PEGASUS: Prevention of Cardiovascular Events (eg, Death From Heart or Vascular Disease, Heart Attack, or Stroke) in Patients With Prior Heart Attack Using Ticagrelor Compared to Placebo on a Background of Aspirin

Sponsor

AstraZeneca (Industry)

Overall Status

Completed

CT.gov ID

NCT01225562

Collaborator

(none)

21,379

Enrollment

847

Locations

Arms

Duration (Months)

25.2

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is being carried out to see if a new drug called ticagrelor given twice daily in addition to the ASA therapy decreases the frequency of cardiovascular events (e.g., death from heart disease, heart attack, or stroke).

Condition or Disease	Intervention/Treatment	Phase
Myocardial Infarction Cardiovascular Death Atherothrombosis Stroke	Drug: Ticagrelor 90 mg Drug: Ticagrelor 60 mg Drug: Ticagrelor Placebo	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

21379 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

A Randomized, Double-Blind, Placebo Controlled, Parallel Group, Multinational Trial, to Assess the Prevention of Thrombotic Events With Ticagrelor Compared to Placebo on a Background of Acetyl Salicylic Acid (ASA) Therapy in Patients With History of Myocardial Infarction

Study Start Date :

Oct 1, 2010

Actual Primary Completion Date :

Dec 1, 2014

Actual Study Completion Date :

Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Oral Treatment	Drug: Ticagrelor 90 mg Oral dose twice a day
Experimental: 2 Oral Treatment	Drug: Ticagrelor 60 mg Oral dose twice a day
Placebo Comparator: 3 Oral Treatment	Drug: Ticagrelor Placebo Oral dose twice a day

Arm

Intervention/Treatment

Experimental: 1

Oral Treatment

Drug: Ticagrelor 90 mg

Oral dose twice a day

Experimental: 2

Oral Treatment

Drug: Ticagrelor 60 mg

Oral dose twice a day

Placebo Comparator: 3

Oral Treatment

Drug: Ticagrelor Placebo

Oral dose twice a day

Outcome Measures

Primary Outcome Measures

Kaplan-Meier Estimate of the Percentage of Patients Who Experienced Cardiovascular Death (CV Death), Myocardial Infarction (MI) or Stroke Within 3 Years From Randomization [Randomization up to 47 months]
Participants with CV death, MI or Stroke. If no event, censoring occurs at the earliest of the efficacy cut-off date 14 Sep 2014, withdrawal of consent, non-CV death or at the last time point of complete clinical event assessment. Events were adjudicated by a blinded endpoint committee. The Kaplan-Meier estimate reports the percentage of patients who experienced CV Death, MI or stroke within 3 years from randomization
Kaplan-Meier Estimate of the Percentage of Patients Who Experienced a TIMI Major Bleeding Within 3 Years From First Dose of Study Drug Units: Percentage of Patients [First dosing up to 48 months]
A Thrombolysis in Myocardial Infarction (TIMI) study group major bleeding is defined as any fatal bleeding (leading directly to death within 7 days), any intrcranial bleeding or any clinically overt signs of haemorrhage associated with a drop in Haemoglobin of >= 5g/dL. Events were adjudicated by a clinical events committee. Censoring ocurrs at 7 days following last dose of study drug. The Kaplan-Meier estimate reports the percentage of patients who experienced a TIMI Major bleeding within 3 years from first dose of study drug

Secondary Outcome Measures

Kaplan-Meier Estimate of the Percentage of Patients Who Experienced Cardiovascular Death (CV Death) Within 3 Years From Randomization [Randomization up to 47 months]
Participants with CV death. If no event, censoring occurs at the earliest of the efficacy cut-off date 14 Sep 2014, withdrawal of consent, non-CV death or at the last time point of complete clinical event assessment. Events were adjudicated by a blinded endpoint committee. The Kaplan-Meier estimate reports the percentage of patients who experienced CV Death within 3 years from randomization
Kaplan-Meier Estimate of the Percentage of Patients Who Died From Any Cause Within 3 Years From Randomization [Randomization up to 47 months]
Participants with death from any cause. If no event, censoring occurs at the earliest of the efficacy cut-off date 14 Sep 2014, withdrawal of consent or the last time point the particapant was known to be alive. Events were adjudicated by a blinded endpoint committee. The Kaplan-Meier estimate reports the percentage of patients who died from any cause within 3 years from randomization

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 130 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Person who had a heart attack within 1 - 3 years ago and at least one additional risk factor: Age ≥ 65 years old, Diabetes requiring medication, Documented history of 2nd prior MI (>1 year ago). Angiographic evidence of multivessel CAD, and / or Chronic, non-end stage renal dysfunction.
Females of child-bearing potential must have a negative pregnancy test at enrollment
Persons who are currently taking aspirin between 75 and 150 mg once daily

Exclusion Criteria:

