) | 1 |
Osteitis deformans | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Osteoarthritis | 75/4668 (1.6%) | 80 | 64/4672 (1.4%) | 69 |
Osteochondrosis | 1/4668 (0%) | 1 | 2/4672 (0%) | 2 |
Osteolysis | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Osteonecrosis | 0/4668 (0%) | 0 | 3/4672 (0.1%) | 3 |
Osteoporotic fracture | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Pain in extremity | 7/4668 (0.1%) | 7 | 1/4672 (0%) | 1 |
Pathological fracture | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Periarthritis | 5/4668 (0.1%) | 5 | 0/4672 (0%) | 0 |
Polyarthritis | 2/4668 (0%) | 2 | 0/4672 (0%) | 0 |
Polymyalgia rheumatica | 1/4668 (0%) | 1 | 4/4672 (0.1%) | 4 |
Rhabdomyolysis | 1/4668 (0%) | 1 | 1/4672 (0%) | 1 |
Rheumatoid arthritis | 2/4668 (0%) | 2 | 1/4672 (0%) | 1 |
Rotator cuff syndrome | 5/4668 (0.1%) | 5 | 7/4672 (0.1%) | 7 |
Sacroiliitis | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Spinal column stenosis | 7/4668 (0.1%) | 7 | 10/4672 (0.2%) | 10 |
Spinal instability | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Spinal osteoarthritis | 9/4668 (0.2%) | 9 | 8/4672 (0.2%) | 8 |
Spinal pain | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Spondylolisthesis | 3/4668 (0.1%) | 3 | 1/4672 (0%) | 1 |
Synovial cyst | 2/4668 (0%) | 2 | 1/4672 (0%) | 1 |
Synovitis | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Tendonitis | 3/4668 (0.1%) | 3 | 0/4672 (0%) | 0 |
Trigger finger | 1/4668 (0%) | 1 | 1/4672 (0%) | 1 |
Ulnocarpal abutment syndrome | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Vertebral foraminal stenosis | 0/4668 (0%) | 0 | 3/4672 (0.1%) | 4 |
Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
Acute myeloid leukaemia | 2/4668 (0%) | 2 | 2/4672 (0%) | 2 |
Adenocarcinoma | 0/4668 (0%) | 0 | 3/4672 (0.1%) | 3 |
Adenocarcinoma gastric | 3/4668 (0.1%) | 3 | 3/4672 (0.1%) | 3 |
Adenocarcinoma of colon | 14/4668 (0.3%) | 15 | 11/4672 (0.2%) | 11 |
Adenocarcinoma of the cervix | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Adenocarcinoma pancreas | 4/4668 (0.1%) | 4 | 1/4672 (0%) | 1 |
Adrenal adenoma | 2/4668 (0%) | 2 | 2/4672 (0%) | 2 |
Adrenal neoplasm | 2/4668 (0%) | 2 | 2/4672 (0%) | 2 |
Anal squamous cell carcinoma | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Angiomyolipoma | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
B-cell lymphoma | 2/4668 (0%) | 2 | 2/4672 (0%) | 2 |
B-cell unclassifiable lymphoma low grade | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Basal cell carcinoma | 14/4668 (0.3%) | 17 | 7/4672 (0.1%) | 7 |
Basosquamous carcinoma | 1/4668 (0%) | 1 | 1/4672 (0%) | 1 |
Benign anorectal neoplasm | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Benign breast neoplasm | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Benign neoplasm of bladder | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Benign neoplasm of prostate | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Benign neoplasm of thyroid gland | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Benign ovarian tumour | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Benign soft tissue neoplasm | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Biliary adenoma | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Bladder cancer | 3/4668 (0.1%) | 3 | 5/4672 (0.1%) | 5 |
Bladder cancer recurrent | 1/4668 (0%) | 1 | 1/4672 (0%) | 1 |
Bladder cancer stage 0, with cancer in situ | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Bladder cancer stage III | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Bladder neoplasm | 1/4668 (0%) | 1 | 3/4672 (0.1%) | 3 |
Bladder squamous cell carcinoma stage unspecified | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Bladder transitional cell carcinoma | 4/4668 (0.1%) | 4 | 5/4672 (0.1%) | 5 |
Bladder transitional cell carcinoma recurrent | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Bladder transitional cell carcinoma stage III | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Blepharal papilloma | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Bone neoplasm | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Bowen's disease | 1/4668 (0%) | 1 | 2/4672 (0%) | 2 |
Brain neoplasm | 1/4668 (0%) | 1 | 1/4672 (0%) | 1 |
Breast cancer | 6/4668 (0.1%) | 6 | 6/4672 (0.1%) | 6 |
Breast cancer female | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Breast cancer in situ | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Breast cancer metastatic | 1/4668 (0%) | 1 | 1/4672 (0%) | 1 |
Bronchial carcinoma | 3/4668 (0.1%) | 3 | 2/4672 (0%) | 2 |
Carcinoid tumour of the small bowel | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Carcinoid tumour pulmonary | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Central nervous system lymphoma | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Cerebellar tumour | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Cerebral haemangioma | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Cholangiocarcinoma | 5/4668 (0.1%) | 5 | 3/4672 (0.1%) | 3 |
Cholesteatoma | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Cholesterol granuloma | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Chondrosarcoma metastatic | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Chondrosarcoma recurrent | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Chronic lymphocytic leukaemia | 1/4668 (0%) | 1 | 3/4672 (0.1%) | 3 |
Chronic lymphocytic leukaemia stage 1 | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Chronic myeloid leukaemia | 1/4668 (0%) | 1 | 1/4672 (0%) | 1 |
Chronic myelomonocytic leukaemia | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Clear cell renal cell carcinoma | 6/4668 (0.1%) | 6 | 3/4672 (0.1%) | 3 |
Colon adenoma | 13/4668 (0.3%) | 14 | 16/4672 (0.3%) | 18 |
Colon cancer | 3/4668 (0.1%) | 3 | 6/4672 (0.1%) | 6 |
Colon cancer metastatic | 3/4668 (0.1%) | 3 | 1/4672 (0%) | 1 |
