EngageAFTIMI48: Global Study to Assess the Safety and Effectiveness of Edoxaban (DU-176b) vs Standard Practice of Dosing With Warfarin in Patients With Atrial Fibrillation

• Sponsor: Daiichi Sankyo, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00781391
• Collaborator: The TIMI Study Group (Other)
• Enrollment: 21,105
• Locations: 1016
• Arms: 3
• Duration (Months): 53.9
• Patients Per Site: 20.8
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

This study is to demonstrate the safety and efficacy profile, in two different dose regimens of Edoxaban (DU-176b), (an investigational new drug being tested for the prevention of stroke/systemic embolic events (SEE)), in individuals with atrial fibrillation. Patients will be randomized to one of three treatment groups: High Dose Regimen, Low Dose Regimen, & Warfarin. The expected duration of the study is 24 months.

Condition or Disease	Intervention/Treatment	Phase
Stroke; Atrial Fibrillation; Embolism	Drug: warfarin tablets; Drug: Edoxaban tablets (high dose regimen-60mg); Drug: Edoxaban tablets (low dose regimen-30mg); Drug: placebo warfarin; Drug: placebo edoxaban	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 21105 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: A Phase 3, Randomized, Double-Blind, Double-Dummy, Parallel Group, Multi-Center, Multi-National Study for Evaluation of Efficacy and Safety of Edoxaban (DU-176b) Versus Warfarin In Subjects With Atrial Fibrillation - Effective Anticoagulation With Factor Xa Next Generation in Atrial Fibrillation (ENGAGE - AF TIMI - 48)
• Study Start Date: Nov 1, 2008
• Actual Primary Completion Date: Apr 1, 2013
• Actual Study Completion Date: May 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Warfarin/placebo edoxaban Warfarin tablets plus placebo Edoxaban tablets	Drug: warfarin tablets; Warfarin tablets plus Edoxaban placebo tablets each taken once daily for 24 months; Drug: placebo edoxaban; placebo edoxaban
Experimental: high dose edoxaban/placebo warfarin Edoxaban tablets (60mg) plus warfarin placebo tablets	Drug: Edoxaban tablets (high dose regimen-60mg); Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months; Drug: placebo warfarin; placebo warfarin
Experimental: low dose edoxaban/placebo warfarin Edoxaban tablets (30mg) plus warfarin placebo tablets	Drug: Edoxaban tablets (low dose regimen-30mg); Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months; Drug: placebo warfarin; placebo warfarin

Outcome Measures

Primary Outcome Measures

1. Compare Edoxaban to Warfarin for Composite of Stroke and Systemic Embolic Events (SEE). [on-treatment period 2.5 years of median study drug exposure and 2.8 year of median follow-up]

   The composite of stroke and Systemic Embolic Events (SEE) during the on treatment period in the mITT analysis population with a non-inferiority analysis.

2. Compare Edoxaban to Warfarin for Composite of Stroke and Systemic Embolic Events (SEE). [overall study period 2.5 years of median study drug exposure and 2.8 year of median follow-up]

   The composite of stroke and Systemic Embolic Events (SEE) during the overall study period in the mITT analysis population.

3. Compare Edoxaban to Warfarin for Composite of Stroke and Systemic Embolic Events (SEE). [on-treatment period 2.5 years of median study drug exposure and 2.8 year of median follow-up]

   The composite of stroke and Systemic Embolic Events (SEE) during the on treatment period in the PP (per protocol) analysis set population.

4. Compare Edoxaban to Warfarin for Composite of Stroke and Systemic Embolic Events (SEE). [overall study period 2.5 years of median study drug exposure and 2.8 year of median follow-up]

   The composite of stroke and Systemic Embolic Events (SEE) during the overall study period in the PP (per protocol) analysis set population.

5. Compare Edoxaban to Warfarin for Superiority for Composite of Stroke and Systemic Embolic Events (SEE). [overall study period 2.5 years of median study drug exposure and 2.8 year of median follow-up]

   Compare edoxaban to warfarin for the composite of stroke and Systemic Embolic Events (SEE) during the overall study period in the ITT analysis set with a superiority analysis.

Secondary Outcome Measures

1. Compare Edoxaban to Warfarin for Composite of Stroke, Systemic Embolic Event (SEE), and Cardiovascular (CV) Mortality [overall study period 2.5 years of median study drug exposure and 2.8 year of median follow-up]

   Compare edoxaban to warfarin for the composite of stroke, Systemic Embolic Events, and Cardiovascular mortality during the overall study period in the ITT analysis set.

2. Compare Edoxaban to Warfarin for Major Adverse Cardiac Event (MACE): a Composite of Non-fatal MI, Non-fatal Stroke, Non-fatal SEE, and Death Due to CV Cause or Bleeding [overall study period 2.5 years of median study drug exposure and 2.8 year of median follow-up]

   Compare edoxaban to warfarin for Major Adverse Cardiac Event (MACE): a composite of non-fatal Myocardial Infarction, non-fatal stroke, non-fatal Systemic Embolic Events, and death due to Cardiovascular cause or bleeding during the overall study period in the ITT analysis set.

3. Compare Edoxaban to Warfarin for Composite of Stroke, SEE, and All-cause Mortality [overall study period 2.5 years of median study drug exposure and 2.8 year of median follow-up]

   Compare Edoxaban to warfarin for Composite of stroke, Systemic Embolic Events, and all-cause mortality during the overall study period in the ITT analysis set.

4. Adjudicated Bleeding Events [on-treatment period 2.5 years of median study drug exposure and 2.8 year of median follow-up]

   Compare edoxaban versus warfarin for Adjudicated Bleeding Events during the on-treatment period in the Safety Analysis set. Major bleeding was adjudicated by the Clinical Events Committee (CEC) and defined based on published guidance from the International Society on Thrombosis and Haemostasis (ISTH), with minor modifications for Hgb decrease and blood transfusion requirements.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 21 years of age or older; male or female.

• Able to provide written informed consent.

• History of documented AF within the prior 12 months

• A moderate to high risk of stroke, as defined by CHADS2 index score of at least 2

Exclusion Criteria:

• Transient atrial fibrillation secondary to other reversible disorders

• Subjects with moderate or severe mitral stenosis, unresected atrial myxoma, or a mechanical heart valve

• Subjects with any contraindication for anticoagulant agents;

• Subjects with conditions associated with high risk of bleeding or have known or suspected hereditary or acquired bleeding disorders

• Females of childbearing potential including the following:

• Females with a history of tubal-ligation

• Females less than 2 years post-menopausal

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Birmingham	Alabama	United States
2		Mobile	Alabama	United States
3		Gilbert	Arizona	United States
4		Glendale	Arizona	United States
5		Lake Havasu City	Arizona	United States
6		Sierra Vista	Arizona	United States	85635
7		Tempe	Arizona	United States	85283
8		Tucson	Arizona	United States
9		Harrisburg	Arkansas	United States
10		Hot Springs	Arkansas	United States
11		Little Rock	Arkansas	United States
12		Alhambra	California	United States
13		Anaheim	California	United States
14		Burbank	California	United States
15		Chula Vista	California	United States
16		Encinitas	California	United States
17		Fountain Valley	California	United States
18		Glendale	California	United States
19		Healdsburg	California	United States
20		Lakewood	California	United States
21		Long Beach	California	United States
22		Los Alamitos	California	United States
23		Los Angeles	California	United States
24		Los Banos	California	United States
25		Mather	California	United States
26		Merced	California	United States
27		Newport Beach	California	United States
28		Oceanside	California	United States
29		Pacific Palisades	California	United States
30		Palm Springs	California	United States
31		Pismo Beach	California	United States
32		Redondo Beach	California	United States
33		Sacramento	California	United States
34		San Diego	California	United States
35		Santa Rosa	California	United States
36		Torrance	California	United States
37		Ventura	California	United States
38		Aurora	Colorado	United States
39		Colorado Springs	Colorado	United States	80904
40		Denver	Colorado	United States
41		Englewood	Colorado	United States
42		Greeley	Colorado	United States
43		Bridgeport	Connecticut	United States
44		Guilford	Connecticut	United States
45		Hamden	Connecticut	United States
46		Manchester	Connecticut	United States
47		New Haven	Connecticut	United States
48		North Haven	Connecticut	United States
49		Shelton	Connecticut	United States
50		Stamford	Connecticut	United States
51		Trumbull	Connecticut	United States
52		Newark	Delaware	United States
53		Washington	District of Columbia	United States
54		Aventura	Florida	United States
55		Chipley	Florida	United States
56		Clearwater	Florida	United States
57		Daytona Beach	Florida	United States	32114
58		Daytona Beach	Florida	United States
59		DeBary	Florida	United States
60		Deerfield Beach	Florida	United States
61		Delray Beach	Florida	United States	33484
62		Delray Beach	Florida	United States
63		Hialeah	Florida	United States
64		Hollywood	Florida	United States
65		Jacksonville Beach	Florida	United States
66		Jacksonville	Florida	United States
67		Jupiter	Florida	United States
68		Leesburg	Florida	United States	34748
69		Melbourne	Florida	United States
70		Miami	Florida	United States	33173
71		Miami	Florida	United States
72		Naples	Florida	United States
73		Orange Park	Florida	United States
74		Orlando	Florida	United States
75		Ormond Beach	Florida	United States
76		Panama City	Florida	United States
77		Pembroke Pines	Florida	United States
78		Pensacola	Florida	United States
79		Plantation	Florida	United States
80		Port Charlotte	Florida	United States
81		Rockledge	Florida	United States
82		Saint Augustine	Florida	United States
83		Saint Petersburg	Florida	United States
84		Sarasota	Florida	United States
85		Stuart	Florida	United States
86		Tamarac	Florida	United States
87		Tampa	Florida	United States
88		The Villages	Florida	United States
89		Vero Beach	Florida	United States
90		West Palm Beach	Florida	United States
91		Athens	Georgia	United States
92		Atlanta	Georgia	United States
93		Conyers	Georgia	United States	30013
94		Covington	Georgia	United States
95		Cumming	Georgia	United States
96		Savannah	Georgia	United States
97		Snellville	Georgia	United States	30039
98		Tucker	Georgia	United States
99		Watkinsville	Georgia	United States
100		Waycross	Georgia	United States
101		Woodstock	Georgia	United States	30188
102		Honolulu	Hawaii	United States
103		Boise	Idaho	United States
104		Hayden Lake	Idaho	United States
105		Bannockburn	Illinois	United States
106		Belleville	Illinois	United States	82220
107		Chicago	Illinois	United States
108		Elgin	Illinois	United States
109		Joliet	Illinois	United States
110		Libertyville	Illinois	United States
111		Maywood	Illinois	United States
112		Melrose Park	Illinois	United States
113		Oak Lawn	Illinois	United States
114		Springfield	Illinois	United States
115		Winfield	Illinois	United States
116		Bloomington	Indiana	United States
117		Munster	Indiana	United States
118		Ames	Iowa	United States
119		Council Bluffs	Iowa	United States
120		Iowa City	Iowa	United States
121		Shell Rock	Iowa	United States
122		Wichita	Kansas	United States
123		Bowling Green	Kentucky	United States
124		Campbellsville	Kentucky	United States
125		Elizabethtown	Kentucky	United States
126		Richmond	Kentucky	United States
127		Marrero	Louisiana	United States
128		West Monroe	Louisiana	United States	71291
129		West Monroe	Louisiana	United States
130		Auburn	Maine	United States
131		Biddeford	Maine	United States
132		Baltimore	Maryland	United States
133		Bel Air	Maryland	United States
134		Bethesda	Maryland	United States
135		Lexington Park	Maryland	United States
136		Rockville	Maryland	United States
137		Salisbury	Maryland	United States
138		Towson	Maryland	United States
139		Westminster	Maryland	United States
140		Ayer	Massachusetts	United States
141		Boston	Massachusetts	United States
142		Concord	Massachusetts	United States
143		East Bridgewater	Massachusetts	United States
144		Haverhill	Massachusetts	United States
145		Methuen	Massachusetts	United States
146		Worcester	Massachusetts	United States
147		Bay City	Michigan	United States
148		Benzonia	Michigan	United States
149		Chelsea	Michigan	United States
150		Commerce	Michigan	United States
151		Detroit	Michigan	United States
152		Grand Rapids	Michigan	United States
153		Interlochen	Michigan	United States
154		Kalamazoo	Michigan	United States
155		Lapeer	Michigan	United States
156		Midland	Michigan	United States
157		Rochester Hills	Michigan	United States
158		Saginaw	Michigan	United States
159		Troy	Michigan	United States
160		Warren	Michigan	United States
161		Golden Valley	Minnesota	United States
162		Minneapolis	Minnesota	United States
163		Saint Paul	Minnesota	United States
164		Biloxi	Mississippi	United States
165		Chesterfield	Missouri	United States
166		Joplin	Missouri	United States
167		Kansas City	Missouri	United States
168		Saint Charles	Missouri	United States
169		Saint Louis	Missouri	United States
170		Kalispell	Montana	United States
171		Fremont	Nebraska	United States	68025
172		Grand Island	Nebraska	United States
173		Lincoln	Nebraska	United States
174		Omaha	Nebraska	United States
175		Henderson	Nevada	United States
176		Belvidere	New Jersey	United States
177		Brick	New Jersey	United States
178		Bridgewater	New Jersey	United States
179		Browns Mills	New Jersey	United States
180		Cherry Hill	New Jersey	United States
181		Elizabeth	New Jersey	United States
182		Haddon Heights	New Jersey	United States
183		Hamilton	New Jersey	United States
184		Mine Hill	New Jersey	United States
185		Ocean City	New Jersey	United States
186		Passaic	New Jersey	United States
187		Ridgewood	New Jersey	United States
188		Somerset	New Jersey	United States
189		Toms River	New Jersey	United States
190		Albuquerque	New Mexico	United States
191		Albany	New York	United States
192		Brooklyn	New York	United States
193		Buffalo	New York	United States
194		Cortlandt Manor	New York	United States
195		Hawthorne	New York	United States
196		Jamaica	New York	United States
197		Mineola	New York	United States
198		New York	New York	United States
199		North Massapequa	New York	United States
200		Saratoga Springs	New York	United States
201		Troy	New York	United States
202		Cary	North Carolina	United States
203		Chapel Hill	North Carolina	United States
204		Charlotte	North Carolina	United States	28207
205		Greensboro	North Carolina	United States	27408
206		Mooresville	North Carolina	United States
207		Morehead City	North Carolina	United States	28557
208		Morganton	North Carolina	United States	28655
209		Morganton	North Carolina	United States
210		Oxford	North Carolina	United States
211		Pinehurst	North Carolina	United States
212		Statesville	North Carolina	United States
213		Winston-Salem	North Carolina	United States
214		Fargo	North Dakota	United States
215		Oakes	North Dakota	United States
216		Akron	Ohio	United States
217		Canal Fulton	Ohio	United States
218		Canton	Ohio	United States
219		Cincinnati	Ohio	United States
220		Cleveland	Ohio	United States
221		Columbus	Ohio	United States
222		Cuyahoga Falls	Ohio	United States
223		Dayton	Ohio	United States
224		Fairfield	Ohio	United States
225		Marion	Ohio	United States
226		Middletown	Ohio	United States
227		Pitsburg	Ohio	United States
228		Springfield	Ohio	United States	45505
229		Thornville	Ohio	United States
230		Toledo	Ohio	United States
231		Willoughby Hills	Ohio	United States
232		Bartlesville	Oklahoma	United States
233		Oklahoma City	Oklahoma	United States
234		Bend	Oregon	United States
235		Corvallis	Oregon	United States
236		Altoona	Pennsylvania	United States	16602
237		Beaver	Pennsylvania	United States
238		Chester	Pennsylvania	United States
239		Clymer	Pennsylvania	United States
240		Danville	Pennsylvania	United States
241		Doylestown	Pennsylvania	United States
242		Ephrata	Pennsylvania	United States
243		Feasterville	Pennsylvania	United States
244		Fleetwood	Pennsylvania	United States	19522
245		Greenville	Pennsylvania	United States
246		Johnstown	Pennsylvania	United States
247		Lancaster	Pennsylvania	United States
248		Lewistown	Pennsylvania	United States
249		Newport	Pennsylvania	United States
250		Norristown	Pennsylvania	United States
251		Philadelphia	Pennsylvania	United States
252		Pittsburgh	Pennsylvania	United States
253		Pottstown	Pennsylvania	United States
254		Scranton	Pennsylvania	United States
255		Sellersville	Pennsylvania	United States
256		Somerset	Pennsylvania	United States
257		State College	Pennsylvania	United States
258		Uniontown	Pennsylvania	United States
259		Wilkes-Barre	Pennsylvania	United States
260		Wynnewood	Pennsylvania	United States
261		Yardley	Pennsylvania	United States
262		Providence	Rhode Island	United States
263		Anderson	South Carolina	United States
264		Charleston	South Carolina	United States
265		Columbia	South Carolina	United States
266		Florence	South Carolina	United States
267		Greenville	South Carolina	United States
268		Greer	South Carolina	United States	29651
269		Mount Pleasant	South Carolina	United States
270		Spartanburg	South Carolina	United States	29302
271		Summerville	South Carolina	United States
272		Taylors	South Carolina	United States
273		Walterboro	South Carolina	United States
274		Rapid City	South Dakota	United States
275		Columbia	Tennessee	United States
276		Jackson	Tennessee	United States
277		Johnson City	Tennessee	United States
278		Nashville	Tennessee	United States
279		Oak Ridge	Tennessee	United States
280		Arlington	Texas	United States
281		Austin	Texas	United States
282		Carrollton	Texas	United States
283		Corsicana	Texas	United States
284		Dallas	Texas	United States
285		Fort Worth	Texas	United States
286		Georgetown	Texas	United States
287		Grapevine	Texas	United States
288		Houston	Texas	United States
289		Lubbock	Texas	United States
290		McAllen	Texas	United States
291		Odessa	Texas	United States
292		Plano	Texas	United States
293		San Antonio	Texas	United States
294		Tomball	Texas	United States
295		Wichita Falls	Texas	United States
296		Provo	Utah	United States
297		West Valley City	Utah	United States	84120
298		Danville	Virginia	United States
299		Hopewell	Virginia	United States
300		Newport News	Virginia	United States
301		Norfolk	Virginia	United States	23502
302		Richmond	Virginia	United States	23294
303		Springfield	Virginia	United States
304		Suffolk	Virginia	United States
305		Virginia Beach	Virginia	United States
306		Winchester	Virginia	United States
307		Bellevue	Washington	United States
308		Kirkland	Washington	United States
309		Renton	Washington	United States
310		Seattle	Washington	United States
311		Spokane	Washington	United States
312		Tacoma	Washington	United States
313		Clarksburg	West Virginia	United States
314		Madison	Wisconsin	United States
315		Manitowoc	Wisconsin	United States
316		Menomonee Falls	Wisconsin	United States
317		Bahia Blanca		Argentina
318		Buenos Aires		Argentina
319		Cordoba		Argentina
320		Corrientes		Argentina
321		Formosa		Argentina
322		Godoy Cruz		Argentina
323		Jujuy		Argentina
324		Mar del Plata		Argentina
325		Mendoza		Argentina
326		Paraguay		Argentina
327		Provincia De Chaco		Argentina
328		Provincia De Rio Negro		Argentina
329		Provincia De Salta		Argentina
330		San Luis		Argentina
331		Santa Fe		Argentina
332		Sante Fe		Argentina
333		Tucuman		Argentina
334		Broken Hill	New South Wales	Australia
335		East Gosford	New South Wales	Australia
336		Carina Heights	Queensland	Australia
337		Milton	Queensland	Australia
338		Adelaide	South Australia	Australia
339		Frankston	Victoria	Australia
340		Ashford		Australia
341		Camperdown		Australia
342		Elizabeth Vale		Australia
343		Joondalup		Australia
344		Melbourne		Australia
345		Parkville		Australia
346		Perth		Australia
347		Antwerpen		Belgium
348		Arlon		Belgium
349		Brugge		Belgium
350		Bruxelles		Belgium
351		Genk		Belgium
352		Hasselt		Belgium
353		Leuven		Belgium
354		Liege		Belgium
355		Mechelen		Belgium
356		Merksem		Belgium
357		Moerkerke		Belgium
358		Montegnee		Belgium
359		Mousron		Belgium
360		Torhout		Belgium
361		Veurne		Belgium
362		Wetteren		Belgium
363		Belo Horizonte		Brazil
364		Blumenau		Brazil
365		Brasilia		Brazil
366		Campina Grande do Sul		Brazil
367		Campinas		Brazil
368		Caxias do Sul		Brazil
369		Curitiba		Brazil
370		Goiania		Brazil
371		Lajeados		Brazil
372		Maceio		Brazil
373		Marilia		Brazil
374		Passo Fundo		Brazil
375		Porto Alegre		Brazil
376		Recife		Brazil
377		Ribeirao Preto		Brazil
378		Rio de Janeiro		Brazil
379		Salvador		Brazil
380		Santo Andre		Brazil
381		Sao Jose		Brazil
382		Sao Paulo		Brazil
383		Uberlandia		Brazil
384		Burgas		Bulgaria
385		Dimitrovgrad		Bulgaria
386		Haskovo		Bulgaria
387		Pleven		Bulgaria
388		Plovdiv		Bulgaria
389		Ruse		Bulgaria
390		Sofia		Bulgaria
391		Varna		Bulgaria
392		Calgary	Alberta	Canada
393		Campbell River	British Columbia	Canada
394		Chilliwack	British Columbia	Canada
395		Coquitlam	British Columbia	Canada
396		Kamloops	British Columbia	Canada
397		Kelowna	British Columbia	Canada
398		New Westminster	British Columbia	Canada
399		Penticton	British Columbia	Canada
400		Quesnel	British Columbia	Canada
401		Victoria	British Columbia	Canada
402		Saint John	New Brunswick	Canada
403		Bridgewater	Nova Scotia	Canada
404		Halifax	Nova Scotia	Canada
405		Liverpool	Nova Scotia	Canada
406		Ajax	Ontario	Canada
407		Beamsville	Ontario	Canada
408		Brampton	Ontario	Canada
409		Corunna	Ontario	Canada
410		Hamilton	Ontario	Canada
411		Kitchener	Ontario	Canada
412		Listowel	Ontario	Canada
413		London	Ontario	Canada
414		Oshawa	Ontario	Canada
415		Ottawa	Ontario	Canada
416		Richmond Hill	Ontario	Canada
417		Sarnia	Ontario	Canada
418		Scarborough	Ontario	Canada
419		Sudbury	Ontario	Canada
420		Toronto	Ontario	Canada
421		Greenfield Park	Quebec	Canada
422		Longueuil	Quebec	Canada
423		Montreal	Quebec	Canada
424		Quebec City	Quebec	Canada
425		Saint Georges De Beauce	Quebec	Canada
426		Saint-Lambert	Quebec	Canada
427		St-Charles-Borromee	Quebec	Canada
428		St.-Jerome	Quebec	Canada
429		Terrebonne	Quebec	Canada
430		Trois-Rivieres	Quebec	Canada
431		Westmount	Quebec	Canada
432		Saskatoon	Saskatchewan	Canada
433		Mount Pearl		Canada
434		Quebec		Canada
435		St. John's		Canada
436		Iquique		Chile
437		La Serena		Chile
438		Osorno		Chile
439		Puerto Montt		Chile
440		Rancagua		Chile
441		Santiago		Chile
442		Talcahuano		Chile
443		Temuco		Chile
444		Victoria		Chile
445		Vina del Mar		Chile
446		Baotou		China
447		Beijing		China
448		Changchun		China
449		Changsha		China
450		Chendu City		China
451		Chongqing		China
452		Guangxi		China
453		Guangzhou		China
454		Hainan Province		China
455		Hangzhou		China
456		Harbin		China
457		Jinzhou		China
458		Lanzhou		China
459		Liaoning Province		China
460		Nanchang		China
461		Shaanxi Province		China
462		Shanghai		China
463		Shenyang		China
464		Shijiazhuang City		China
465		Tianjin		China
466		Wenzhou		China
467		Wuhan		China
468		Antioquia		Colombia
469		Armenia		Colombia
470		Barranquilla		Colombia
471		Bogota		Colombia
472		Bucaramanga		Colombia
473		Cartagena		Colombia
474		Envigado		Colombia
475		Manizales		Colombia
476		Medellin		Colombia
477		Dubrovnik		Croatia
478		Karlovac		Croatia
479		Koprivnica		Croatia
480		Krapinski Toplice		Croatia
481		Osijek		Croatia
482		Rijeka		Croatia
483		Slavonski Brod		Croatia
484		Split		Croatia
485		Varazdin		Croatia
486		Zadar		Croatia
487		Zagreb		Croatia
488		Benatky nad Jizerou		Czechia
489		Benesov		Czechia
490		Bilovec		Czechia
491		Brno-Lesna		Czechia
492		Brno		Czechia
493		Cesky Krumlov		Czechia
494		Chrudim		Czechia
495		Havlickux Brod		Czechia
496		Hradec Kralove		Czechia
497		Hranice		Czechia
498		Jindrichuv Hradec		Czechia
499		Kolin		Czechia
500		Kromeriz		Czechia
501		Marianske Lazne		Czechia
502		Mlada Boleslav		Czechia
503		Nachod		Czechia
504		Ostrava-Trebovice		Czechia
505		Ostrava		Czechia
506		Pardubice		Czechia
507		Plzen		Czechia
508		Praha		Czechia
509		Pribram		Czechia
510		Revnice		Czechia
511		Semily		Czechia
512		Slany		Czechia
513		Teplice		Czechia
514		Trutnov		Czechia
515		Usti nad Labem		Czechia
516		Aarhus N		Denmark
517		Esbjerg		Denmark
518		Frederiksberg		Denmark
519		Glostrup		Denmark
520		Hellerup		Denmark
521		Holbaek		Denmark
522		Horsens		Denmark
523		Kobenhaven		Denmark
524		Kobenhavn		Denmark
525		Haabneeme	Harjumaa	Estonia
526		Puusepa	Tartu	Estonia
527		Parnu		Estonia
528		Tallinn		Estonia
529		Tallin		Estonia
530		Tartu		Estonia
531		Jyvaskyla		Finland
532		Kuopio		Finland
533		Lappeenranta		Finland
534		Oulu		Finland
535		Seinajoki		Finland
536		Tampere		Finland
537		Abbeville		France
538		Amiens Cedex		France
539		Brest		France
540		Cambrai		France
541		Clamart		France
542		La Roche sur Yon		France
543		Lille		France
544		Lyon Cedex		France
545		Massy		France
546		Nantes		France
547		Paris		France
548		Pau		France
549		Pessac		France
550		Poitiers		France
551		Tours Cedex		France
552		Valenciennes		France
553		Altenburg		Germany
554		Aschaffenburg		Germany
555		Augsburg		Germany
556		Bad Nauheim		Germany
557		Berlin		Germany
558		Bochum		Germany
559		Cloppenburg		Germany
560		Dortmund		Germany
561		Dresden		Germany
562		Essen		Germany
563		Frankfurt		Germany
564		Giengen		Germany
565		Goerlitz		Germany
566		Grossheirath		Germany
567		Hamburg		Germany
568		Heidelberg		Germany
569		Heilbronn		Germany
570		Homburg		Germany
571		Ingelheim		Germany
572		Kallstadt		Germany
573		Kassel		Germany
574		Kiel-Kronshagen		Germany
575		Koeln		Germany
576		Leipzig		Germany
577		Ludwigshafen		Germany
578		Luebeck		Germany
579		Magdeburg		Germany
580		Mainz		Germany
581		Mannheim		Germany
582		Markkleeberg		Germany
583		Muenchen		Germany
584		Nienburg		Germany
585		Northeinm		Germany
586		Offenbach-beiber		Germany
587		Potsdam		Germany
588		Ruedersdorf		Germany
589		Siegen		Germany
590		Stuhr		Germany
591		Ulm		Germany
592		Unterschneidheim		Germany
593		Wardenburg		Germany
594		Wermsdorf		Germany
595		Weyhe		Germany
596		Witten		Germany
597		Woerishofen		Germany
598		Wuppertal		Germany
599		Athens		Greece
600		Larissa		Greece
601		Rhodes		Greece
602		Rio-Patras		Greece
603		Thessaloniki		Greece
604		Trikala		Greece
605		Voula		Greece
606		Ciudad		Guatemala
607		Clinica		Guatemala
608		Edificio Multimedica		Guatemala
609		Nivel		Guatemala
610		Oficina		Guatemala
611		Quetzaltenango		Guatemala
612		Zacapa		Guatemala
613		Ajka		Hungary
614		Baja		Hungary
615		Bekescsaba		Hungary
616		Budapest		Hungary
617		Debrecen		Hungary
618		Hodmezovasarhely		Hungary
619		Kecskemet		Hungary
620		Keeskemet		Hungary
621		Kistarcsa		Hungary
622		Komarom		Hungary
623		Mako		Hungary
624		Nagykanizsa		Hungary
625		Nyiregyhaza		Hungary
626		Pecs		Hungary
627		Sopron		Hungary
628		Szekszard		Hungary
629		Szombathely		Hungary
630		Zalaegerszeg		Hungary
631		Hyderabad	AP	India
632		Vijayawada	AP	India
633		Angamaly	Kerala	India
634		Kochi	Kerala	India
635		Thrissur	Kerala	India
636		Ahmedabad		India
637		Anddhra Pradesh		India
638		Andhra Pradesh		India
639		Aurangabad		India
640		Bangalore		India
641		Bikaner		India
642		Chennai		India
643		Coimbatore		India
644		Delhi		India
645		Gujrat		India
646		Indore		India
647		Jaipur		India
648		Karnataka		India
649		Kerala		India
650		Kolkata		India
651		Ludhiana		India
652		Madhya Pradesh		India
653		Maharashtra		India
654		Mangalore		India
655		Mumbai		India
656		Nagpur		India
657		Nashik		India
658		New Delhi		India
659		Pune		India
660		Puni		India
661		Punjab		India
662		Rajasthan		India
663		Ramnagar		India
664		Shimoga		India
665		Surat		India
666		Trivandrum		India
667		Vadodara		India
668		Afula		Israel
669		Beer-Sheva		Israel
670		Dimona		Israel
671		Givatayim		Israel
672		Hadera		Israel
673		Haifa		Israel
674		Holon		Israel
675		Jerusalem		Israel
676		Kfar Saba		Israel
677		Nahariya		Israel
678		Nazareth		Israel
679		Petach Tikva		Israel
680		Petah-Tikva		Israel
681		Poriya		Israel
682		Raanana		Israel
683		Rehovot		Israel
684		Tel Aviv		Israel
685		Tel Hashomer		Israel
686		Zerifin		Israel
687		Bologna		Italy
688		Brescia		Italy
689		Cantania		Italy
690		Casarano		Italy
691		Caserta		Italy
692		Chieti		Italy
693		Cremona		Italy
694		Genova		Italy
695		Grosseto		Italy
696		Legnano		Italy
697		Manerbio		Italy
698		Milano		Italy
699		Monserrato		Italy
700		Napoli		Italy
701		Novara		Italy
702		Ostia		Italy
703		Pavia		Italy
704		Pisa		Italy
705		Pozzuoli		Italy
706		Roma		Italy
707		Santa Maria Capua Vetere		Italy
708		Sassari		Italy
709		Seriate		Italy
710		Siena		Italy
711		Trieste		Italy
712		Venezia Mestre		Italy
713		Kyoto-shi	Kyoto	Japan
714		Lida-shi	Nagano	Japan
715		Ueda-shi	Nagano	Japan
716		Minato-ku	Tokyo	Japan
717		Aichi		Japan
718		Aomori		Japan
719		Chiaki		Japan
720		Chiba		Japan
721		Ehime		Japan
722		Fukuoka		Japan
723		Fukushima		Japan
724		Gifu		Japan
725		Gunma		Japan
726		Hiroshima		Japan
727		Hokkai-do		Japan
728		Hokkaido		Japan
729		Hyogo		Japan
730		Ibaraki		Japan
731		Isesaki-shi		Japan
732		Ishikawa		Japan
733		Iwate		Japan
734		Kagawa		Japan
735		Kanagawa		Japan
736		Kumamoto		Japan
737		Kyota		Japan
738		Mie		Japan
739		Miyagi		Japan
740		Nagaoka-shi		Japan
741		Nagasaki		Japan
742		Niigata		Japan
743		Okayama		Japan
744		Osaka		Japan
745		Saitama		Japan
746		Shimane		Japan
747		Shizuoka		Japan
748		Tokushima		Japan
749		Tokyo		Japan
750		Yamaguchi		Japan
751		Yokohama-shi		Japan
752		Busan		Korea, Republic of
753		Daegu		Korea, Republic of
754		Daejeon		Korea, Republic of
755		Gangwon-do		Korea, Republic of
756		Gwangju-si		Korea, Republic of
757		Gyeonggi-do		Korea, Republic of
758		Incheon		Korea, Republic of
759		Pusan		Korea, Republic of
760		Seoul		Korea, Republic of
761		Guadalajara	Jalisco	Mexico
762		Xalapa	Veracruz	Mexico
763		Aguascalientes		Mexico
764		Chihuahua		Mexico
765		Distrito Federal		Mexico
766		Durango		Mexico
767		Monterrey		Mexico
768		San Luis Potosi		Mexico
769		Yucatan		Mexico
770		Almere		Netherlands
771		Amstelveen		Netherlands
772		Amsterdam		Netherlands
773		Dordrecht		Netherlands
774		Eindhoven		Netherlands
775		Ewijk		Netherlands
776		Leiderdorp		Netherlands
777		Maastricht		Netherlands
778		Rotterdam		Netherlands
779		Venlo		Netherlands
780		Wildervlank		Netherlands
781		Lower Hutt	Wellington	New Zealand
782		Auckland		New Zealand
783		Christchurch		New Zealand
784		Dunedin		New Zealand
785		Hamilton		New Zealand
786		Nelson		New Zealand
787		Tauranga		New Zealand
788		Bodo		Norway
789		Harstad		Norway
790		Haugesund		Norway
791		Oslo		Norway
792		Rud		Norway
793		Arequipa		Peru
794		Callao		Peru
795		Lima		Peru
796		Cebu City		Philippines
797		Cebu		Philippines
798		Davao City		Philippines
799		Pasig City		Philippines
800		Quezon City		Philippines
801		Ostrow	Mazowiecka	Poland
802		Bydgoszcz		Poland
803		Chojnice		Poland
804		Elblag		Poland
805		Elk		Poland
806		Gdansk		Poland
807		Inowroclaw		Poland
808		Jaroslaw		Poland
809		Katowice		Poland
810		Kolobrzeg		Poland
811		Komenskiego		Poland
812		Krakow		Poland
813		Kutno		Poland
814		Libiaz		Poland
815		Lodz		Poland
816		Lubartow		Poland
817		Lublin		Poland
818		Plock		Poland
819		Pomorskie		Poland
820		Pulawy		Poland
821		Ruda Slaska		Poland
822		Rzeszow		Poland
823		Skierniewice		Poland
824		Sopot		Poland
825		Sucharskiego		Poland
826		Szczecin		Poland
827		Tarnow		Poland
828		Torun		Poland
829		Warszawa		Poland
830		Warzawa		Poland
831		Wroclaw		Poland
832		Amadora		Portugal
833		Aveiro		Portugal
834		Braga		Portugal
835		Coimbra		Portugal
836		Leiria		Portugal
837		Lisboa		Portugal
838		Lisbon		Portugal
839		Ponta Delgada		Portugal
840		Setubal		Portugal
841		Viseu		Portugal
842		Bacau		Romania
843		Braila		Romania
844		Brasov		Romania
845		Buccuresti		Romania
846		Bucuresti		Romania
847		Buzau		Romania
848		Covasna		Romania
849		Dambovita		Romania
850		Iasi		Romania
851		Judetul Maramures		Romania
852		Judetul Mures		Romania
853		Judetul Suceava		Romania
854		Judetul Vrancea		Romania
855		Oradea		Romania
856		Timisoara		Romania
857		Barnaul		Russian Federation
858		Chelyabinsk		Russian Federation
859		Kemerovo		Russian Federation
860		Krasnoyarsk		Russian Federation
861		Moscow		Russian Federation
862		Nizhny Novgorod		Russian Federation
863		Novosibirsk		Russian Federation
864		Omsk		Russian Federation
865		Orenburg		Russian Federation
866		Perm		Russian Federation
867		Ryazan		Russian Federation
868		Saratov		Russian Federation
869		Smolensk		Russian Federation
870		St-Petersburg		Russian Federation
871		St. Petersburg		Russian Federation
872		Tula		Russian Federation
873		Tyumen		Russian Federation
874		Volgograd		Russian Federation
875		Voronezh		Russian Federation
876		Yaroslavl		Russian Federation
877		Belgrade		Serbia
878		Niska Banja		Serbia
879		Nis		Serbia
880		Sremska Kamenica		Serbia
881		Zemun		Serbia
882		Zmaj Jovina		Serbia
883		Bardejov		Slovakia
884		Bratislava		Slovakia
885		Dolny Kubin		Slovakia
886		Galanta		Slovakia
887		Kosice		Slovakia
888		Levice		Slovakia
889		Lucenec		Slovakia
890		Nitra		Slovakia
891		Nove Zamky		Slovakia
892		Presov		Slovakia
893		Rimavska Sobota		Slovakia
894		Alberton		South Africa
895		Benoni		South Africa
896		Bloemfontein		South Africa
897		Cape Town		South Africa
898		Diepkloof		South Africa
899		Durban		South Africa
900		Lyttelton		South Africa
901		Parktown West		South Africa
902		Port Elizabeth		South Africa
903		Potchefstroom		South Africa
904		Pretoria		South Africa
905		Somerset West		South Africa
906		Worcester		South Africa
907		Alcoy		Spain
908		Almeria		Spain
909		Barcelona		Spain
910		Bilbao		Spain
911		De La Castellana		Spain
912		Donostia-San Sebastian		Spain
913		Figueras		Spain
914		Jaen		Spain
915		La Coruna		Spain
916		Lleida		Spain
917		Madrid		Spain
918		Murcia		Spain
919		Santiago De Compostela		Spain
920		Sevilla		Spain
921		Vigo		Spain
922		Vitoria		Spain
923		Alingsas		Sweden
924		Enkoping		Sweden
925		Goteborg		Sweden
926		Halmstad		Sweden
927		Karlshamn		Sweden
928		Koping		Sweden
929		Lindesberg		Sweden
930		Lulea		Sweden
931		Lund		Sweden
932		Malmo		Sweden
933		Molndal		Sweden
934		Mora		Sweden
935		Orebro		Sweden
936		Skene		Sweden
937		Umea		Sweden
938		Uppsala		Sweden
939		Varberg		Sweden
940		Lausanne		Switzerland
941		Lugano		Switzerland
942		Changhua City		Taiwan
943		Hualien City		Taiwan
944		Kaohsiung City		Taiwan
945		Taichung City		Taiwan
946		Taipei City		Taiwan
947		Taipei		Taiwan
948		Taoyuan County		Taiwan
949		Yongkang City		Taiwan
950		Bangkok		Thailand
951		Chang Mai		Thailand
952		Khon Kaen		Thailand
953		Nakhon Ratchasima		Thailand
954		Pathumthani		Thailand
955		Sai Mai		Thailand
956		Songkhla		Thailand
957		Adana		Turkey
958		Ankara		Turkey
959		Antalya		Turkey
960		Aydin		Turkey
961		Erzurum		Turkey
962		Eskisehir		Turkey
963		Isparta		Turkey
964		Istanbul		Turkey
965		Izmir		Turkey
966		Konya		Turkey
967		Sivas		Turkey
968		Cherkasy		Ukraine
969		Chernigiv		Ukraine
970		Dnipropetrovsk		Ukraine
971		Donetsk		Ukraine
972		Ivano-Frankivsh		Ukraine
973		Ivano-Frankivsk		Ukraine
974		Kharkiv		Ukraine
975		Kherson		Ukraine
976		Kyiv		Ukraine
977		Lugansk		Ukraine
978		Lutsk		Ukraine
979		Lviv		Ukraine
980		Mykolayiv		Ukraine
981		Odesa		Ukraine
982		Poltava		Ukraine
983		Uzhgorod		Ukraine
984		Vinnytsya		Ukraine
985		Zaporizhzhya		Ukraine
986		Birmingham		United Kingdom
987		Blackpool		United Kingdom
988		Bournemouth		United Kingdom
989		Bradford		United Kingdom
990		Cambridge		United Kingdom
991		Chesterfield		United Kingdom
992		Coventry		United Kingdom
993		Devon		United Kingdom
994		Dundee		United Kingdom
995		East Horsley		United Kingdom
996		East Sussex		United Kingdom
997		Edinburgh		United Kingdom
998		Essex		United Kingdom
999		Glasgow		United Kingdom
1000		Harrow		United Kingdom
1001		Leicester		United Kingdom
1002		Liverpool		United Kingdom
1003		London		United Kingdom
1004		Middlesbrough		United Kingdom
1005		Orpington		United Kingdom
1006		Peterborough		United Kingdom
1007		Portadown		United Kingdom
1008		Sheffield		United Kingdom
1009		Stirling		United Kingdom
1010		Stockport		United Kingdom
1011		Surrey		United Kingdom
1012		Sutton Coldfield		United Kingdom
1013		Swindon		United Kingdom
1014		Warwickshire		United Kingdom
1015		Wolverhampton		United Kingdom
1016		York		United Kingdom