Persons who are being treated with agents inhibiting blood clotting if the agent cannot be stopped at study start
Persons who have planned coronary, cerebrovascular, or peripheral arterial Revascularization (invasive surgery) at study start
Persons with known bleeding disorders
Persons who need chronic oral anticoagulant therapy or chronic low-molecular-weight heparin
Persons with a history of ischemic stroke
Persons with a history of intracranial bleeding at any time, a tumor or blood vessel abnormality in the brain and/or spinal cord at any time, a history of surgery involving the brain or spinal cord within the last 5 years, or a history of bleeding from the gastrointestinal tract (eg, esophagus, stomach, colon, rectum) within the last 6 months or a major surgery within the last 30 days.
Persons considered to be at risk of bradycardic events unless already treated with a permanent pacemaker
Persons who have had open heart surgery within the past 5 years, unless the person had a heart attack after the surgery
Persons with known severe liver disease
Persons with kidney failure requiring dialysis
Persons with life expectancy < 1 year

Contacts and Locations

Locations

	Site	City	State	Country
1	Research Site	Alexander City	Alabama	United States
2	Research Site	Athens	Alabama	United States
3	Research Site	Birmingham	Alabama	United States
4	Research Site	Huntsville	Alabama	United States
5	Research Site	Mobile	Alabama	United States
6	Research Site	Sheffield	Alabama	United States
7	Research Site	Glendale	Arizona	United States
8	Research Site	Phoenix	Arizona	United States
9	Research Site	Jonesboro	Arkansas	United States
10	Research Site	Little Rock	Arkansas	United States
11	Research Site	Alhambra	California	United States
12	Research Site	Anaheim	California	United States
13	Research Site	Bakersfield	California	United States
14	Research Site	Fountain Valley	California	United States
15	Research Site	La Mesa	California	United States
16	Research Site	Larkspur	California	United States
17	Research Site	Lomita	California	United States
18	Research Site	Los Angeles	California	United States
19	Research Site	Modesto	California	United States
20	Research Site	Newport Beach	California	United States
21	Research Site	Oakland	California	United States
22	Research Site	Oceanside	California	United States
23	Research Site	San Diego	California	United States
24	Research Site	San Marino	California	United States
25	Research Site	Santa Rosa	California	United States
26	Research Site	Ventura	California	United States
27	Research Site	Westlake Village	California	United States
28	Research Site	Aurora	Colorado	United States
29	Research Site	Colorado Springs	Colorado	United States
30	Research Site	Littleton	Colorado	United States
31	Research Site	Loveland	Colorado	United States
32	Research Site	Hartford	Connecticut	United States
33	Research Site	Stamford	Connecticut	United States
34	Research Site	Newark	Delaware	United States
35	Research Site	Washington	District of Columbia	United States
36	Research Site	Boca Raton	Florida	United States
37	Research Site	Clearwater	Florida	United States
38	Research Site	Coral Springs	Florida	United States
39	Research Site	Crystal River	Florida	United States
40	Research Site	Davie	Florida	United States
41	Research Site	Daytona Beach	Florida	United States
42	Research Site	Daytona	Florida	United States
43	Research Site	Ft Lauderdale	Florida	United States
44	Research Site	Gainesville	Florida	United States
45	Research Site	Hialeah	Florida	United States
46	Research Site	Hollywood	Florida	United States
47	Research Site	Jacksonville	Florida	United States
48	Research Site	Jupiter	Florida	United States
49	Research Site	Largo	Florida	United States
50	Research Site	Leesburg	Florida	United States
51	Research Site	Miami Beach	Florida	United States
52	Research Site	Miami	Florida	United States
53	Research Site	Naples	Florida	United States
54	Research Site	Ocala	Florida	United States
55	Research Site	Orlando	Florida	United States
56	Research Site	Pannama City	Florida	United States
57	Research Site	Pensacola	Florida	United States
58	Research Site	Port Charlotte	Florida	United States
59	Research Site	Safety Harbor	Florida	United States
60	Research Site	Sarasota	Florida	United States
61	Research Site	South Miami	Florida	United States
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63	Research Site	Tallahassee	Florida	United States
64	Research Site	The Villages	Florida	United States