Colon cancer stage 0 | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Colorectal adenocarcinoma | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Colorectal cancer | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Diffuse large B-cell lymphoma | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Endometrial adenocarcinoma | 0/4668 (0%) | 0 | 2/4672 (0%) | 2 |
Extranodal marginal zone B-cell lymphoma (MALT type) | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Follicle centre lymphoma, follicular grade I, II, III stage I | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Follicle centre lymphoma, follicular grade I, II, III stage IV | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Gallbladder adenocarcinoma | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Gastric cancer | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Gastric cancer stage III | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Gastrointestinal stromal tumour | 0/4668 (0%) | 0 | 2/4672 (0%) | 2 |
Gastrointestinal tract adenoma | 1/4668 (0%) | 1 | 2/4672 (0%) | 2 |
Giant cell tumour of tendon sheath | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Glioblastoma | 2/4668 (0%) | 2 | 1/4672 (0%) | 1 |
Glioblastoma multiforme | 2/4668 (0%) | 2 | 0/4672 (0%) | 0 |
Glomus tumour | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Haemangioma | 1/4668 (0%) | 1 | 1/4672 (0%) | 1 |
Haemangioma of bone | 0/4668 (0%) | 0 | 1/4672 (0%) | 2 |
Haemangioma of spleen | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Hairy cell leukaemia | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Hepatic cancer | 3/4668 (0.1%) | 3 | 1/4672 (0%) | 1 |
Hepatic cancer metastatic | 1/4668 (0%) | 1 | 1/4672 (0%) | 1 |
Hepatocellular carcinoma | 5/4668 (0.1%) | 5 | 4/4672 (0.1%) | 4 |
Hypopharyngeal cancer | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Intraductal papillary mucinous neoplasm | 1/4668 (0%) | 1 | 2/4672 (0%) | 2 |
Intraductal proliferative breast lesion | 2/4668 (0%) | 2 | 3/4672 (0.1%) | 3 |
Invasive breast carcinoma | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Invasive ductal breast carcinoma | 11/4668 (0.2%) | 11 | 9/4672 (0.2%) | 9 |
Invasive lobular breast carcinoma | 1/4668 (0%) | 1 | 2/4672 (0%) | 2 |
Keratoacanthoma | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Large cell lung cancer | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Large granular lymphocytosis | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Large intestine benign neoplasm | 1/4668 (0%) | 2 | 1/4672 (0%) | 1 |
Laryngeal cancer | 1/4668 (0%) | 1 | 1/4672 (0%) | 1 |
Laryngeal cancer stage I | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Laryngeal squamous cell carcinoma | 1/4668 (0%) | 1 | 1/4672 (0%) | 1 |
Lip squamous cell carcinoma | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Lipoma | 2/4668 (0%) | 2 | 1/4672 (0%) | 1 |
Liposarcoma | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Liposarcoma metastatic | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Lung adenocarcinoma | 6/4668 (0.1%) | 6 | 3/4672 (0.1%) | 3 |
Lung adenocarcinoma metastatic | 1/4668 (0%) | 1 | 3/4672 (0.1%) | 3 |
Lung adenocarcinoma stage IV | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Lung cancer metastatic | 3/4668 (0.1%) | 3 | 2/4672 (0%) | 2 |
Lung carcinoma cell type unspecified stage III | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Lung neoplasm | 2/4668 (0%) | 2 | 0/4672 (0%) | 0 |
Lung neoplasm malignant | 2/4668 (0%) | 2 | 9/4672 (0.2%) | 10 |
Lung squamous cell carcinoma stage III | 0/4668 (0%) | 0 | 2/4672 (0%) | 2 |
Lung squamous cell carcinoma stage IV | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Malignant glioma | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Malignant melanoma | 8/4668 (0.2%) | 8 | 6/4672 (0.1%) | 6 |
Malignant melanoma in situ | 2/4668 (0%) | 2 | 0/4672 (0%) | 0 |
Malignant neoplasm of pleura | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Medullary thyroid cancer | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Melanocytic naevus | 2/4668 (0%) | 2 | 0/4672 (0%) | 0 |
Meningioma | 2/4668 (0%) | 2 | 2/4672 (0%) | 2 |
Meningioma benign | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Mesothelioma malignant | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Metastases to bone | 2/4668 (0%) | 2 | 1/4672 (0%) | 1 |
Metastases to central nervous system | 2/4668 (0%) | 2 | 2/4672 (0%) | 2 |
Metastases to liver | 5/4668 (0.1%) | 6 | 4/4672 (0.1%) | 4 |
Metastases to lung | 3/4668 (0.1%) | 3 | 2/4672 (0%) | 2 |
Metastases to lymph nodes | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Metastases to peritoneum | 1/4668 (0%) | 1 | 2/4672 (0%) | 2 |
Metastases to spine | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Metastatic bronchial carcinoma | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Metastatic malignant melanoma | 2/4668 (0%) | 2 | 2/4672 (0%) | 2 |
Metastatic neoplasm | 2/4668 (0%) | 2 | 0/4672 (0%) | 0 |
Metastatic renal cell carcinoma | 1/4668 (0%) | 1 | 1/4672 (0%) | 1 |
Metastatic squamous cell carcinoma | 0/4668 (0%) | 0 | 2/4672 (0%) | 2 |
Mucinous breast carcinoma | 1/4668 (0%) | 1 | 1/4672 (0%) | 1 |
Myelodysplastic syndrome | 0/4668 (0%) | 0 | 2/4672 (0%) | 2 |
Myxofibrosarcoma | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Neoplasm | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Neoplasm of appendix | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Neoplasm skin | 2/4668 (0%) | 2 | 0/4672 (0%) | 0 |
Neuroendocrine carcinoma of the skin | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Non-Hodgkin's lymphoma | 3/4668 (0.1%) | 3 | 2/4672 (0%) | 2 |
Non-Hodgkin's lymphoma recurrent | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Non-Hodgkin's lymphoma stage III | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Non-small cell lung cancer | 4/4668 (0.1%) | 4 | 2/4672 (0%) | 2 |
Non-small cell lung cancer metastatic | 1/4668 (0%) | 1 | 1/4672 (0%) | 1 |