Sponsors and Collaborators

• Daiichi Sankyo, Inc.
• The TIMI Study Group

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Daiichi Sankyo, Inc.
• ClinicalTrials.gov Identifier: NCT00781391
• Other Study ID Numbers: DU176b-C-U301
• First Posted: Oct 29, 2008
• Last Update Posted: Mar 5, 2019
• Last Verified: Mar 1, 2015

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by Daiichi Sankyo, Inc.: Systemic embolic events
• Additional relevant MeSH terms: Atrial Fibrillation; Embolism; Warfarin; Edoxaban

Study Results

Participant Flow

Arm/Group Title	Warfarin/Placebo Edoxaban	High Dose Edoxaban/Placebo Warfarin	Low Dose Edoxaban/Placebo Warfarin
Arm/Group Description	Warfarin tablets plus placebo Edoxaban tablets warfarin tablets: Warfarin tablets plus Edoxaban placebo tablets each taken once daily for 24 months placebo edoxaban: placebo edoxaban	Edoxaban tablets plus warfarin placebo tablets 60mg Edoxaban tablets (high dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months placebo warfarin: placebo warfarin	Edoxaban tablets plus warfarin placebo tablets 30mg Edoxaban tablets (low dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months placebo warfarin: placebo warfarin
Period Title: Overall Study
STARTED	7036	7035	7034
Safety Analysis Set (Received Drug)	7012	7012	7002
mITT Analysis Set (Received Drug)	7012	7012	7002
Per Protocol Analysis Set	6993	6995	6982
COMPLETED	6157	6228	6250
NOT COMPLETED	879	807	784

Baseline Characteristics

Arm/Group Title	Warfarin/Placebo Edoxaban	High Dose Edoxaban/Placebo Warfarin	Low Dose Edoxaban/Placebo Warfarin	Total
Arm/Group Description	Warfarin tablets plus placebo Edoxaban tablets warfarin tablets: Warfarin tablets plus Edoxaban placebo tablets each taken once daily for 24 months placebo edoxaban: placebo edoxaban	Edoxaban tablets plus warfarin placebo tablets 60mg Edoxaban tablets (high dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months placebo warfarin: placebo warfarin	Edoxaban tablets plus warfarin placebo tablets 30mg Edoxaban tablets (low dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months placebo warfarin: placebo warfarin	Total of all reporting groups
Overall Participants	7012	7012	7002	21026
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	1869 26.7%	1830 26.1%	1784 25.5%	5483 26.1%
>=65 years	5143 73.3%	5182 73.9%	5218 74.5%	15543 73.9%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	70.5 (9.44)	70.6 (9.51)	70.6 (9.31)	70.6 (9.42)
Sex: Female, Male (Count of Participants)
Female	2629 37.5%	2659 37.9%	2718 38.8%	8006 38.1%
Male	4383 62.5%	4353 62.1%	4284 61.2%	13020 61.9%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%
Asian	963 13.7%	956 13.6%	975 13.9%	2894 13.8%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%
Black or African American	88 1.3%	96 1.4%	94 1.3%	278 1.3%
White	5679 81%	5679 81%	5650 80.7%	17008 80.9%
More than one race	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	282 4%	281 4%	283 4%	846 4%
Region of Enrollment (participants) [Number]
Portugal	46 0.7%	71 1%	61 0.9%	178 0.8%
United States	1297 18.5%	1288 18.4%	1308 18.7%	3893 18.5%
Serbia	95 1.4%	107 1.5%	74 1.1%	276 1.3%
Philippines	43 0.6%	36 0.5%	45 0.6%	124 0.6%
Estonia	76 1.1%	55 0.8%	60 0.9%	191 0.9%
Taiwan	77 1.1%	72 1%	85 1.2%	234 1.1%
Slovakia	143 2%	133 1.9%	129 1.8%	405 1.9%
Greece	14 0.2%	27 0.4%	9 0.1%	50 0.2%
Spain	44 0.6%	65 0.9%	54 0.8%	163 0.8%
Thailand	40 0.6%	40 0.6%	33 0.5%	113 0.5%
Ukraine	360 5.1%	386 5.5%	402 5.7%	1148 5.5%
Israel	104 1.5%	88 1.3%	88 1.3%	280 1.3%
Chile	74 1.1%	91 1.3%	88 1.3%	253 1.2%
Russian Federation	375 5.3%	406 5.8%	369 5.3%	1150 5.5%
Colombia	51 0.7%	42 0.6%	48 0.7%	141 0.7%
Switzerland	0 0%	1 0%	4 0.1%	5 0%
Italy	60 0.9%	55 0.8%	54 0.8%	169 0.8%
India	232 3.3%	220 3.1%	234 3.3%	686 3.3%
France	40 0.6%	38 0.5%	32 0.5%	110 0.5%
Peru	64 0.9%	46 0.7%	60 0.9%	170 0.8%
Denmark	68 1%	80 1.1%	70 1%	218 1%
Australia	30 0.4%	40 0.6%	32 0.5%	102 0.5%
South Africa	97 1.4%	92 1.3%	90 1.3%	279 1.3%
Netherlands	64 0.9%	49 0.7%	40 0.6%	153 0.7%
China	163 2.3%	150 2.1%	152 2.2%	465 2.2%
Korea, Republic of	64 0.9%	84 1.2%	78 1.1%	226 1.1%
Finland	9 0.1%	18 0.3%	15 0.2%	42 0.2%
Guatemala	48 0.7%	48 0.7%	39 0.6%	135 0.6%
Turkey	40 0.6%	39 0.6%	31 0.4%	110 0.5%
United Kingdom	132 1.9%	121 1.7%	145 2.1%	398 1.9%
Hungary	151 2.2%	143 2%	167 2.4%	461 2.2%
Czech Republic	410 5.8%	369 5.3%	386 5.5%	1165 5.5%
Mexico	60 0.9%	70 1%	60 0.9%	190 0.9%
Canada	259 3.7%	271 3.9%	242 3.5%	772 3.7%
Argentina	352 5%	345 4.9%	362 5.2%	1059 5%
Brazil	236 3.4%	242 3.5%	225 3.2%	703 3.3%
Belgium	41 0.6%	44 0.6%	64 0.9%	149 0.7%
Poland	395 5.6%	424 6%	454 6.5%	1273 6.1%
Croatia	53 0.8%	33 0.5%	39 0.6%	125 0.6%
Romania	141 2%	144 2.1%	124 1.8%	409 1.9%
Bulgaria	179 2.6%	174 2.5%	165 2.4%	518 2.5%
Norway	11 0.2%	8 0.1%	15 0.2%	34 0.2%
Germany	308 4.4%	293 4.2%	307 4.4%	908 4.3%
Japan	337 4.8%	336 4.8%	337 4.8%	1010 4.8%
New Zealand	40 0.6%	50 0.7%	40 0.6%	130 0.6%
Sweden	89 1.3%	78 1.1%	86 1.2%	253 1.2%

Outcome Measures

1. Primary Outcome

Title	Compare Edoxaban to Warfarin for Composite of Stroke and Systemic Embolic Events (SEE).
Description	The composite of stroke and Systemic Embolic Events (SEE) during the on treatment period in the mITT analysis population with a non-inferiority analysis.
Time Frame	on-treatment period 2.5 years of median study drug exposure and 2.8 year of median follow-up

Outcome Measure Data

Analysis Population Description

mITT (modified Intent To Treat) Analysis set; which included randomized subjects who received 1 or more dose of study drug. The time period included the subject was taking study drug and up to 3 days after their last dose (On-Treatment ).

Arm/Group Title	Low Dose Edoxaban/Placebo Warfarin	High Dose Edoxaban/Placebo Warfarin	Warfarin/Placebo Edoxaban
Arm/Group Description	Edoxaban tablets plus warfarin placebo tablets 30mg Edoxaban tablets (low dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months placebo warfarin: placebo warfarin	Edoxaban tablets plus warfarin placebo tablets 60mg Edoxaban tablets (high dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months placebo warfarin: placebo warfarin	Warfarin tablets plus placebo Edoxaban tablets warfarin tablets: Warfarin tablets plus Edoxaban placebo tablets each taken once daily for 24 months placebo edoxaban: placebo edoxaban
Measure Participants	7002	7012	7012
Number [number of participants with event]	253 3.6%	182 2.6%	232 3.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	High Dose Edoxaban/Placebo Warfarin, Warfarin/Placebo Edoxaban
	Comments	The primary efficacy endpoint, time to the first occurrence of stroke/SEE, was first compared concurrently between each of the 2 edoxaban groups and warfarin group using the mITT Analysis Set in the on-treatment period for non-inferiority. In order to control the study-wise type-I error rate of two-sided α=0.05 for non-inferiority, each of these 2 comparisons were performed at the statistical significance level of two-sided α=0.025, respectively.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	The non-inferiority analysis included the mITT and PP analysis sets for both the on treatment and overall study period, although mITT on-treatment was considered primary
Statistical Test of Hypothesis	p-Value	<.0001
	Comments	Two stratification factor covariates: 1) CHADS2 score 2) dose-adjustment factor. If upper limit of CI of HR was below 1.38, then non-inferiority to warfarin was established for group.
	Method	Cox proportional hazards model
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.79
	Confidence Interval	(2-Sided) 97.5%; .632 to .985
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Low Dose Edoxaban/Placebo Warfarin, Warfarin/Placebo Edoxaban
	Comments	The primary efficacy endpoint, time to the first occurrence of stroke/SEE, was first compared concurrently between each of the 2 edoxaban groups and warfarin group using the mITT Analysis Set in the on-treatment period for non-inferiority. In order to control the study-wise type-I error rate of two-sided α=0.05 for non-inferiority, each of these 2 comparisons were performed at the statistical significance level of two-sided α=0.025, respectively.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	The non-inferiority analysis included the mITT and PP analysis sets for both the on treatment and overall study period, although mITT on-treatment was considered primary
Statistical Test of Hypothesis	p-Value	.0055
	Comments	Two stratification factor covariates: 1) CHADS2 score 2) dose-adjustment factor. If upper limit of CI of HR was below 1.38, then non-inferiority to warfarin was established for group.
	Method	Cox proportional hazards model
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.07
	Confidence Interval	(2-Sided) 97.5%; .874 to 1.314
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Primary Outcome

Title	Compare Edoxaban to Warfarin for Composite of Stroke and Systemic Embolic Events (SEE).
Description	The composite of stroke and Systemic Embolic Events (SEE) during the overall study period in the mITT analysis population.
Time Frame	overall study period 2.5 years of median study drug exposure and 2.8 year of median follow-up

Outcome Measure Data

Analysis Population Description

mITT (modified Intent To Treat) Analysis set; which included randomized subjects who received 1 or more dose of study drug. The time frame included overall study period (first dose to end of study).

Arm/Group Title	Low Dose Edoxaban/Placebo Warfarin	High Dose Edoxaban/Placebo Warfarin	Warfarin/Placebo Edoxaban
Arm/Group Description	Edoxaban tablets plus warfarin placebo tablets 30mg Edoxaban tablets (low dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months placebo warfarin: placebo warfarin	Edoxaban tablets plus warfarin placebo tablets 60mg Edoxaban tablets (high dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months placebo warfarin: placebo warfarin	Warfarin tablets plus placebo Edoxaban tablets warfarin tablets: Warfarin tablets plus Edoxaban placebo tablets each taken once daily for 24 months placebo edoxaban: placebo edoxaban
Measure Participants	7002	7012	7012
Number [Number of participants with event]	382 5.4%	292 4.2%	336 4.8%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	High Dose Edoxaban/Placebo Warfarin, Warfarin/Placebo Edoxaban
	Comments	Non-inferiority or equivalence analysis; Non-inferiority analysis. The non-inferiority analysis included the mITT and PP analysis sets for both the on treatment and overall study period, although mITT on-treatment was considered primary.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	If the upper limit of this CI of the hazard ratio was below 1.38, then non-inferiority to warfarin was considered established for the edoxaban treatment group.
Statistical Test of Hypothesis	p-Value	<.0001
	Comments
	Method	Cox proportional hazards model
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	.86
	Confidence Interval	(2-Sided) 97.5%; .719 to 1.029
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Low Dose Edoxaban/Placebo Warfarin, Warfarin/Placebo Edoxaban
	Comments	Non-inferiority or equivalence analysis; Non-inferiority analysis. The non-inferiority analysis included the mITT and PP analysis sets for both the on treatment and overall study period, although mITT on-treatment was considered primary.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	If the upper limit of this CI of the hazard ratio was below 1.38, then non-inferiority to warfarin was considered established for the edoxaban treatment group.
Statistical Test of Hypothesis	p-Value	.0074
	Comments
	Method	Cox proportional hazards model
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.13
	Confidence Interval	(2-Sided) 97.5%; .955 to 1.336
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Primary Outcome

Title	Compare Edoxaban to Warfarin for Composite of Stroke and Systemic Embolic Events (SEE).
Description	The composite of stroke and Systemic Embolic Events (SEE) during the on treatment period in the PP (per protocol) analysis set population.
Time Frame	on-treatment period 2.5 years of median study drug exposure and 2.8 year of median follow-up

Outcome Measure Data

Analysis Population Description

PP (Per Protocol) Analysis set; which included all randomized subjects who received at least 1 dose of randomized study drug and did not have any major protocol violations. The time period included the time the subject was taking study drug and up to 3 days after their last dose (On Treatment Period).

Arm/Group Title	Low Dose Edoxaban/Placebo Warfarin	High Dose Edoxaban/Placebo Warfarin	Warfarin/Placebo Edoxaban
Arm/Group Description	Edoxaban tablets plus warfarin placebo tablets 30mg Edoxaban tablets (low dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months placebo warfarin: placebo warfarin	Edoxaban tablets plus warfarin placebo tablets 60mg Edoxaban tablets (high dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months placebo warfarin: placebo warfarin	Warfarin tablets plus placebo Edoxaban tablets warfarin tablets: Warfarin tablets plus Edoxaban placebo tablets each taken once daily for 24 months placebo edoxaban: placebo edoxaban
Measure Participants	6982	6995	6996
Number [number of participants with event]	253 3.6%	182 2.6%	231 3.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	High Dose Edoxaban/Placebo Warfarin, Warfarin/Placebo Edoxaban
	Comments	The non-inferiority analysis included the mITT and PP analysis sets for both the on treatment and overall study period, although mITT on-treatment was considered primary.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	The primary efficacy endpoint, time to the first occurrence of stroke/SEE, was first compared concurrently between each of the 2 edoxaban groups and warfarin group using the mITT Analysis Set in the on-treatment period for non-inferiority. In order to control the study-wise type-I error rate of two-sided α=0.05 for non-inferiority, each of these 2 comparisons were performed at the statistical significance level of two-sided α=0.025, respectively
Statistical Test of Hypothesis	p-Value	<.0001
	Comments
	Method	Cox proportional hazards model
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.79
	Confidence Interval	(2-Sided) 97.5%; .634 to .989
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Low Dose Edoxaban/Placebo Warfarin, Warfarin/Placebo Edoxaban
	Comments	The non-inferiority analysis included the mITT and PP analysis sets for both the on treatment and overall study period, although mITT on-treatment was considered primary.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	The primary efficacy endpoint, time to the first occurrence of stroke/SEE, was first compared concurrently between each of the 2 edoxaban groups and warfarin group using the mITT Analysis Set in the on-treatment period for non-inferiority. In order to control the study-wise type-I error rate of two-sided α=0.05 for non-inferiority, each of these 2 comparisons were performed at the statistical significance level of two-sided α=0.025, respectively.
Statistical Test of Hypothesis	p-Value	.0064
	Comments
	Method	Cox proportional hazards model
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.08
	Confidence Interval	(2-Sided) 97.5%; .878 to 1.32
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Primary Outcome

Title	Compare Edoxaban to Warfarin for Composite of Stroke and Systemic Embolic Events (SEE).
Description	The composite of stroke and Systemic Embolic Events (SEE) during the overall study period in the PP (per protocol) analysis set population.
Time Frame	overall study period 2.5 years of median study drug exposure and 2.8 year of median follow-up

Outcome Measure Data

Analysis Population Description

PP (per Protocol) Analysis set; which included all randomized subjects who received 1 or more dose of study drug for the overall study period (first dose to end of study) and did not have any major protocol violations. The time period included from the reference date (initial dose of study drug date) to the common study end date (CSED) Visit.

Arm/Group Title	Low Dose Edoxaban/Placebo Warfarin	High Dose Edoxaban/Placebo Warfarin	Warfarin/Placebo Edoxaban
Arm/Group Description	Edoxaban tablets plus warfarin placebo tablets 30mg Edoxaban tablets (low dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months placebo warfarin: placebo warfarin	Edoxaban tablets plus warfarin placebo tablets 60mg Edoxaban tablets (high dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months placebo warfarin: placebo warfarin	Warfarin tablets plus placebo Edoxaban tablets warfarin tablets: Warfarin tablets plus Edoxaban placebo tablets each taken once daily for 24 months placebo edoxaban: placebo edoxaban
Measure Participants	6982	6995	6993
Number [number of participants with event]	382 5.4%	292 4.2%	335 4.8%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	High Dose Edoxaban/Placebo Warfarin, Warfarin/Placebo Edoxaban
	Comments	The non-inferiority analysis included the mITT and PP analysis sets for both the on-treatment and overall study period, although mITT on-treatment was considered primary.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	In order to control the study-wise type-I error rate of two-sided α=0.05 for non-inferiority, each of these 2 comparisons were performed at the statistical significance level of two-sided α=0.025, respectively. If the upper limit of this CI of the hazard ratio was below 1.38, then non-inferiority to warfarin was considered established for the edoxaban treatment group.
Statistical Test of Hypothesis	p-Value	<.0001
	Comments
	Method	Cox proportional hazards model
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	.86
	Confidence Interval	(2-Sided) 97.5%; .720 to 1.032
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Low Dose Edoxaban/Placebo Warfarin, Warfarin/Placebo Edoxaban
	Comments	The non-inferiority analysis included the mITT and PP analysis sets for both the on-treatment and overall study period, although mITT on-treatment was considered primary.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	In order to control the study-wise type-I error rate of two-sided α=0.05 for non-inferiority, each of these 2 comparisons were performed at the statistical significance level of two-sided α=0.025, respectively. If the upper limit of this CI of the hazard ratio was below 1.38, then non-inferiority to warfarin was considered established for the edoxaban treatment group.
Statistical Test of Hypothesis	p-Value	.0084
	Comments
	Method	Cox proportional hazards model
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.13
	Confidence Interval	(2-Sided) 97.5%; .958 to 1.34
	Parameter Dispersion	Type: Value:
	Estimation Comments

5. Primary Outcome

Title	Compare Edoxaban to Warfarin for Superiority for Composite of Stroke and Systemic Embolic Events (SEE).
Description	Compare edoxaban to warfarin for the composite of stroke and Systemic Embolic Events (SEE) during the overall study period in the ITT analysis set with a superiority analysis.
Time Frame	overall study period 2.5 years of median study drug exposure and 2.8 year of median follow-up

Outcome Measure Data

Analysis Population Description

ITT (Intent To Treat) Analysis set; which included all randomized subjects whether or not they received a single dose of randomized study drug. The time frame included from reference date (randomization date) to the common study end date (CSED) Visit.

Arm/Group Title	Low Dose Edoxaban/Placebo Warfarin	High Dose Edoxaban/Placebo Warfarin	Warfarin/Placebo Edoxaban
Arm/Group Description	Edoxaban tablets plus warfarin placebo tablets 30mg Edoxaban tablets (low dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months placebo warfarin: placebo warfarin	Edoxaban tablets plus warfarin placebo tablets 60mg Edoxaban tablets (high dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months placebo warfarin: placebo warfarin	Warfarin tablets plus placebo Edoxaban tablets warfarin tablets: Warfarin tablets plus Edoxaban placebo tablets each taken once daily for 24 months placebo edoxaban: placebo edoxaban
Measure Participants	7034	7035	7036
Number [number of participants with event]	383 5.5%	296 4.2%	337 4.8%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	High Dose Edoxaban/Placebo Warfarin, Warfarin/Placebo Edoxaban
	Comments	The superiority analysis included the ITT analysis set
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.081
	Comments
	Method	Log Rank
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.87
	Confidence Interval	(2-Sided) 99%; .709 to 1.068
	Parameter Dispersion	Type: Value:
	Estimation Comments

6. Secondary Outcome

Title	Compare Edoxaban to Warfarin for Composite of Stroke, Systemic Embolic Event (SEE), and Cardiovascular (CV) Mortality
Description	Compare edoxaban to warfarin for the composite of stroke, Systemic Embolic Events, and Cardiovascular mortality during the overall study period in the ITT analysis set.
Time Frame	overall study period 2.5 years of median study drug exposure and 2.8 year of median follow-up

Outcome Measure Data

Analysis Population Description

ITT (Intent To Treat) Analysis set; overall study period, which included all randomized subjects whether or not they received a single dose of randomized study drug. The time frame included from reference date (randomization date) to the common study end date (CSED) Visit..