65	Research Site	Wellington	Florida	United States
66	Research Site	West Palm Beach	Florida	United States
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129	Research Site	Biloxi	Mississippi	United States
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156	Research Site	Poughkeepsie	New York	United States
157	Research Site	Saratoga Springs	New York	United States
158	Research Site	Southampton	New York	United States
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160	Research Site	Williamsville	New York	United States
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164	Research Site	Greensboro	North Carolina	United States
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170	Research Site	Sanford	North Carolina	United States
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180	Research Site	Dayton	Ohio	United States
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207	Research Site	Providence	Rhode Island	United States
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221	Research Site	Dallas	Texas	United States
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223	Research Site	Georgetown	Texas	United States
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226	Research Site	Katy	Texas	United States
227	Research Site	Kingwood	Texas	United States
228	Research Site	MC Allen	Texas	United States
229	Research Site	McAllen	Texas	United States
230	Research Site	Plano	Texas	United States
231	Research Site	Round Rock	Texas	United States
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234	Research Site	Tyler	Texas	United States
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236	Research Site	Provo	Utah	United States
237	Research Site	Burlington	Vermont	United States
238	Research Site	Alexandria	Virginia	United States
239	Research Site	Charlottesville	Virginia	United States
240	Research Site	Danville	Virginia	United States
241	Research Site	Falls Church	Virginia	United States
242	Research Site	Lynchburg	Virginia	United States
243	Research Site	Manassas	Virginia	United States
244	Research Site	Norfolk	Virginia	United States
245	Research Site	Richmond	Virginia	United States
246	Research Site	Winchester	Virginia	United States
247	Research Site	Bellevue	Washington	United States
248	Research Site	Everett	Washington	United States
249	Research Site	Spokane	Washington	United States
250	Research Site	Tacoma	Washington	United States
251	Research Site	Green Bay	Wisconsin	United States
252	Research Site	Wausau	Wisconsin	United States
253	Research Site	Bahia Blanca		Argentina
254	Research Site	Buenos Aires		Argentina
255	Research Site	Ciudad Autonoma de BA		Argentina
256	Research Site	Ciudad de Buenos Aires		Argentina
257	Research Site	Ciudadela		Argentina
258	Research Site	Cordoba		Argentina
259	Research Site	Coronel Suarez		Argentina
260	Research Site	Corrientes		Argentina
261	Research Site	Córdoba		Argentina
262	Research Site	Haedo		Argentina
263	Research Site	La Plata		Argentina
264	Research Site	Mar del Plata		Argentina
265	Research Site	Ramos Mejía		Argentina
266	Research Site	Rosario Santa Fe		Argentina
267	Research Site	Rosario		Argentina
268	Research Site	San Luis		Argentina
269	Research Site	San Miguel de Tucuman		Argentina
270	Research Site	San Nicolas		Argentina
271	Research Site	San Salvador de Jujuy		Argentina
272	Research Site	Santa Fe		Argentina
273	Research Site	Santa Fé		Argentina
274	Research Site	Tucuman		Argentina
275	Research Site	Tucumán		Argentina
276	Research Site	Zarate		Argentina
277	Research Site	Adelaide		Australia
278	Research Site	Ashford		Australia
279	Research Site	Auchenflower		Australia
280	Research Site	Ballarat		Australia
281	Research Site	Bruce		Australia
282	Research Site	Chermside		Australia
283	Research Site	Clayton		Australia
284	Research Site	Concord		Australia
285	Research Site	East St Kilda		Australia
286	Research Site	Elizabeth Vale		Australia
287	Research Site	Epping		Australia
288	Research Site	Fremantle		Australia
289	Research Site	Geelong		Australia
290	Research Site	Gosford		Australia
291	Research Site	Greenslopes		Australia
292	Research Site	Herston		Australia
293	Research Site	Joondalup		Australia
294	Research Site	Kingswood		Australia
295	Research Site	Kogorah		Australia
296	Research Site	Launceston		Australia
297	Research Site	Melbourne		Australia
298	Research Site	Nedlands		Australia
299	Research Site	New Lambton Heights		Australia
300	Research Site	Richmond		Australia