Non-small cell lung cancer stage I | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Oesophageal adenocarcinoma | 3/4668 (0.1%) | 3 | 0/4672 (0%) | 0 |
Oesophageal adenocarcinoma metastatic | 1/4668 (0%) | 1 | 1/4672 (0%) | 1 |
Oesophageal cancer metastatic | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Oesophageal squamous cell carcinoma | 0/4668 (0%) | 0 | 3/4672 (0.1%) | 3 |
Oesophageal squamous cell carcinoma stage IV | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Oropharyngeal cancer stage IV | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Ovarian adenoma | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Ovarian cancer | 2/4668 (0%) | 2 | 0/4672 (0%) | 0 |
Ovarian cancer metastatic | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Ovarian epithelial cancer | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Ovarian epithelial cancer metastatic | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Pancreatic carcinoma | 4/4668 (0.1%) | 4 | 7/4672 (0.1%) | 7 |
Pancreatic carcinoma metastatic | 2/4668 (0%) | 2 | 2/4672 (0%) | 2 |
Pancreatic carcinoma stage IV | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Pancreatic neoplasm | 2/4668 (0%) | 2 | 0/4672 (0%) | 0 |
Papillary cystadenoma lymphomatosum | 1/4668 (0%) | 1 | 2/4672 (0%) | 2 |
Papillary serous endometrial carcinoma | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Papillary thyroid cancer | 4/4668 (0.1%) | 5 | 3/4672 (0.1%) | 3 |
Parathyroid tumour benign | 3/4668 (0.1%) | 3 | 2/4672 (0%) | 2 |
Pelvic neoplasm | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Phyllodes tumour | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Pituitary tumour benign | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Plasma cell myeloma | 3/4668 (0.1%) | 3 | 5/4672 (0.1%) | 5 |
Plasmacytoma | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Pleural mesothelioma | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Prostate cancer | 24/4668 (0.5%) | 24 | 39/4672 (0.8%) | 39 |
Prostate cancer metastatic | 2/4668 (0%) | 2 | 4/4672 (0.1%) | 4 |
Prostate cancer recurrent | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Prostate cancer stage II | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Rectal adenocarcinoma | 6/4668 (0.1%) | 6 | 3/4672 (0.1%) | 3 |
Rectal adenoma | 1/4668 (0%) | 1 | 2/4672 (0%) | 2 |
Rectal cancer | 4/4668 (0.1%) | 4 | 3/4672 (0.1%) | 3 |
Rectal cancer metastatic | 1/4668 (0%) | 1 | 1/4672 (0%) | 1 |
Rectal cancer stage II | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Renal cancer | 1/4668 (0%) | 1 | 2/4672 (0%) | 2 |
Renal cancer metastatic | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Renal cancer recurrent | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Renal cell carcinoma | 2/4668 (0%) | 2 | 5/4672 (0.1%) | 5 |
Renal cell carcinoma stage II | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Renal neoplasm | 1/4668 (0%) | 1 | 2/4672 (0%) | 2 |
Salivary gland neoplasm | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Seborrhoeic keratosis | 2/4668 (0%) | 2 | 1/4672 (0%) | 1 |
Skin cancer | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Small cell lung cancer | 2/4668 (0%) | 2 | 2/4672 (0%) | 2 |
Small cell lung cancer metastatic | 3/4668 (0.1%) | 3 | 1/4672 (0%) | 1 |
Small intestine carcinoma | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Small intestine carcinoma metastatic | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Squamous cell carcinoma | 4/4668 (0.1%) | 4 | 2/4672 (0%) | 2 |
Squamous cell carcinoma of lung | 1/4668 (0%) | 1 | 5/4672 (0.1%) | 5 |
Squamous cell carcinoma of skin | 7/4668 (0.1%) | 8 | 2/4672 (0%) | 2 |
Squamous cell carcinoma of the cervix | 4/4668 (0.1%) | 5 | 0/4672 (0%) | 0 |
Squamous cell carcinoma of the oral cavity | 1/4668 (0%) | 1 | 1/4672 (0%) | 1 |
Squamous cell carcinoma of the tongue | 1/4668 (0%) | 1 | 1/4672 (0%) | 1 |
Squamous cell carcinoma of the vulva | 1/4668 (0%) | 1 | 1/4672 (0%) | 1 |
Thyroid adenoma | 0/4668 (0%) | 0 | 2/4672 (0%) | 2 |
Thyroid cancer | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Thyroid neoplasm | 4/4668 (0.1%) | 4 | 3/4672 (0.1%) | 3 |
Tonsil cancer | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Transitional cell carcinoma | 8/4668 (0.2%) | 8 | 3/4672 (0.1%) | 3 |
Transitional cell carcinoma metastatic | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Urinary tract neoplasm | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Uterine leiomyoma | 2/4668 (0%) | 2 | 3/4672 (0.1%) | 3 |
Uterine leiomyosarcoma | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Vocal cord neoplasm | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Vulval neoplasm | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Nervous system disorders | ||||
Altered state of consciousness | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Ataxia | 2/4668 (0%) | 2 | 1/4672 (0%) | 1 |
Autonomic nervous system imbalance | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Basal ganglia haemorrhage | 1/4668 (0%) | 1 | 1/4672 (0%) | 1 |
Basal ganglia stroke | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Brain injury | 0/4668 (0%) | 0 | 2/4672 (0%) | 2 |
Brain oedema | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Brain stem infarction | 1/4668 (0%) | 1 | 1/4672 (0%) | 1 |
Carotid arteriosclerosis | 1/4668 (0%) | 1 | 1/4672 (0%) | 1 |
Carotid artery aneurysm | 2/4668 (0%) | 2 | 0/4672 (0%) | 0 |
Carotid artery disease | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Carotid artery occlusion | 3/4668 (0.1%) | 3 | 2/4672 (0%) | 2 |
Carotid artery stenosis | 28/4668 (0.6%) | 30 | 16/4672 (0.3%) | 18 |
Carpal tunnel syndrome | 6/4668 (0.1%) | 7 | 4/4672 (0.1%) | 4 |
Cauda equina syndrome | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Cerebellar haematoma | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Cerebellar infarction | 1/4668 (0%) | 1 | 2/4672 (0%) | 2 |