Arm/Group Title	Low Dose Edoxaban/Placebo Warfarin	High Dose Edoxaban/Placebo Warfarin	Warfarin/Placebo Edoxaban
Arm/Group Description	Edoxaban tablets plus warfarin placebo tablets 30mg Edoxaban tablets (low dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months placebo warfarin: placebo warfarin	Edoxaban tablets plus warfarin placebo tablets 60mg Edoxaban tablets (high dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months placebo warfarin: placebo warfarin	Warfarin tablets plus placebo Edoxaban tablets warfarin tablets: Warfarin tablets plus Edoxaban placebo tablets each taken once daily for 24 months placebo edoxaban: placebo edoxaban
Measure Participants	7034	7035	7036
Number [number of participants with event]	796 11.4%	728 10.4%	831 11.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	High Dose Edoxaban/Placebo Warfarin, Warfarin/Placebo Edoxaban
	Comments	the time to first event was estimated by a KM estimate and was compared between the edoxaban 60 mg group and the warfarin group using a log-rank test at a pairwise comparison significance level of α=0.01.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.0053
	Comments
	Method	Log Rank
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	.87
	Confidence Interval	(2-Sided) 95%; .786 to .959
	Parameter Dispersion	Type: Value:
	Estimation Comments

7. Secondary Outcome

Title	Compare Edoxaban to Warfarin for Major Adverse Cardiac Event (MACE): a Composite of Non-fatal MI, Non-fatal Stroke, Non-fatal SEE, and Death Due to CV Cause or Bleeding
Description	Compare edoxaban to warfarin for Major Adverse Cardiac Event (MACE): a composite of non-fatal Myocardial Infarction, non-fatal stroke, non-fatal Systemic Embolic Events, and death due to Cardiovascular cause or bleeding during the overall study period in the ITT analysis set.
Time Frame	overall study period 2.5 years of median study drug exposure and 2.8 year of median follow-up

Outcome Measure Data

Analysis Population Description

ITT overall study period, which included all randomized subjects whether or not they received a single dose of randomized study drug. The time frame included from the reference date (randomization date) to the common study end date (CSED) Visit.

Arm/Group Title	Low Dose Edoxaban/Placebo Warfarin	High Dose Edoxaban/Placebo Warfarin	Warfarin/Placebo Edoxaban
Arm/Group Description	Edoxaban tablets plus warfarin placebo tablets 30mg Edoxaban tablets (low dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months placebo warfarin: placebo warfarin	Edoxaban tablets plus warfarin placebo tablets 60mg Edoxaban tablets (high dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months placebo warfarin: placebo warfarin	Warfarin tablets plus placebo Edoxaban tablets warfarin tablets: Warfarin tablets plus Edoxaban placebo tablets each taken once daily for 24 months placebo edoxaban: placebo edoxaban
Measure Participants	7034	7035	7036
Number [number of participants with event]	913 13%	827 11.8%	926 13.2%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	High Dose Edoxaban/Placebo Warfarin, Warfarin/Placebo Edoxaban
	Comments	the time to first event was estimated by a KM estimate and was compared between the edoxaban 60 mg group and the warfarin group using a log-rank test at a pairwise comparison significance level of α=0.01.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.0109
	Comments
	Method	Log Rank
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	.89
	Confidence Interval	(2-Sided) 95%; .806 to .972
	Parameter Dispersion	Type: Value:
	Estimation Comments

8. Secondary Outcome

Title	Compare Edoxaban to Warfarin for Composite of Stroke, SEE, and All-cause Mortality
Description	Compare Edoxaban to warfarin for Composite of stroke, Systemic Embolic Events, and all-cause mortality during the overall study period in the ITT analysis set.
Time Frame	overall study period 2.5 years of median study drug exposure and 2.8 year of median follow-up

Outcome Measure Data

Analysis Population Description

ITT overall study period, which included all randomized subjects whether or not they received a single dose of randomized study drug. The time frame included from the reference date (randomization date) to the common study end date (CSED) Visit.

Arm/Group Title	Low Dose Edoxaban/Placebo Warfarin	High Dose Edoxaban/Placebo Warfarin	Warfarin/Placebo Edoxaban
Arm/Group Description	Edoxaban tablets plus warfarin placebo tablets 30mg Edoxaban tablets (low dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months placebo warfarin: placebo warfarin	Edoxaban tablets plus warfarin placebo tablets 60mg Edoxaban tablets (high dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months placebo warfarin: placebo warfarin	Warfarin tablets plus placebo Edoxaban tablets warfarin tablets: Warfarin tablets plus Edoxaban placebo tablets each taken once daily for 24 months placebo edoxaban: placebo edoxaban
Measure Participants	7034	7035	7036
Number [number of participants with event]	985 14%	949 13.5%	1046 14.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	High Dose Edoxaban/Placebo Warfarin, Warfarin/Placebo Edoxaban
	Comments	the time to first event was estimated by a KM estimate and was compared between the edoxaban 60 mg group and the warfarin group using a log-rank test at a pairwise comparison significance level of α=0.01.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.0168
	Comments
	Method	Log Rank
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	.90
	Confidence Interval	(2-Sided) 95%; .823 to .981
	Parameter Dispersion	Type: Value:
	Estimation Comments

9. Secondary Outcome

Title	Adjudicated Bleeding Events
Description	Compare edoxaban versus warfarin for Adjudicated Bleeding Events during the on-treatment period in the Safety Analysis set. Major bleeding was adjudicated by the Clinical Events Committee (CEC) and defined based on published guidance from the International Society on Thrombosis and Haemostasis (ISTH), with minor modifications for Hgb decrease and blood transfusion requirements.
Time Frame	on-treatment period 2.5 years of median study drug exposure and 2.8 year of median follow-up