301	Research Site	St Leonards		Australia
302	Research Site	Wollongong		Australia
303	Research Site	Woodville		Australia
304	Research Site	Woolloongabba		Australia
305	Research Site	Aalst		Belgium
306	Research Site	Antwerpen		Belgium
307	Research Site	Bonheiden		Belgium
308	Research Site	Bouge		Belgium
309	Research Site	Brasschaat		Belgium
310	Research Site	Brussels (Anderlecht)		Belgium
311	Research Site	Brussels (Jette)		Belgium
312	Research Site	Brussels (Woluwé-St-Lambert)		Belgium
313	Research Site	Brussels		Belgium
314	Research Site	Charleroi		Belgium
315	Research Site	Edegem		Belgium
316	Research Site	Genk		Belgium
317	Research Site	Gent		Belgium
318	Research Site	Hasselt		Belgium
319	Research Site	Huy		Belgium
320	Research Site	La Louvière		Belgium
321	Research Site	Leuven		Belgium
322	Research Site	Liege		Belgium
323	Research Site	Liège		Belgium
324	Research Site	Mechelen		Belgium
325	Research Site	Mol		Belgium
326	Research Site	Ottignies		Belgium
327	Research Site	Roeselare		Belgium
328	Research Site	Tienen		Belgium
329	Research Site	Turnhout		Belgium
330	Research Site	Yvoir		Belgium
331	Research Site	Zottegem		Belgium
332	Research Site	Aracaju		Brazil
333	Research Site	Belo Horizonte		Brazil
334	Research Site	Blumenau		Brazil
335	Research Site	Brasília		Brazil
336	Research Site	Campina Grande do Sul		Brazil
337	Research Site	Campinas		Brazil
338	Research Site	Campo Grande		Brazil
339	Research Site	Curitiba		Brazil
340	Research Site	Goiânia		Brazil
341	Research Site	Maceio		Brazil
342	Research Site	Marilia		Brazil
343	Research Site	Porto Alegre		Brazil
344	Research Site	Ribeirão Preto		Brazil
345	Research Site	Rio de Janeiro		Brazil
346	Research Site	S.J.Rio Preto		Brazil
347	Research Site	Salvador		Brazil
348	Research Site	São José do Rio Preto		Brazil
349	Research Site	São Paulo		Brazil
350	Research Site	Uberlândia		Brazil
351	Research Site	Votuporanga		Brazil
352	Research Site	Dimitrovgrad		Bulgaria
353	Research Site	Gotse Delchev		Bulgaria
354	Research Site	Pernik		Bulgaria
355	Research Site	Pleven		Bulgaria
356	Research Site	Plovdiv		Bulgaria
357	Research Site	Razlog		Bulgaria
358	Research Site	Ruse		Bulgaria
359	Research Site	Sevlievo		Bulgaria
360	Research Site	Sofia		Bulgaria
361	Research Site	Varna		Bulgaria
362	Research Site	Veliko Tarnovo		Bulgaria
363	Research Site	Edmonton	Alberta	Canada
364	Research Site	Kelowna	British Columbia	Canada
365	Research Site	New Westminster	British Columbia	Canada
366	Research Site	Penticton	British Columbia	Canada
367	Research Site	Surrey	British Columbia	Canada
368	Research Site	Vancouver	British Columbia	Canada
369	Research Site	Victoria	British Columbia	Canada
370	Research Site	Moncton	New Brunswick	Canada
371	Research Site	Saint John	New Brunswick	Canada
372	Research Site	St. John's	Newfoundland and Labrador	Canada
373	Research Site	Halifax	Nova Scotia	Canada
374	Research Site	Brampton	Ontario	Canada
375	Research Site	Burlington	Ontario	Canada
376	Research Site	Cambridge	Ontario	Canada
377	Research Site	Cornwall	Ontario	Canada
378	Research Site	Hamilton	Ontario	Canada
379	Research Site	Kitchener	Ontario	Canada
380	Research Site	London	Ontario	Canada
381	Research Site	Mississauga	Ontario	Canada
382	Research Site	Newmarket	Ontario	Canada
383	Research Site	North York	Ontario	Canada
384	Research Site	Oshawa	Ontario	Canada
385	Research Site	Ottawa	Ontario	Canada
386	Research Site	Sarnia	Ontario	Canada
387	Research Site	Scarborough	Ontario	Canada
388	Research Site	Sudbury	Ontario	Canada
389	Research Site	Thunder Bay	Ontario	Canada
390	Research Site	Toronto	Ontario	Canada
391	Research Site	Windsor	Ontario	Canada
392	Research Site	Chicoutimi	Quebec	Canada
393	Research Site	Gatineau	Quebec	Canada
394	Research Site	Greenfield Park	Quebec	Canada
395	Research Site	Laval	Quebec	Canada
396	Research Site	Levis	Quebec	Canada
397	Research Site	Longueuil	Quebec	Canada
398	Research Site	Montreal	Quebec	Canada
399	Research Site	Montréal	Quebec	Canada
400	Research Site	Saint-Charles-Borromee	Quebec	Canada
401	Research Site	Saint-Georges	Quebec	Canada
402	Research Site	Saint-Jerome	Quebec	Canada
403	Research Site	St-Lambert	Quebec	Canada
404	Research Site	Terrebonne	Quebec	Canada
405	Research Site	Thetford Mines	Quebec	Canada
406	Research Site	Val d'Or	Quebec	Canada
407	Research Site	Saskatoon	Saskatchewan	Canada
408	Research Site	Quebec		Canada
409	Research Site	Concepcion		Chile
410	Research Site	Osorno		Chile