Cerebellar ischaemia | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Cerebral haematoma | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Cerebral haemorrhage | 4/4668 (0.1%) | 4 | 5/4672 (0.1%) | 5 |
Cerebral hypoperfusion | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Cerebral infarction | 14/4668 (0.3%) | 14 | 20/4672 (0.4%) | 21 |
Cerebral ischaemia | 3/4668 (0.1%) | 3 | 3/4672 (0.1%) | 3 |
Cerebral small vessel ischaemic disease | 3/4668 (0.1%) | 3 | 0/4672 (0%) | 0 |
Cerebrovascular accident | 52/4668 (1.1%) | 56 | 65/4672 (1.4%) | 68 |
Cerebrovascular insufficiency | 0/4668 (0%) | 0 | 2/4672 (0%) | 2 |
Cervical myelopathy | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Cervical radiculopathy | 1/4668 (0%) | 1 | 1/4672 (0%) | 1 |
Chronic inflammatory demyelinating polyradiculoneuropathy | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Cognitive disorder | 4/4668 (0.1%) | 4 | 3/4672 (0.1%) | 4 |
Coma | 0/4668 (0%) | 0 | 2/4672 (0%) | 3 |
Dementia | 3/4668 (0.1%) | 3 | 3/4672 (0.1%) | 3 |
Dementia Alzheimer's type | 2/4668 (0%) | 2 | 0/4672 (0%) | 0 |
Dementia with Lewy bodies | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Depressed level of consciousness | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Diabetic mononeuropathy | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Diabetic neuropathy | 9/4668 (0.2%) | 10 | 7/4672 (0.1%) | 12 |
Dizziness | 12/4668 (0.3%) | 12 | 6/4672 (0.1%) | 6 |
Dysarthria | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Dyskinesia | 0/4668 (0%) | 0 | 1/4672 (0%) | 2 |
Embolic cerebral infarction | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Embolic stroke | 5/4668 (0.1%) | 6 | 1/4672 (0%) | 1 |
Encephalopathy | 1/4668 (0%) | 1 | 2/4672 (0%) | 2 |
Epilepsy | 4/4668 (0.1%) | 5 | 2/4672 (0%) | 3 |
Generalised tonic-clonic seizure | 2/4668 (0%) | 2 | 1/4672 (0%) | 1 |
Guillain-Barre syndrome | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Haemorrhage intracranial | 6/4668 (0.1%) | 6 | 3/4672 (0.1%) | 4 |
Haemorrhagic cerebral infarction | 1/4668 (0%) | 1 | 1/4672 (0%) | 1 |
Haemorrhagic stroke | 10/4668 (0.2%) | 10 | 13/4672 (0.3%) | 13 |
Headache | 2/4668 (0%) | 2 | 7/4672 (0.1%) | 7 |
Hemiparesis | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Hemiplegia | 1/4668 (0%) | 3 | 1/4672 (0%) | 1 |
Hepatic encephalopathy | 3/4668 (0.1%) | 3 | 0/4672 (0%) | 0 |
Hydrocephalus | 0/4668 (0%) | 0 | 2/4672 (0%) | 2 |
Hyperaesthesia | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Hypertensive encephalopathy | 0/4668 (0%) | 0 | 2/4672 (0%) | 2 |
Hypoaesthesia | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Hypoglycaemic coma | 1/4668 (0%) | 1 | 2/4672 (0%) | 2 |
Hypoglycaemic seizure | 2/4668 (0%) | 2 | 0/4672 (0%) | 0 |
Hypoglycaemic unconsciousness | 21/4668 (0.4%) | 24 | 28/4672 (0.6%) | 28 |
Hypoxic-ischaemic encephalopathy | 2/4668 (0%) | 2 | 4/4672 (0.1%) | 5 |
IIIrd nerve disorder | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Intercostal neuralgia | 1/4668 (0%) | 1 | 1/4672 (0%) | 1 |
Internal carotid artery kinking | 1/4668 (0%) | 2 | 0/4672 (0%) | 0 |
Intracranial aneurysm | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Ischaemic cerebral infarction | 2/4668 (0%) | 3 | 4/4672 (0.1%) | 4 |
Ischaemic stroke | 50/4668 (1.1%) | 54 | 54/4672 (1.2%) | 59 |
Lacunar infarction | 6/4668 (0.1%) | 7 | 8/4672 (0.2%) | 8 |
Lethargy | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Loss of consciousness | 5/4668 (0.1%) | 6 | 7/4672 (0.1%) | 7 |
Lumbar radiculopathy | 4/4668 (0.1%) | 4 | 1/4672 (0%) | 1 |
Memory impairment | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Metabolic encephalopathy | 6/4668 (0.1%) | 6 | 0/4672 (0%) | 0 |
Migraine | 0/4668 (0%) | 0 | 4/4672 (0.1%) | 4 |
Mononeuropathy | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Multiple system atrophy | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Myasthenia gravis | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Myelopathy | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Nerve compression | 0/4668 (0%) | 0 | 2/4672 (0%) | 2 |
Nervous system disorder | 0/4668 (0%) | 0 | 2/4672 (0%) | 2 |
Neuralgia | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Neuritis cranial | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Neuropathy peripheral | 3/4668 (0.1%) | 3 | 1/4672 (0%) | 1 |
Normal pressure hydrocephalus | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Orthostatic intolerance | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Paraplegia | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Parkinson's disease | 1/4668 (0%) | 1 | 2/4672 (0%) | 2 |
Parkinsonism | 1/4668 (0%) | 1 | 1/4672 (0%) | 1 |
Partial seizures | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Peripheral nerve lesion | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Peroneal nerve palsy | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Petit mal epilepsy | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Polyneuropathy | 2/4668 (0%) | 2 | 2/4672 (0%) | 2 |
Post herpetic neuralgia | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Post-traumatic headache | 1/4668 (0%) | 2 | 0/4672 (0%) | 0 |
Presyncope | 6/4668 (0.1%) | 7 | 6/4672 (0.1%) | 6 |
Radiculopathy | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Restless legs syndrome | 2/4668 (0%) | 2 | 0/4672 (0%) | 0 |
Reversible ischaemic neurological deficit | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Sciatica | 4/4668 (0.1%) | 4 | 3/4672 (0.1%) | 3 |
Seizure | 7/4668 (0.1%) | 7 | 6/4672 (0.1%) | 6 |
Seizure like phenomena | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Serotonin syndrome | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Spinal claudication | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Status epilepticus | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Subarachnoid haemorrhage | 4/4668 (0.1%) | 4 | 3/4672 (0.1%) | 3 |
Syncope | 39/4668 (0.8%) | 43 | 26/4672 (0.6%) | 27 |
Tension headache | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Thalamic infarction | 3/4668 (0.1%) | 3 | 0/4672 (0%) | 0 |