Outcome Measure Data

Analysis Population Description

Safety-analysis set, on-treatment period

Arm/Group Title	Low Dose Edoxaban/Placebo Warfarin	High Dose Edoxaban/Placebo Warfarin	Warfarin/Placebo Edoxaban
Arm/Group Description	Edoxaban tablets plus warfarin placebo tablets 30mg Edoxaban tablets (low dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months placebo warfarin: placebo warfarin	Edoxaban tablets plus warfarin placebo tablets 60mg Edoxaban tablets (high dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months placebo warfarin: placebo warfarin	Warfarin tablets plus placebo Edoxaban tablets warfarin tablets: Warfarin tablets plus Edoxaban placebo tablets each taken once daily for 24 months placebo edoxaban: placebo edoxaban
Measure Participants	7002	7012	7012
Major bleed	254 3.6%	418 6%	524 7.5%
ICH Major bleed	41 0.6%	61 0.9%	132 1.9%
Non-ICH Major bleed	214 3.1%	359 5.1%	398 5.7%
Fatal bleed	21 0.3%	32 0.5%	59 0.8%
non-fatal (Major) bleed	234 3.3%	386 5.5%	466 6.7%
life-threatening bleed	40 0.6%	62 0.9%	122 1.7%
clinically relevant non-major bleed	969 13.8%	1214 17.3%	1396 19.9%
major or clinically relevant non-major	1161 16.6%	1528 21.8%	1761 25.1%
minor	533 7.6%	604 8.6%	714 10.2%
any confirmed bleed	1499 21.4%	1865 26.6%	2114 30.2%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	High Dose Edoxaban/Placebo Warfarin, Warfarin/Placebo Edoxaban
	Comments	All Major Adjudicated Bleeding Events, Safety Analysis Set On-treatment period
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.0009
	Comments
	Method	Regression, Cox
	Comments
Method of Estimation	Estimation Parameter	Cox Proportional Hazard
	Estimated Value	.80
	Confidence Interval	(2-Sided) 95%; .707 to .914
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Low Dose Edoxaban/Placebo Warfarin, Warfarin/Placebo Edoxaban
	Comments	All Major Adjudicated Bleeding Events, Safety Analysis Set On-treatment period. The HR, two-sided CI, and p-value for pairwise comparisons versus Warfarin are based on the Cox regression model with counting process approach for on-treatment including treatment and the two stratification factors as covariates: the dichotomized CHADS2 score and the dichotomized dose-adjustment factor
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<.0001
	Comments
	Method	Regression, Cox
	Comments
Method of Estimation	Estimation Parameter	Cox Proportional Hazard
	Estimated Value	0.47
	Confidence Interval	(2-Sided) 95%; .406 to .548
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	High Dose Edoxaban/Placebo Warfarin, Warfarin/Placebo Edoxaban
	Comments	Major or Clinically Relevant Non-Major, high dose vs. warfarin
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<.0001
	Comments
	Method	Regression, Cox
	Comments
Method of Estimation	Estimation Parameter	Cox Proportional Hazard
	Estimated Value	.86
	Confidence Interval	(2-Sided) 95%; .800 to .918
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Low Dose Edoxaban/Placebo Warfarin, Warfarin/Placebo Edoxaban
	Comments	Major or Clinically Relevant Non-Major, low dose vs. warfarin
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<.0001
	Comments
	Method	Regression, Cox
	Comments
Method of Estimation	Estimation Parameter	Cox Proportional Hazard
	Estimated Value	.62
	Confidence Interval	(2-Sided) 95%; .575 to .666
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Time Frame	On treatment (safety analysis set)
Arm/Group Title	Warfarin/Placebo Edoxaban		High Dose Edoxaban/Placebo Warfarin		Low Dose Edoxaban/Placebo Warfarin
Arm/Group Description	Warfarin tablets plus placebo Edoxaban tablets warfarin tablets: Warfarin tablets plus Edoxaban placebo tablets each taken once daily for 24 months placebo edoxaban: placebo edoxaban		Edoxaban tablets plus warfarin placebo tablets Edoxaban tablets (high dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months placebo warfarin: placebo warfarin		Edoxaban tablets plus warfarin placebo tablets Edoxaban tablets (low dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months placebo warfarin: placebo warfarin
All Cause Mortality
	Warfarin/Placebo Edoxaban		High Dose Edoxaban/Placebo Warfarin		Low Dose Edoxaban/Placebo Warfarin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Warfarin/Placebo Edoxaban		High Dose Edoxaban/Placebo Warfarin		Low Dose Edoxaban/Placebo Warfarin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3581/7012 (51.1%)		3393/7012 (48.4%)		3448/7002 (49.2%)
Blood and lymphatic system disorders
ANAEMIA	62/7012 (0.9%)	74	91/7012 (1.3%)	106	70/7002 (1%)	77
IRON DEFICIENCY ANAEMIA	13/7012 (0.2%)	14	34/7012 (0.5%)	37	14/7002 (0.2%)	15
SPONTANEOUS HAEMATOMA	22/7012 (0.3%)	23	10/7012 (0.1%)	10	5/7002 (0.1%)	5
HYPOCHROMIC ANAEMIA	0/7012 (0%)	0	6/7012 (0.1%)	6	2/7002 (0%)	2
HAEMORRHAGIC ANAEMIA	4/7012 (0.1%)	4	3/7012 (0%)	3	8/7002 (0.1%)	8
NORMOCHROMIC NORMOCYTIC ANAEMIA	5/7012 (0.1%)	5	3/7012 (0%)	3	3/7002 (0%)	13
THROMBOCYTOPENIA	1/7012 (0%)	1	3/7012 (0%)	3	1/7002 (0%)	2
LEUKOCYTOSIS	0/7012 (0%)	0	2/7012 (0%)	2	2/7002 (0%)	2
LYMPHADENITIS	0/7012 (0%)	0	2/7012 (0%)	2	0/7002 (0%)	0
LYMPHADENOPATHY	0/7012 (0%)	0	2/7012 (0%)	2	1/7002 (0%)	1
MICROCYTIC ANAEMIA	1/7012 (0%)	1	2/7012 (0%)	2	3/7002 (0%)	3
PANCYTOPENIA	1/7012 (0%)	1	2/7012 (0%)	2	3/7002 (0%)	3
ANAEMIA MEGALOBLASTIC	2/7012 (0%)	2	1/7012 (0%)	1	0/7002 (0%)	0
ANAEMIA OF CHRONIC DISEASE	0/7012 (0%)	0	1/7012 (0%)	1	1/7002 (0%)	1
ANAEMIA VITAMIN B12 DEFICIENCY	1/7012 (0%)	1	1/7012 (0%)	1	0/7002 (0%)	0
AUTOIMMUNE THROMBOCYTOPENIA	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
COAGULOPATHY	9/7012 (0.1%)	10	1/7012 (0%)	1	4/7002 (0.1%)	4
DISSEMINATED INTRAVASCULAR COAGULATION	1/7012 (0%)	1	1/7012 (0%)	1	2/7002 (0%)	2
HAEMOLYTIC ANAEMIA	0/7012 (0%)	0	1/7012 (0%)	2	0/7002 (0%)	0
MACROCYTOSIS	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
POLYCYTHAEMIA	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
THROMBOCYTOSIS	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
ANAEMIA FOLATE DEFICIENCY	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
ANAEMIA MACROCYTIC	1/7012 (0%)	1	0/7012 (0%)	0	1/7002 (0%)	1
ANAEMIA OF MALIGNANT DISEASE	2/7012 (0%)	2	0/7012 (0%)	0	3/7002 (0%)	3
APLASTIC ANAEMIA	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
BONE MARROW FAILURE	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
FEBRILE NEUTROPENIA	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
HAEMORRHAGIC DIATHESIS	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
HEPARIN-INDUCED THROMBOCYTOPENIA	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
HYPERCOAGULATION	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
HYPOCOAGULABLE STATE	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
IDIOPATHIC THROMBOCYTOPENIC PURPURA	2/7012 (0%)	2	0/7012 (0%)	0	0/7002 (0%)	0
LYMPHADENOPATHY MEDIASTINAL	2/7012 (0%)	2	0/7012 (0%)	0	0/7002 (0%)	0
NEPHROGENIC ANAEMIA	1/7012 (0%)	1	0/7012 (0%)	0	1/7002 (0%)	1
NEUTROPENIA	1/7012 (0%)	1	0/7012 (0%)	0	1/7002 (0%)	1
PERNICIOUS ANAEMIA	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
SPLENOMEGALY	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
Cardiac disorders
CARDIAC FAILURE	371/7012 (5.3%)	534	318/7012 (4.5%)	458	300/7002 (4.3%)	418
ATRIAL FIBRILLATION	343/7012 (4.9%)	495	315/7012 (4.5%)	466	367/7002 (5.2%)	534
CARDIAC FAILURE CONGESTIVE	291/7012 (4.2%)	406	291/7012 (4.2%)	421	270/7002 (3.9%)	374
MYOCARDIAL INFARCTION	142/7012 (2%)	154	147/7012 (2.1%)	164	189/7002 (2.7%)	204
ANGINA UNSTABLE	137/7012 (2%)	154	127/7012 (1.8%)	141	120/7002 (1.7%)	146
ANGINA PECTORIS	80/7012 (1.1%)	88	61/7012 (0.9%)	64	77/7002 (1.1%)	80
SICK SINUS SYNDROME	67/7012 (1%)	68	50/7012 (0.7%)	51	64/7002 (0.9%)	65
BRADYCARDIA	56/7012 (0.8%)	58	44/7012 (0.6%)	47	40/7002 (0.6%)	41
CARDIAC FAILURE CHRONIC	38/7012 (0.5%)	41	44/7012 (0.6%)	55	46/7002 (0.7%)	65
ATRIAL FLUTTER	46/7012 (0.7%)	62	35/7012 (0.5%)	44	41/7002 (0.6%)	48
VENTRICULAR TACHYCARDIA	41/7012 (0.6%)	44	33/7012 (0.5%)	38	39/7002 (0.6%)	47
CARDIAC ARREST	26/7012 (0.4%)	27	27/7012 (0.4%)	27	21/7002 (0.3%)	23
CARDIAC FAILURE ACUTE	28/7012 (0.4%)	31	27/7012 (0.4%)	29	23/7002 (0.3%)	27
CORONARY ARTERY DISEASE	36/7012 (0.5%)	38	27/7012 (0.4%)	30	27/7002 (0.4%)	27
CARDIO-RESPIRATORY ARREST	22/7012 (0.3%)	22	23/7012 (0.3%)	23	18/7002 (0.3%)	18
ARRHYTHMIA	13/7012 (0.2%)	13	16/7012 (0.2%)	17	13/7002 (0.2%)	14
CARDIOMYOPATHY	9/7012 (0.1%)	9	13/7012 (0.2%)	13	7/7002 (0.1%)	11
CARDIOGENIC SHOCK	15/7012 (0.2%)	15	12/7012 (0.2%)	12	18/7002 (0.3%)	18
BRADYARRHYTHMIA	10/7012 (0.1%)	10	11/7012 (0.2%)	11	10/7002 (0.1%)	10
MYOCARDIAL ISCHAEMIA	6/7012 (0.1%)	8	11/7012 (0.2%)	11	12/7002 (0.2%)	13
ATRIOVENTRICULAR BLOCK	6/7012 (0.1%)	6	10/7012 (0.1%)	11	4/7002 (0.1%)	4
LEFT VENTRICULAR FAILURE	4/7012 (0.1%)	6	10/7012 (0.1%)	12	4/7002 (0.1%)	4
SUPRAVENTRICULAR TACHYCARDIA	7/7012 (0.1%)	8	10/7012 (0.1%)	13	7/7002 (0.1%)	10
MITRAL VALVE INCOMPETENCE	14/7012 (0.2%)	14	9/7012 (0.1%)	9	17/7002 (0.2%)	19
VENTRICULAR FIBRILLATION	11/7012 (0.2%)	11	9/7012 (0.1%)	11	7/7002 (0.1%)	7
ACUTE LEFT VENTRICULAR FAILURE	4/7012 (0.1%)	5	8/7012 (0.1%)	8	4/7002 (0.1%)	5
CONGESTIVE CARDIOMYOPATHY	10/7012 (0.1%)	13	7/7012 (0.1%)	7	12/7002 (0.2%)	13
CORONARY ARTERY STENOSIS	5/7012 (0.1%)	7	6/7012 (0.1%)	7	5/7002 (0.1%)	5
PALPITATIONS	6/7012 (0.1%)	6	6/7012 (0.1%)	6	3/7002 (0%)	3
SINUS BRADYCARDIA	9/7012 (0.1%)	9	6/7012 (0.1%)	6	6/7002 (0.1%)	6
TACHYARRHYTHMIA	8/7012 (0.1%)	9	6/7012 (0.1%)	6	15/7002 (0.2%)	19
AORTIC VALVE STENOSIS	5/7012 (0.1%)	6	5/7012 (0.1%)	5	6/7002 (0.1%)	6
ATRIAL THROMBOSIS	7/7012 (0.1%)	7	5/7012 (0.1%)	5	7/7002 (0.1%)	7
PERICARDIAL EFFUSION	5/7012 (0.1%)	5	5/7012 (0.1%)	6	2/7002 (0%)	2
ACUTE CORONARY SYNDROME	2/7012 (0%)	2	4/7012 (0.1%)	5	2/7002 (0%)	2
ATRIAL TACHYCARDIA	7/7012 (0.1%)	8	4/7012 (0.1%)	5	6/7002 (0.1%)	9
ATRIOVENTRICULAR BLOCK COMPLETE	12/7012 (0.2%)	12	4/7012 (0.1%)	4	22/7002 (0.3%)	23
ATRIOVENTRICULAR BLOCK SECOND DEGREE	0/7012 (0%)	0	4/7012 (0.1%)	4	3/7002 (0%)	3
CARDIOPULMONARY FAILURE	4/7012 (0.1%)	4	4/7012 (0.1%)	4	8/7002 (0.1%)	9
CORONARY ARTERY INSUFFICIENCY	1/7012 (0%)	1	4/7012 (0.1%)	4	1/7002 (0%)	1
ISCHAEMIC CARDIOMYOPATHY	7/7012 (0.1%)	8	4/7012 (0.1%)	4	4/7002 (0.1%)	4
MYOCARDIAL FIBROSIS	3/7012 (0%)	3	4/7012 (0.1%)	4	1/7002 (0%)	1
RIGHT VENTRICULAR FAILURE	7/7012 (0.1%)	9	4/7012 (0.1%)	4	2/7002 (0%)	2
ADAMS-STOKES SYNDROME	0/7012 (0%)	0	3/7012 (0%)	3	2/7002 (0%)	2
ARTERIOSCLEROSIS CORONARY ARTERY	6/7012 (0.1%)	6	3/7012 (0%)	3	3/7002 (0%)	3
PERICARDIAL HAEMORRHAGE	1/7012 (0%)	1	3/7012 (0%)	3	0/7002 (0%)	0
VENTRICULAR ARRHYTHMIA	7/7012 (0.1%)	7	3/7012 (0%)	3	3/7002 (0%)	3
AORTIC VALVE DISEASE	0/7012 (0%)	0	2/7012 (0%)	2	1/7002 (0%)	1
AORTIC VALVE INCOMPETENCE	2/7012 (0%)	2	2/7012 (0%)	2	2/7002 (0%)	2
CARDIAC VALVE DISEASE	5/7012 (0.1%)	5	2/7012 (0%)	2	3/7002 (0%)	4
CARDIOVASCULAR INSUFFICIENCY	3/7012 (0%)	3	2/7012 (0%)	2	4/7002 (0.1%)	4
COR PULMONALE	2/7012 (0%)	2	2/7012 (0%)	2	1/7002 (0%)	2
HEART VALVE INCOMPETENCE	4/7012 (0.1%)	5	2/7012 (0%)	2	2/7002 (0%)	2
HYPERTROPHIC CARDIOMYOPATHY	0/7012 (0%)	0	2/7012 (0%)	2	1/7002 (0%)	1
STRESS CARDIOMYOPATHY	2/7012 (0%)	2	2/7012 (0%)	2	1/7002 (0%)	1
SUPRAVENTRICULAR TACHYARRHYTHMIA	0/7012 (0%)	0	2/7012 (0%)	2	0/7002 (0%)	0
TACHYCARDIA	2/7012 (0%)	2	2/7012 (0%)	2	5/7002 (0.1%)	5
TRICUSPID VALVE INCOMPETENCE	2/7012 (0%)	2	2/7012 (0%)	2	2/7002 (0%)	2
VENTRICULAR EXTRASYSTOLES	3/7012 (0%)	3	2/7012 (0%)	2	0/7002 (0%)	0
ACUTE MYOCARDIAL INFARCTION	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
AORTIC VALVE CALCIFICATION	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
ATRIOVENTRICULAR BLOCK FIRST DEGREE	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
BIFASCICULAR BLOCK	1/7012 (0%)	1	1/7012 (0%)	1	1/7002 (0%)	1
BUNDLE BRANCH BLOCK LEFT	0/7012 (0%)	0	1/7012 (0%)	1	1/7002 (0%)	1
CARDIAC ASTHMA	0/7012 (0%)	0	1/7012 (0%)	1	1/7002 (0%)	1
CARDIAC DISORDER	1/7012 (0%)	1	1/7012 (0%)	1	1/7002 (0%)	1
CARDIORENAL SYNDROME	0/7012 (0%)	0	1/7012 (0%)	2	1/7002 (0%)	1
CARDIOVASCULAR DISORDER	0/7012 (0%)	0	1/7012 (0%)	1	2/7002 (0%)	2
CHORDAE TENDINAE RUPTURE	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
CHRONOTROPIC INCOMPETENCE	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
CONDUCTION DISORDER	0/7012 (0%)	0	1/7012 (0%)	1	1/7002 (0%)	1
CORONARY ARTERY ANEURYSM	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
CORONARY ARTERY OCCLUSION	1/7012 (0%)	1	1/7012 (0%)	1	0/7002 (0%)	0
DRESSLER'S SYNDROME	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
HYPERTENSIVE HEART DISEASE	1/7012 (0%)	1	1/7012 (0%)	1	2/7002 (0%)	2
INTRACARDIAC THROMBUS	6/7012 (0.1%)	6	1/7012 (0%)	1	0/7002 (0%)	0
LEFT VENTRICULAR DYSFUNCTION	5/7012 (0.1%)	5	1/7012 (0%)	1	3/7002 (0%)	3
MITRAL VALVE DISEASE	1/7012 (0%)	1	1/7012 (0%)	1	0/7002 (0%)	0
MITRAL VALVE STENOSIS	1/7012 (0%)	1	1/7012 (0%)	1	1/7002 (0%)	1
PULSELESS ELECTRICAL ACTIVITY	1/7012 (0%)	1	1/7012 (0%)	1	2/7002 (0%)	2
RHEUMATIC HEART DISEASE	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
SUPRAVENTRICULAR EXTRASYSTOLES	0/7012 (0%)	0	1/7012 (0%)	1	1/7002 (0%)	1
VENTRICULAR TACHYARRHYTHMIA	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
AORTIC VALVE DISEASE MIXED	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
ARRHYTHMIA SUPRAVENTRICULAR	2/7012 (0%)	2	0/7012 (0%)	0	2/7002 (0%)	2
BUNDLE BRANCH BLOCK RIGHT	1/7012 (0%)	1	0/7012 (0%)	0	1/7002 (0%)	1
CARDIAC FIBRILLATION	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
CARDIAC TAMPONADE	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
COR PULMONALE ACUTE	0/7012 (0%)	0	0/7012 (0%)	0	2/7002 (0%)	4
CORONARY ARTERY EMBOLISM	0/7012 (0%)	0	0/7012 (0%)	0	2/7002 (0%)	2
CORONARY ARTERY THROMBOSIS	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
CYTOTOXIC CARDIOMYOPATHY	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
DIASTOLIC DYSFUNCTION	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
ENDOCARDITIS NONINFECTIVE	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
METABOLIC CARDIOMYOPATHY	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
MITRAL VALVE PROLAPSE	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
NODAL ARRHYTHMIA	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
PERICARDITIS	4/7012 (0.1%)	4	0/7012 (0%)	0	4/7002 (0.1%)	4
PRINZMETAL ANGINA	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
RHYTHM IDIOVENTRICULAR	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
SINUS ARREST	1/7012 (0%)	1	0/7012 (0%)	0	1/7002 (0%)	1
SINUS ARRHYTHMIA	1/7012 (0%)	1	0/7012 (0%)	0	1/7002 (0%)	1
SYSTOLIC DYSFUNCTION	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
TACHYCARDIA PAROXYSMAL	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
TORSADE DE POINTES	1/7012 (0%)	1	0/7012 (0%)	0	1/7002 (0%)	1
TRIFASCICULAR BLOCK	1/7012 (0%)	1	0/7012 (0%)	0	1/7002 (0%)	1
VENTRICULAR DYSFUNCTION	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
WOLFF-PARKINSON-WHITE SYNDROME	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
Congenital, familial and genetic disorders
ARTERIOVENOUS MALFORMATION	0/7012 (0%)	0	1/7012 (0%)	2	0/7002 (0%)	0
DIVERTICULITIS MECKEL'S	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
GASTROINTESTINAL ANGIODYSPLASIA	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
GASTROINTESTINAL ANGIODYSPLASIA HAEMORRHAGIC	0/7012 (0%)	0	1/7012 (0%)	2	0/7002 (0%)	0
GITELMAN'S SYNDROME	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
HAEMORRHAGIC ARTERIOVENOUS MALFORMATION	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
HIP DYSPLASIA	1/7012 (0%)	1	1/7012 (0%)	1	0/7002 (0%)	0
HYDROCELE	0/7012 (0%)	0	1/7012 (0%)	1	2/7002 (0%)	2
ATRIAL SEPTAL DEFECT	3/7012 (0%)	3	0/7012 (0%)	0	0/7002 (0%)	0
FRIEDREICH'S ATAXIA	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
PENOSCROTAL FUSION	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
PHIMOSIS	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
RILEY-DAY SYNDROME	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
VENTRICULAR SEPTAL DEFECT	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
Ear and labyrinth disorders
VERTIGO	11/7012 (0.2%)	11	15/7012 (0.2%)	16	15/7002 (0.2%)	17
VERTIGO POSITIONAL	7/7012 (0.1%)	9	5/7012 (0.1%)	6	4/7002 (0.1%)	5
VESTIBULAR DISORDER	2/7012 (0%)	2	2/7012 (0%)	2	0/7002 (0%)	0
HYPOACUSIS	1/7012 (0%)	1	1/7012 (0%)	1	0/7002 (0%)	0
MENIERE'S DISEASE	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
TYMPANIC MEMBRANE PERFORATION	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
DEAFNESS NEUROSENSORY	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
DEAFNESS UNILATERAL	2/7012 (0%)	2	0/7012 (0%)	0	1/7002 (0%)	1
SUDDEN HEARING LOSS	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
Endocrine disorders
GOITRE	1/7012 (0%)	1	3/7012 (0%)	3	6/7002 (0.1%)	6
HYPOTHYROIDISM	1/7012 (0%)	1	3/7012 (0%)	3	0/7002 (0%)	0
HYPERTHYROIDISM	5/7012 (0.1%)	5	2/7012 (0%)	3	6/7002 (0.1%)	6
CARCINOID SYNDROME	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
HYPERPARATHYROIDISM	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION	0/7012 (0%)	0	1/7012 (0%)	1	1/7002 (0%)	1
AUTOIMMUNE THYROIDITIS	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
BASEDOW'S DISEASE	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
HYPERPARATHYROIDISM PRIMARY	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
MYXOEDEMA	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
SECONDARY ADRENOCORTICAL INSUFFICIENCY	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
THYROIDITIS	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
Eye disorders
CATARACT	47/7012 (0.7%)	63	58/7012 (0.8%)	65	60/7002 (0.9%)	72
GLAUCOMA	2/7012 (0%)	2	5/7012 (0.1%)	5	4/7002 (0.1%)	5
VITREOUS HAEMORRHAGE	1/7012 (0%)	1	3/7012 (0%)	3	0/7002 (0%)	0
AGE-RELATED MACULAR DEGENERATION	0/7012 (0%)	0	2/7012 (0%)	2	1/7002 (0%)	1
OPTIC ISCHAEMIC NEUROPATHY	0/7012 (0%)	0	2/7012 (0%)	2	0/7002 (0%)	0
RETINAL DETACHMENT	3/7012 (0%)	4	2/7012 (0%)	2	5/7002 (0.1%)	7
RETINAL VEIN OCCLUSION	0/7012 (0%)	0	2/7012 (0%)	2	1/7002 (0%)	1
AMAUROSIS FUGAX	0/7012 (0%)	0	1/7012 (0%)	2	1/7002 (0%)	2
ANGLE CLOSURE GLAUCOMA	1/7012 (0%)	1	1/7012 (0%)	1	0/7002 (0%)	0
BLINDNESS	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
CATARACT NUCLEAR	1/7012 (0%)	2	1/7012 (0%)	1	0/7002 (0%)	0
CONJUNCTIVAL HAEMORRHAGE	1/7012 (0%)	1	1/7012 (0%)	1	1/7002 (0%)	1
CORNEAL DEGENERATION	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
ENTROPION	1/7012 (0%)	1	1/7012 (0%)	1	0/7002 (0%)	0
EYE HAEMORRHAGE	3/7012 (0%)	3	1/7012 (0%)	1	2/7002 (0%)	2
MACULAR OEDEMA	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
RETINAL ARTERY EMBOLISM	0/7012 (0%)	0	1/7012 (0%)	1	1/7002 (0%)	1
RETINAL ARTERY OCCLUSION	1/7012 (0%)	2	1/7012 (0%)	1	4/7002 (0.1%)	4
RETINAL HAEMORRHAGE	6/7012 (0.1%)	7	1/7012 (0%)	1	2/7002 (0%)	2
RETINOPATHY	0/7012 (0%)	0	1/7012 (0%)	2	0/7002 (0%)	0
SCOTOMA	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
AMBLYOPIA	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
APHAKIA	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
ARTERIOSCLEROTIC RETINOPATHY	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
BLEPHARITIS	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
CHOROIDAL HAEMORRHAGE	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
CONJUNCTIVITIS	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
CORNEAL DECOMPENSATION	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
DIABETIC RETINOPATHY	5/7012 (0.1%)	6	0/7012 (0%)	0	1/7002 (0%)	2
DIPLOPIA	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
EYELID PTOSIS	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
FUCHS' SYNDROME	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
KERATOPATHY	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
LACRIMATION INCREASED	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
LENS DISLOCATION	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
MACULAR DEGENERATION	1/7012 (0%)	1	0/7012 (0%)	0	1/7002 (0%)	1
MACULAR FIBROSIS	0/7012 (0%)	0	0/7012 (0%)	0	2/7002 (0%)	3
MACULAR HOLE	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
MACULOPATHY	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
OPEN ANGLE GLAUCOMA	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
PANOPHTHALMITIS	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
PAPILLOEDEMA	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
PTERYGIUM	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
RETINAL ARTERY THROMBOSIS	2/7012 (0%)	3	0/7012 (0%)	0	1/7002 (0%)	2
RETINAL VASCULAR THROMBOSIS	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
RETINAL VEIN THROMBOSIS	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
SCLERAL HAEMORRHAGE	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
SCLERITIS	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
STRABISMUS	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
ULCERATIVE KERATITIS	2/7012 (0%)	2	0/7012 (0%)	0	1/7002 (0%)	1
VISUAL IMPAIRMENT	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
Gastrointestinal disorders
GASTROINTESTINAL HAEMORRHAGE	83/7012 (1.2%)	85	89/7012 (1.3%)	97	59/7002 (0.8%)	64
RECTAL HAEMORRHAGE	24/7012 (0.3%)	28	42/7012 (0.6%)	44	28/7002 (0.4%)	30
INGUINAL HERNIA	24/7012 (0.3%)	25	33/7012 (0.5%)	37	36/7002 (0.5%)	36
UPPER GASTROINTESTINAL HAEMORRHAGE	28/7012 (0.4%)	32	29/7012 (0.4%)	33	38/7002 (0.5%)	41
GASTRITIS	11/7012 (0.2%)	12	27/7012 (0.4%)	28	12/7002 (0.2%)	12
MELAENA	8/7012 (0.1%)	9	26/7012 (0.4%)	27	7/7002 (0.1%)	8
LOWER GASTROINTESTINAL HAEMORRHAGE	22/7012 (0.3%)	23	19/7012 (0.3%)	19	13/7002 (0.2%)	13
COLONIC POLYP	9/7012 (0.1%)	10	18/7012 (0.3%)	19	16/7002 (0.2%)	17
DIARRHOEA	17/7012 (0.2%)	17	17/7012 (0.2%)	17	7/7002 (0.1%)	7
PANCREATITIS ACUTE	13/7012 (0.2%)	14	14/7012 (0.2%)	14	19/7002 (0.3%)	27
SMALL INTESTINAL OBSTRUCTION	9/7012 (0.1%)	13	14/7012 (0.2%)	16	11/7002 (0.2%)	12
HAEMATOCHEZIA	8/7012 (0.1%)	8	13/7012 (0.2%)	13	10/7002 (0.1%)	10
PANCREATITIS	23/7012 (0.3%)	23	13/7012 (0.2%)	14	6/7002 (0.1%)	6
ILEUS	6/7012 (0.1%)	6	11/7012 (0.2%)	12	6/7002 (0.1%)	7
GASTRITIS EROSIVE	2/7012 (0%)	2	10/7012 (0.1%)	10	10/7002 (0.1%)	10
HAEMORRHOIDAL HAEMORRHAGE	6/7012 (0.1%)	6	10/7012 (0.1%)	11	3/7002 (0%)	3
INTESTINAL OBSTRUCTION	8/7012 (0.1%)	8	10/7012 (0.1%)	11	4/7002 (0.1%)	4
ABDOMINAL PAIN	9/7012 (0.1%)	10	9/7012 (0.1%)	10	11/7002 (0.2%)	12
CONSTIPATION	13/7012 (0.2%)	14	9/7012 (0.1%)	9	5/7002 (0.1%)	5
DYSPEPSIA	4/7012 (0.1%)	4	8/7012 (0.1%)	8	4/7002 (0.1%)	4
UMBILICAL HERNIA	6/7012 (0.1%)	6	8/7012 (0.1%)	8	2/7002 (0%)	2
HAEMATEMESIS	7/7012 (0.1%)	7	7/7012 (0.1%)	7	2/7002 (0%)	2
HAEMORRHOIDS	3/7012 (0%)	3	7/7012 (0.1%)	7	6/7002 (0.1%)	6
DUODENAL ULCER	3/7012 (0%)	3	6/7012 (0.1%)	7	3/7002 (0%)	3
GASTROOESOPHAGEAL REFLUX DISEASE	6/7012 (0.1%)	6	6/7012 (0.1%)	6	5/7002 (0.1%)	5
GASTRIC ULCER	13/7012 (0.2%)	14	5/7012 (0.1%)	6	11/7002 (0.2%)	11
GASTRIC ULCER HAEMORRHAGE	9/7012 (0.1%)	9	5/7012 (0.1%)	5	8/7002 (0.1%)	8
GASTRITIS HAEMORRHAGIC	1/7012 (0%)	1	5/7012 (0.1%)	5	0/7002 (0%)	0
VOMITING	3/7012 (0%)	3	5/7012 (0.1%)	6	4/7002 (0.1%)	4
ABDOMINAL PAIN UPPER	4/7012 (0.1%)	4	4/7012 (0.1%)	4	6/7002 (0.1%)	7
ABDOMINAL STRANGULATED HERNIA	0/7012 (0%)	0	4/7012 (0.1%)	4	2/7002 (0%)	2
ASCITES	3/7012 (0%)	3	4/7012 (0.1%)	4	3/7002 (0%)	3
COLITIS	5/7012 (0.1%)	6	4/7012 (0.1%)	4	6/7002 (0.1%)	6
GASTRIC HAEMORRHAGE	5/7012 (0.1%)	5	4/7012 (0.1%)	4	1/7002 (0%)	1
GASTRIC POLYPS	0/7012 (0%)	0	4/7012 (0.1%)	4	1/7002 (0%)	1
INTESTINAL HAEMORRHAGE	4/7012 (0.1%)	4	4/7012 (0.1%)	5	0/7002 (0%)	0
LARGE INTESTINAL HAEMORRHAGE	4/7012 (0.1%)	4	4/7012 (0.1%)	4	2/7002 (0%)	2
ABDOMINAL HERNIA	3/7012 (0%)	3	3/7012 (0%)	3	3/7002 (0%)	3
ABDOMINAL PAIN LOWER	0/7012 (0%)	0	3/7012 (0%)	3	0/7002 (0%)	0
COLITIS ISCHAEMIC	4/7012 (0.1%)	4	3/7012 (0%)	3	2/7002 (0%)	2
DENTAL CARIES	0/7012 (0%)	0	3/7012 (0%)	3	1/7002 (0%)	1
DIVERTICULUM	3/7012 (0%)	3	3/7012 (0%)	3	1/7002 (0%)	1
FAECALOMA	2/7012 (0%)	2	3/7012 (0%)	4	3/7002 (0%)	3
FAECES DISCOLOURED	2/7012 (0%)	2	3/7012 (0%)	3	0/7002 (0%)	0
GASTRIC ANTRAL VASCULAR ECTASIA	1/7012 (0%)	1	3/7012 (0%)	4	0/7002 (0%)	0
HIATUS HERNIA	1/7012 (0%)	1	3/7012 (0%)	3	4/7002 (0.1%)	4
INGUINAL HERNIA STRANGULATED	1/7012 (0%)	1	3/7012 (0%)	3	3/7002 (0%)	3
NAUSEA	2/7012 (0%)	2	3/7012 (0%)	3	2/7002 (0%)	2
PANCREATIC MASS	0/7012 (0%)	0	3/7012 (0%)	3	0/7002 (0%)	0
PERIODONTITIS	3/7012 (0%)	3	3/7012 (0%)	3	7/7002 (0.1%)	7
RETROPERITONEAL HAEMORRHAGE	5/7012 (0.1%)	5	3/7012 (0%)	3	2/7002 (0%)	2
ANAL HAEMORRHAGE	3/7012 (0%)	3	2/7012 (0%)	2	2/7002 (0%)	2
CAECITIS	0/7012 (0%)	0	2/7012 (0%)	2	0/7002 (0%)	0
DIARRHOEA HAEMORRHAGIC	1/7012 (0%)	1	2/7012 (0%)	2	1/7002 (0%)	1
DIVERTICULAR PERFORATION	1/7012 (0%)	1	2/7012 (0%)	2	4/7002 (0.1%)	4
DIVERTICULUM INTESTINAL HAEMORRHAGIC	7/7012 (0.1%)	7	2/7012 (0%)	2	2/7002 (0%)	2
DYSPHAGIA	5/7012 (0.1%)	6	2/7012 (0%)	2	2/7002 (0%)	2
FEMORAL HERNIA, OBSTRUCTIVE	0/7012 (0%)	0	2/7012 (0%)	2	2/7002 (0%)	2
GASTROINTESTINAL VASCULAR MALFORMATION	0/7012 (0%)	0	2/7012 (0%)	2	0/7002 (0%)	0
INGUINAL HERNIA, OBSTRUCTIVE	4/7012 (0.1%)	4	2/7012 (0%)	2	5/7002 (0.1%)	5
INTESTINAL POLYP	2/7012 (0%)	2	2/7012 (0%)	2	0/7002 (0%)	0
LARGE INTESTINE PERFORATION	1/7012 (0%)	1	2/7012 (0%)	2	2/7002 (0%)	2
PEPTIC ULCER	6/7012 (0.1%)	6	2/7012 (0%)	2	1/7002 (0%)	1
PEPTIC ULCER HAEMORRHAGE	2/7012 (0%)	2	2/7012 (0%)	2	1/7002 (0%)	1
POLYP COLORECTAL	1/7012 (0%)	1	2/7012 (0%)	2	0/7002 (0%)	0
UMBILICAL HERNIA, OBSTRUCTIVE	3/7012 (0%)	3	2/7012 (0%)	2	2/7002 (0%)	2
ABDOMINAL ADHESIONS	0/7012 (0%)	0	1/7012 (0%)	1	1/7002 (0%)	2
ABDOMINAL HERNIA OBSTRUCTIVE	1/7012 (0%)	1	1/7012 (0%)	1	0/7002 (0%)	0
ANAL FISSURE	2/7012 (0%)	2	1/7012 (0%)	1	0/7002 (0%)	0
CHRONIC GASTROINTESTINAL BLEEDING	0/7012 (0%)	0	1/7012 (0%)	1	1/7002 (0%)	1
COLITIS MICROSCOPIC	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
COLITIS ULCERATIVE	1/7012 (0%)	1	1/7012 (0%)	1	1/7002 (0%)	1
COLONIC STENOSIS	1/7012 (0%)	1	1/7012 (0%)	1	0/7002 (0%)	0
CROHN'S DISEASE	0/7012 (0%)	0	1/7012 (0%)	1	1/7002 (0%)	1
DIVERTICULUM INTESTINAL	3/7012 (0%)	3	1/7012 (0%)	1	5/7002 (0.1%)	5
DUODENAL POLYP	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
DUODENITIS	1/7012 (0%)	1	1/7012 (0%)	1	1/7002 (0%)	1
ENTEROCOLITIS HAEMORRHAGIC	1/7012 (0%)	1	1/7012 (0%)	1	0/7002 (0%)	0
FAECAL INCONTINENCE	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
FEMORAL HERNIA	1/7012 (0%)	1	1/7012 (0%)	1	2/7002 (0%)	2
GASTRIC DYSPLASIA	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
GASTRIC MUCOSAL LESION	1/7012 (0%)	1	1/7012 (0%)	1	0/7002 (0%)	0
GASTRITIS ATROPHIC	2/7012 (0%)	2	1/7012 (0%)	1	1/7002 (0%)	1
GASTRODUODENITIS	1/7012 (0%)	1	1/7012 (0%)	1	1/7002 (0%)	1
GASTROINTESTINAL INFLAMMATION	1/7012 (0%)	1	1/7012 (0%)	1	1/7002 (0%)	1
GASTROINTESTINAL TOXICITY	1/7012 (0%)	2	1/7012 (0%)	1	0/7002 (0%)	0
GASTROINTESTINAL ULCER HAEMORRHAGE	1/7012 (0%)	1	1/7012 (0%)	1	0/7002 (0%)	0
GINGIVAL BLEEDING	3/7012 (0%)	3	1/7012 (0%)	1	1/7002 (0%)	1
GLOSSITIS	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
HAEMORRHAGIC EROSIVE GASTRITIS	1/7012 (0%)	1	1/7012 (0%)	1	0/7002 (0%)	0
ILEUS PARALYTIC	3/7012 (0%)	3	1/7012 (0%)	1	3/7002 (0%)	3
INFLAMMATORY BOWEL DISEASE	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
INTESTINAL ISCHAEMIA	2/7012 (0%)	2	1/7012 (0%)	1	6/7002 (0.1%)	6
INTESTINAL MASS	1/7012 (0%)	1	1/7012 (0%)	1	2/7002 (0%)	2
INTESTINAL POLYP HAEMORRHAGE	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
INTESTINAL STENOSIS	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
MOUTH HAEMORRHAGE	3/7012 (0%)	3	1/7012 (0%)	1	3/7002 (0%)	3