411	Research Site	Rancagua		Chile
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414	Research Site	Temuco		Chile
415	Research Site	Vina del Mar		Chile
416	Research Site	Beijing		China
417	Research Site	Changsha		China
418	Research Site	Chongqing		China
419	Research Site	Guang Zhou		China
420	Research Site	Guangzhou		China
421	Research Site	Hang Zhou		China
422	Research Site	Lanzhou		China
423	Research Site	Nanjing		China
424	Research Site	Shanghai		China
425	Research Site	Shengyang		China
426	Research Site	Shenyang		China
427	Research Site	Taiyuan		China
428	Research Site	Wuhan		China
429	Research Site	Xi'an		China
430	Research Site	Armenia		Colombia
431	Research Site	Barranquilla		Colombia
432	Research Site	Bogota		Colombia
433	Research Site	Bogotá D.C.		Colombia
434	Research Site	Bucaramanga		Colombia
435	Research Site	Cali		Colombia
436	Research Site	Cartagena		Colombia
437	Research Site	Manizales		Colombia
438	Research Site	Medellin		Colombia
439	Research Site	Medellín		Colombia
440	Research Site	Medillin		Colombia
441	Research Site	Brno		Czech Republic
442	Research Site	Caslav		Czech Republic
443	Research Site	Ceska Lipa		Czech Republic
444	Research Site	Cesky Krumlov		Czech Republic
445	Research Site	Chomutov		Czech Republic
446	Research Site	Havirov		Czech Republic
447	Research Site	Kromeriz		Czech Republic
448	Research Site	Kyjov		Czech Republic
449	Research Site	Liberec		Czech Republic
450	Research Site	Marianske Lazne		Czech Republic
451	Research Site	Ostrava-Poruba		Czech Republic
452	Research Site	Ostrava-Zabreh		Czech Republic
453	Research Site	Ostrava		Czech Republic
454	Research Site	Pelhrimov		Czech Republic
455	Research Site	Praha 2		Czech Republic
456	Research Site	Praha 5		Czech Republic
457	Research Site	Praha 6		Czech Republic
458	Research Site	Pribram		Czech Republic
459	Research Site	Slany		Czech Republic
460	Research Site	Teplice		Czech Republic
461	Research Site	Usti nad Labem		Czech Republic
462	Research Site	Usti nad Orlici		Czech Republic
463	Research Site	Znojmo		Czech Republic
464	Research Site	ABBEVILLE cedex		France
465	Research Site	Albi		France
466	Research Site	ANGERS Cedex 9		France
467	Research Site	Angers		France
468	Research Site	Avignon Cedex		France
469	Research Site	Bayonne		France
470	Research Site	Cannes		France
471	Research Site	Creteil		France
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473	Research Site	Jossigny		France
474	Research Site	La Rochelle Cedex		France
475	Research Site	Le Chesnay		France
476	Research Site	Le Coudray Cedex		France
477	Research Site	Limoges Cedex		France
478	Research Site	MARSEILLE Cedex 5		France
479	Research Site	Metz Cedex 1		France
480	Research Site	NICE Cedex 01		France
481	Research Site	NIMES Cedex 9		France
482	Research Site	Orléans Cedex 2		France
483	Research Site	Paris		France
484	Research Site	Pessac		France
485	Research Site	Poitiers		France
486	Research Site	Toulouse Cedex		France
487	Research Site	TOURCOING cedex		France
488	Research Site	Bad Krozingen		Germany
489	Research Site	Bad Mergentheim		Germany
490	Research Site	Bad Nauheim		Germany
491	Research Site	Berlin		Germany
492	Research Site	Bielefeld		Germany
493	Research Site	Coburg		Germany
494	Research Site	Deggingen		Germany
495	Research Site	Dortmund		Germany
496	Research Site	Dresden		Germany
497	Research Site	Essen		Germany
498	Research Site	Esslingen		Germany
499	Research Site	Frankfurt		Germany
500	Research Site	Hamburg		Germany
501	Research Site	Heidelberg		Germany
502	Research Site	Kassel		Germany
503	Research Site	Kiel		Germany
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506	Research Site	Ludwigshafen		Germany
507	Research Site	Lübeck		Germany
508	Research Site	Mainz		Germany
509	Research Site	Mönchengladbach		Germany
510	Research Site	Ulm		Germany
511	Research Site	Warendorf		Germany
512	Research Site	Witten		Germany
513	Research Site	Ballasagyarmat		Hungary
514	Research Site	Budapest		Hungary
515	Research Site	Békéscsaba		Hungary
516	Research Site	Cegléd		Hungary
517	Research Site	Debrecen		Hungary
518	Research Site	Eger		Hungary
519	Research Site	Gyula		Hungary
520	Research Site	Kalocsa		Hungary
521	Research Site	Kecskemét		Hungary
522	Research Site	Mosonmagyaróvár		Hungary
523	Research Site	Nyíregyháza		Hungary
524	Research Site	Pécs		Hungary
525	Research Site	Sopron		Hungary
526	Research Site	Szeged		Hungary
527	Research Site	Szekszárd		Hungary
528	Research Site	Szolnok		Hungary