Thrombotic cerebral infarction | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Thrombotic stroke | 3/4668 (0.1%) | 3 | 0/4672 (0%) | 0 |
Toxic encephalopathy | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Transient ischaemic attack | 52/4668 (1.1%) | 57 | 68/4672 (1.5%) | 73 |
Unresponsive to stimuli | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Uraemic encephalopathy | 2/4668 (0%) | 2 | 0/4672 (0%) | 0 |
VIIth nerve paralysis | 3/4668 (0.1%) | 3 | 5/4672 (0.1%) | 6 |
Vascular dementia | 1/4668 (0%) | 1 | 2/4672 (0%) | 2 |
Vertebral artery stenosis | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Vertebrobasilar insufficiency | 1/4668 (0%) | 1 | 3/4672 (0.1%) | 3 |
Vocal cord paralysis | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Psychiatric disorders | ||||
Alcohol abuse | 1/4668 (0%) | 2 | 1/4672 (0%) | 1 |
Alcoholism | 1/4668 (0%) | 1 | 1/4672 (0%) | 1 |
Anxiety | 2/4668 (0%) | 2 | 2/4672 (0%) | 2 |
Bipolar disorder | 3/4668 (0.1%) | 5 | 2/4672 (0%) | 3 |
Completed suicide | 1/4668 (0%) | 1 | 4/4672 (0.1%) | 4 |
Confusional state | 0/4668 (0%) | 0 | 9/4672 (0.2%) | 9 |
Delirium | 1/4668 (0%) | 1 | 3/4672 (0.1%) | 3 |
Depression | 9/4668 (0.2%) | 11 | 7/4672 (0.1%) | 7 |
Disorientation | 1/4668 (0%) | 2 | 0/4672 (0%) | 0 |
Major depression | 1/4668 (0%) | 1 | 4/4672 (0.1%) | 5 |
Mania | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Mental disorder | 1/4668 (0%) | 2 | 1/4672 (0%) | 1 |
Mental status changes | 3/4668 (0.1%) | 3 | 3/4672 (0.1%) | 4 |
Personality disorder | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Somatisation disorder | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Suicidal ideation | 1/4668 (0%) | 1 | 1/4672 (0%) | 1 |
Suicide attempt | 4/4668 (0.1%) | 4 | 2/4672 (0%) | 2 |
Renal and urinary disorders | ||||
Acute kidney injury | 108/4668 (2.3%) | 124 | 94/4672 (2%) | 105 |
Acute prerenal failure | 1/4668 (0%) | 1 | 1/4672 (0%) | 1 |
Azotaemia | 3/4668 (0.1%) | 3 | 2/4672 (0%) | 2 |
Bladder diverticulum | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Bladder dysplasia | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Bladder hypertrophy | 0/4668 (0%) | 0 | 2/4672 (0%) | 2 |
Bladder neck obstruction | 2/4668 (0%) | 2 | 0/4672 (0%) | 0 |
Bladder outlet obstruction | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Bladder prolapse | 3/4668 (0.1%) | 3 | 1/4672 (0%) | 1 |
Bladder stenosis | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Calculus bladder | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Calculus ureteric | 10/4668 (0.2%) | 10 | 9/4672 (0.2%) | 9 |
Calculus urinary | 2/4668 (0%) | 2 | 2/4672 (0%) | 2 |
Chronic kidney disease | 52/4668 (1.1%) | 60 | 52/4672 (1.1%) | 55 |
Diabetic nephropathy | 6/4668 (0.1%) | 7 | 11/4672 (0.2%) | 11 |
Dysuria | 1/4668 (0%) | 1 | 3/4672 (0.1%) | 3 |
Fibrillary glomerulonephritis | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Focal segmental glomerulosclerosis | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Glomerulonephritis membranous | 1/4668 (0%) | 2 | 0/4672 (0%) | 0 |
Glomerulosclerosis | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Haematuria | 7/4668 (0.1%) | 7 | 2/4672 (0%) | 2 |
Haemorrhage urinary tract | 1/4668 (0%) | 2 | 0/4672 (0%) | 0 |
Hydronephrosis | 5/4668 (0.1%) | 6 | 2/4672 (0%) | 2 |
Mesangioproliferative glomerulonephritis | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Microalbuminuria | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Nephritis | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Nephrolithiasis | 26/4668 (0.6%) | 27 | 21/4672 (0.4%) | 22 |
Nephropathy | 6/4668 (0.1%) | 6 | 13/4672 (0.3%) | 15 |
Nephropathy toxic | 1/4668 (0%) | 1 | 2/4672 (0%) | 2 |
Nephrotic syndrome | 2/4668 (0%) | 2 | 1/4672 (0%) | 1 |
Nocturia | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Obstructive uropathy | 2/4668 (0%) | 2 | 0/4672 (0%) | 0 |
Pelvi-ureteric obstruction | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Polyuria | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Proteinuria | 2/4668 (0%) | 2 | 3/4672 (0.1%) | 3 |
Renal artery arteriosclerosis | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Renal artery occlusion | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Renal artery stenosis | 2/4668 (0%) | 2 | 3/4672 (0.1%) | 3 |
Renal colic | 3/4668 (0.1%) | 3 | 1/4672 (0%) | 1 |
Renal cyst | 5/4668 (0.1%) | 5 | 11/4672 (0.2%) | 11 |
Renal failure | 20/4668 (0.4%) | 21 | 31/4672 (0.7%) | 33 |
Renal haemorrhage | 2/4668 (0%) | 2 | 0/4672 (0%) | 0 |
Renal impairment | 14/4668 (0.3%) | 14 | 10/4672 (0.2%) | 10 |
Renal infarct | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Renal injury | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Renal pain | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Renal tubular necrosis | 1/4668 (0%) | 1 | 5/4672 (0.1%) | 5 |
Single functional kidney | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Stress urinary incontinence | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Tubulointerstitial nephritis | 1/4668 (0%) | 1 | 3/4672 (0.1%) | 3 |
Ureteral necrosis | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Ureteral polyp | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Ureteric obstruction | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Ureteric stenosis | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Urethral stenosis | 4/4668 (0.1%) | 4 | 6/4672 (0.1%) | 7 |
Urinary bladder polyp | 0/4668 (0%) | 0 | 2/4672 (0%) | 2 |
Urinary incontinence | 2/4668 (0%) | 2 | 1/4672 (0%) | 1 |
Urinary retention | 8/4668 (0.2%) | 8 | 12/4672 (0.3%) | 13 |
Urinary tract obstruction | 1/4668 (0%) | 1 | 1/4672 (0%) | 1 |
Reproductive system and breast disorders | ||||
Acquired phimosis | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Benign prostatic hyperplasia | 25/4668 (0.5%) | 25 | 23/4672 (0.5%) | 23 |
Breast mass | 2/4668 (0%) | 2 | 0/4672 (0%) | 0 |