OESOPHAGEAL FOOD IMPACTION	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
OESOPHAGEAL HAEMORRHAGE	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
OESOPHAGEAL RUPTURE	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
OESOPHAGEAL SPASM	0/7012 (0%)	0	1/7012 (0%)	1	1/7002 (0%)	1
OESOPHAGEAL STENOSIS	0/7012 (0%)	0	1/7012 (0%)	1	1/7002 (0%)	1
OESOPHAGEAL ULCER	1/7012 (0%)	2	1/7012 (0%)	1	1/7002 (0%)	1
OESOPHAGITIS	4/7012 (0.1%)	4	1/7012 (0%)	1	0/7002 (0%)	0
PANCREATIC NECROSIS	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
PANCREATITIS CHRONIC	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
PANCREATITIS NECROTISING	0/7012 (0%)	0	1/7012 (0%)	2	1/7002 (0%)	1
PERIODONTAL DISEASE	0/7012 (0%)	0	1/7012 (0%)	1	1/7002 (0%)	1
PNEUMOPERITONEUM	0/7012 (0%)	0	1/7012 (0%)	1	1/7002 (0%)	1
PROTEIN-LOSING GASTROENTEROPATHY	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
PYLORUS DILATATION	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
RADICULAR CYST	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
RECTAL POLYP	0/7012 (0%)	0	1/7012 (0%)	1	1/7002 (0%)	1
RECTAL ULCER	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
REFLUX GASTRITIS	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
RETROPERITONEAL HAEMATOMA	0/7012 (0%)	0	1/7012 (0%)	1	1/7002 (0%)	1
ABDOMINAL DISTENSION	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
ABDOMINAL MASS	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
ABDOMINAL WALL HAEMATOMA	3/7012 (0%)	4	0/7012 (0%)	0	0/7002 (0%)	0
ACUTE ABDOMEN	2/7012 (0%)	2	0/7012 (0%)	0	0/7002 (0%)	0
ALCOHOLIC PANCREATITIS	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	2
ANAL FISTULA	1/7012 (0%)	1	0/7012 (0%)	0	1/7002 (0%)	1
ANAL ULCER HAEMORRHAGE	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
COELIAC DISEASE	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
COLON DYSPLASIA	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
COLONIC FISTULA	2/7012 (0%)	2	0/7012 (0%)	0	0/7002 (0%)	0
COLONIC PSEUDO-OBSTRUCTION	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
DIABETIC GASTROPATHY	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
DIVERTICULITIS INTESTINAL HAEMORRHAGIC	2/7012 (0%)	3	0/7012 (0%)	0	0/7002 (0%)	0
DIVERTICULUM OESOPHAGEAL	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
DUODENAL ULCER HAEMORRHAGE	3/7012 (0%)	3	0/7012 (0%)	0	1/7002 (0%)	1
ENTERITIS	2/7012 (0%)	2	0/7012 (0%)	0	1/7002 (0%)	1
ENTEROCOLITIS	1/7012 (0%)	1	0/7012 (0%)	0	3/7002 (0%)	3
ENTEROVESICAL FISTULA	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
FOOD POISONING	4/7012 (0.1%)	4	0/7012 (0%)	0	2/7002 (0%)	2
GASTRIC VARICES	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
GASTRODUODENAL ULCER	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
GASTROINTESTINAL DISORDER	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
GASTROINTESTINAL DYSPLASIA	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
GASTROINTESTINAL HYPOMOTILITY	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
GASTROINTESTINAL ISCHAEMIA	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
GASTROINTESTINAL NECROSIS	0/7012 (0%)	0	0/7012 (0%)	0	3/7002 (0%)	3
GASTROINTESTINAL OBSTRUCTION	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
GASTROINTESTINAL PERFORATION	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
GASTROPLEURAL FISTULA	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
GIANT CELL EPULIS	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
ILEITIS	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
INTESTINAL HAEMATOMA	2/7012 (0%)	2	0/7012 (0%)	0	0/7002 (0%)	0
INTESTINAL INFARCTION	2/7012 (0%)	2	0/7012 (0%)	0	0/7002 (0%)	0
INTESTINAL PERFORATION	1/7012 (0%)	1	0/7012 (0%)	0	2/7002 (0%)	2
LARGE INTESTINAL OBSTRUCTION	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
LARGE INTESTINAL ULCER	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
LIP HAEMORRHAGE	1/7012 (0%)	1	0/7012 (0%)	0	1/7002 (0%)	1
MALLORY-WEISS SYNDROME	3/7012 (0%)	3	0/7012 (0%)	0	0/7002 (0%)	0
MESENTERIC ARTERY EMBOLISM	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
MESENTERIC ARTERY THROMBOSIS	1/7012 (0%)	1	0/7012 (0%)	0	1/7002 (0%)	1
MESENTERIC VEIN THROMBOSIS	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
MOUTH ULCERATION	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
ODYNOPHAGIA	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
OESOPHAGEAL ACHALASIA	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
OESOPHAGEAL VARICES HAEMORRHAGE	1/7012 (0%)	1	0/7012 (0%)	0	1/7002 (0%)	1
ORAL DYSAESTHESIA	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
PANCREATIC CYST	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
PANCREATITIS RELAPSING	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	2
PANCREATOLITHIASIS	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
PAROTID GLAND INFLAMMATION	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
PERITONEAL HAEMORRHAGE	2/7012 (0%)	2	0/7012 (0%)	0	2/7002 (0%)	2
PNEUMATOSIS INTESTINALIS	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
POOR DENTAL CONDITION	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
PROCTALGIA	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
RECTAL PROLAPSE	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
SALIVARY GLAND CALCULUS	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
SMALL INTESTINAL HAEMORRHAGE	2/7012 (0%)	2	0/7012 (0%)	0	3/7002 (0%)	3
SMALL INTESTINAL PERFORATION	3/7012 (0%)	3	0/7012 (0%)	0	0/7002 (0%)	0
SPIGELIAN HERNIA	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
SUBILEUS	0/7012 (0%)	0	0/7012 (0%)	0	3/7002 (0%)	3
TONGUE CYST	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
TOOTHACHE	2/7012 (0%)	2	0/7012 (0%)	0	0/7002 (0%)	0
VARICES OESOPHAGEAL	1/7012 (0%)	1	0/7012 (0%)	0	1/7002 (0%)	1
VOLVULUS	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
General disorders
DEATH	91/7012 (1.3%)	91	80/7012 (1.1%)	80	78/7002 (1.1%)	78
NON-CARDIAC CHEST PAIN	39/7012 (0.6%)	40	50/7012 (0.7%)	54	54/7002 (0.8%)	58
SUDDEN DEATH	45/7012 (0.6%)	46	29/7012 (0.4%)	29	35/7002 (0.5%)	35
CHEST PAIN	24/7012 (0.3%)	26	26/7012 (0.4%)	27	33/7002 (0.5%)	35
SUDDEN CARDIAC DEATH	24/7012 (0.3%)	24	23/7012 (0.3%)	23	24/7002 (0.3%)	24
DEVICE DISLOCATION	12/7012 (0.2%)	14	11/7012 (0.2%)	13	6/7002 (0.1%)	7
ASTHENIA	12/7012 (0.2%)	12	8/7012 (0.1%)	8	17/7002 (0.2%)	19
PYREXIA	6/7012 (0.1%)	6	8/7012 (0.1%)	8	10/7002 (0.1%)	11
CHEST DISCOMFORT	7/7012 (0.1%)	7	7/7012 (0.1%)	7	7/7002 (0.1%)	7
MULTI-ORGAN FAILURE	14/7012 (0.2%)	14	7/7012 (0.1%)	7	18/7002 (0.3%)	18
DEVICE BATTERY ISSUE	6/7012 (0.1%)	6	5/7012 (0.1%)	5	8/7002 (0.1%)	8
DEVICE MALFUNCTION	6/7012 (0.1%)	6	5/7012 (0.1%)	6	7/7002 (0.1%)	7
OEDEMA PERIPHERAL	5/7012 (0.1%)	5	5/7012 (0.1%)	5	3/7002 (0%)	3
GENERAL PHYSICAL HEALTH DETERIORATION	7/7012 (0.1%)	7	4/7012 (0.1%)	4	7/7002 (0.1%)	9
DEVICE FAILURE	4/7012 (0.1%)	4	3/7012 (0%)	3	1/7002 (0%)	1
FATIGUE	2/7012 (0%)	2	3/7012 (0%)	3	1/7002 (0%)	1
SYSTEMIC INFLAMMATORY RESPONSE SYNDROME	2/7012 (0%)	2	3/7012 (0%)	3	0/7002 (0%)	0
ADVERSE DRUG REACTION	2/7012 (0%)	2	2/7012 (0%)	2	0/7002 (0%)	0
CARDIAC DEATH	5/7012 (0.1%)	5	2/7012 (0%)	2	5/7002 (0.1%)	5
GAIT DISTURBANCE	2/7012 (0%)	2	2/7012 (0%)	2	3/7002 (0%)	3
MEDICAL DEVICE COMPLICATION	0/7012 (0%)	0	2/7012 (0%)	2	2/7002 (0%)	2
APPLICATION SITE BLEEDING	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
CALCINOSIS	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
DEVICE CONNECTION ISSUE	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
DEVICE LEAD DAMAGE	0/7012 (0%)	0	1/7012 (0%)	1	2/7002 (0%)	2
DEVICE PACING ISSUE	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
DISCOMFORT	1/7012 (0%)	1	1/7012 (0%)	1	0/7002 (0%)	0
DRUG WITHDRAWAL SYNDROME	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
GRAVITATIONAL OEDEMA	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
HERNIA	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
HERNIA OBSTRUCTIVE	0/7012 (0%)	0	1/7012 (0%)	1	2/7002 (0%)	2
IMPAIRED HEALING	0/7012 (0%)	0	1/7012 (0%)	1	2/7002 (0%)	2
IMPLANT SITE HAEMATOMA	0/7012 (0%)	0	1/7012 (0%)	1	1/7002 (0%)	1
IMPLANT SITE REACTION	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
INFLUENZA LIKE ILLNESS	0/7012 (0%)	0	1/7012 (0%)	2	0/7002 (0%)	0
INJECTION SITE HAEMATOMA	2/7012 (0%)	2	1/7012 (0%)	1	1/7002 (0%)	1
ISCHAEMIC ULCER	0/7012 (0%)	0	1/7012 (0%)	1	1/7002 (0%)	1
MUCOSAL HAEMORRHAGE	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
OEDEMA	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
PACEMAKER SYNDROME	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
PUNCTURE SITE HAEMORRHAGE	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
VESSEL PUNCTURE SITE HAEMATOMA	1/7012 (0%)	1	1/7012 (0%)	1	2/7002 (0%)	2
ACCIDENTAL DEATH	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
CATHETER SITE HAEMORRHAGE	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
DEVICE BREAKAGE	2/7012 (0%)	2	0/7012 (0%)	0	0/7002 (0%)	0
DEVICE CAPTURING ISSUE	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
DEVICE ISSUE	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
DEVICE LEAD ISSUE	3/7012 (0%)	3	0/7012 (0%)	0	0/7002 (0%)	0
DEVICE LEAKAGE	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
DEVICE OCCLUSION	0/7012 (0%)	0	0/7012 (0%)	0	2/7002 (0%)	2
DROWNING	0/7012 (0%)	0	0/7012 (0%)	0	2/7002 (0%)	2
GENERALISED OEDEMA	2/7012 (0%)	2	0/7012 (0%)	0	3/7002 (0%)	3
IMPLANT SITE EROSION	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
IMPLANT SITE IRRITATION	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
INFLAMMATION	2/7012 (0%)	2	0/7012 (0%)	0	1/7002 (0%)	1
MALAISE	1/7012 (0%)	1	0/7012 (0%)	0	2/7002 (0%)	2
PAIN	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
PERFORATED ULCER	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
PNEUMATOSIS	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
PRODUCT ADHESION ISSUE	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
SOFT TISSUE INFLAMMATION	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
VESSEL PUNCTURE SITE HAEMORRHAGE	1/7012 (0%)	1	0/7012 (0%)	0	1/7002 (0%)	1
XEROSIS	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
Hepatobiliary disorders
CHOLELITHIASIS	25/7012 (0.4%)	27	26/7012 (0.4%)	27	31/7002 (0.4%)	31
CHOLECYSTITIS	23/7012 (0.3%)	23	25/7012 (0.4%)	27	15/7002 (0.2%)	15
CHOLECYSTITIS ACUTE	18/7012 (0.3%)	18	22/7012 (0.3%)	23	18/7002 (0.3%)	20
BILE DUCT STONE	15/7012 (0.2%)	15	9/7012 (0.1%)	10	11/7002 (0.2%)	12
HEPATIC CIRRHOSIS	4/7012 (0.1%)	4	7/7012 (0.1%)	7	9/7002 (0.1%)	9
CHOLECYSTITIS CHRONIC	3/7012 (0%)	3	5/7012 (0.1%)	5	2/7002 (0%)	2
JAUNDICE	0/7012 (0%)	0	4/7012 (0.1%)	4	3/7002 (0%)	3
AUTOIMMUNE HEPATITIS	0/7012 (0%)	0	3/7012 (0%)	3	0/7002 (0%)	0
HEPATITIS CHRONIC ACTIVE	0/7012 (0%)	0	3/7012 (0%)	4	0/7002 (0%)	0
BILE DUCT OBSTRUCTION	0/7012 (0%)	0	2/7012 (0%)	3	0/7002 (0%)	0
BILIARY COLIC	2/7012 (0%)	2	2/7012 (0%)	2	2/7002 (0%)	2
CHOLANGITIS	2/7012 (0%)	2	2/7012 (0%)	2	4/7002 (0.1%)	4
HEPATIC FAILURE	4/7012 (0.1%)	4	2/7012 (0%)	3	1/7002 (0%)	1
HEPATIC FUNCTION ABNORMAL	3/7012 (0%)	3	2/7012 (0%)	2	2/7002 (0%)	2
ISCHAEMIC HEPATITIS	1/7012 (0%)	1	2/7012 (0%)	2	2/7002 (0%)	2
ACUTE HEPATIC FAILURE	2/7012 (0%)	2	1/7012 (0%)	1	0/7002 (0%)	0
ALCOHOLIC LIVER DISEASE	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
BILIARY FISTULA	0/7012 (0%)	0	1/7012 (0%)	1	1/7002 (0%)	1
CHOLANGITIS ACUTE	2/7012 (0%)	2	1/7012 (0%)	1	2/7002 (0%)	2
GALLBLADDER POLYP	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
HEPATIC CYST	1/7012 (0%)	1	1/7012 (0%)	1	1/7002 (0%)	1
HEPATIC CYST RUPTURED	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
HEPATIC STEATOSIS	3/7012 (0%)	3	1/7012 (0%)	1	3/7002 (0%)	3
HEPATITIS	0/7012 (0%)	0	1/7012 (0%)	1	4/7002 (0.1%)	4
HEPATOTOXICITY	0/7012 (0%)	0	1/7012 (0%)	1	1/7002 (0%)	1
HYDROCHOLECYSTIS	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
JAUNDICE CHOLESTATIC	6/7012 (0.1%)	6	1/7012 (0%)	1	5/7002 (0.1%)	5
AMPULLA OF VATER STENOSIS	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
BILE DUCT STENOSIS	2/7012 (0%)	3	0/7012 (0%)	0	0/7002 (0%)	0
BILIARY DYSKINESIA	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
CHOLELITHIASIS OBSTRUCTIVE	1/7012 (0%)	2	0/7012 (0%)	0	0/7002 (0%)	0
CHOLESTASIS	4/7012 (0.1%)	4	0/7012 (0%)	0	1/7002 (0%)	1
CHRONIC HEPATIC FAILURE	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
GALLBLADDER DISORDER	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
HAEMOBILIA	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
HEPATIC CONGESTION	2/7012 (0%)	2	0/7012 (0%)	0	2/7002 (0%)	3
HEPATIC ISCHAEMIA	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
HEPATITIS ACUTE	1/7012 (0%)	1	0/7012 (0%)	0	2/7002 (0%)	2
HEPATITIS ALCOHOLIC	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
HEPATITIS TOXIC	1/7012 (0%)	1	0/7012 (0%)	0	1/7002 (0%)	1
HEPATOMEGALY	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
HEPATORENAL FAILURE	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
HEPATORENAL SYNDROME	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
HYPERBILIRUBINAEMIA	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
LIVER DISORDER	1/7012 (0%)	1	0/7012 (0%)	0	2/7002 (0%)	2
LIVER INJURY	1/7012 (0%)	1	0/7012 (0%)	0	1/7002 (0%)	1
PORTAL VEIN THROMBOSIS	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
POST CHOLECYSTECTOMY SYNDROME	2/7012 (0%)	2	0/7012 (0%)	0	1/7002 (0%)	1
Immune system disorders
DRUG HYPERSENSITIVITY	3/7012 (0%)	3	3/7012 (0%)	3	1/7002 (0%)	1
HYPERSENSITIVITY	1/7012 (0%)	1	2/7012 (0%)	2	2/7002 (0%)	2
ANAPHYLACTIC REACTION	1/7012 (0%)	1	1/7012 (0%)	1	0/7002 (0%)	0
ANAPHYLACTIC SHOCK	0/7012 (0%)	0	1/7012 (0%)	1	1/7002 (0%)	1
SECONDARY IMMUNODEFICIENCY	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
ALLERGY TO ARTHROPOD BITE	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
AMYLOIDOSIS	1/7012 (0%)	1	0/7012 (0%)	0	1/7002 (0%)	1
SARCOIDOSIS	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
Infections and infestations
PNEUMONIA	262/7012 (3.7%)	292	259/7012 (3.7%)	298	219/7002 (3.1%)	237
URINARY TRACT INFECTION	78/7012 (1.1%)	86	60/7012 (0.9%)	75	57/7002 (0.8%)	62
BRONCHITIS	60/7012 (0.9%)	64	56/7012 (0.8%)	58	57/7002 (0.8%)	63
CELLULITIS	62/7012 (0.9%)	71	52/7012 (0.7%)	64	59/7002 (0.8%)	69
SEPSIS	35/7012 (0.5%)	35	38/7012 (0.5%)	39	43/7002 (0.6%)	44
GASTROENTERITIS	30/7012 (0.4%)	31	27/7012 (0.4%)	29	29/7002 (0.4%)	29
LOBAR PNEUMONIA	24/7012 (0.3%)	25	23/7012 (0.3%)	24	23/7002 (0.3%)	23
BRONCHOPNEUMONIA	35/7012 (0.5%)	35	22/7012 (0.3%)	24	29/7002 (0.4%)	29
DIVERTICULITIS	22/7012 (0.3%)	26	15/7012 (0.2%)	15	10/7002 (0.1%)	10
LOWER RESPIRATORY TRACT INFECTION	8/7012 (0.1%)	8	15/7012 (0.2%)	17	14/7002 (0.2%)	14
SEPTIC SHOCK	27/7012 (0.4%)	27	14/7012 (0.2%)	14	16/7002 (0.2%)	16
UPPER RESPIRATORY TRACT INFECTION	7/7012 (0.1%)	8	12/7012 (0.2%)	12	10/7002 (0.1%)	10
ERYSIPELAS	15/7012 (0.2%)	19	11/7012 (0.2%)	12	19/7002 (0.3%)	19
OSTEOMYELITIS	11/7012 (0.2%)	12	10/7012 (0.1%)	10	13/7002 (0.2%)	16
PNEUMONIA BACTERIAL	14/7012 (0.2%)	15	10/7012 (0.1%)	11	11/7002 (0.2%)	13
APPENDICITIS	9/7012 (0.1%)	9	9/7012 (0.1%)	9	8/7002 (0.1%)	8
PYELONEPHRITIS	13/7012 (0.2%)	17	9/7012 (0.1%)	9	5/7002 (0.1%)	5
UROSEPSIS	13/7012 (0.2%)	13	9/7012 (0.1%)	10	19/7002 (0.3%)	22
CYSTITIS	2/7012 (0%)	2	8/7012 (0.1%)	8	1/7002 (0%)	1
PYELONEPHRITIS ACUTE	5/7012 (0.1%)	5	8/7012 (0.1%)	8	3/7002 (0%)	3
GASTROENTERITIS VIRAL	6/7012 (0.1%)	6	7/7012 (0.1%)	8	3/7002 (0%)	3
POSTOPERATIVE WOUND INFECTION	6/7012 (0.1%)	7	7/7012 (0.1%)	7	3/7002 (0%)	3
CLOSTRIDIUM DIFFICILE COLITIS	2/7012 (0%)	2	6/7012 (0.1%)	8	3/7002 (0%)	3
GANGRENE	9/7012 (0.1%)	9	6/7012 (0.1%)	7	8/7002 (0.1%)	10
INFECTION	2/7012 (0%)	2	6/7012 (0.1%)	6	6/7002 (0.1%)	6
INFLUENZA	5/7012 (0.1%)	5	6/7012 (0.1%)	6	6/7002 (0.1%)	6
LUNG INFECTION	6/7012 (0.1%)	7	6/7012 (0.1%)	7	3/7002 (0%)	3
CHOLECYSTITIS INFECTIVE	2/7012 (0%)	2	5/7012 (0.1%)	5	3/7002 (0%)	3
HERPES ZOSTER	4/7012 (0.1%)	4	5/7012 (0.1%)	6	9/7002 (0.1%)	9
INFECTED SKIN ULCER	2/7012 (0%)	2	5/7012 (0.1%)	5	5/7002 (0.1%)	5
INFECTIOUS PERITONITIS	2/7012 (0%)	2	5/7012 (0.1%)	5	4/7002 (0.1%)	4
RESPIRATORY TRACT INFECTION	9/7012 (0.1%)	9	5/7012 (0.1%)	6	8/7002 (0.1%)	8
ENDOCARDITIS	5/7012 (0.1%)	5	4/7012 (0.1%)	4	6/7002 (0.1%)	6
ORCHITIS	1/7012 (0%)	1	4/7012 (0.1%)	5	4/7002 (0.1%)	4
PULMONARY TUBERCULOSIS	1/7012 (0%)	1	4/7012 (0.1%)	4	2/7002 (0%)	2
STAPHYLOCOCCAL BACTERAEMIA	2/7012 (0%)	2	4/7012 (0.1%)	4	1/7002 (0%)	1
WOUND INFECTION	5/7012 (0.1%)	5	4/7012 (0.1%)	4	3/7002 (0%)	3
ABSCESS LIMB	4/7012 (0.1%)	4	3/7012 (0%)	3	4/7002 (0.1%)	4
BACTERIAL SEPSIS	0/7012 (0%)	0	3/7012 (0%)	3	2/7002 (0%)	2
CLOSTRIDIAL INFECTION	0/7012 (0%)	0	3/7012 (0%)	4	2/7002 (0%)	2
GASTROENTERITIS SALMONELLA	1/7012 (0%)	1	3/7012 (0%)	3	1/7002 (0%)	1
IMPLANT SITE INFECTION	3/7012 (0%)	3	3/7012 (0%)	3	1/7002 (0%)	1
INFECTIVE EXACERBATION OF CHRONIC OBSTRUCTIVE AIRWAYS DISEASE	0/7012 (0%)	0	3/7012 (0%)	3	4/7002 (0.1%)	4
STAPHYLOCOCCAL SEPSIS	2/7012 (0%)	2	3/7012 (0%)	3	2/7002 (0%)	2
TRACHEOBRONCHITIS	3/7012 (0%)	3	3/7012 (0%)	3	2/7002 (0%)	2
URINARY TRACT INFECTION PSEUDOMONAL	0/7012 (0%)	0	3/7012 (0%)	3	1/7002 (0%)	1
VIRAL INFECTION	3/7012 (0%)	3	3/7012 (0%)	3	6/7002 (0.1%)	6
APPENDICITIS PERFORATED	2/7012 (0%)	2	2/7012 (0%)	2	2/7002 (0%)	2
ARTHRITIS BACTERIAL	8/7012 (0.1%)	8	2/7012 (0%)	2	3/7002 (0%)	3
BACTERAEMIA	2/7012 (0%)	2	2/7012 (0%)	2	2/7002 (0%)	2
BRONCHITIS BACTERIAL	0/7012 (0%)	0	2/7012 (0%)	2	1/7002 (0%)	1
CAMPYLOBACTER GASTROENTERITIS	0/7012 (0%)	0	2/7012 (0%)	2	0/7002 (0%)	0
CREUTZFELDT-JAKOB DISEASE	0/7012 (0%)	0	2/7012 (0%)	2	0/7002 (0%)	0
DEVICE RELATED INFECTION	2/7012 (0%)	2	2/7012 (0%)	2	4/7002 (0.1%)	5
DIABETIC GANGRENE	5/7012 (0.1%)	5	2/7012 (0%)	4	3/7002 (0%)	3
DIARRHOEA INFECTIOUS	1/7012 (0%)	1	2/7012 (0%)	2	2/7002 (0%)	2
ENDOCARDITIS BACTERIAL	2/7012 (0%)	2	2/7012 (0%)	2	2/7002 (0%)	2
ENTEROCOLITIS INFECTIOUS	0/7012 (0%)	0	2/7012 (0%)	2	0/7002 (0%)	0
ESCHERICHIA SEPSIS	3/7012 (0%)	3	2/7012 (0%)	2	2/7002 (0%)	2
ESCHERICHIA URINARY TRACT INFECTION	6/7012 (0.1%)	6	2/7012 (0%)	2	2/7002 (0%)	2
HEPATITIS E	0/7012 (0%)	0	2/7012 (0%)	2	1/7002 (0%)	1
INTERVERTEBRAL DISCITIS	2/7012 (0%)	2	2/7012 (0%)	2	3/7002 (0%)	3
KLEBSIELLA BACTERAEMIA	0/7012 (0%)	0	2/7012 (0%)	2	1/7002 (0%)	1
LARYNGITIS	1/7012 (0%)	1	2/7012 (0%)	2	0/7002 (0%)	0
LOCALISED INFECTION	4/7012 (0.1%)	4	2/7012 (0%)	2	3/7002 (0%)	3
LUNG INFECTION PSEUDOMONAL	0/7012 (0%)	0	2/7012 (0%)	2	4/7002 (0.1%)	4
NECROTISING FASCIITIS	0/7012 (0%)	0	2/7012 (0%)	2	0/7002 (0%)	0
PERIORBITAL CELLULITIS	0/7012 (0%)	0	2/7012 (0%)	2	0/7002 (0%)	0
PERITONITIS BACTERIAL	1/7012 (0%)	1	2/7012 (0%)	2	0/7002 (0%)	0
PNEUMONIA PNEUMOCOCCAL	2/7012 (0%)	2	2/7012 (0%)	2	2/7002 (0%)	2
PULMONARY SEPSIS	1/7012 (0%)	1	2/7012 (0%)	2	1/7002 (0%)	1
SALMONELLOSIS	2/7012 (0%)	2	2/7012 (0%)	2	1/7002 (0%)	1
SCROTAL ABSCESS	1/7012 (0%)	1	2/7012 (0%)	2	1/7002 (0%)	1
SINUSITIS	2/7012 (0%)	2	2/7012 (0%)	2	3/7002 (0%)	3
SOFT TISSUE INFECTION	0/7012 (0%)	0	2/7012 (0%)	2	0/7002 (0%)	0
STAPHYLOCOCCAL INFECTION	10/7012 (0.1%)	11	2/7012 (0%)	2	7/7002 (0.1%)	7
STREPTOCOCCAL SEPSIS	2/7012 (0%)	2	2/7012 (0%)	2	1/7002 (0%)	1
TOOTH ABSCESS	0/7012 (0%)	0	2/7012 (0%)	2	0/7002 (0%)	0
TUBERCULOUS PLEURISY	0/7012 (0%)	0	2/7012 (0%)	2	0/7002 (0%)	0
URINARY TRACT INFECTION BACTERIAL	4/7012 (0.1%)	5	2/7012 (0%)	2	2/7002 (0%)	2
WOUND INFECTION STAPHYLOCOCCAL	1/7012 (0%)	1	2/7012 (0%)	2	2/7002 (0%)	2
ABDOMINAL ABSCESS	2/7012 (0%)	2	1/7012 (0%)	1	2/7002 (0%)	2
ABDOMINAL WALL ABSCESS	2/7012 (0%)	2	1/7012 (0%)	1	0/7002 (0%)	0
ABSCESS	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
ABSCESS INTESTINAL	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
ACINETOBACTER BACTERAEMIA	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
AMOEBIC COLITIS	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
ANAL ABSCESS	1/7012 (0%)	1	1/7012 (0%)	1	3/7002 (0%)	3
ARTERIOSCLEROTIC GANGRENE	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
ARTHRITIS INFECTIVE	1/7012 (0%)	1	1/7012 (0%)	1	1/7002 (0%)	1
ATYPICAL MYCOBACTERIAL PNEUMONIA	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
BACTERIAL PROSTATITIS	0/7012 (0%)	0	1/7012 (0%)	1	1/7002 (0%)	1
BACTEROIDES BACTERAEMIA	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
BILIARY SEPSIS	0/7012 (0%)	0	1/7012 (0%)	1	2/7002 (0%)	2
BRAIN ABSCESS	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
BRONCHIOLITIS	1/7012 (0%)	1	1/7012 (0%)	1	0/7002 (0%)	0
CANDIDA PNEUMONIA	1/7012 (0%)	1	1/7012 (0%)	1	0/7002 (0%)	0
CELLULITIS STAPHYLOCOCCAL	1/7012 (0%)	1	1/7012 (0%)	1	0/7002 (0%)	0
CHOLANGITIS SUPPURATIVE	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
CYSTITIS KLEBSIELLA	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
DENGUE FEVER	0/7012 (0%)	0	1/7012 (0%)	1	4/7002 (0.1%)	4
DEVICE RELATED SEPSIS	1/7012 (0%)	1	1/7012 (0%)	1	0/7002 (0%)	0
DISSEMINATED TUBERCULOSIS	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
ECZEMA INFECTED	1/7012 (0%)	1	1/7012 (0%)	1	0/7002 (0%)	0
EMPYEMA	1/7012 (0%)	1	1/7012 (0%)	1	2/7002 (0%)	2
ENCEPHALITIS VIRAL	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
ENTEROCOCCAL BACTERAEMIA	1/7012 (0%)	1	1/7012 (0%)	1	2/7002 (0%)	2
ENTEROCOCCAL INFECTION	0/7012 (0%)	0	1/7012 (0%)	1	1/7002 (0%)	1
ENTEROCOCCAL SEPSIS	0/7012 (0%)	0	1/7012 (0%)	2	1/7002 (0%)	1
ESCHERICHIA BACTERAEMIA	1/7012 (0%)	1	1/7012 (0%)	1	0/7002 (0%)	0
ESCHERICHIA INFECTION	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
FEBRILE INFECTION	1/7012 (0%)	1	1/7012 (0%)	1	1/7002 (0%)	1
FURUNCLE	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
GAS GANGRENE	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
GASTRIC ULCER HELICOBACTER	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
GASTRITIS VIRAL	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
GASTROENTERITIS AEROMONAS	1/7012 (0%)	1	1/7012 (0%)	1	1/7002 (0%)	1
GROIN ABSCESS	0/7012 (0%)	0	1/7012 (0%)	1	4/7002 (0.1%)	4
HAEMATOMA INFECTION	0/7012 (0%)	0	1/7012 (0%)	1	1/7002 (0%)	1
HELICOBACTER GASTRITIS	2/7012 (0%)	2	1/7012 (0%)	1	1/7002 (0%)	1
HEPATIC CYST INFECTION	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
HEPATITIS VIRAL	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
HERPES ZOSTER OPHTHALMIC	2/7012 (0%)	2	1/7012 (0%)	1	0/7002 (0%)	0
INFECTIOUS PLEURAL EFFUSION	3/7012 (0%)	4	1/7012 (0%)	1	0/7002 (0%)	0
INFECTIVE MYOSITIS	0/7012 (0%)	0	1/7012 (0%)	1	1/7002 (0%)	1
INFUSION SITE INFECTION	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
KLEBSIELLA SEPSIS	1/7012 (0%)	1	1/7012 (0%)	1	3/7002 (0%)	3
LABYRINTHITIS	0/7012 (0%)	0	1/7012 (0%)	1	1/7002 (0%)	1
LOWER RESPIRATORY TRACT INFECTION BACTERIAL	0/7012 (0%)	0	1/7012 (0%)	1	1/7002 (0%)	1
LYMPH NODE TUBERCULOSIS	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
MASTOIDITIS	1/7012 (0%)	1	1/7012 (0%)	1	0/7002 (0%)	0
MENINGITIS MENINGOCOCCAL	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
MYIASIS	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
NEUROCYSTICERCOSIS	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
NEUTROPENIC SEPSIS	1/7012 (0%)	1	1/7012 (0%)	1	0/7002 (0%)	0
NOSOCOMIAL INFECTION	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
ORAL CANDIDIASIS	0/7012 (0%)	0	1/7012 (0%)	1	2/7002 (0%)	2
PARAOESOPHAGEAL ABSCESS	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
PERITONSILLAR ABSCESS	1/7012 (0%)	1	1/7012 (0%)	1	1/7002 (0%)	1
PHARYNGITIS	0/7012 (0%)	0	1/7012 (0%)	1	2/7002 (0%)	2
PNEUMONIA HAEMOPHILUS	2/7012 (0%)	2	1/7012 (0%)	1	0/7002 (0%)	0
PNEUMONIA NECROTISING	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
PNEUMONIA PRIMARY ATYPICAL	2/7012 (0%)	2	1/7012 (0%)	1	1/7002 (0%)	1
PNEUMONIA STAPHYLOCOCCAL	1/7012 (0%)	1	1/7012 (0%)	1	1/7002 (0%)	1
PNEUMONIA VIRAL	1/7012 (0%)	1	1/7012 (0%)	1	1/7002 (0%)	1
POST PROCEDURAL CELLULITIS	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
PSEUDOMEMBRANOUS COLITIS	0/7012 (0%)	0	1/7012 (0%)	1	2/7002 (0%)	3
PSEUDOMONAL BACTERAEMIA	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
PSEUDOMONAS BRONCHITIS	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
PULMONARY TUBERCULOMA	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
PYELONEPHRITIS CHRONIC	2/7012 (0%)	3	1/7012 (0%)	1	3/7002 (0%)	3
SEPSIS SYNDROME	1/7012 (0%)	1	1/7012 (0%)	1	1/7002 (0%)	1
SEPTIC ARTHRITIS STAPHYLOCOCCAL	1/7012 (0%)	1	1/7012 (0%)	1	0/7002 (0%)	0
SIALOADENITIS	0/7012 (0%)	0	1/7012 (0%)	1	1/7002 (0%)	1
SINOBRONCHITIS	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
SKIN INFECTION	1/7012 (0%)	1	1/7012 (0%)	2	1/7002 (0%)	1
STAPHYLOCOCCAL SKIN INFECTION	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
STREPTOCOCCAL INFECTION	0/7012 (0%)	0	1/7012 (0%)	1	1/7002 (0%)	1
SUBDIAPHRAGMATIC ABSCESS	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
TOXIC SHOCK SYNDROME	0/7012 (0%)	0	1/7012 (0%)	1	1/7002 (0%)	1
VESTIBULAR NEURONITIS	5/7012 (0.1%)	5	1/7012 (0%)	1	0/7002 (0%)	0
VIRAL DIARRHOEA	0/7012 (0%)	0	1/7012 (0%)	1	1/7002 (0%)	1
VIRAL LABYRINTHITIS	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
VIRAL PHARYNGITIS	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
WOUND SEPSIS	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
ABDOMINAL SEPSIS	2/7012 (0%)	2	0/7012 (0%)	0	0/7002 (0%)	0
ABSCESS ORAL	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
ACARODERMATITIS	1/7012 (0%)	1	0/7012 (0%)	0	1/7002 (0%)	1
ACINETOBACTER INFECTION	3/7012 (0%)	3	0/7012 (0%)	0	0/7002 (0%)	0
AMERICAN TRYPANOSOMIASIS	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
BACTERIAL FOOD POISONING	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
BRONCHITIS VIRAL	1/7012 (0%)	1	0/7012 (0%)	0	1/7002 (0%)	1
BURSITIS INFECTIVE	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
CAMPYLOBACTER INTESTINAL INFECTION	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
CARBUNCLE	2/7012 (0%)	2	0/7012 (0%)	0	0/7002 (0%)	0
CELLULITIS GANGRENOUS	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
CELLULITIS STREPTOCOCCAL	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
CHIKUNGUNYA VIRUS INFECTION	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
CHRONIC SINUSITIS	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
CHRONIC TONSILLITIS	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
CITROBACTER SEPSIS	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
CYSTITIS BACTERIAL	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
CYSTITIS ESCHERICHIA	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
DIABETIC FOOT INFECTION	0/7012 (0%)	0	0/7012 (0%)	0	2/7002 (0%)	2
DOUGLAS' ABSCESS	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
EMPHYSEMATOUS CHOLECYSTITIS	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
ENCEPHALITIS HERPES	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
ENDOCARDITIS ENTEROCOCCAL	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
ENTERITIS INFECTIOUS	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
ENTEROBACTER BACTERAEMIA	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
ENTEROBACTER SEPSIS	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
EPIGLOTTITIS	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
EXTRADURAL ABSCESS	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
GASTROENTERITIS BACTERIAL	2/7012 (0%)	2	0/7012 (0%)	0	1/7002 (0%)	1
GASTROENTERITIS CLOSTRIDIAL	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
GASTROENTERITIS ROTAVIRUS	2/7012 (0%)	2	0/7012 (0%)	0	0/7002 (0%)	0
GASTROINTESTINAL INFECTION	1/7012 (0%)	1	0/7012 (0%)	0	2/7002 (0%)	2