529	Research Site	Székesfehérvár		Hungary
530	Research Site	Zalaegerszeg		Hungary
531	Research Site	Albano Laziale		Italy
532	Research Site	Bari		Italy
533	Research Site	Benevento		Italy
534	Research Site	Brescia		Italy
535	Research Site	Carpi		Italy
536	Research Site	Catania		Italy
537	Research Site	Genova		Italy
538	Research Site	Legnano		Italy
539	Research Site	Lucca		Italy
540	Research Site	Massa		Italy
541	Research Site	Milano		Italy
542	Research Site	Napoli		Italy
543	Research Site	Osio Sotto frazione di Zingoni		Italy
544	Research Site	Parma		Italy
545	Research Site	Pavia		Italy
546	Research Site	Perugia		Italy
547	Research Site	Pescara		Italy
548	Research Site	Pisa		Italy
549	Research Site	Reggio Emilia		Italy
550	Research Site	Roma		Italy
551	Research Site	Rozzano		Italy
552	Research Site	S Maria Capua Vetere		Italy
553	Research Site	San Remo		Italy
554	Research Site	Sassari		Italy
555	Research Site	Sessa Aurunca		Italy
556	Research Site	Siena		Italy
557	Research Site	Sorrento NA		Italy
558	Research Site	Vimercate		Italy
559	Research Site	Akishima-shi		Japan
560	Research Site	Amagasaki-shi		Japan
561	Research Site	Beppu-shi		Japan
562	Research Site	Chuo-ku		Japan
563	Research Site	Daito-shi		Japan
564	Research Site	Fukui-shi		Japan
565	Research Site	Funabashi-shi		Japan
566	Research Site	Gifu-shi		Japan
567	Research Site	Hamamatsu-shi		Japan
568	Research Site	Himeji-shi		Japan
569	Research Site	Imabari-shi		Japan
570	Research Site	Isehara-shi		Japan
571	Research Site	Kamogawa-shi		Japan
572	Research Site	Kanazawa-shi		Japan
573	Research Site	Kawachinagano-shi		Japan
574	Research Site	Kisarazu-shi		Japan
575	Research Site	Komatsushima-shi		Japan
576	Research Site	Koriyama-shi		Japan
577	Research Site	Kumamoto-shi		Japan
578	Research Site	Kure-shi		Japan
579	Research Site	Kusatsu-shi		Japan
580	Research Site	Kyoto-shi		Japan
581	Research Site	Maebashi-shi		Japan
582	Research Site	Matsue-shi		Japan
583	Research Site	Matsumoto-shi		Japan
584	Research Site	Matsuyama-shi		Japan
585	Research Site	Meguro-ku		Japan
586	Research Site	Miyazaki-shi		Japan
587	Research Site	Osaka-shi		Japan
588	Research Site	Saga-shi		Japan
589	Research Site	Sagamihara-shi		Japan
590	Research Site	Saitama-shi		Japan
591	Research Site	Sakai-shi		Japan
592	Research Site	Sakaide-shi		Japan
593	Research Site	Sapporo-shi		Japan
594	Research Site	Sayama-shi		Japan
595	Research Site	Shimada-shi		Japan
596	Research Site	Shinagawa-ku		Japan
597	Research Site	Shizuoka-shi		Japan
598	Research Site	Suwa-shi		Japan
599	Research Site	Takarazuka-shi		Japan
600	Research Site	Takasaki-shi		Japan
601	Research Site	Takatsuki-shi		Japan
602	Research Site	Tomakomai-shi		Japan
603	Research Site	Toyonaka-shi		Japan
604	Research Site	Ueda-shi		Japan
605	Research Site	Wakayama-shi		Japan
606	Research Site	Wako-shi		Japan
607	Research Site	Yatsushiro-shi		Japan
608	Research Site	Yokohama-shi		Japan
609	Research Site	Bucheon-si		Korea, Republic of
610	Research Site	Busan		Korea, Republic of
611	Research Site	Cheongju		Korea, Republic of
612	Research Site	Daegu		Korea, Republic of
613	Research Site	Daejeon		Korea, Republic of
614	Research Site	Gwangju		Korea, Republic of
615	Research Site	Jeonju		Korea, Republic of
616	Research Site	Seongnam-si		Korea, Republic of
617	Research Site	Seoul		Korea, Republic of
618	Research Site	Suwon-si		Korea, Republic of
619	Research Site	Uijeongbu		Korea, Republic of
620	Research Site	Wonju-si		Korea, Republic of
621	Research Site	Almere		Netherlands
622	Research Site	Amersfoort		Netherlands
623	Research Site	Amsterdam		Netherlands
624	Research Site	Arnhem		Netherlands
625	Research Site	Beverwijk		Netherlands
626	Research Site	Breda		Netherlands
627	Research Site	Delft		Netherlands
628	Research Site	Den Haag		Netherlands
629	Research Site	Den Helder		Netherlands
630	Research Site	Deventer		Netherlands
631	Research Site	Drachten		Netherlands
632	Research Site	EDE		Netherlands
633	Research Site	Eindhoven		Netherlands
634	Research Site	Goes		Netherlands
635	Research Site	Groningen		Netherlands
636	Research Site	Hardenberg		Netherlands
637	Research Site	Heerenveen		Netherlands
638	Research Site	Heerlen		Netherlands
639	Research Site	Helmond		Netherlands
640	Research Site	Hilversum		Netherlands
641	Research Site	Hoofddorp		Netherlands
642	Research Site	Hoogeveen		Netherlands
643	Research Site	Leiderdorp		Netherlands
644	Research Site	Maastricht		Netherlands
645	Research Site	Nieuwegein		Netherlands