Cervical dysplasia | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Cervical polyp | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Cystocele | 2/4668 (0%) | 2 | 0/4672 (0%) | 0 |
Endometrial hyperplasia | 2/4668 (0%) | 2 | 0/4672 (0%) | 0 |
Erectile dysfunction | 3/4668 (0.1%) | 3 | 0/4672 (0%) | 0 |
Genital prolapse | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Haematospermia | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Ovarian cyst | 1/4668 (0%) | 1 | 2/4672 (0%) | 2 |
Peyronie's disease | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Postmenopausal haemorrhage | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Prostatic dysplasia | 1/4668 (0%) | 2 | 0/4672 (0%) | 0 |
Prostatitis | 7/4668 (0.1%) | 7 | 2/4672 (0%) | 2 |
Prostatomegaly | 3/4668 (0.1%) | 3 | 1/4672 (0%) | 1 |
Testicular cyst | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Testicular mass | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Testicular necrosis | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Uterine polyp | 1/4668 (0%) | 1 | 6/4672 (0.1%) | 6 |
Uterine prolapse | 3/4668 (0.1%) | 3 | 0/4672 (0%) | 0 |
Vaginal fistula | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Vaginal haemorrhage | 2/4668 (0%) | 2 | 2/4672 (0%) | 2 |
Vaginal prolapse | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Respiratory, thoracic and mediastinal disorders | ||||
Acute interstitial pneumonitis | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Acute pulmonary oedema | 13/4668 (0.3%) | 15 | 10/4672 (0.2%) | 13 |
Acute respiratory distress syndrome | 2/4668 (0%) | 2 | 3/4672 (0.1%) | 3 |
Acute respiratory failure | 22/4668 (0.5%) | 23 | 18/4672 (0.4%) | 21 |
Asphyxia | 0/4668 (0%) | 0 | 2/4672 (0%) | 2 |
Aspiration | 1/4668 (0%) | 1 | 1/4672 (0%) | 1 |
Asthma | 12/4668 (0.3%) | 14 | 14/4672 (0.3%) | 23 |
Asthmatic crisis | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Atelectasis | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Bronchial hyperreactivity | 1/4668 (0%) | 1 | 1/4672 (0%) | 1 |
Bronchiectasis | 0/4668 (0%) | 0 | 2/4672 (0%) | 2 |
Bronchitis chronic | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Bronchopneumopathy | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Bronchospasm | 2/4668 (0%) | 6 | 1/4672 (0%) | 1 |
Chronic obstructive pulmonary disease | 50/4668 (1.1%) | 68 | 59/4672 (1.3%) | 82 |
Chronic respiratory failure | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Dependence on respirator | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Dyspnoea | 20/4668 (0.4%) | 21 | 32/4672 (0.7%) | 36 |
Dyspnoea exertional | 6/4668 (0.1%) | 6 | 7/4672 (0.1%) | 7 |
Emphysema | 1/4668 (0%) | 1 | 3/4672 (0.1%) | 3 |
Epistaxis | 8/4668 (0.2%) | 8 | 3/4672 (0.1%) | 3 |
Haemoptysis | 3/4668 (0.1%) | 3 | 1/4672 (0%) | 1 |
Haemothorax | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Hepatopulmonary syndrome | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Hypercapnia | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Hypoxia | 5/4668 (0.1%) | 5 | 3/4672 (0.1%) | 3 |
Idiopathic pulmonary fibrosis | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Interstitial lung disease | 3/4668 (0.1%) | 3 | 1/4672 (0%) | 1 |
Laryngeal dysplasia | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Laryngeal oedema | 1/4668 (0%) | 1 | 1/4672 (0%) | 1 |
Laryngeal stenosis | 1/4668 (0%) | 1 | 1/4672 (0%) | 1 |
Lung infiltration | 1/4668 (0%) | 1 | 2/4672 (0%) | 2 |
Nasal polyps | 0/4668 (0%) | 0 | 2/4672 (0%) | 2 |
Nasal septum deviation | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Nasopharyngeal polyp | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Non-cardiogenic pulmonary oedema | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Obstructive airways disorder | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Organising pneumonia | 2/4668 (0%) | 2 | 1/4672 (0%) | 1 |
Paranasal cyst | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Pharyngeal cyst | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Pharyngeal inflammation | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Pleural effusion | 4/4668 (0.1%) | 4 | 15/4672 (0.3%) | 18 |
Pleurisy | 1/4668 (0%) | 1 | 2/4672 (0%) | 2 |
Pleuritic pain | 2/4668 (0%) | 2 | 1/4672 (0%) | 1 |
Pneumonia aspiration | 7/4668 (0.1%) | 7 | 6/4672 (0.1%) | 7 |
Pneumonitis | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Pneumothorax | 1/4668 (0%) | 1 | 2/4672 (0%) | 2 |
Pulmonary cavitation | 2/4668 (0%) | 2 | 0/4672 (0%) | 0 |
Pulmonary congestion | 0/4668 (0%) | 0 | 2/4672 (0%) | 2 |
Pulmonary embolism | 21/4668 (0.4%) | 21 | 24/4672 (0.5%) | 26 |
Pulmonary fibrosis | 1/4668 (0%) | 2 | 3/4672 (0.1%) | 4 |
Pulmonary hypertension | 3/4668 (0.1%) | 3 | 4/4672 (0.1%) | 5 |
Pulmonary mass | 3/4668 (0.1%) | 3 | 6/4672 (0.1%) | 8 |
Pulmonary oedema | 17/4668 (0.4%) | 22 | 21/4672 (0.4%) | 25 |
Pulmonary sarcoidosis | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Respiratory arrest | 2/4668 (0%) | 2 | 0/4672 (0%) | 0 |
Respiratory distress | 5/4668 (0.1%) | 5 | 0/4672 (0%) | 0 |
Respiratory failure | 18/4668 (0.4%) | 20 | 19/4672 (0.4%) | 21 |
Restrictive pulmonary disease | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Rhinitis allergic | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Rhinitis hypertrophic | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Sinus polyp | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Sleep apnoea syndrome | 9/4668 (0.2%) | 9 | 7/4672 (0.1%) | 7 |
Status asthmaticus | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Upper airway obstruction | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Vocal cord polyp | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Skin and subcutaneous tissue disorders | ||||
Actinic elastosis | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Actinic keratosis | 4/4668 (0.1%) | 5 | 1/4672 (0%) | 1 |