GINGIVAL ABSCESS	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
GROIN INFECTION	1/7012 (0%)	1	0/7012 (0%)	0	1/7002 (0%)	1
H1N1 INFLUENZA	1/7012 (0%)	1	0/7012 (0%)	0	1/7002 (0%)	1
HAEMOPHILUS INFECTION	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
HELICOBACTER INFECTION	1/7012 (0%)	1	0/7012 (0%)	0	1/7002 (0%)	1
HEPATITIS B	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
HEPATITIS INFECTIOUS	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
IMPLANT SITE ABSCESS	1/7012 (0%)	1	0/7012 (0%)	0	1/7002 (0%)	1
INCISION SITE INFECTION	1/7012 (0%)	1	0/7012 (0%)	0	2/7002 (0%)	2
INFECTED DERMAL CYST	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
JOINT ABSCESS	2/7012 (0%)	3	0/7012 (0%)	0	0/7002 (0%)	0
KERATITIS HERPETIC	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
KIDNEY INFECTION	0/7012 (0%)	0	0/7012 (0%)	0	2/7002 (0%)	2
LEGIONELLA INFECTION	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
LIVER ABSCESS	1/7012 (0%)	1	0/7012 (0%)	0	2/7002 (0%)	2
LOWER RESPIRATORY TRACT INFECTION VIRAL	2/7012 (0%)	2	0/7012 (0%)	0	0/7002 (0%)	0
MALARIA	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
MENINGITIS ASEPTIC	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
MENINGITIS BACTERIAL	3/7012 (0%)	3	0/7012 (0%)	0	0/7002 (0%)	0
MENINGITIS STREPTOCOCCAL	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
MENINGITIS TUBERCULOUS	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
MENINGITIS VIRAL	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
MOLLUSCUM CONTAGIOSUM	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
MURINE TYPHUS	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
MUSCLE ABSCESS	0/7012 (0%)	0	0/7012 (0%)	0	2/7002 (0%)	2
MYCOTOXICOSIS	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
NEUROBORRELIOSIS	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
OESOPHAGEAL CANDIDIASIS	2/7012 (0%)	2	0/7012 (0%)	0	1/7002 (0%)	1
OSTEOMYELITIS CHRONIC	2/7012 (0%)	2	0/7012 (0%)	0	1/7002 (0%)	1
OTITIS MEDIA	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
OTITIS MEDIA ACUTE	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
PARONYCHIA	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
PAROTITIS	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
PERICORONITIS	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
PERIRECTAL ABSCESS	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
PHARYNGITIS STREPTOCOCCAL	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
PLASMODIUM FALCIPARUM INFECTION	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
PNEUMONIA FUNGAL	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
PNEUMONIA INFLUENZAL	2/7012 (0%)	2	0/7012 (0%)	0	0/7002 (0%)	0
PNEUMONIA KLEBSIELLA	1/7012 (0%)	1	0/7012 (0%)	0	2/7002 (0%)	2
PNEUMONIA LEGIONELLA	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
PNEUMONIA MYCOPLASMAL	1/7012 (0%)	1	0/7012 (0%)	0	2/7002 (0%)	2
PNEUMONIA STREPTOCOCCAL	1/7012 (0%)	1	0/7012 (0%)	0	2/7002 (0%)	2
POST PROCEDURAL INFECTION	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
POST PROCEDURAL PNEUMONIA	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
PROTEUS INFECTION	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
PSEUDOMONAS INFECTION	0/7012 (0%)	0	0/7012 (0%)	0	2/7002 (0%)	2
PSOAS ABSCESS	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
RECTAL ABSCESS	1/7012 (0%)	1	0/7012 (0%)	0	1/7002 (0%)	1
RENAL CYST INFECTION	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
RESPIRATORY TRACT INFECTION VIRAL	3/7012 (0%)	3	0/7012 (0%)	0	1/7002 (0%)	1
RETROPERITONEAL ABSCESS	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
SEPTIC ARTHRITIS STREPTOCOCCAL	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
SEPTIC EMBOLUS	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
SEPTIC ENCEPHALOPATHY	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
SERRATIA SEPSIS	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
SPLENIC ABSCESS	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
STREPTOCOCCAL BACTERAEMIA	1/7012 (0%)	1	0/7012 (0%)	0	1/7002 (0%)	1
SUBCUTANEOUS ABSCESS	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
TUBERCULOSIS OF CENTRAL NERVOUS SYSTEM	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
TYPHOID FEVER	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
URINARY TRACT INFECTION ENTEROCOCCAL	2/7012 (0%)	2	0/7012 (0%)	0	0/7002 (0%)	0
VIRAL UPPER RESPIRATORY TRACT INFECTION	1/7012 (0%)	1	0/7012 (0%)	0	3/7002 (0%)	3
VULVAL CELLULITIS	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
Injury, poisoning and procedural complications
FALL	50/7012 (0.7%)	51	47/7012 (0.7%)	47	45/7002 (0.6%)	48
FEMUR FRACTURE	30/7012 (0.4%)	31	37/7012 (0.5%)	37	31/7002 (0.4%)	31
POST PROCEDURAL HAEMORRHAGE	12/7012 (0.2%)	12	20/7012 (0.3%)	20	16/7002 (0.2%)	16
HIP FRACTURE	28/7012 (0.4%)	28	19/7012 (0.3%)	19	29/7002 (0.4%)	29
RIB FRACTURE	15/7012 (0.2%)	15	19/7012 (0.3%)	19	18/7002 (0.3%)	18
HUMERUS FRACTURE	10/7012 (0.1%)	10	16/7012 (0.2%)	17	17/7002 (0.2%)	17
TRAUMATIC HAEMATOMA	40/7012 (0.6%)	40	15/7012 (0.2%)	15	16/7002 (0.2%)	16
SPINAL COMPRESSION FRACTURE	19/7012 (0.3%)	19	14/7012 (0.2%)	15	12/7002 (0.2%)	14
TOXICITY TO VARIOUS AGENTS	13/7012 (0.2%)	13	14/7012 (0.2%)	14	13/7002 (0.2%)	13
FEMORAL NECK FRACTURE	17/7012 (0.2%)	17	12/7012 (0.2%)	12	19/7002 (0.3%)	19
LACERATION	13/7012 (0.2%)	14	12/7012 (0.2%)	12	12/7002 (0.2%)	12
OPERATIVE HAEMORRHAGE	10/7012 (0.1%)	11	12/7012 (0.2%)	12	5/7002 (0.1%)	5
SUBDURAL HAEMATOMA	40/7012 (0.6%)	43	11/7012 (0.2%)	12	10/7002 (0.1%)	10
POST PROCEDURAL HAEMATOMA	6/7012 (0.1%)	6	10/7012 (0.1%)	10	7/7002 (0.1%)	7
LOWER LIMB FRACTURE	8/7012 (0.1%)	8	8/7012 (0.1%)	8	5/7002 (0.1%)	5
TRAUMATIC HAEMORRHAGE	9/7012 (0.1%)	9	8/7012 (0.1%)	8	9/7002 (0.1%)	9
LUMBAR VERTEBRAL FRACTURE	8/7012 (0.1%)	8	7/7012 (0.1%)	7	6/7002 (0.1%)	9
CONCUSSION	10/7012 (0.1%)	10	6/7012 (0.1%)	6	9/7002 (0.1%)	9
FACIAL BONES FRACTURE	7/7012 (0.1%)	8	6/7012 (0.1%)	6	6/7002 (0.1%)	7
PELVIC FRACTURE	7/7012 (0.1%)	7	6/7012 (0.1%)	6	5/7002 (0.1%)	5
FIBULA FRACTURE	3/7012 (0%)	3	5/7012 (0.1%)	5	1/7002 (0%)	1
SUBDURAL HAEMORRHAGE	4/7012 (0.1%)	4	5/7012 (0.1%)	5	2/7002 (0%)	2
THORACIC VERTEBRAL FRACTURE	4/7012 (0.1%)	4	5/7012 (0.1%)	5	3/7002 (0%)	3
ANKLE FRACTURE	13/7012 (0.2%)	13	4/7012 (0.1%)	4	9/7002 (0.1%)	9
PUBIS FRACTURE	4/7012 (0.1%)	4	4/7012 (0.1%)	4	9/7002 (0.1%)	9
ROAD TRAFFIC ACCIDENT	5/7012 (0.1%)	5	4/7012 (0.1%)	4	1/7002 (0%)	1
CERVICAL VERTEBRAL FRACTURE	5/7012 (0.1%)	5	3/7012 (0%)	3	4/7002 (0.1%)	4
CONTUSION	26/7012 (0.4%)	29	3/7012 (0%)	3	15/7002 (0.2%)	15
FOOT FRACTURE	4/7012 (0.1%)	4	3/7012 (0%)	3	6/7002 (0.1%)	6
FOREARM FRACTURE	2/7012 (0%)	2	3/7012 (0%)	3	2/7002 (0%)	2
MUSCLE STRAIN	0/7012 (0%)	0	3/7012 (0%)	3	1/7002 (0%)	1
PATELLA FRACTURE	2/7012 (0%)	2	3/7012 (0%)	3	0/7002 (0%)	0
POST PROCEDURAL COMPLICATION	1/7012 (0%)	1	3/7012 (0%)	3	1/7002 (0%)	1
POST PROCEDURAL HAEMATURIA	0/7012 (0%)	0	3/7012 (0%)	3	1/7002 (0%)	2
RADIUS FRACTURE	2/7012 (0%)	2	3/7012 (0%)	3	4/7002 (0.1%)	4
ULNA FRACTURE	2/7012 (0%)	2	3/7012 (0%)	3	1/7002 (0%)	1
WOUND DEHISCENCE	2/7012 (0%)	2	3/7012 (0%)	3	2/7002 (0%)	2
WRIST FRACTURE	5/7012 (0.1%)	5	3/7012 (0%)	3	4/7002 (0.1%)	4
ACCIDENTAL OVERDOSE	6/7012 (0.1%)	6	2/7012 (0%)	2	9/7002 (0.1%)	9
ACETABULUM FRACTURE	2/7012 (0%)	2	2/7012 (0%)	2	1/7002 (0%)	1
ANASTOMOTIC LEAK	0/7012 (0%)	0	2/7012 (0%)	2	1/7002 (0%)	1
CRANIOCEREBRAL INJURY	3/7012 (0%)	3	2/7012 (0%)	2	3/7002 (0%)	3
FRACTURED SACRUM	1/7012 (0%)	1	2/7012 (0%)	2	1/7002 (0%)	1
HAND FRACTURE	4/7012 (0.1%)	4	2/7012 (0%)	2	1/7002 (0%)	1
HEAD INJURY	10/7012 (0.1%)	10	2/7012 (0%)	2	9/7002 (0.1%)	9
INCISION SITE HAEMATOMA	2/7012 (0%)	2	2/7012 (0%)	2	2/7002 (0%)	2
INJURY	4/7012 (0.1%)	4	2/7012 (0%)	2	0/7002 (0%)	0
JOINT DISLOCATION	7/7012 (0.1%)	7	2/7012 (0%)	2	1/7002 (0%)	1
LIGAMENT INJURY	0/7012 (0%)	0	2/7012 (0%)	2	0/7002 (0%)	0
MENISCUS LESION	3/7012 (0%)	4	2/7012 (0%)	2	4/7002 (0.1%)	5
MULTIPLE INJURIES	1/7012 (0%)	1	2/7012 (0%)	2	1/7002 (0%)	1
PERIPROSTHETIC FRACTURE	1/7012 (0%)	1	2/7012 (0%)	2	0/7002 (0%)	0
POST CONCUSSION SYNDROME	0/7012 (0%)	0	2/7012 (0%)	2	0/7002 (0%)	0
PROCEDURAL PAIN	0/7012 (0%)	0	2/7012 (0%)	2	2/7002 (0%)	2
SPINAL COLUMN INJURY	1/7012 (0%)	1	2/7012 (0%)	2	0/7002 (0%)	0
SPINAL FRACTURE	4/7012 (0.1%)	4	2/7012 (0%)	2	5/7002 (0.1%)	5
SUBCUTANEOUS HAEMATOMA	1/7012 (0%)	1	2/7012 (0%)	2	0/7002 (0%)	0
TENDON RUPTURE	1/7012 (0%)	1	2/7012 (0%)	2	1/7002 (0%)	1
TIBIA FRACTURE	6/7012 (0.1%)	6	2/7012 (0%)	2	3/7002 (0%)	3
UPPER LIMB FRACTURE	7/7012 (0.1%)	7	2/7012 (0%)	2	6/7002 (0.1%)	6
WOUND	3/7012 (0%)	3	2/7012 (0%)	2	2/7002 (0%)	2
ANAPHYLACTIC TRANSFUSION REACTION	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
AORTIC INJURY	0/7012 (0%)	0	1/7012 (0%)	1	1/7002 (0%)	1
BLAST INJURY	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
BRAIN CONTUSION	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
BURNS FOURTH DEGREE	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
CHEMICAL PERITONITIS	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
CLAVICLE FRACTURE	3/7012 (0%)	3	1/7012 (0%)	1	1/7002 (0%)	1
COMPRESSION FRACTURE	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
ELECTRIC SHOCK	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
ESCHAR	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
EXCORIATION	4/7012 (0.1%)	4	1/7012 (0%)	1	0/7002 (0%)	0
EYE INJURY	0/7012 (0%)	0	1/7012 (0%)	1	1/7002 (0%)	1
FOREIGN BODY	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
FRACTURE DISPLACEMENT	0/7012 (0%)	0	1/7012 (0%)	1	1/7002 (0%)	1
IN-STENT ARTERIAL RESTENOSIS	1/7012 (0%)	1	1/7012 (0%)	1	1/7002 (0%)	2
IN-STENT CORONARY ARTERY RESTENOSIS	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
INCISIONAL HERNIA	4/7012 (0.1%)	4	1/7012 (0%)	1	1/7002 (0%)	1
INTESTINAL ANASTOMOSIS COMPLICATION	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
JAW FRACTURE	0/7012 (0%)	0	1/7012 (0%)	1	2/7002 (0%)	2
JOINT INJURY	4/7012 (0.1%)	4	1/7012 (0%)	1	1/7002 (0%)	1
LIGAMENT SPRAIN	1/7012 (0%)	1	1/7012 (0%)	1	1/7002 (0%)	1
MULTIPLE FRACTURES	3/7012 (0%)	3	1/7012 (0%)	1	1/7002 (0%)	1
MUSCLE INJURY	2/7012 (0%)	2	1/7012 (0%)	1	0/7002 (0%)	0
OVERDOSE	3/7012 (0%)	3	1/7012 (0%)	1	0/7002 (0%)	0
PERIORBITAL HAEMORRHAGE	0/7012 (0%)	0	1/7012 (0%)	1	1/7002 (0%)	1
PERIRENAL HAEMATOMA	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
PNEUMOTHORAX TRAUMATIC	0/7012 (0%)	0	1/7012 (0%)	1	1/7002 (0%)	1
POCKET EROSION	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
POSTOPERATIVE ILEUS	1/7012 (0%)	1	1/7012 (0%)	1	1/7002 (0%)	1
PROCEDURAL COMPLICATION	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
RADIATION PNEUMONITIS	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
SCAPULA FRACTURE	1/7012 (0%)	1	1/7012 (0%)	1	1/7002 (0%)	1
SHUNT MALFUNCTION	0/7012 (0%)	0	1/7012 (0%)	1	2/7002 (0%)	2
SKELETAL INJURY	1/7012 (0%)	1	1/7012 (0%)	1	0/7002 (0%)	0
SKIN INJURY	2/7012 (0%)	2	1/7012 (0%)	1	0/7002 (0%)	0
SKULL FRACTURE	2/7012 (0%)	2	1/7012 (0%)	1	1/7002 (0%)	1
TOOTH FRACTURE	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
TRAUMATIC ARTHRITIS	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
VASCULAR GRAFT OCCLUSION	1/7012 (0%)	1	1/7012 (0%)	1	3/7002 (0%)	3
VASCULAR INJURY	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
VASCULAR PSEUDOANEURYSM	2/7012 (0%)	2	1/7012 (0%)	1	4/7002 (0.1%)	4
WOUND EVISCERATION	0/7012 (0%)	0	1/7012 (0%)	1	1/7002 (0%)	1
WOUND HAEMORRHAGE	3/7012 (0%)	3	1/7012 (0%)	1	0/7002 (0%)	0
ABDOMINAL WOUND DEHISCENCE	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
AFFERENT LOOP SYNDROME	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
ANAEMIA POSTOPERATIVE	4/7012 (0.1%)	4	0/7012 (0%)	0	1/7002 (0%)	1
ANAESTHETIC COMPLICATION PULMONARY	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
ANASTOMOTIC HAEMORRHAGE	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
ANASTOMOTIC ULCER	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
ARTERIAL INJURY	3/7012 (0%)	3	0/7012 (0%)	0	0/7002 (0%)	0
ARTERIAL RESTENOSIS	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
BURNS SECOND DEGREE	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
BURNS THIRD DEGREE	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
CARBON MONOXIDE POISONING	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
CARDIAC PROCEDURE COMPLICATION	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
CARTILAGE INJURY	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
CEREBRAL HAEMORRHAGE TRAUMATIC	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
CHEST INJURY	2/7012 (0%)	2	0/7012 (0%)	0	0/7002 (0%)	0
EXTRADURAL HAEMATOMA	2/7012 (0%)	2	0/7012 (0%)	0	1/7002 (0%)	1
EYEBALL RUPTURE	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
FACE INJURY	2/7012 (0%)	2	0/7012 (0%)	0	0/7002 (0%)	0
FRACTURE	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
FRACTURED COCCYX	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
FRACTURED ISCHIUM	1/7012 (0%)	1	0/7012 (0%)	0	1/7002 (0%)	1
GALLBLADDER INJURY	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
GASTROSTOMY FAILURE	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
HAEMATURIA TRAUMATIC	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
HEAT ILLNESS	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
INCISION SITE HAEMORRHAGE	1/7012 (0%)	1	0/7012 (0%)	0	1/7002 (0%)	1
INTENTIONAL OVERDOSE	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
KIDNEY RUPTURE	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
LIMB CRUSHING INJURY	0/7012 (0%)	0	0/7012 (0%)	0	2/7002 (0%)	2
LIMB INJURY	3/7012 (0%)	3	0/7012 (0%)	0	1/7002 (0%)	1
MUSCLE RUPTURE	1/7012 (0%)	1	0/7012 (0%)	0	4/7002 (0.1%)	4
OPEN WOUND	2/7012 (0%)	2	0/7012 (0%)	0	0/7002 (0%)	0
PERIORBITAL HAEMATOMA	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
POISONING	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
POST GASTRIC SURGERY SYNDROME	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
POST LAMINECTOMY SYNDROME	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
POST-TRAUMATIC PAIN	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
POSTOPERATIVE RESPIRATORY DISTRESS	1/7012 (0%)	1	0/7012 (0%)	0	1/7002 (0%)	1
POSTPERICARDIOTOMY SYNDROME	0/7012 (0%)	0	0/7012 (0%)	0	2/7002 (0%)	2
RADIATION SKIN INJURY	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
RENAL HAEMATOMA	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
RESPIRATORY FUME INHALATION DISORDER	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
SKULL FRACTURED BASE	1/7012 (0%)	2	0/7012 (0%)	0	0/7002 (0%)	0
SOFT TISSUE INJURY	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
SPLENIC RUPTURE	1/7012 (0%)	1	0/7012 (0%)	0	1/7002 (0%)	1
STERNAL FRACTURE	4/7012 (0.1%)	4	0/7012 (0%)	0	0/7002 (0%)	0
TENDON INJURY	0/7012 (0%)	0	0/7012 (0%)	0	2/7002 (0%)	2
THERMAL BURN	0/7012 (0%)	0	0/7012 (0%)	0	2/7002 (0%)	2
TRACHEAL INJURY	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
TRANSFUSION REACTION	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
TRAUMATIC INTRACRANIAL HAEMORRHAGE	1/7012 (0%)	1	0/7012 (0%)	0	2/7002 (0%)	2
TWIDDLER'S SYNDROME	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
URINARY RETENTION POSTOPERATIVE	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
VASCULAR GRAFT COMPLICATION	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
WOUND HAEMATOMA	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
WOUND NECROSIS	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
WOUND SECRETION	1/7012 (0%)	1	0/7012 (0%)	0	1/7002 (0%)	2
Investigations
INTERNATIONAL NORMALISED RATIO INCREASED	76/7012 (1.1%)	81	14/7012 (0.2%)	14	25/7002 (0.4%)	29
HEPATIC ENZYME INCREASED	6/7012 (0.1%)	7	13/7012 (0.2%)	13	5/7002 (0.1%)	5
HAEMOGLOBIN DECREASED	11/7012 (0.2%)	12	10/7012 (0.1%)	11	7/7002 (0.1%)	11
LIVER FUNCTION TEST ABNORMAL	2/7012 (0%)	2	5/7012 (0.1%)	5	4/7002 (0.1%)	4
OCCULT BLOOD POSITIVE	3/7012 (0%)	3	3/7012 (0%)	3	5/7002 (0.1%)	5
TRANSAMINASES INCREASED	4/7012 (0.1%)	4	3/7012 (0%)	3	2/7002 (0%)	2
HAEMATOCRIT DECREASED	1/7012 (0%)	1	2/7012 (0%)	2	1/7002 (0%)	1
OCCULT BLOOD	2/7012 (0%)	2	2/7012 (0%)	2	3/7002 (0%)	3
PROSTATIC SPECIFIC ANTIGEN INCREASED	1/7012 (0%)	1	2/7012 (0%)	2	3/7002 (0%)	4
5-HYDROXYINDOLACETIC ACID INCREASED	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
ALANINE AMINOTRANSFERASE INCREASED	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
BLOOD GLUCOSE ABNORMAL	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
BLOOD GLUCOSE INCREASED	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
BLOOD POTASSIUM DECREASED	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
C-REACTIVE PROTEIN INCREASED	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
COAGULATION TIME PROLONGED	1/7012 (0%)	1	1/7012 (0%)	1	0/7002 (0%)	0
EJECTION FRACTION ABNORMAL	1/7012 (0%)	1	1/7012 (0%)	1	0/7002 (0%)	0
ELECTROCARDIOGRAM ST SEGMENT DEPRESSION	0/7012 (0%)	0	1/7012 (0%)	1	1/7002 (0%)	1
INTERNATIONAL NORMALISED RATIO DECREASED	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
SCAN MYOCARDIAL PERFUSION ABNORMAL	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
WEIGHT DECREASED	1/7012 (0%)	1	1/7012 (0%)	1	0/7002 (0%)	0
ANGIOGRAM	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
ANTICOAGULATION DRUG LEVEL ABOVE THERAPEUTIC	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
BLOOD BILIRUBIN INCREASED	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
BLOOD CREATINE PHOSPHOKINASE INCREASED	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
BLOOD CREATININE INCREASED	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
BLOOD ELECTROLYTES INCREASED	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
BLOOD OSMOLARITY DECREASED	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
BLOOD PRESSURE DECREASED	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
BLOOD PRESSURE INCREASED	2/7012 (0%)	2	0/7012 (0%)	0	2/7002 (0%)	2
BLOOD SODIUM DECREASED	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
BLOOD UREA INCREASED	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
CARDIAC OUTPUT DECREASED	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
CREATININE RENAL CLEARANCE DECREASED	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
EJECTION FRACTION DECREASED	2/7012 (0%)	2	0/7012 (0%)	0	1/7002 (0%)	1
ELECTROCARDIOGRAM QT PROLONGED	1/7012 (0%)	1	0/7012 (0%)	0	2/7002 (0%)	2
HEART RATE DECREASED	1/7012 (0%)	1	0/7012 (0%)	0	2/7002 (0%)	2
HEART RATE INCREASED	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
INTRAOCULAR PRESSURE INCREASED	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
NEUTROPHIL COUNT DECREASED	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
OXYGEN SATURATION DECREASED	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
PROTHROMBIN TIME PROLONGED	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
TROPONIN INCREASED	2/7012 (0%)	2	0/7012 (0%)	0	0/7002 (0%)	0
TUMOUR MARKER INCREASED	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
WHITE BLOOD CELL COUNT INCREASED	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
Metabolism and nutrition disorders
DEHYDRATION	33/7012 (0.5%)	33	28/7012 (0.4%)	31	42/7002 (0.6%)	45
HYPOGLYCAEMIA	16/7012 (0.2%)	18	24/7012 (0.3%)	24	16/7002 (0.2%)	17
DIABETES MELLITUS	18/7012 (0.3%)	18	21/7012 (0.3%)	21	36/7002 (0.5%)	41
HYPONATRAEMIA	16/7012 (0.2%)	17	15/7012 (0.2%)	15	13/7002 (0.2%)	13
HYPERGLYCAEMIA	2/7012 (0%)	2	11/7012 (0.2%)	11	9/7002 (0.1%)	10
DIABETES MELLITUS INADEQUATE CONTROL	7/7012 (0.1%)	7	10/7012 (0.1%)	10	15/7002 (0.2%)	18
HYPERKALAEMIA	3/7012 (0%)	3	7/7012 (0.1%)	7	15/7002 (0.2%)	17
HYPOKALAEMIA	11/7012 (0.2%)	11	6/7012 (0.1%)	6	8/7002 (0.1%)	10
GOUT	4/7012 (0.1%)	4	5/7012 (0.1%)	5	4/7002 (0.1%)	4
TYPE 2 DIABETES MELLITUS	4/7012 (0.1%)	4	5/7012 (0.1%)	5	5/7002 (0.1%)	5
DIABETIC FOOT	10/7012 (0.1%)	10	4/7012 (0.1%)	4	3/7002 (0%)	4
HYPERCALCAEMIA	1/7012 (0%)	1	3/7012 (0%)	3	0/7002 (0%)	0
DECREASED APPETITE	0/7012 (0%)	0	2/7012 (0%)	2	3/7002 (0%)	3
DIABETIC KETOACIDOSIS	1/7012 (0%)	1	2/7012 (0%)	2	3/7002 (0%)	3
FAILURE TO THRIVE	2/7012 (0%)	2	2/7012 (0%)	2	1/7002 (0%)	1
FLUID OVERLOAD	4/7012 (0.1%)	4	2/7012 (0%)	2	0/7002 (0%)	0
MALNUTRITION	2/7012 (0%)	3	2/7012 (0%)	2	1/7002 (0%)	1
METABOLIC ACIDOSIS	0/7012 (0%)	0	2/7012 (0%)	2	1/7002 (0%)	1
CACHEXIA	1/7012 (0%)	1	1/7012 (0%)	1	1/7002 (0%)	1
HYPEROSMOLAR STATE	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
HYPERVOLAEMIA	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
HYPOVOLAEMIA	2/7012 (0%)	2	1/7012 (0%)	1	4/7002 (0.1%)	4
METABOLIC DISORDER	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
SHOCK HYPOGLYCAEMIC	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
CALCIPHYLAXIS	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
DYSLIPIDAEMIA	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
ELECTROLYTE IMBALANCE	1/7012 (0%)	1	0/7012 (0%)	0	3/7002 (0%)	3
FOLATE DEFICIENCY	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
HYPERNATRAEMIA	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
HYPERURICAEMIA	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
IRON DEFICIENCY	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
LACTIC ACIDOSIS	0/7012 (0%)	0	0/7012 (0%)	0	2/7002 (0%)	2
NEUROGLYCOPENIA	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
OBESITY	1/7012 (0%)	1	0/7012 (0%)	0	2/7002 (0%)	2
VITAMIN B12 DEFICIENCY	1/7012 (0%)	1	0/7012 (0%)	0	1/7002 (0%)	2
Musculoskeletal and connective tissue disorders
OSTEOARTHRITIS	62/7012 (0.9%)	69	70/7012 (1%)	78	61/7002 (0.9%)	65
BACK PAIN	14/7012 (0.2%)	14	16/7012 (0.2%)	17	12/7002 (0.2%)	12
ARTHRITIS	6/7012 (0.1%)	6	13/7012 (0.2%)	13	10/7002 (0.1%)	11
LUMBAR SPINAL STENOSIS	11/7012 (0.2%)	12	8/7012 (0.1%)	11	9/7002 (0.1%)	10
MUSCULOSKELETAL CHEST PAIN	6/7012 (0.1%)	6	7/7012 (0.1%)	9	8/7002 (0.1%)	8
ARTHRALGIA	6/7012 (0.1%)	6	6/7012 (0.1%)	7	7/7002 (0.1%)	7
INTERVERTEBRAL DISC PROTRUSION	15/7012 (0.2%)	16	5/7012 (0.1%)	5	7/7002 (0.1%)	9
MUSCULAR WEAKNESS	4/7012 (0.1%)	4	5/7012 (0.1%)	5	3/7002 (0%)	3
MUSCULOSKELETAL PAIN	10/7012 (0.1%)	13	5/7012 (0.1%)	5	4/7002 (0.1%)	4
PAIN IN EXTREMITY	5/7012 (0.1%)	5	5/7012 (0.1%)	5	1/7002 (0%)	1
SPINAL OSTEOARTHRITIS	5/7012 (0.1%)	5	5/7012 (0.1%)	5	14/7002 (0.2%)	15
COSTOCHONDRITIS	1/7012 (0%)	1	4/7012 (0.1%)	4	0/7002 (0%)	0
HAEMARTHROSIS	7/7012 (0.1%)	7	3/7012 (0%)	3	1/7002 (0%)	1
OSTEOPOROSIS	1/7012 (0%)	1	3/7012 (0%)	3	1/7002 (0%)	1
SPINAL COLUMN STENOSIS	9/7012 (0.1%)	10	3/7012 (0%)	3	14/7002 (0.2%)	16
SYNOVIAL CYST	1/7012 (0%)	1	3/7012 (0%)	3	0/7002 (0%)	0
GOUTY ARTHRITIS	3/7012 (0%)	3	2/7012 (0%)	2	7/7002 (0.1%)	9
INTERVERTEBRAL DISC DISORDER	1/7012 (0%)	1	2/7012 (0%)	2	1/7002 (0%)	1
OSTEONECROSIS	4/7012 (0.1%)	4	2/7012 (0%)	3	0/7002 (0%)	0
POLYARTHRITIS	1/7012 (0%)	1	2/7012 (0%)	2	0/7002 (0%)	0
RHEUMATOID ARTHRITIS	4/7012 (0.1%)	4	2/7012 (0%)	2	2/7002 (0%)	2
ANKYLOSING SPONDYLITIS	0/7012 (0%)	0	1/7012 (0%)	2	0/7002 (0%)	0
ARTHROPATHY	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
AXILLARY MASS	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
BONE PAIN	1/7012 (0%)	1	1/7012 (0%)	1	1/7002 (0%)	1
BURSITIS	2/7012 (0%)	2	1/7012 (0%)	1	2/7002 (0%)	2
CERVICAL SPINAL STENOSIS	1/7012 (0%)	1	1/7012 (0%)	1	0/7002 (0%)	0
CHONDROCALCINOSIS PYROPHOSPHATE	0/7012 (0%)	0	1/7012 (0%)	1	1/7002 (0%)	1
INCLUSION BODY MYOSITIS	1/7012 (0%)	1	1/7012 (0%)	1	0/7002 (0%)	0
JOINT INSTABILITY	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
MUSCLE SPASMS	1/7012 (0%)	1	1/7012 (0%)	1	0/7002 (0%)	0
MYALGIA	3/7012 (0%)	3	1/7012 (0%)	3	3/7002 (0%)	3
MYOSITIS	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
OSTEOPOROTIC FRACTURE	1/7012 (0%)	2	1/7012 (0%)	1	0/7002 (0%)	0
PATHOLOGICAL FRACTURE	1/7012 (0%)	1	1/7012 (0%)	1	0/7002 (0%)	0
PERIARTHRITIS	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
PERIOSTITIS	1/7012 (0%)	1	1/7012 (0%)	1	1/7002 (0%)	1
POLYMYALGIA RHEUMATICA	0/7012 (0%)	0	1/7012 (0%)	1	1/7002 (0%)	1
RHABDOMYOLYSIS	4/7012 (0.1%)	4	1/7012 (0%)	1	5/7002 (0.1%)	5
ROTATOR CUFF SYNDROME	4/7012 (0.1%)	4	1/7012 (0%)	1	7/7002 (0.1%)	7
SPONDYLITIS	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
SPONDYLOARTHROPATHY	0/7012 (0%)	0	1/7012 (0%)	1	1/7002 (0%)	1
SPONDYLOLISTHESIS	1/7012 (0%)	1	1/7012 (0%)	1	3/7002 (0%)	3
SYNOVITIS	1/7012 (0%)	1	1/7012 (0%)	1	0/7002 (0%)	0
TORTICOLLIS	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
TRIGGER FINGER	2/7012 (0%)	2	1/7012 (0%)	1	1/7002 (0%)	2
ARTICULAR CALCIFICATION	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
BACK DISORDER	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
BONE CYST	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
CHONDROPATHY	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
DEFORMITY THORAX	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
DUPUYTREN'S CONTRACTURE	0/7012 (0%)	0	0/7012 (0%)	0	3/7002 (0%)	4
EXOSTOSIS	0/7012 (0%)	0	0/7012 (0%)	0	2/7002 (0%)	2
FASCIITIS	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
FISTULA	0/7012 (0%)	0	0/7012 (0%)	0	2/7002 (0%)	2
FOOT DEFORMITY	0/7012 (0%)	0	0/7012 (0%)	0	5/7002 (0.1%)	5
FRACTURE MALUNION	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
GOUTY TOPHUS	2/7012 (0%)	2	0/7012 (0%)	0	0/7002 (0%)	0
GROIN PAIN	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
INTERVERTEBRAL DISC COMPRESSION	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
INTERVERTEBRAL DISC DEGENERATION	0/7012 (0%)	0	0/7012 (0%)	0	4/7002 (0.1%)	4
JOINT EFFUSION	1/7012 (0%)	1	0/7012 (0%)	0	2/7002 (0%)	2
JOINT SWELLING	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
LATERAL PATELLAR COMPRESSION SYNDROME	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
MUSCLE ATROPHY	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
MUSCLE DISORDER	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
MUSCLE HAEMORRHAGE	1/7012 (0%)	1	0/7012 (0%)	0	5/7002 (0.1%)	5
MUSCLE TWITCHING	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
MUSCULOSKELETAL DISCOMFORT	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
MYOPATHY	1/7012 (0%)	1	0/7012 (0%)	0	1/7002 (0%)	1
NECK PAIN	2/7012 (0%)	2	0/7012 (0%)	0	2/7002 (0%)	2
NEUROPATHIC ARTHROPATHY	0/7012 (0%)	0	0/7012 (0%)	0	2/7002 (0%)	2
OSTEITIS	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
OSTEOCHONDROSIS	1/7012 (0%)	1	0/7012 (0%)	0	4/7002 (0.1%)	5
OSTEONECROSIS OF JAW	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
SCOLIOSIS	2/7012 (0%)	2	0/7012 (0%)	0	0/7002 (0%)	0
SPINAL DISORDER	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
SYMPATHETIC POSTERIOR CERVICAL SYNDROME	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
TENDONITIS	1/7012 (0%)	2	0/7012 (0%)	0	0/7002 (0%)	0
UNDIFFERENTIATED CONNECTIVE TISSUE DISEASE	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PROSTATE CANCER	32/7012 (0.5%)	32	34/7012 (0.5%)	34	34/7002 (0.5%)	34
COLON CANCER	37/7012 (0.5%)	38	29/7012 (0.4%)	29	30/7002 (0.4%)	30
BASAL CELL CARCINOMA	23/7012 (0.3%)	23	21/7012 (0.3%)	31	26/7002 (0.4%)	36
BREAST CANCER	18/7012 (0.3%)	18	18/7012 (0.3%)	18	19/7002 (0.3%)	19
LUNG NEOPLASM MALIGNANT	15/7012 (0.2%)	15	16/7012 (0.2%)	16	13/7002 (0.2%)	13
BLADDER CANCER	7/7012 (0.1%)	10	13/7012 (0.2%)	13	4/7002 (0.1%)	5
GASTRIC CANCER	15/7012 (0.2%)	15	10/7012 (0.1%)	10	12/7002 (0.2%)	12
COLON ADENOMA	1/7012 (0%)	1	9/7012 (0.1%)	9	6/7002 (0.1%)	6
LUNG ADENOCARCINOMA	8/7012 (0.1%)	8	9/7012 (0.1%)	9	6/7002 (0.1%)	6
RECTAL CANCER	7/7012 (0.1%)	7	9/7012 (0.1%)	9	7/7002 (0.1%)	7
BLADDER TRANSITIONAL CELL CARCINOMA	12/7012 (0.2%)	12	8/7012 (0.1%)	8	13/7002 (0.2%)	13