646	Research Site	Nijmegen		Netherlands
647	Research Site	OSS		Netherlands
648	Research Site	Roosendaal		Netherlands
649	Research Site	Rotterdam		Netherlands
650	Research Site	Schiedam		Netherlands
651	Research Site	Shertogenbosch		Netherlands
652	Research Site	Sittardgeleen		Netherlands
653	Research Site	Sneek		Netherlands
654	Research Site	Tiel		Netherlands
655	Research Site	Tilburg		Netherlands
656	Research Site	Veldhoven		Netherlands
657	Research Site	Bergen		Norway
658	Research Site	Bodo		Norway
659	Research Site	Bodø		Norway
660	Research Site	Flekkefjord		Norway
661	Research Site	Hamar		Norway
662	Research Site	Levanger		Norway
663	Research Site	Lillehammer		Norway
664	Research Site	Nesttun		Norway
665	Research Site	Oslo		Norway
666	Research Site	Skien		Norway
667	Research Site	Tromsø		Norway
668	Research Site	Tynset		Norway
669	Research Site	Arequipa		Peru
670	Research Site	Callao		Peru
671	Research Site	Lima		Peru
672	Research Site	San Borja		Peru
673	Research Site	Trujillo		Peru
674	Research Site	Cebu City		Philippines
675	Research Site	Fuente Osmena Cebu City		Philippines
676	Research Site	Iloilo City		Philippines
677	Research Site	Las Pinas City		Philippines
678	Research Site	Lipa City		Philippines
679	Research Site	Mandaluyong City		Philippines
680	Research Site	Manila		Philippines
681	Research Site	Pasig City		Philippines
682	Research Site	Quezon City		Philippines
683	Research Site	Quezon		Philippines
684	Research Site	San Juan		Philippines
685	Research Site	Białystok		Poland
686	Research Site	Bielsko Biala		Poland
687	Research Site	Bydgoszcz		Poland
688	Research Site	Chorzow		Poland
689	Research Site	Gdańsk		Poland
690	Research Site	Gdynia		Poland
691	Research Site	Giżycko		Poland
692	Research Site	Kraków		Poland
693	Research Site	Legnica		Poland
694	Research Site	Lubin		Poland
695	Research Site	Nowa Sól		Poland
696	Research Site	Olsztyn		Poland
697	Research Site	Opole		Poland
698	Research Site	Ostrów Mazowiecka		Poland
699	Research Site	Oława		Poland
700	Research Site	Piotrkow		Poland
701	Research Site	Poznań		Poland
702	Research Site	Płock		Poland
703	Research Site	Skierniewice		Poland
704	Research Site	Sobótka		Poland
705	Research Site	Sokolka		Poland
706	Research Site	Szczecin		Poland
707	Research Site	Tarnów		Poland
708	Research Site	Torun		Poland
709	Research Site	Toruń		Poland
710	Research Site	Warszawa		Poland
711	Research Site	Wrocław		Poland
712	Research Site	Włocławek		Poland
713	Research Site	Łańcut		Poland
714	Research Site	Łódź		Poland
715	Research Site	Łęczna		Poland
716	Research Site	Bacau		Romania
717	Research Site	Braila		Romania
718	Research Site	Brasov		Romania
719	Research Site	Bucharest		Romania
720	Research Site	Bucuresti		Romania
721	Research Site	Buzau		Romania
722	Research Site	Cluj Napoca		Romania
723	Research Site	Craiova		Romania
724	Research Site	Deva		Romania
725	Research Site	Focsani		Romania
726	Research Site	Iasi		Romania
727	Research Site	Pitesti		Romania
728	Research Site	Sibiu		Romania
729	Research Site	Suceava		Romania
730	Research Site	Tg. Mures		Romania
731	Research Site	Timisoara		Romania
732	Research Site	Ekaterinburg		Russian Federation
733	Research Site	Gatchina		Russian Federation
734	Research Site	Kazan		Russian Federation
735	Research Site	Krasnodar		Russian Federation
736	Research Site	Moscow		Russian Federation
737	Research Site	Nizhnii Novgorod		Russian Federation
738	Research Site	Novosibirsk		Russian Federation
739	Research Site	Perm		Russian Federation
740	Research Site	Saint Petersburg		Russian Federation
741	Research Site	Saint-Petersburg		Russian Federation
742	Research Site	Saratov		Russian Federation
743	Research Site	St.-Petersburg,		Russian Federation
744	Research Site	St.-Petersburg		Russian Federation
745	Research Site	St.Petersburg		Russian Federation
746	Research Site	StPetersburg		Russian Federation
747	Research Site	Vladikavkaz		Russian Federation
748	Research Site	Volgograd		Russian Federation
749	Research Site	Banska Bystrica		Slovakia
750	Research Site	Bardejov		Slovakia
751	Research Site	Bratislava		Slovakia
752	Research Site	Komarno		Slovakia
753	Research Site	Kosice		Slovakia
754	Research Site	Liptovsky Hradok		Slovakia
755	Research Site	Liptovsky Mikulas		Slovakia
756	Research Site	Martin		Slovakia
757	Research Site	Nitra		Slovakia
758	Research Site	Partizanske		Slovakia
759	Research Site	Piestany		Slovakia
760	Research Site	Povazska Bystrica		Slovakia