Alopecia areata | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Angioedema | 6/4668 (0.1%) | 8 | 7/4672 (0.1%) | 7 |
Chronic pigmented purpura | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Chronic spontaneous urticaria | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Decubitus ulcer | 1/4668 (0%) | 1 | 1/4672 (0%) | 1 |
Dermatitis | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Dermatitis contact | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Diabetic foot | 66/4668 (1.4%) | 88 | 80/4672 (1.7%) | 94 |
Diabetic neuropathic ulcer | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Diabetic ulcer | 1/4668 (0%) | 4 | 2/4672 (0%) | 2 |
Eczema | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Haemorrhage subcutaneous | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Keloid scar | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Lichen sclerosus | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Lividity | 1/4668 (0%) | 2 | 0/4672 (0%) | 0 |
Melanocytic hyperplasia | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Nail bed inflammation | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Necrobiosis lipoidica diabeticorum | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Neurodermatitis | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Neuropathic ulcer | 3/4668 (0.1%) | 3 | 0/4672 (0%) | 0 |
Parapsoriasis | 0/4668 (0%) | 0 | 2/4672 (0%) | 2 |
Pemphigoid | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Psoriasis | 2/4668 (0%) | 2 | 1/4672 (0%) | 2 |
Skin lesion | 1/4668 (0%) | 1 | 2/4672 (0%) | 2 |
Skin necrosis | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Skin ulcer | 10/4668 (0.2%) | 10 | 15/4672 (0.3%) | 15 |
Stasis dermatitis | 1/4668 (0%) | 1 | 1/4672 (0%) | 1 |
Toxic epidermal necrolysis | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Urticaria papular | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Social circumstances | ||||
Social stay hospitalisation | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Walking disability | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Surgical and medical procedures | ||||
Abdominal panniculectomy | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Abdominoplasty | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Angioplasty | 7/4668 (0.1%) | 8 | 11/4672 (0.2%) | 12 |
Ankle operation | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Aortic aneurysm repair | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Aortic bypass | 2/4668 (0%) | 2 | 1/4672 (0%) | 2 |
Aortic surgery | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Arterial repair | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Arterial stent insertion | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Arterial therapeutic procedure | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Arteriovenous fistula operation | 0/4668 (0%) | 0 | 2/4672 (0%) | 3 |
Atherectomy | 1/4668 (0%) | 2 | 0/4672 (0%) | 0 |
Cardiac ablation | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Cardiac pacemaker battery replacement | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Cardiac pacemaker removal | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Cardiac pacemaker replacement | 1/4668 (0%) | 1 | 3/4672 (0.1%) | 3 |
Cardiac resynchronisation therapy | 1/4668 (0%) | 1 | 1/4672 (0%) | 1 |
Cardiopulmonary bypass | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Cardiovascular event prophylaxis | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Carotid angioplasty | 5/4668 (0.1%) | 5 | 0/4672 (0%) | 0 |
Carotid artery bypass | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Carotid artery stent insertion | 6/4668 (0.1%) | 6 | 2/4672 (0%) | 2 |
Carotid endarterectomy | 19/4668 (0.4%) | 23 | 14/4672 (0.3%) | 14 |
Carotid revascularisation | 6/4668 (0.1%) | 6 | 2/4672 (0%) | 2 |
Cataract operation | 2/4668 (0%) | 4 | 0/4672 (0%) | 0 |
Cerebral revascularisation | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Cholecystectomy | 1/4668 (0%) | 1 | 1/4672 (0%) | 1 |
Colostomy closure | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Coronary angioplasty | 46/4668 (1%) | 56 | 39/4672 (0.8%) | 42 |
Coronary arterial stent insertion | 110/4668 (2.4%) | 117 | 112/4672 (2.4%) | 136 |
Coronary artery bypass | 84/4668 (1.8%) | 86 | 102/4672 (2.2%) | 105 |
Coronary revascularisation | 120/4668 (2.6%) | 144 | 132/4672 (2.8%) | 157 |
Deep brain stimulation | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Endarterectomy | 0/4668 (0%) | 0 | 3/4672 (0.1%) | 3 |
Gastric banding | 1/4668 (0%) | 1 | 1/4672 (0%) | 1 |
Gastric bypass | 1/4668 (0%) | 1 | 1/4672 (0%) | 1 |
Gastroplasty | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Hip arthroplasty | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Hospitalisation | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Implantable defibrillator insertion | 2/4668 (0%) | 2 | 5/4672 (0.1%) | 5 |
Implantable defibrillator replacement | 1/4668 (0%) | 1 | 1/4672 (0%) | 1 |
Inguinal hernia repair | 2/4668 (0%) | 2 | 0/4672 (0%) | 0 |
Ischaemic heart disease prophylaxis | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Joint arthroplasty | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Knee arthroplasty | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Knee operation | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Lipoma excision | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Medical device battery replacement | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Medical device change | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Mitral valve replacement | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Obesity surgery | 1/4668 (0%) | 1 | 1/4672 (0%) | 1 |
Parathyroidectomy | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Pelvic floor repair | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Percutaneous coronary intervention | 59/4668 (1.3%) | 71 | 57/4672 (1.2%) | 66 |
Peripheral artery angioplasty | 20/4668 (0.4%) | 25 | 27/4672 (0.6%) | 29 |