PROSTATIC ADENOMA	2/7012 (0%)	2	8/7012 (0.1%)	8	2/7002 (0%)	2
MYELODYSPLASTIC SYNDROME	1/7012 (0%)	1	7/7012 (0.1%)	7	1/7002 (0%)	1
SQUAMOUS CELL CARCINOMA	9/7012 (0.1%)	11	7/7012 (0.1%)	7	4/7002 (0.1%)	19
HEPATIC NEOPLASM MALIGNANT	7/7012 (0.1%)	9	6/7012 (0.1%)	6	8/7002 (0.1%)	8
MALIGNANT MELANOMA	7/7012 (0.1%)	7	6/7012 (0.1%)	6	6/7002 (0.1%)	6
UTERINE CANCER	3/7012 (0%)	3	6/7012 (0.1%)	6	2/7002 (0%)	2
BRONCHIAL CARCINOMA	2/7012 (0%)	2	5/7012 (0.1%)	5	0/7002 (0%)	0
ADENOCARCINOMA PANCREAS	3/7012 (0%)	3	4/7012 (0.1%)	4	4/7002 (0.1%)	4
B-CELL LYMPHOMA	2/7012 (0%)	2	4/7012 (0.1%)	4	1/7002 (0%)	1
OESOPHAGEAL ADENOCARCINOMA	1/7012 (0%)	1	4/7012 (0.1%)	4	3/7002 (0%)	3
OESOPHAGEAL CARCINOMA	3/7012 (0%)	3	4/7012 (0.1%)	4	8/7002 (0.1%)	8
PANCREATIC CARCINOMA	6/7012 (0.1%)	6	4/7012 (0.1%)	4	7/7002 (0.1%)	7
RENAL CELL CARCINOMA	2/7012 (0%)	2	4/7012 (0.1%)	4	1/7002 (0%)	1
SMALL CELL LUNG CANCER STAGE UNSPECIFIED	1/7012 (0%)	1	4/7012 (0.1%)	4	3/7002 (0%)	3
SQUAMOUS CELL CARCINOMA OF SKIN	4/7012 (0.1%)	5	4/7012 (0.1%)	4	8/7002 (0.1%)	10
TRANSITIONAL CELL CARCINOMA	4/7012 (0.1%)	4	4/7012 (0.1%)	4	5/7002 (0.1%)	5
COLORECTAL CANCER	3/7012 (0%)	3	3/7012 (0%)	3	3/7002 (0%)	3
ENDOMETRIAL CANCER	2/7012 (0%)	2	3/7012 (0%)	3	4/7002 (0.1%)	4
GASTRIC CANCER STAGE 0	1/7012 (0%)	2	3/7012 (0%)	3	1/7002 (0%)	1
GASTROINTESTINAL STROMAL TUMOUR	0/7012 (0%)	0	3/7012 (0%)	3	0/7002 (0%)	0
LIPOMA	0/7012 (0%)	0	3/7012 (0%)	3	2/7002 (0%)	2
LUNG CANCER METASTATIC	4/7012 (0.1%)	4	3/7012 (0%)	3	0/7002 (0%)	0
LUNG SQUAMOUS CELL CARCINOMA STAGE UNSPECIFIED	2/7012 (0%)	2	3/7012 (0%)	3	5/7002 (0.1%)	5
OESOPHAGEAL CANCER METASTATIC	0/7012 (0%)	0	3/7012 (0%)	3	0/7002 (0%)	0
PANCREATIC CARCINOMA METASTATIC	1/7012 (0%)	1	3/7012 (0%)	3	4/7002 (0.1%)	4
PROSTATE CANCER METASTATIC	3/7012 (0%)	3	3/7012 (0%)	3	1/7002 (0%)	1
RENAL CANCER	5/7012 (0.1%)	5	3/7012 (0%)	3	4/7002 (0.1%)	4
THYROID CANCER	2/7012 (0%)	2	3/7012 (0%)	3	1/7002 (0%)	1
ACUTE MYELOID LEUKAEMIA	4/7012 (0.1%)	4	2/7012 (0%)	2	3/7002 (0%)	3
ADENOCARCINOMA	0/7012 (0%)	0	2/7012 (0%)	2	1/7002 (0%)	1
BILE DUCT CANCER	2/7012 (0%)	2	2/7012 (0%)	2	3/7002 (0%)	3
BLADDER CANCER RECURRENT	3/7012 (0%)	3	2/7012 (0%)	2	1/7002 (0%)	1
BRAIN NEOPLASM	2/7012 (0%)	2	2/7012 (0%)	2	3/7002 (0%)	3
DIFFUSE LARGE B-CELL LYMPHOMA	3/7012 (0%)	3	2/7012 (0%)	2	1/7002 (0%)	1
FIBROADENOMA OF BREAST	0/7012 (0%)	0	2/7012 (0%)	2	0/7002 (0%)	0
GALLBLADDER CANCER	0/7012 (0%)	0	2/7012 (0%)	2	2/7002 (0%)	2
GASTRIC NEOPLASM	0/7012 (0%)	0	2/7012 (0%)	2	1/7002 (0%)	1
GASTROINTESTINAL TRACT ADENOMA	1/7012 (0%)	1	2/7012 (0%)	2	0/7002 (0%)	0
LARYNGEAL CANCER	3/7012 (0%)	3	2/7012 (0%)	2	2/7002 (0%)	2
LEIOMYOMA	0/7012 (0%)	0	2/7012 (0%)	2	0/7002 (0%)	0
LUNG ADENOCARCINOMA METASTATIC	1/7012 (0%)	2	2/7012 (0%)	2	1/7002 (0%)	1
LYMPHOMA	1/7012 (0%)	1	2/7012 (0%)	2	1/7002 (0%)	1
MENINGIOMA BENIGN	1/7012 (0%)	1	2/7012 (0%)	2	3/7002 (0%)	3
METASTASES TO LIVER	5/7012 (0.1%)	5	2/7012 (0%)	2	3/7002 (0%)	3
METASTATIC GASTRIC CANCER	2/7012 (0%)	2	2/7012 (0%)	2	2/7002 (0%)	2
NEOPLASM MALIGNANT	2/7012 (0%)	2	2/7012 (0%)	2	3/7002 (0%)	3
OVARIAN CANCER	3/7012 (0%)	3	2/7012 (0%)	2	1/7002 (0%)	1
PANCREATIC NEOPLASM	1/7012 (0%)	1	2/7012 (0%)	2	0/7002 (0%)	0
PARATHYROID TUMOUR BENIGN	0/7012 (0%)	0	2/7012 (0%)	2	0/7002 (0%)	0
PLASMACYTOMA	0/7012 (0%)	0	2/7012 (0%)	2	0/7002 (0%)	0
SKIN CANCER	4/7012 (0.1%)	4	2/7012 (0%)	2	3/7002 (0%)	3
URETERIC CANCER	0/7012 (0%)	0	2/7012 (0%)	2	1/7002 (0%)	1
UTERINE LEIOMYOMA	1/7012 (0%)	1	2/7012 (0%)	2	2/7002 (0%)	2
ABDOMINAL NEOPLASM	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
ACUTE PROMYELOCYTIC LEUKAEMIA	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
ANGIOSARCOMA	1/7012 (0%)	1	1/7012 (0%)	1	0/7002 (0%)	0
BENIGN DUODENAL NEOPLASM	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
BENIGN GASTRIC NEOPLASM	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
BENIGN LUNG NEOPLASM	1/7012 (0%)	1	1/7012 (0%)	1	2/7002 (0%)	2
BENIGN NEOPLASM OF ADRENAL GLAND	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
BENIGN NEOPLASM OF BLADDER	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
BENIGN NEOPLASM OF PROSTATE	1/7012 (0%)	1	1/7012 (0%)	1	0/7002 (0%)	0
BENIGN NEOPLASM OF URETHRA	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
BENIGN PANCREATIC NEOPLASM	1/7012 (0%)	1	1/7012 (0%)	1	0/7002 (0%)	0
BENIGN SALIVARY GLAND NEOPLASM	3/7012 (0%)	3	1/7012 (0%)	1	1/7002 (0%)	1
BENIGN URINARY TRACT NEOPLASM	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
BILIARY NEOPLASM	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
BLADDER NEOPLASM	2/7012 (0%)	2	1/7012 (0%)	1	1/7002 (0%)	1
BONE CANCER METASTATIC	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
BONE GIANT CELL TUMOUR BENIGN	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
BREAST CANCER STAGE II	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
BREAST NEOPLASM	1/7012 (0%)	1	1/7012 (0%)	1	0/7002 (0%)	0
BRONCHIAL NEOPLASM	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
COLON CANCER METASTATIC	2/7012 (0%)	2	1/7012 (0%)	1	0/7002 (0%)	0
FOLLICLE CENTRE LYMPHOMA, FOLLICULAR GRADE I, II, III STAGE III	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
GASTRIC CANCER STAGE II	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
GASTROINTESTINAL CARCINOMA	1/7012 (0%)	1	1/7012 (0%)	1	1/7002 (0%)	1
GLIOBLASTOMA	0/7012 (0%)	0	1/7012 (0%)	1	1/7002 (0%)	1
HAEMANGIOMA OF SKIN	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
HEAD AND NECK CANCER	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
HEPATIC CANCER METASTATIC	2/7012 (0%)	3	1/7012 (0%)	1	1/7002 (0%)	1
HEPATIC NEOPLASM	1/7012 (0%)	1	1/7012 (0%)	1	1/7002 (0%)	1
HODGKIN'S DISEASE	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
HYPOPHARYNGEAL CANCER	0/7012 (0%)	0	1/7012 (0%)	1	1/7002 (0%)	1
INTRADUCTAL PAPILLOMA OF BREAST	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
IRITIC MELANOMA	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
KERATOACANTHOMA	1/7012 (0%)	1	1/7012 (0%)	1	0/7002 (0%)	0
LARGE INTESTINE CARCINOMA	0/7012 (0%)	0	1/7012 (0%)	1	1/7002 (0%)	1
LARYNGEAL PAPILLOMA	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
LIP AND/OR ORAL CAVITY CANCER	1/7012 (0%)	1	1/7012 (0%)	1	1/7002 (0%)	1
LUNG ADENOCARCINOMA STAGE IV	0/7012 (0%)	0	1/7012 (0%)	1	1/7002 (0%)	1
LUNG CARCINOMA CELL TYPE UNSPECIFIED STAGE III	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
LUNG NEOPLASM	0/7012 (0%)	0	1/7012 (0%)	1	4/7002 (0.1%)	4
LYMPHANGIOSIS CARCINOMATOSA	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
LYMPHOPLASMACYTOID LYMPHOMA/IMMUNOCYTOMA	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
MALIGNANT NEOPLASM OF PLEURA	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
MALIGNANT PALATE NEOPLASM	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
MALIGNANT PLEURAL EFFUSION	0/7012 (0%)	0	1/7012 (0%)	1	2/7002 (0%)	2
MANTLE CELL LYMPHOMA	1/7012 (0%)	1	1/7012 (0%)	1	0/7002 (0%)	0
MELANOMA RECURRENT	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
MENINGIOMA	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
MESOTHELIOMA	2/7012 (0%)	2	1/7012 (0%)	1	2/7002 (0%)	2
METASTASES TO BONE	0/7012 (0%)	0	1/7012 (0%)	1	3/7002 (0%)	3
METASTASES TO CENTRAL NERVOUS SYSTEM	1/7012 (0%)	1	1/7012 (0%)	1	0/7002 (0%)	0
METASTATIC BRONCHIAL CARCINOMA	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
METASTATIC MALIGNANT MELANOMA	2/7012 (0%)	3	1/7012 (0%)	1	0/7002 (0%)	0
METASTATIC PAIN	0/7012 (0%)	0	1/7012 (0%)	1	1/7002 (0%)	1
METASTATIC SQUAMOUS CELL CARCINOMA	1/7012 (0%)	1	1/7012 (0%)	1	2/7002 (0%)	2
NEOPLASM PROSTATE	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
NEUROENDOCRINE TUMOUR	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
NON-HODGKIN'S LYMPHOMA	4/7012 (0.1%)	4	1/7012 (0%)	1	1/7002 (0%)	1
NON-HODGKIN'S LYMPHOMA STAGE I	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
NON-SMALL CELL LUNG CANCER	2/7012 (0%)	2	1/7012 (0%)	1	2/7002 (0%)	2
NON-SMALL CELL LUNG CANCER STAGE I	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
OESOPHAGEAL ADENOCARCINOMA METASTATIC	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
OESOPHAGEAL ADENOCARCINOMA STAGE II	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
OESOPHAGEAL SQUAMOUS CELL CARCINOMA	0/7012 (0%)	0	1/7012 (0%)	1	1/7002 (0%)	1
ORAL PAPILLOMA	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
OVARIAN NEOPLASM	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
PARANEOPLASTIC SYNDROME	1/7012 (0%)	1	1/7012 (0%)	1	0/7002 (0%)	0
PARATHYROID TUMOUR MALIGNANT	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
PHARYNGEAL NEOPLASM	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
RECTAL CANCER STAGE I	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
RECTOSIGMOID CANCER	1/7012 (0%)	1	1/7012 (0%)	1	1/7002 (0%)	1
RENAL ADENOMA	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
SEBORRHOEIC KERATOSIS	1/7012 (0%)	1	1/7012 (0%)	1	1/7002 (0%)	1
SINONASAL PAPILLOMA	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
SMALL INTESTINE CARCINOMA	1/7012 (0%)	1	1/7012 (0%)	1	1/7002 (0%)	1
THYROID ADENOMA	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
TUMOUR HAEMORRHAGE	2/7012 (0%)	2	1/7012 (0%)	1	2/7002 (0%)	2
URINARY TRACT NEOPLASM	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
ACUTE LYMPHOCYTIC LEUKAEMIA	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
ADRENAL CARCINOMA	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
ANGIOSARCOMA METASTATIC	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
BENIGN BILIARY NEOPLASM	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
BENIGN BREAST NEOPLASM	2/7012 (0%)	2	0/7012 (0%)	0	1/7002 (0%)	1
BENIGN COLONIC NEOPLASM	0/7012 (0%)	0	0/7012 (0%)	0	3/7002 (0%)	3
BENIGN NEOPLASM	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	2
BENIGN NEOPLASM OF CERVIX UTERI	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
BENIGN NEOPLASM OF SKIN	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
BENIGN NEOPLASM OF THYROID GLAND	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
BENIGN PENILE NEOPLASM	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
BENIGN RENAL NEOPLASM	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
BLADDER PAPILLOMA	1/7012 (0%)	1	0/7012 (0%)	0	1/7002 (0%)	1
BLADDER TRANSITIONAL CELL CARCINOMA RECURRENT	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
BONE NEOPLASM	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
BONE NEOPLASM MALIGNANT	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
BOWEN'S DISEASE	1/7012 (0%)	1	0/7012 (0%)	0	1/7002 (0%)	1
BRAIN NEOPLASM MALIGNANT	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
BREAST CANCER METASTATIC	3/7012 (0%)	3	0/7012 (0%)	0	2/7002 (0%)	2
BREAST CANCER STAGE I	1/7012 (0%)	1	0/7012 (0%)	0	1/7002 (0%)	1
BRONCHIOLOALVEOLAR CARCINOMA	1/7012 (0%)	1	0/7012 (0%)	0	1/7002 (0%)	1
CANCER PAIN	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
CARCINOID TUMOUR OF THE DUODENUM	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
CARCINOID TUMOUR PULMONARY	0/7012 (0%)	0	0/7012 (0%)	0	2/7002 (0%)	2
CARDIAC MYXOMA	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
CENTRAL NERVOUS SYSTEM LYMPHOMA	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
CEREBELLAR TUMOUR	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
CERVIX CARCINOMA	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
CHOLESTEATOMA	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
CHRONIC LYMPHOCYTIC LEUKAEMIA	2/7012 (0%)	2	0/7012 (0%)	0	3/7002 (0%)	3
CHRONIC MYELOID LEUKAEMIA	1/7012 (0%)	1	0/7012 (0%)	0	1/7002 (0%)	1
COLON CANCER RECURRENT	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
COLON CANCER STAGE II	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
COLON NEOPLASM	2/7012 (0%)	2	0/7012 (0%)	0	3/7002 (0%)	3
ESSENTIAL THROMBOCYTHAEMIA	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
FOLLICLE CENTRE LYMPHOMA, FOLLICULAR GRADE I, II, III	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
FOLLICLE CENTRE LYMPHOMA, FOLLICULAR GRADE I, II, III STAGE II	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
GASTRIC ADENOMA	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
GENITOURINARY TRACT NEOPLASM	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
GLIOBLASTOMA MULTIFORME	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
GLIOMA	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
HAEMANGIOMA	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
INTESTINAL ADENOCARCINOMA	1/7012 (0%)	1	0/7012 (0%)	0	2/7002 (0%)	2
LARGE CELL CARCINOMA OF THE RESPIRATORY TRACT STAGE UNSPECIFIED	2/7012 (0%)	2	0/7012 (0%)	0	0/7002 (0%)	0
LARYNGEAL NEOPLASM	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
LENTIGO MALIGNA STAGE UNSPECIFIED	1/7012 (0%)	1	0/7012 (0%)	0	1/7002 (0%)	1
LUNG CARCINOMA CELL TYPE UNSPECIFIED STAGE IV	2/7012 (0%)	2	0/7012 (0%)	0	0/7002 (0%)	0
LUNG INFILTRATION MALIGNANT	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
LUNG SQUAMOUS CELL CARCINOMA METASTATIC	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
LUNG SQUAMOUS CELL CARCINOMA STAGE I	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
LUNG SQUAMOUS CELL CARCINOMA STAGE III	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
LYMPHOCYTIC LYMPHOMA	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
MALIGNANT ASCITES	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
MALIGNANT MELANOMA IN SITU	2/7012 (0%)	2	0/7012 (0%)	0	0/7002 (0%)	0
MALIGNANT MESENCHYMOMA	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
MALIGNANT NEOPLASM OF AMPULLA OF VATER	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
MALIGNANT NEOPLASM OF RENAL PELVIS	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
MALIGNANT PERITONEAL NEOPLASM	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
METASTASES TO GALLBLADDER	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
METASTASES TO LARGE INTESTINE	1/7012 (0%)	1	0/7012 (0%)	0	1/7002 (0%)	1
METASTASES TO LUNG	2/7012 (0%)	2	0/7012 (0%)	0	2/7002 (0%)	2
METASTASES TO PERITONEUM	0/7012 (0%)	0	0/7012 (0%)	0	2/7002 (0%)	2
METASTASES TO SPINE	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
METASTATIC LYMPHOMA	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
METASTATIC NEOPLASM	2/7012 (0%)	2	0/7012 (0%)	0	0/7002 (0%)	0
MULTIPLE MYELOMA	6/7012 (0.1%)	6	0/7012 (0%)	0	3/7002 (0%)	3
NASAL CAVITY CANCER	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
NASOPHARYNGEAL CANCER	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
NEOPLASM	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
NEOPLASM SKIN	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
NEUROENDOCRINE CARCINOMA OF THE SKIN	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
NON-SMALL CELL LUNG CANCER METASTATIC	1/7012 (0%)	1	0/7012 (0%)	0	1/7002 (0%)	1
OVARIAN ADENOMA	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
PENIS CARCINOMA RECURRENT	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
PITUITARY TUMOUR BENIGN	1/7012 (0%)	1	0/7012 (0%)	0	2/7002 (0%)	2
RECTAL ADENOMA	0/7012 (0%)	0	0/7012 (0%)	0	2/7002 (0%)	2
RECTAL NEOPLASM	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
REFRACTORY CYTOPENIA WITH MULTILINEAGE DYSPLASIA	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
RENAL CANCER METASTATIC	1/7012 (0%)	1	0/7012 (0%)	0	2/7002 (0%)	2
RENAL CANCER STAGE II	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
RENAL NEOPLASM	2/7012 (0%)	2	0/7012 (0%)	0	0/7002 (0%)	0
RENAL ONCOCYTOMA	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
RETROPERITONEAL CANCER	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
SALIVARY GLAND ADENOMA	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
SARCOMA	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
SARCOMA OF SKIN	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
SMALL CELL CARCINOMA	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
SPINAL HAEMANGIOMA	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
TESTIS CANCER	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
TONGUE NEOPLASM MALIGNANT STAGE UNSPECIFIED	0/7012 (0%)	0	0/7012 (0%)	0	2/7002 (0%)	2
TONSIL CANCER	1/7012 (0%)	1	0/7012 (0%)	0	1/7002 (0%)	1
UNDIFFERENTIATED SARCOMA	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
URETERAL NEOPLASM	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
URETHRAL CANCER METASTATIC	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
UTERINE LEIOMYOSARCOMA	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
VULVAL CANCER	2/7012 (0%)	2	0/7012 (0%)	0	0/7002 (0%)	0
VULVAL CANCER METASTATIC	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
VULVAL CANCER RECURRENT	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
Nervous system disorders
CEREBROVASCULAR ACCIDENT	88/7012 (1.3%)	94	104/7012 (1.5%)	111	125/7002 (1.8%)	138
TRANSIENT ISCHAEMIC ATTACK	74/7012 (1.1%)	81	85/7012 (1.2%)	97	107/7002 (1.5%)	125
ISCHAEMIC STROKE	95/7012 (1.4%)	105	83/7012 (1.2%)	85	141/7002 (2%)	152
SYNCOPE	65/7012 (0.9%)	68	53/7012 (0.8%)	55	64/7002 (0.9%)	65
CEREBRAL INFARCTION	21/7012 (0.3%)	22	30/7012 (0.4%)	33	45/7002 (0.6%)	51
CEREBRAL HAEMORRHAGE	32/7012 (0.5%)	33	23/7012 (0.3%)	23	11/7002 (0.2%)	11
DIZZINESS	12/7012 (0.2%)	13	15/7012 (0.2%)	15	15/7002 (0.2%)	17
HAEMORRHAGE INTRACRANIAL	36/7012 (0.5%)	37	13/7012 (0.2%)	14	12/7002 (0.2%)	12
CAROTID ARTERY STENOSIS	13/7012 (0.2%)	13	12/7012 (0.2%)	12	12/7002 (0.2%)	12
PRESYNCOPE	10/7012 (0.1%)	10	12/7012 (0.2%)	12	15/7002 (0.2%)	15
CONVULSION	12/7012 (0.2%)	12	11/7012 (0.2%)	12	12/7002 (0.2%)	14
SUBARACHNOID HAEMORRHAGE	17/7012 (0.2%)	17	11/7012 (0.2%)	13	3/7002 (0%)	3
DEMENTIA	10/7012 (0.1%)	10	8/7012 (0.1%)	8	1/7002 (0%)	1
HAEMORRHAGIC STROKE	20/7012 (0.3%)	22	8/7012 (0.1%)	8	6/7002 (0.1%)	7
GRAND MAL CONVULSION	2/7012 (0%)	2	5/7012 (0.1%)	5	5/7002 (0.1%)	5
VERTEBROBASILAR INSUFFICIENCY	10/7012 (0.1%)	12	5/7012 (0.1%)	6	4/7002 (0.1%)	5
CEREBRAL ISCHAEMIA	6/7012 (0.1%)	6	4/7012 (0.1%)	5	4/7002 (0.1%)	4
EMBOLIC STROKE	8/7012 (0.1%)	9	4/7012 (0.1%)	4	5/7002 (0.1%)	5
EPILEPSY	14/7012 (0.2%)	16	4/7012 (0.1%)	10	14/7002 (0.2%)	15
HEADACHE	5/7012 (0.1%)	5	4/7012 (0.1%)	4	3/7002 (0%)	3
HEMIPARESIS	2/7012 (0%)	2	4/7012 (0.1%)	4	1/7002 (0%)	1
LOSS OF CONSCIOUSNESS	7/7012 (0.1%)	7	4/7012 (0.1%)	4	1/7002 (0%)	1
VASCULAR ENCEPHALOPATHY	4/7012 (0.1%)	4	4/7012 (0.1%)	5	5/7002 (0.1%)	5
BRAIN STEM INFARCTION	1/7012 (0%)	1	3/7012 (0%)	3	0/7002 (0%)	0
COMPLEX PARTIAL SEIZURES	0/7012 (0%)	0	3/7012 (0%)	3	2/7002 (0%)	2
DEMENTIA ALZHEIMER'S TYPE	1/7012 (0%)	1	3/7012 (0%)	3	1/7002 (0%)	1
HYPOXIC-ISCHAEMIC ENCEPHALOPATHY	2/7012 (0%)	2	3/7012 (0%)	3	2/7002 (0%)	2
LACUNAR INFARCTION	7/7012 (0.1%)	7	3/7012 (0%)	3	6/7002 (0.1%)	8
RADICULOPATHY	0/7012 (0%)	0	3/7012 (0%)	3	1/7002 (0%)	2
THALAMUS HAEMORRHAGE	2/7012 (0%)	2	3/7012 (0%)	3	2/7002 (0%)	2
AMNESIA	1/7012 (0%)	1	2/7012 (0%)	2	0/7002 (0%)	0
BRAIN STEM HAEMORRHAGE	2/7012 (0%)	2	2/7012 (0%)	2	1/7002 (0%)	1
BRAIN STEM STROKE	0/7012 (0%)	0	2/7012 (0%)	2	0/7002 (0%)	0
CAROTID ARTERY DISEASE	0/7012 (0%)	0	2/7012 (0%)	2	1/7002 (0%)	1
CEREBELLAR HAEMORRHAGE	1/7012 (0%)	1	2/7012 (0%)	2	0/7002 (0%)	0
CEREBELLAR INFARCTION	6/7012 (0.1%)	6	2/7012 (0%)	2	4/7002 (0.1%)	4
CEREBRAL ARTERIOSCLEROSIS	1/7012 (0%)	1	2/7012 (0%)	2	2/7002 (0%)	2
CEREBROVASCULAR DISORDER	3/7012 (0%)	3	2/7012 (0%)	2	3/7002 (0%)	3
DIABETIC NEUROPATHY	3/7012 (0%)	3	2/7012 (0%)	2	1/7002 (0%)	1
ENCEPHALOPATHY	5/7012 (0.1%)	7	2/7012 (0%)	2	2/7002 (0%)	2
INTERCOSTAL NEURALGIA	0/7012 (0%)	0	2/7012 (0%)	2	0/7002 (0%)	0
METABOLIC ENCEPHALOPATHY	3/7012 (0%)	3	2/7012 (0%)	2	0/7002 (0%)	0
PARKINSONISM	0/7012 (0%)	0	2/7012 (0%)	2	2/7002 (0%)	2
PERIPHERAL SENSORIMOTOR NEUROPATHY	2/7012 (0%)	2	2/7012 (0%)	2	0/7002 (0%)	0
SCIATICA	5/7012 (0.1%)	5	2/7012 (0%)	2	4/7002 (0.1%)	4
THROMBOTIC CEREBRAL INFARCTION	1/7012 (0%)	1	2/7012 (0%)	2	0/7002 (0%)	0
TRANSIENT GLOBAL AMNESIA	0/7012 (0%)	0	2/7012 (0%)	2	0/7002 (0%)	0
VIITH NERVE PARALYSIS	2/7012 (0%)	2	2/7012 (0%)	2	3/7002 (0%)	3
AMNESTIC DISORDER	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
AMYOTROPHIC LATERAL SCLEROSIS	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
APHASIA	2/7012 (0%)	2	1/7012 (0%)	1	1/7002 (0%)	1
ASTERIXIS	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
ATAXIA	1/7012 (0%)	1	1/7012 (0%)	1	0/7002 (0%)	0
BASILAR ARTERY THROMBOSIS	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
BRAIN INJURY	1/7012 (0%)	1	1/7012 (0%)	1	3/7002 (0%)	3
BRAIN MASS	1/7012 (0%)	1	1/7012 (0%)	1	0/7002 (0%)	0
BRAIN STEM ISCHAEMIA	0/7012 (0%)	0	1/7012 (0%)	1	1/7002 (0%)	1
CAROTID ARTERY OCCLUSION	0/7012 (0%)	0	1/7012 (0%)	1	1/7002 (0%)	1
CAROTID SINUS SYNDROME	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
CARPAL TUNNEL SYNDROME	3/7012 (0%)	4	1/7012 (0%)	1	2/7002 (0%)	2
CENTRAL NERVOUS SYSTEM LESION	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
CEREBELLAR ATAXIA	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
CEREBRAL ARTERY OCCLUSION	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
CEREBRAL ATROPHY	1/7012 (0%)	1	1/7012 (0%)	1	0/7002 (0%)	0
CEREBRAL CIRCULATORY FAILURE	0/7012 (0%)	0	1/7012 (0%)	1	3/7002 (0%)	3
CEREBRAL HAEMATOMA	2/7012 (0%)	2	1/7012 (0%)	1	0/7002 (0%)	0
CERVICOBRACHIAL SYNDROME	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
CLUSTER HEADACHE	1/7012 (0%)	1	1/7012 (0%)	1	0/7002 (0%)	0
COGNITIVE DISORDER	0/7012 (0%)	0	1/7012 (0%)	1	1/7002 (0%)	1
COMA	0/7012 (0%)	0	1/7012 (0%)	1	2/7002 (0%)	2
COMA HEPATIC	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
DRUG WITHDRAWAL CONVULSIONS	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
DYSARTHRIA	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
ENCEPHALOMALACIA	1/7012 (0%)	1	1/7012 (0%)	1	0/7002 (0%)	0
FACIAL PARESIS	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
HEPATIC ENCEPHALOPATHY	1/7012 (0%)	1	1/7012 (0%)	3	0/7002 (0%)	0
HYPERTENSIVE ENCEPHALOPATHY	1/7012 (0%)	1	1/7012 (0%)	1	4/7002 (0.1%)	4
HYPOAESTHESIA	1/7012 (0%)	1	1/7012 (0%)	1	0/7002 (0%)	0
HYPOGLYCAEMIC COMA	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
MIGRAINE WITH AURA	1/7012 (0%)	1	1/7012 (0%)	1	0/7002 (0%)	0
MONONEUROPATHY MULTIPLEX	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
MOTOR NEURONE DISEASE	1/7012 (0%)	1	1/7012 (0%)	1	0/7002 (0%)	0
MYELOPATHY	2/7012 (0%)	2	1/7012 (0%)	1	0/7002 (0%)	0
NARCOLEPSY	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
NERVE COMPRESSION	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
NEURALGIA	1/7012 (0%)	1	1/7012 (0%)	1	0/7002 (0%)	0
NEURITIS	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
NEUROPATHY PERIPHERAL	0/7012 (0%)	0	1/7012 (0%)	2	0/7002 (0%)	0
PARKINSON'S DISEASE	3/7012 (0%)	4	1/7012 (0%)	1	3/7002 (0%)	4
PARTIAL SEIZURES	1/7012 (0%)	1	1/7012 (0%)	1	0/7002 (0%)	0
PARTIAL SEIZURES WITH SECONDARY GENERALISATION	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
PUTAMEN HAEMORRHAGE	1/7012 (0%)	1	1/7012 (0%)	1	0/7002 (0%)	0
RADICULAR PAIN	1/7012 (0%)	1	1/7012 (0%)	1	0/7002 (0%)	0
RADICULAR SYNDROME	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
RADICULITIS LUMBOSACRAL	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
SOMNOLENCE	1/7012 (0%)	1	1/7012 (0%)	1	1/7002 (0%)	1
SPINAL CORD DISORDER	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
THROMBOTIC STROKE	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
TRIGEMINAL NEURALGIA	3/7012 (0%)	3	1/7012 (0%)	1	0/7002 (0%)	0
ULNAR NERVE PALSY	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
UNRESPONSIVE TO STIMULI	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
VASCULAR DEMENTIA	4/7012 (0.1%)	4	1/7012 (0%)	1	0/7002 (0%)	0
VERTIGO CNS ORIGIN	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
ACOUSTIC NEURITIS	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
AKINESIA	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
ALCOHOL INDUCED PERSISTING DEMENTIA	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
ALTERED STATE OF CONSCIOUSNESS	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
BALANCE DISORDER	2/7012 (0%)	2	0/7012 (0%)	0	1/7002 (0%)	1
BASAL GANGLIA HAEMORRHAGE	2/7012 (0%)	2	0/7012 (0%)	0	1/7002 (0%)	1
BRACHIAL PLEXOPATHY	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
BRAIN OEDEMA	1/7012 (0%)	1	0/7012 (0%)	0	2/7002 (0%)	2
CAROTID ARTERIOSCLEROSIS	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
CAROTID ARTERY THROMBOSIS	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
CAUDA EQUINA SYNDROME	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
CEREBELLAR ISCHAEMIA	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
CEREBELLAR SYNDROME	0/7012 (0%)	0	0/7012 (0%)	0	2/7002 (0%)	2
CEREBRAL AMYLOID ANGIOPATHY	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
CEREBRAL ARTERY EMBOLISM	3/7012 (0%)	3	0/7012 (0%)	0	3/7002 (0%)	3
CEREBRAL HYPOPERFUSION	0/7012 (0%)	0	0/7012 (0%)	0	2/7002 (0%)	2
CEREBRAL THROMBOSIS	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
CEREBROVASCULAR INSUFFICIENCY	3/7012 (0%)	3	0/7012 (0%)	0	3/7002 (0%)	3
CERVICAL CORD COMPRESSION	2/7012 (0%)	2	0/7012 (0%)	0	0/7002 (0%)	0
CERVICAL MYELOPATHY	1/7012 (0%)	1	0/7012 (0%)	0	1/7002 (0%)	1
CRITICAL ILLNESS POLYNEUROPATHY	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
CUBITAL TUNNEL SYNDROME	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
DEMENTIA WITH LEWY BODIES	2/7012 (0%)	2	0/7012 (0%)	0	0/7002 (0%)	0
DEMYELINATING POLYNEUROPATHY	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
DEPRESSED LEVEL OF CONSCIOUSNESS	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
EMBOLIC CEREBRAL INFARCTION	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
ENCEPHALITIS	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
ESSENTIAL TREMOR	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
GUILLAIN-BARRE SYNDROME	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
HAEMORRHAGIC CEREBRAL INFARCTION	2/7012 (0%)	2	0/7012 (0%)	0	3/7002 (0%)	3
HAEMORRHAGIC TRANSFORMATION STROKE	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
HYDROCEPHALUS	1/7012 (0%)	1	0/7012 (0%)	0	2/7002 (0%)	2
HYPERCAPNIC ENCEPHALOPATHY	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
HYPOKINESIA	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
HYPONATRAEMIC ENCEPHALOPATHY	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
IIIRD NERVE PARALYSIS	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
INTRACRANIAL ANEURYSM	1/7012 (0%)	1	0/7012 (0%)	0	1/7002 (0%)	1
INTRACRANIAL HAEMATOMA	1/7012 (0%)	2	0/7012 (0%)	0	0/7002 (0%)	0
INTRAVENTRICULAR HAEMORRHAGE	1/7012 (0%)	1	0/7012 (0%)	0	2/7002 (0%)	2
ISCHAEMIC CEREBRAL INFARCTION	3/7012 (0%)	3	0/7012 (0%)	0	5/7002 (0.1%)	5
ISCHAEMIC NEUROPATHY	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
LATERAL MEDULLARY SYNDROME	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
LUMBAR RADICULOPATHY	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
MIGRAINE	1/7012 (0%)	1	0/7012 (0%)	0	2/7002 (0%)	2
MONOPARESIS	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
MYASTHENIA GRAVIS	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
NEUROLOGICAL SYMPTOM	1/7012 (0%)	1	0/7012 (0%)	0	1/7002 (0%)	1
NEUROMYOPATHY	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
NORMAL PRESSURE HYDROCEPHALUS	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
OPTIC NEURITIS	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
ORTHOSTATIC INTOLERANCE	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