Peripheral artery bypass | 11/4668 (0.2%) | 12 | 14/4672 (0.3%) | 19 |
Peripheral artery stent insertion | 7/4668 (0.1%) | 10 | 9/4672 (0.2%) | 10 |
Peripheral endarterectomy | 6/4668 (0.1%) | 7 | 2/4672 (0%) | 2 |
Peripheral revascularisation | 29/4668 (0.6%) | 33 | 36/4672 (0.8%) | 47 |
Prophylaxis against dehydration | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Rehabilitation therapy | 1/4668 (0%) | 1 | 1/4672 (0%) | 1 |
Renal artery stent placement | 0/4668 (0%) | 0 | 3/4672 (0.1%) | 3 |
Renal revascularisation surgery | 2/4668 (0%) | 2 | 0/4672 (0%) | 0 |
Skin graft | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Spinal decompression | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Stent placement | 3/4668 (0.1%) | 3 | 4/4672 (0.1%) | 4 |
Thrombectomy | 0/4668 (0%) | 0 | 4/4672 (0.1%) | 5 |
Vascular graft | 1/4668 (0%) | 1 | 1/4672 (0%) | 1 |
Vascular operation | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Vascular stent insertion | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Wrist surgery | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Vascular disorders | ||||
Accelerated hypertension | 1/4668 (0%) | 1 | 4/4672 (0.1%) | 4 |
Air embolism | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Aortic aneurysm | 8/4668 (0.2%) | 8 | 5/4672 (0.1%) | 5 |
Aortic aneurysm rupture | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Aortic arteriosclerosis | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Aortic dissection | 3/4668 (0.1%) | 3 | 0/4672 (0%) | 0 |
Aortic occlusion | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Aortic stenosis | 11/4668 (0.2%) | 11 | 7/4672 (0.1%) | 7 |
Arteriosclerosis | 3/4668 (0.1%) | 3 | 5/4672 (0.1%) | 5 |
Blood pressure fluctuation | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Blood pressure inadequately controlled | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Circulatory collapse | 4/4668 (0.1%) | 5 | 6/4672 (0.1%) | 6 |
Deep vein thrombosis | 20/4668 (0.4%) | 23 | 10/4672 (0.2%) | 11 |
Diabetic vascular disorder | 2/4668 (0%) | 2 | 1/4672 (0%) | 1 |
Dry gangrene | 2/4668 (0%) | 2 | 1/4672 (0%) | 1 |
Extremity necrosis | 4/4668 (0.1%) | 4 | 1/4672 (0%) | 1 |
Femoral artery occlusion | 6/4668 (0.1%) | 7 | 5/4672 (0.1%) | 5 |
Granulomatosis with polyangiitis | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Haematoma | 1/4668 (0%) | 1 | 2/4672 (0%) | 2 |
Haemorrhage | 1/4668 (0%) | 1 | 2/4672 (0%) | 2 |
Hypertension | 32/4668 (0.7%) | 36 | 25/4672 (0.5%) | 27 |
Hypertensive crisis | 14/4668 (0.3%) | 18 | 12/4672 (0.3%) | 13 |
Hypertensive emergency | 2/4668 (0%) | 2 | 0/4672 (0%) | 0 |
Hypotension | 18/4668 (0.4%) | 18 | 16/4672 (0.3%) | 17 |
Hypovolaemic shock | 2/4668 (0%) | 2 | 5/4672 (0.1%) | 5 |
Iliac artery occlusion | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Intermittent claudication | 5/4668 (0.1%) | 7 | 3/4672 (0.1%) | 3 |
Internal haemorrhage | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Labile hypertension | 1/4668 (0%) | 1 | 1/4672 (0%) | 1 |
Leriche syndrome | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Lymphocele | 1/4668 (0%) | 1 | 1/4672 (0%) | 1 |
Lymphoedema | 1/4668 (0%) | 2 | 1/4672 (0%) | 1 |
Malignant hypertension | 0/4668 (0%) | 0 | 3/4672 (0.1%) | 3 |
Microangiopathy | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Necrosis ischaemic | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Neurogenic shock | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Orthostatic hypotension | 10/4668 (0.2%) | 10 | 8/4672 (0.2%) | 8 |
Penetrating atherosclerotic ulcer | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Peripheral arterial occlusive disease | 24/4668 (0.5%) | 27 | 34/4672 (0.7%) | 38 |
Peripheral artery aneurysm | 2/4668 (0%) | 2 | 1/4672 (0%) | 1 |
Peripheral artery stenosis | 8/4668 (0.2%) | 9 | 12/4672 (0.3%) | 19 |
Peripheral artery thrombosis | 4/4668 (0.1%) | 5 | 4/4672 (0.1%) | 5 |
Peripheral circulatory failure | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Peripheral ischaemia | 13/4668 (0.3%) | 14 | 11/4672 (0.2%) | 12 |
Peripheral vascular disorder | 10/4668 (0.2%) | 11 | 8/4672 (0.2%) | 9 |
Peripheral venous disease | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Phlebitis | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Phlebosclerosis | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Shock | 1/4668 (0%) | 1 | 0/4672 (0%) | 0 |
Shock haemorrhagic | 5/4668 (0.1%) | 5 | 0/4672 (0%) | 0 |
Steal syndrome | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Subclavian artery stenosis | 2/4668 (0%) | 2 | 1/4672 (0%) | 1 |
Subgaleal haematoma | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Thromboangiitis obliterans | 0/4668 (0%) | 0 | 1/4672 (0%) | 2 |
Thrombophlebitis | 1/4668 (0%) | 1 | 1/4672 (0%) | 1 |
Thrombophlebitis superficial | 3/4668 (0.1%) | 4 | 0/4672 (0%) | 0 |
Thrombosis | 1/4668 (0%) | 2 | 0/4672 (0%) | 0 |
Varicose vein | 1/4668 (0%) | 2 | 2/4672 (0%) | 2 |
Vasculitis necrotising | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Venous thrombosis | 0/4668 (0%) | 0 | 1/4672 (0%) | 1 |
Other (Not Including Serious) Adverse Events |
||||
Liraglutide | Placebo | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 684/4668 (14.7%) | 210/4672 (4.5%) | ||
Gastrointestinal disorders | ||||
Diarrhoea | 266/4668 (5.7%) | 355 | 102/4672 (2.2%) | 124 |
Nausea | 517/4668 (11.1%) | 655 | 129/4672 (2.8%) | 149 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
At the end of the trial, one or more scientific publications may be prepared collaboratively by the investigator(s) and Novo Nordisk. Novo Nordisk reserves the right to postpone publication and/or communication for up to 60 days to protect intellectual property.
Results Point of Contact
Name/Title | Global Clinical Registry (GCR, 1452) |
---|---|
Organization | Novo Nordisk A/S |
Phone | |
clinicaltrials@novonordisk.com |
- EX2211-3748
- 2009-012201-19
- U1111-1113-7090
- CTR20130003