PARAESTHESIA	1/7012 (0%)	1	0/7012 (0%)	0	1/7002 (0%)	1
PARAPLEGIA	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
PHRENIC NERVE PARALYSIS	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
POLYNEUROPATHY	2/7012 (0%)	2	0/7012 (0%)	0	2/7002 (0%)	2
POST-TRAUMATIC EPILEPSY	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
REVERSIBLE ISCHAEMIC NEUROLOGICAL DEFICIT	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
SENILE DEMENTIA	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
SIMPLE PARTIAL SEIZURES	1/7012 (0%)	2	0/7012 (0%)	0	0/7002 (0%)	0
SPEECH DISORDER	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
SPINAL HAEMATOMA	2/7012 (0%)	2	0/7012 (0%)	0	0/7002 (0%)	0
STATUS EPILEPTICUS	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	3
SUBDURAL HYGROMA	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
TENSION HEADACHE	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
TREMOR	0/7012 (0%)	0	0/7012 (0%)	0	3/7002 (0%)	3
VOCAL CORD PARALYSIS	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
Psychiatric disorders
MENTAL STATUS CHANGES	7/7012 (0.1%)	7	12/7012 (0.2%)	13	8/7002 (0.1%)	8
DEPRESSION	5/7012 (0.1%)	5	11/7012 (0.2%)	12	12/7002 (0.2%)	12
ANXIETY	4/7012 (0.1%)	4	8/7012 (0.1%)	9	0/7002 (0%)	0
DELIRIUM	2/7012 (0%)	2	8/7012 (0.1%)	9	4/7002 (0.1%)	5
CONFUSIONAL STATE	6/7012 (0.1%)	7	6/7012 (0.1%)	6	5/7002 (0.1%)	5
ALCOHOL ABUSE	0/7012 (0%)	0	3/7012 (0%)	3	0/7002 (0%)	0
COMPLETED SUICIDE	2/7012 (0%)	2	3/7012 (0%)	3	1/7002 (0%)	1
PSYCHOTIC DISORDER	0/7012 (0%)	0	3/7012 (0%)	3	1/7002 (0%)	1
ANXIETY DISORDER	0/7012 (0%)	0	2/7012 (0%)	2	0/7002 (0%)	0
SUICIDE ATTEMPT	4/7012 (0.1%)	4	2/7012 (0%)	2	1/7002 (0%)	1
AGITATION	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
ALCOHOLISM	0/7012 (0%)	0	1/7012 (0%)	1	1/7002 (0%)	1
DEPRESSED MOOD	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
EMOTIONAL DISTRESS	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
HALLUCINATION	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
INTENTIONAL SELF-INJURY	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
MENTAL DISORDER	0/7012 (0%)	0	1/7012 (0%)	2	0/7002 (0%)	0
SUICIDAL IDEATION	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
ACUTE PSYCHOSIS	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
ACUTE STRESS DISORDER	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
AGGRESSION	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
BIPOLAR DISORDER	1/7012 (0%)	1	0/7012 (0%)	0	1/7002 (0%)	1
BURNOUT SYNDROME	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
DELIRIUM TREMENS	3/7012 (0%)	3	0/7012 (0%)	0	0/7002 (0%)	0
DEPRESSION SUICIDAL	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
DISORIENTATION	1/7012 (0%)	1	0/7012 (0%)	0	1/7002 (0%)	1
DRUG ABUSE	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
DRUG DEPENDENCE	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
DYSPHORIA	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
GENERALISED ANXIETY DISORDER	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
MAJOR DEPRESSION	2/7012 (0%)	2	0/7012 (0%)	0	3/7002 (0%)	3
MENTAL DISORDER DUE TO A GENERAL MEDICAL CONDITION	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
PANIC ATTACK	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
PANIC DISORDER	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
PSYCHOSOMATIC DISEASE	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
SCHIZOPHRENIA	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
Renal and urinary disorders
HAEMATURIA	64/7012 (0.9%)	67	68/7012 (1%)	71	57/7002 (0.8%)	60
RENAL FAILURE ACUTE	63/7012 (0.9%)	68	53/7012 (0.8%)	56	62/7002 (0.9%)	67
RENAL FAILURE	29/7012 (0.4%)	30	29/7012 (0.4%)	30	16/7002 (0.2%)	17
NEPHROLITHIASIS	7/7012 (0.1%)	8	17/7012 (0.2%)	19	7/7002 (0.1%)	8
RENAL FAILURE CHRONIC	14/7012 (0.2%)	15	13/7012 (0.2%)	14	12/7002 (0.2%)	14
CALCULUS URETERIC	2/7012 (0%)	2	9/7012 (0.1%)	9	8/7002 (0.1%)	8
URINARY RETENTION	3/7012 (0%)	3	7/7012 (0.1%)	7	9/7002 (0.1%)	9
CALCULUS URINARY	4/7012 (0.1%)	4	6/7012 (0.1%)	7	2/7002 (0%)	2
RENAL IMPAIRMENT	7/7012 (0.1%)	8	6/7012 (0.1%)	6	13/7002 (0.2%)	15
ACUTE PRERENAL FAILURE	5/7012 (0.1%)	5	5/7012 (0.1%)	5	0/7002 (0%)	0
RENAL CYST	1/7012 (0%)	1	4/7012 (0.1%)	5	2/7002 (0%)	2
URETHRAL STENOSIS	4/7012 (0.1%)	4	4/7012 (0.1%)	4	2/7002 (0%)	2
CALCULUS BLADDER	3/7012 (0%)	3	3/7012 (0%)	3	1/7002 (0%)	1
DIABETIC NEPHROPATHY	1/7012 (0%)	1	3/7012 (0%)	3	1/7002 (0%)	1
RENAL ARTERY STENOSIS	0/7012 (0%)	0	3/7012 (0%)	3	2/7002 (0%)	2
STAG HORN CALCULUS	0/7012 (0%)	0	3/7012 (0%)	3	0/7002 (0%)	0
RENAL COLIC	2/7012 (0%)	2	2/7012 (0%)	2	3/7002 (0%)	3
RENAL INFARCT	0/7012 (0%)	0	2/7012 (0%)	2	0/7002 (0%)	0
URINARY INCONTINENCE	3/7012 (0%)	3	2/7012 (0%)	2	1/7002 (0%)	2
AZOTAEMIA	1/7012 (0%)	1	1/7012 (0%)	1	2/7002 (0%)	2
BLADDER MASS	0/7012 (0%)	0	1/7012 (0%)	1	1/7002 (0%)	1
BLADDER STENOSIS	1/7012 (0%)	1	1/7012 (0%)	1	0/7002 (0%)	0
BLADDER TAMPONADE	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
CYSTITIS GLANDULARIS	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
CYSTITIS HAEMORRHAGIC	1/7012 (0%)	1	1/7012 (0%)	1	0/7002 (0%)	0
DYSURIA	2/7012 (0%)	2	1/7012 (0%)	1	0/7002 (0%)	0
HYDRONEPHROSIS	2/7012 (0%)	2	1/7012 (0%)	1	5/7002 (0.1%)	5
NEPHROPATHY	1/7012 (0%)	1	1/7012 (0%)	1	2/7002 (0%)	2
NEPHROSCLEROSIS	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
NEPHROTIC SYNDROME	1/7012 (0%)	1	1/7012 (0%)	1	1/7002 (0%)	1
OBSTRUCTIVE UROPATHY	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
POLLAKIURIA	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
POLYURIA	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
RENAL INJURY	1/7012 (0%)	1	1/7012 (0%)	1	0/7002 (0%)	0
STRESS URINARY INCONTINENCE	1/7012 (0%)	1	1/7012 (0%)	1	0/7002 (0%)	0
TUBULOINTERSTITIAL NEPHRITIS	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
URETHRAL HAEMORRHAGE	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
URINARY BLADDER POLYP	1/7012 (0%)	2	1/7012 (0%)	2	1/7002 (0%)	1
URINARY TRACT DISORDER	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
BLADDER OUTLET OBSTRUCTION	1/7012 (0%)	1	0/7012 (0%)	0	2/7002 (0%)	2
BLADDER PROLAPSE	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
CYSTITIS NONINFECTIVE	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
GLOMERULONEPHRITIS	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
GLOMERULONEPHROPATHY	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
HAEMORRHAGE URINARY TRACT	2/7012 (0%)	2	0/7012 (0%)	0	2/7002 (0%)	2
HYPERTENSIVE NEPHROPATHY	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
NEPHRITIS AUTOIMMUNE	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
NEUROGENIC BLADDER	1/7012 (0%)	1	0/7012 (0%)	0	1/7002 (0%)	1
RENAL MASS	1/7012 (0%)	1	0/7012 (0%)	0	3/7002 (0%)	3
RENAL TUBULAR NECROSIS	2/7012 (0%)	2	0/7012 (0%)	0	0/7002 (0%)	0
URETERIC STENOSIS	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
URETHRAL DISCHARGE	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
URETHRAL OBSTRUCTION	1/7012 (0%)	1	0/7012 (0%)	0	1/7002 (0%)	1
URETHRAL POLYP	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
URINARY BLADDER HAEMORRHAGE	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
URINARY TRACT OBSTRUCTION	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
UROGENITAL HAEMORRHAGE	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
Reproductive system and breast disorders
BENIGN PROSTATIC HYPERPLASIA	35/7012 (0.5%)	37	29/7012 (0.4%)	31	17/7002 (0.2%)	18
PROSTATITIS	6/7012 (0.1%)	7	5/7012 (0.1%)	5	2/7002 (0%)	2
VAGINAL HAEMORRHAGE	7/7012 (0.1%)	7	4/7012 (0.1%)	4	3/7002 (0%)	3
METRORRHAGIA	3/7012 (0%)	3	3/7012 (0%)	3	1/7002 (0%)	1
PROSTATOMEGALY	1/7012 (0%)	1	3/7012 (0%)	3	2/7002 (0%)	2
UTERINE POLYP	1/7012 (0%)	1	3/7012 (0%)	3	1/7002 (0%)	1
BREAST MASS	0/7012 (0%)	0	2/7012 (0%)	2	0/7002 (0%)	0
CERVIX HAEMORRHAGE UTERINE	0/7012 (0%)	0	2/7012 (0%)	2	0/7002 (0%)	0
ACQUIRED HYDROCELE	2/7012 (0%)	2	1/7012 (0%)	1	2/7002 (0%)	2
ACQUIRED PHIMOSIS	2/7012 (0%)	2	1/7012 (0%)	1	2/7002 (0%)	2
BALANITIS	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
CERVICAL POLYP	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
CERVIX HAEMATOMA UTERINE	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
COLPOCELE	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
ENDOMETRIAL HYPERPLASIA	1/7012 (0%)	1	1/7012 (0%)	1	0/7002 (0%)	0
EPIDIDYMITIS	2/7012 (0%)	2	1/7012 (0%)	1	0/7002 (0%)	0
GENITAL HAEMORRHAGE	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
OVARIAN CYST	0/7012 (0%)	0	1/7012 (0%)	1	2/7002 (0%)	2
POSTMENOPAUSAL HAEMORRHAGE	0/7012 (0%)	0	1/7012 (0%)	1	1/7002 (0%)	1
PROSTATISM	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
RECTOCELE	0/7012 (0%)	0	1/7012 (0%)	1	1/7002 (0%)	1
UTERINE HAEMORRHAGE	1/7012 (0%)	1	1/7012 (0%)	1	7/7002 (0.1%)	7
UTERINE PROLAPSE	1/7012 (0%)	1	1/7012 (0%)	1	1/7002 (0%)	1
BREAST CALCIFICATIONS	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
BREAST CYST	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	2
BREAST PAIN	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
ENDOMETRIAL HYPERTROPHY	2/7012 (0%)	2	0/7012 (0%)	0	1/7002 (0%)	1
ENDOMETRIOSIS	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
FEMALE GENITAL TRACT FISTULA	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
GYNAECOMASTIA	1/7012 (0%)	1	0/7012 (0%)	0	1/7002 (0%)	1
OVARIAN MASS	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
PELVIC PAIN	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
PENILE HAEMORRHAGE	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
PROSTATIC DYSPLASIA	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
PROSTATIC OBSTRUCTION	0/7012 (0%)	0	0/7012 (0%)	0	2/7002 (0%)	2
SCROTAL OEDEMA	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
UTERINE CYST	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
VAGINAL PROLAPSE	0/7012 (0%)	0	0/7012 (0%)	0	2/7002 (0%)	2
Respiratory, thoracic and mediastinal disorders
CHRONIC OBSTRUCTIVE PULMONARY DISEASE	89/7012 (1.3%)	127	93/7012 (1.3%)	125	105/7002 (1.5%)	150
EPISTAXIS	48/7012 (0.7%)	56	36/7012 (0.5%)	42	18/7002 (0.3%)	18
RESPIRATORY FAILURE	20/7012 (0.3%)	21	29/7012 (0.4%)	29	26/7002 (0.4%)	26
DYSPNOEA	18/7012 (0.3%)	19	26/7012 (0.4%)	27	20/7002 (0.3%)	24
PULMONARY EMBOLISM	26/7012 (0.4%)	28	21/7012 (0.3%)	22	26/7002 (0.4%)	26
ACUTE RESPIRATORY FAILURE	19/7012 (0.3%)	19	20/7012 (0.3%)	23	17/7002 (0.2%)	17
HAEMOPTYSIS	14/7012 (0.2%)	14	20/7012 (0.3%)	23	10/7002 (0.1%)	10
PLEURAL EFFUSION	19/7012 (0.3%)	22	14/7012 (0.2%)	16	23/7002 (0.3%)	24
ASTHMA	19/7012 (0.3%)	28	13/7012 (0.2%)	13	19/7002 (0.3%)	22
PNEUMONIA ASPIRATION	14/7012 (0.2%)	15	13/7012 (0.2%)	13	21/7002 (0.3%)	24
PULMONARY OEDEMA	8/7012 (0.1%)	8	12/7012 (0.2%)	14	12/7002 (0.2%)	12
ACUTE PULMONARY OEDEMA	8/7012 (0.1%)	9	11/7012 (0.2%)	12	8/7002 (0.1%)	8
INTERSTITIAL LUNG DISEASE	4/7012 (0.1%)	5	9/7012 (0.1%)	11	8/7002 (0.1%)	8
SLEEP APNOEA SYNDROME	4/7012 (0.1%)	4	7/7012 (0.1%)	7	6/7002 (0.1%)	7
PNEUMOTHORAX	6/7012 (0.1%)	6	6/7012 (0.1%)	6	7/7002 (0.1%)	9
PULMONARY HYPERTENSION	8/7012 (0.1%)	8	6/7012 (0.1%)	6	5/7002 (0.1%)	6
HAEMOTHORAX	5/7012 (0.1%)	5	5/7012 (0.1%)	5	4/7002 (0.1%)	4
PULMONARY FIBROSIS	1/7012 (0%)	1	5/7012 (0.1%)	5	4/7002 (0.1%)	4
RESPIRATORY DISTRESS	2/7012 (0%)	2	5/7012 (0.1%)	5	3/7002 (0%)	3
ACUTE RESPIRATORY DISTRESS SYNDROME	2/7012 (0%)	2	3/7012 (0%)	3	1/7002 (0%)	1
ATELECTASIS	0/7012 (0%)	0	3/7012 (0%)	3	0/7002 (0%)	0
BRONCHOSPASM	1/7012 (0%)	1	3/7012 (0%)	3	3/7002 (0%)	4
PULMONARY CONGESTION	2/7012 (0%)	2	3/7012 (0%)	3	2/7002 (0%)	2
PULMONARY HAEMORRHAGE	2/7012 (0%)	2	3/7012 (0%)	4	2/7002 (0%)	2
ASPIRATION	1/7012 (0%)	1	2/7012 (0%)	2	0/7002 (0%)	0
BRONCHIECTASIS	3/7012 (0%)	3	2/7012 (0%)	2	1/7002 (0%)	1
CHRONIC RESPIRATORY FAILURE	0/7012 (0%)	0	2/7012 (0%)	2	0/7002 (0%)	0
LUNG DISORDER	2/7012 (0%)	2	2/7012 (0%)	2	4/7002 (0.1%)	4
ORGANISING PNEUMONIA	0/7012 (0%)	0	2/7012 (0%)	2	2/7002 (0%)	2
PNEUMONITIS	2/7012 (0%)	2	2/7012 (0%)	2	2/7002 (0%)	2
PULMONARY MASS	1/7012 (0%)	1	2/7012 (0%)	2	1/7002 (0%)	1
PULMONARY TOXICITY	0/7012 (0%)	0	2/7012 (0%)	2	0/7002 (0%)	0
RESPIRATORY ARREST	2/7012 (0%)	2	2/7012 (0%)	2	0/7002 (0%)	0
ASPHYXIA	1/7012 (0%)	1	1/7012 (0%)	1	0/7002 (0%)	0
BRONCHIAL HYPERREACTIVITY	1/7012 (0%)	1	1/7012 (0%)	1	0/7002 (0%)	0
BRONCHOPNEUMOPATHY	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
COUGH	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
DYSPNOEA AT REST	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
DYSPNOEA EXERTIONAL	3/7012 (0%)	3	1/7012 (0%)	1	8/7002 (0.1%)	9
EMPHYSEMA	0/7012 (0%)	0	1/7012 (0%)	1	1/7002 (0%)	1
FOREIGN BODY ASPIRATION	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
HYPOVENTILATION	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
HYPOXIA	0/7012 (0%)	0	1/7012 (0%)	1	2/7002 (0%)	2
NASAL POLYPS	0/7012 (0%)	0	1/7012 (0%)	1	1/7002 (0%)	1
PULMONARY INFARCTION	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
RESPIRATORY DISORDER	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
THORACIC HAEMORRHAGE	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
VOCAL CORD CYST	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
VOCAL CORD INFLAMMATION	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
ALLERGIC GRANULOMATOUS ANGIITIS	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
ALVEOLITIS ALLERGIC	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
ASTHMATIC CRISIS	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
BRONCHIAL HAEMORRHAGE	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
BRONCHIAL SECRETION RETENTION	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
BRONCHITIS CHRONIC	3/7012 (0%)	3	0/7012 (0%)	0	0/7002 (0%)	0
BRONCHOMALACIA	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
CHOKING	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
DIAPHRAGMATIC HERNIA	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
HYDROPNEUMOTHORAX	1/7012 (0%)	1	0/7012 (0%)	0	1/7002 (0%)	1
HYDROTHORAX	3/7012 (0%)	3	0/7012 (0%)	0	1/7002 (0%)	1
HYPERCAPNIA	2/7012 (0%)	2	0/7012 (0%)	0	0/7002 (0%)	0
LARYNGEAL DISORDER	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
LARYNGEAL OEDEMA	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
NASAL CYST	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
NASAL SEPTUM DEVIATION	2/7012 (0%)	2	0/7012 (0%)	0	0/7002 (0%)	0
NOCTURNAL DYSPNOEA	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
OBSTRUCTIVE AIRWAYS DISORDER	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
PHARYNGEAL HAEMATOMA	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
PHARYNGEAL HAEMORRHAGE	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
PHARYNGEAL MASS	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
PICKWICKIAN SYNDROME	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
PLEURISY	3/7012 (0%)	4	0/7012 (0%)	0	0/7002 (0%)	0
PLEURITIC PAIN	1/7012 (0%)	1	0/7012 (0%)	0	2/7002 (0%)	2
PULMONARY ALVEOLAR HAEMORRHAGE	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
PULMONARY ARTERIAL HYPERTENSION	1/7012 (0%)	1	0/7012 (0%)	0	1/7002 (0%)	2
PULMONARY ARTERY THROMBOSIS	0/7012 (0%)	0	0/7012 (0%)	0	2/7002 (0%)	2
PULMONARY GRANULOMA	1/7012 (0%)	1	0/7012 (0%)	0	1/7002 (0%)	1
RESPIRATORY ACIDOSIS	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
RESPIRATORY TRACT HAEMORRHAGE	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
SINUS POLYP	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
TRACHEAL MASS	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
VOCAL CORD POLYP	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
Skin and subcutaneous tissue disorders
SKIN ULCER	12/7012 (0.2%)	13	6/7012 (0.1%)	6	14/7002 (0.2%)	14
SKIN HAEMORRHAGE	5/7012 (0.1%)	5	5/7012 (0.1%)	5	4/7002 (0.1%)	4
ANGIOEDEMA	0/7012 (0%)	0	2/7012 (0%)	2	0/7002 (0%)	0
DECUBITUS ULCER	3/7012 (0%)	3	2/7012 (0%)	2	1/7002 (0%)	1
DERMAL CYST	0/7012 (0%)	0	2/7012 (0%)	2	2/7002 (0%)	2
ACTINIC KERATOSIS	0/7012 (0%)	0	1/7012 (0%)	1	1/7002 (0%)	1
DERMATITIS ALLERGIC	0/7012 (0%)	0	1/7012 (0%)	1	2/7002 (0%)	2
DERMATITIS CONTACT	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
DERMATOMYOSITIS	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
DRUG ERUPTION	3/7012 (0%)	4	1/7012 (0%)	1	2/7002 (0%)	2
DRUG RASH WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
DRY GANGRENE	1/7012 (0%)	1	1/7012 (0%)	1	1/7002 (0%)	1
ECCHYMOSIS	3/7012 (0%)	3	1/7012 (0%)	1	0/7002 (0%)	0
ERYTHEMA MULTIFORME	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
HYPERKERATOSIS	1/7012 (0%)	1	1/7012 (0%)	1	0/7002 (0%)	0
PSORIASIS	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
PURPURA	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
RASH	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
SKIN NECROSIS	1/7012 (0%)	1	1/7012 (0%)	1	1/7002 (0%)	1
STASIS DERMATITIS	1/7012 (0%)	1	1/7012 (0%)	1	1/7002 (0%)	1
STEVENS-JOHNSON SYNDROME	0/7012 (0%)	0	1/7012 (0%)	1	2/7002 (0%)	2
ACANTHOSIS	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
CUTANEOUS LUPUS ERYTHEMATOSUS	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
DERMATITIS	1/7012 (0%)	2	0/7012 (0%)	0	0/7002 (0%)	0
DERMATITIS ATOPIC	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
ECZEMA	2/7012 (0%)	3	0/7012 (0%)	0	0/7002 (0%)	0
ECZEMA NUMMULAR	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
GRANULOMA SKIN	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
HAEMORRHAGE SUBCUTANEOUS	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
HENOCH-SCHONLEIN PURPURA	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
HYPERHIDROSIS	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
INGROWING NAIL	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
LEUKOCYTOCLASTIC VASCULITIS	2/7012 (0%)	2	0/7012 (0%)	0	0/7002 (0%)	0
NEURODERMATITIS	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
PANNICULITIS	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
PEMPHIGOID	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
PRURIGO	0/7012 (0%)	0	0/7012 (0%)	0	2/7002 (0%)	2
SCAR	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
SEBORRHOEIC DERMATITIS	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
SKIN LESION	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
SKIN ULCER HAEMORRHAGE	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
SUBCUTANEOUS NODULE	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
SWELLING FACE	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
URTICARIA	2/7012 (0%)	2	0/7012 (0%)	0	1/7002 (0%)	1
Social circumstances
IMMOBILE	0/7012 (0%)	0	2/7012 (0%)	2	0/7002 (0%)	0
ACTIVITIES OF DAILY LIVING IMPAIRED	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
CARDIAC ASSISTANCE DEVICE USER	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
PHYSICAL DISABILITY	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
Surgical and medical procedures
AORTIC ANEURYSM REPAIR	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
CARDIAC PACEMAKER REPLACEMENT	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
COLECTOMY	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
HIP ARTHROPLASTY	1/7012 (0%)	1	1/7012 (0%)	1	0/7002 (0%)	0
ARTHRODESIS	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
EPIDURAL BLOOD PATCH	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
Vascular disorders
HYPERTENSION	29/7012 (0.4%)	32	42/7012 (0.6%)	46	36/7002 (0.5%)	38
HYPOTENSION	23/7012 (0.3%)	23	24/7012 (0.3%)	25	30/7002 (0.4%)	30
DEEP VEIN THROMBOSIS	20/7012 (0.3%)	21	17/7012 (0.2%)	18	11/7002 (0.2%)	13
HYPERTENSIVE CRISIS	15/7012 (0.2%)	15	16/7012 (0.2%)	16	13/7002 (0.2%)	14
AORTIC ANEURYSM	12/7012 (0.2%)	12	9/7012 (0.1%)	9	14/7002 (0.2%)	15
PERIPHERAL ARTERIAL OCCLUSIVE DISEASE	11/7012 (0.2%)	12	9/7012 (0.1%)	9	24/7002 (0.3%)	28
PERIPHERAL ISCHAEMIA	5/7012 (0.1%)	6	9/7012 (0.1%)	10	13/7002 (0.2%)	15
AORTIC STENOSIS	15/7012 (0.2%)	15	8/7012 (0.1%)	8	10/7002 (0.1%)	10
ARTERIOSCLEROSIS	7/7012 (0.1%)	7	8/7012 (0.1%)	8	4/7002 (0.1%)	4
PERIPHERAL VASCULAR DISORDER	6/7012 (0.1%)	6	8/7012 (0.1%)	12	5/7002 (0.1%)	7
ORTHOSTATIC HYPOTENSION	9/7012 (0.1%)	11	7/7012 (0.1%)	8	9/7002 (0.1%)	9
ARTERIOSCLEROSIS OBLITERANS	1/7012 (0%)	1	5/7012 (0.1%)	6	1/7002 (0%)	1
AORTIC ANEURYSM RUPTURE	5/7012 (0.1%)	5	4/7012 (0.1%)	4	4/7002 (0.1%)	4
BLEEDING VARICOSE VEIN	0/7012 (0%)	0	4/7012 (0.1%)	4	0/7002 (0%)	0
VARICOSE VEIN	1/7012 (0%)	1	4/7012 (0.1%)	4	4/7002 (0.1%)	4
AORTIC DISSECTION	2/7012 (0%)	2	3/7012 (0%)	3	2/7002 (0%)	2
FEMORAL ARTERIAL STENOSIS	3/7012 (0%)	3	3/7012 (0%)	3	2/7002 (0%)	2
HAEMORRHAGE	2/7012 (0%)	2	3/7012 (0%)	4	0/7002 (0%)	0
HYPERTENSIVE EMERGENCY	1/7012 (0%)	1	3/7012 (0%)	3	2/7002 (0%)	2
PERIPHERAL EMBOLISM	3/7012 (0%)	4	3/7012 (0%)	3	7/7002 (0.1%)	8
THROMBOSIS	1/7012 (0%)	1	3/7012 (0%)	3	2/7002 (0%)	2
ARTERIAL DISORDER	0/7012 (0%)	0	2/7012 (0%)	3	2/7002 (0%)	2
ARTERIAL THROMBOSIS LIMB	6/7012 (0.1%)	6	2/7012 (0%)	2	3/7002 (0%)	4
ARTERITIS OBLITERANS	0/7012 (0%)	0	2/7012 (0%)	2	0/7002 (0%)	0
DISTRIBUTIVE SHOCK	0/7012 (0%)	0	2/7012 (0%)	2	0/7002 (0%)	0
EXTREMITY NECROSIS	5/7012 (0.1%)	5	2/7012 (0%)	2	4/7002 (0.1%)	4
FEMORAL ARTERY EMBOLISM	3/7012 (0%)	3	2/7012 (0%)	3	1/7002 (0%)	1
INTRA-ABDOMINAL HAEMATOMA	0/7012 (0%)	0	2/7012 (0%)	2	0/7002 (0%)	0
SUBCLAVIAN VEIN THROMBOSIS	1/7012 (0%)	1	2/7012 (0%)	2	0/7002 (0%)	0
VENOUS INSUFFICIENCY	0/7012 (0%)	0	2/7012 (0%)	2	4/7002 (0.1%)	4
VENOUS THROMBOSIS	2/7012 (0%)	2	2/7012 (0%)	2	1/7002 (0%)	1
VENOUS THROMBOSIS LIMB	1/7012 (0%)	1	2/7012 (0%)	2	2/7002 (0%)	2
AORTIC DILATATION	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
AORTIC THROMBOSIS	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
ARTERIAL OCCLUSIVE DISEASE	2/7012 (0%)	2	1/7012 (0%)	1	6/7002 (0.1%)	6
ARTERIAL THROMBOSIS	0/7012 (0%)	0	1/7012 (0%)	1	2/7002 (0%)	2
CIRCULATORY COLLAPSE	3/7012 (0%)	3	1/7012 (0%)	1	3/7002 (0%)	3
DIABETIC MACROANGIOPATHY	1/7012 (0%)	1	1/7012 (0%)	1	0/7002 (0%)	0
DIABETIC VASCULAR DISORDER	0/7012 (0%)	0	1/7012 (0%)	3	0/7002 (0%)	0
EMBOLISM ARTERIAL	6/7012 (0.1%)	7	1/7012 (0%)	1	1/7002 (0%)	2
EXTRAVASATION BLOOD	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
FEMORAL ARTERY ANEURYSM	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
FEMORAL ARTERY OCCLUSION	1/7012 (0%)	1	1/7012 (0%)	1	1/7002 (0%)	1
HAEMATOMA	4/7012 (0.1%)	4	1/7012 (0%)	1	0/7002 (0%)	0
HYPOVOLAEMIC SHOCK	5/7012 (0.1%)	5	1/7012 (0%)	1	1/7002 (0%)	1
ILIAC ARTERY EMBOLISM	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
INFARCTION	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
INTERMITTENT CLAUDICATION	0/7012 (0%)	0	1/7012 (0%)	1	1/7002 (0%)	1
ISCHAEMIA	0/7012 (0%)	0	1/7012 (0%)	1	1/7002 (0%)	1
LYMPHATIC FISTULA	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
LYMPHOCELE	1/7012 (0%)	1	1/7012 (0%)	1	0/7002 (0%)	0
LYMPHOEDEMA	1/7012 (0%)	1	1/7012 (0%)	1	1/7002 (0%)	1
PERIPHERAL ARTERY ANEURYSM	1/7012 (0%)	1	1/7012 (0%)	1	3/7002 (0%)	3
RHEUMATOID VASCULITIS	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
SHOCK HAEMORRHAGIC	1/7012 (0%)	1	1/7012 (0%)	1	3/7002 (0%)	3
SUBCLAVIAN STEAL SYNDROME	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
SUPERIOR MESENTERIC ARTERY SYNDROME	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
THROMBOPHLEBITIS	2/7012 (0%)	2	1/7012 (0%)	1	0/7002 (0%)	0
VARICOSE ULCERATION	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
VASCULAR INSUFFICIENCY	0/7012 (0%)	0	1/7012 (0%)	1	0/7002 (0%)	0
VASCULITIS	0/7012 (0%)	0	1/7012 (0%)	2	3/7002 (0%)	3
ACCELERATED HYPERTENSION	6/7012 (0.1%)	6	0/7012 (0%)	0	4/7002 (0.1%)	6
ANEURYSM	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
ANEURYSM RUPTURED	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
ANGIOPATHY	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
AORTIC DISSECTION RUPTURE	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
AORTIC EMBOLUS	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
AORTIC RUPTURE	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
ARTERIAL HAEMORRHAGE	1/7012 (0%)	1	0/7012 (0%)	0	1/7002 (0%)	1
ARTERIAL STENOSIS	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
ARTERIAL STENOSIS LIMB	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
ARTERIOSCLEROSIS MOENCKEBERG-TYPE	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
EMBOLISM	1/7012 (0%)	1	0/7012 (0%)	0	3/7002 (0%)	3
ESSENTIAL HYPERTENSION	1/7012 (0%)	1	0/7012 (0%)	0	1/7002 (0%)	1
FIBROMUSCULAR DYSPLASIA	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
HAEMODYNAMIC INSTABILITY	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
ILIAC ARTERY STENOSIS	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
ILIAC ARTERY THROMBOSIS	2/7012 (0%)	2	0/7012 (0%)	0	0/7002 (0%)	0
LABILE HYPERTENSION	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
POOR PERIPHERAL CIRCULATION	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
SHOCK	0/7012 (0%)	0	0/7012 (0%)	0	2/7002 (0%)	2
TEMPORAL ARTERITIS	2/7012 (0%)	2	0/7012 (0%)	0	0/7002 (0%)	0
THROMBOANGIITIS OBLITERANS	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
THROMBOPHLEBITIS SUPERFICIAL	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
THROMBOSED VARICOSE VEIN	1/7012 (0%)	1	0/7012 (0%)	0	0/7002 (0%)	0
VENOUS HAEMORRHAGE	0/7012 (0%)	0	0/7012 (0%)	0	1/7002 (0%)	1
Other (Not Including Serious) Adverse Events
	Warfarin/Placebo Edoxaban		High Dose Edoxaban/Placebo Warfarin		Low Dose Edoxaban/Placebo Warfarin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4200/7012 (59.9%)		4201/7012 (59.9%)		4057/7002 (57.9%)
Blood and lymphatic system disorders
anaemia	242/7012 (3.5%)		368/7012 (5.2%)		261/7002 (3.7%)
Cardiac disorders
atrial fibrillation	491/7012 (7%)		474/7012 (6.8%)		528/7002 (7.5%)
cardiac failure	448/7012 (6.4%)		425/7012 (6.1%)		373/7002 (5.3%)
Gastrointestinal disorders
diarrhoea	499/7012 (7.1%)		482/7012 (6.9%)		486/7002 (6.9%)
General disorders
oedema peripheral	675/7012 (9.6%)		577/7012 (8.2%)		578/7002 (8.3%)
Infections and infestations
urinary tract infection	703/7012 (10%)		688/7012 (9.8%)		698/7002 (10%)
nasopharyngitis	620/7012 (8.8%)		620/7012 (8.8%)		645/7002 (9.2%)
bronchitis	572/7012 (8.2%)		567/7012 (8.1%)		584/7002 (8.3%)
upper respiratory tract infection	445/7012 (6.3%)		411/7012 (5.9%)		443/7002 (6.3%)
Injury, poisoning and procedural complications
fall	565/7012 (8.1%)		453/7012 (6.5%)		452/7002 (6.5%)
Musculoskeletal and connective tissue disorders
back pain	478/7012 (6.8%)		476/7012 (6.8%)		496/7002 (7.1%)
arthralgia	386/7012 (5.5%)		385/7012 (5.5%)		417/7002 (6%)
Nervous system disorders
dizziness	592/7012 (8.4%)		514/7012 (7.3%)		537/7002 (7.7%)
headache	336/7012 (4.8%)		334/7012 (4.8%)		356/7002 (5.1%)
Respiratory, thoracic and mediastinal disorders
dyspnoea	470/7012 (6.7%)		456/7012 (6.5%)		434/7002 (6.2%)
cough	365/7012 (5.2%)		383/7012 (5.5%)		416/7002 (5.9%)
Vascular disorders
hypertension	438/7012 (6.2%)		481/7012 (6.9%)		475/7002 (6.8%)

Limitations/Caveats

[Not Specified]

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Certain Agreements

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

A study site may not publish results of a study until after a coordinated multicenter publication has been submitted for publication or until one year after the study has ended, whichever occurs first. The study site will have the opportunity to publish results of the study, provided Daiichi Sankyo has had the opportunity to review and comment on the study site's proposed publication prior to being submitted for publication with the advice of patent council and need for subject protection.