761	Research Site	Presov		Slovakia
762	Research Site	Ruzomberok		Slovakia
763	Research Site	Trnava		Slovakia
764	Research Site	Zilina		Slovakia
765	Research Site	Alberton		South Africa
766	Research Site	Bloemfontein		South Africa
767	Research Site	Cape Town		South Africa
768	Research Site	Centurion		South Africa
769	Research Site	Durban		South Africa
770	Research Site	Gatesville		South Africa
771	Research Site	George		South Africa
772	Research Site	Johannesburg		South Africa
773	Research Site	Kempron Park		South Africa
774	Research Site	Panorama		South Africa
775	Research Site	Parow		South Africa
776	Research Site	Pretoria		South Africa
777	Research Site	Somerset West		South Africa
778	Research Site	Soweto		South Africa
779	Research Site	Worcester		South Africa
780	Research Site	Almeria		Spain
781	Research Site	Aviles		Spain
782	Research Site	Barcelona		Spain
783	Research Site	Bilbao		Spain
784	Research Site	Don Benito (Badajoz)		Spain
785	Research Site	Hospitalet de Llobregat(Barcel		Spain
786	Research Site	Madrid		Spain
787	Research Site	Majadahonda		Spain
788	Research Site	Málaga		Spain
789	Research Site	Oviedo		Spain
790	Research Site	Palma de Mallorca		Spain
791	Research Site	Sabadell		Spain
792	Research Site	San Sebastian de los Reyes		Spain
793	Research Site	Santiago(A Coruña)		Spain
794	Research Site	Sevilla		Spain
795	Research Site	Valencia		Spain
796	Research Site	Eksjö		Sweden
797	Research Site	Göteborg		Sweden
798	Research Site	Jönköping		Sweden
799	Research Site	Linkoping		Sweden
800	Research Site	Ljungby		Sweden
801	Research Site	Lund		Sweden
802	Research Site	Molndal		Sweden
803	Research Site	Stockholm		Sweden
804	Research Site	Sundsvall		Sweden
805	Research Site	Umea		Sweden
806	Research Site	Västerås		Sweden
807	Research Site	Örebro		Sweden
808	Research Site	Östersund		Sweden
809	Research Site	Adana		Turkey
810	Research Site	Ankara		Turkey
811	Research Site	Istanbul		Turkey
812	Research Site	Izmir		Turkey
813	Research Site	Malatya		Turkey
814	Research Site	Mersin		Turkey
815	Research Site	Dnepropetrovsk		Ukraine
816	Research Site	Donetsk		Ukraine
817	Research Site	Kharkiv		Ukraine
818	Research Site	Kharkov		Ukraine
819	Research Site	Kiev		Ukraine
820	Research Site	Kyiv		Ukraine
821	Research Site	Lviv		Ukraine
822	Research Site	Uzhgorod		Ukraine
823	Research Site	Vinnitsa		Ukraine
824	Research Site	Zaporozye		Ukraine
825	Research Site	Airdrie		United Kingdom
826	Research Site	Antrim		United Kingdom
827	Research Site	Belfast		United Kingdom
828	Research Site	Blackpool		United Kingdom
829	Research Site	Bournemouth		United Kingdom
830	Research Site	Brighton		United Kingdom
831	Research Site	Bristol		United Kingdom
832	Research Site	Coventry		United Kingdom
833	Research Site	Dundee		United Kingdom
834	Research Site	East Kilbride		United Kingdom
835	Research Site	Ely		United Kingdom
836	Research Site	Hastings		United Kingdom
837	Research Site	London		United Kingdom
838	Research Site	Manchester		United Kingdom
839	Research Site	Middlesborough		United Kingdom
840	Research Site	Northampton		United Kingdom
841	Research Site	Nottingham		United Kingdom
842	Research Site	Peterborough		United Kingdom
843	Research Site	Rotherham		United Kingdom
844	Research Site	Sheffield		United Kingdom
845	Research Site	Swansea		United Kingdom
846	Research Site	Torquay		United Kingdom
847	Research Site	York		United Kingdom

Sponsors and Collaborators

AstraZeneca

Investigators

Study Chair: Eugene Braunwald, MD, TIMI Study Group
Principal Investigator: Marc Sabatine, MD, MPh, TIMI Study Group

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

D5132C00001_Protocol

Publications

None provided.

Responsible Party:

AstraZeneca

ClinicalTrials.gov Identifier:

NCT01225562

Other Study ID Numbers:

D5132C00001
2009-017242-30

First Posted:

Oct 21, 2010

Last Update Posted:

Jan 25, 2016

Last Verified:

Dec 1, 2015

Keywords provided by AstraZeneca

Heart attack

Heart Disease

Acute coronary syndrome

ACS

Cardiovascular Disease

Additional relevant MeSH terms:

Stroke

Myocardial Infarction

Infarction

Death

Ticagrelor

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail	The Participant Flow shows patients randomized. This number is different from patients enrolled in the protocol section which includes patients who were enrolled, but not randomized.

Arm/Group Title	Ticagrelor 90 mg	Ticagrelor 60 mg	Placebo
Arm/Group Description	Ticagrelor 90 mg twice daily (BD)	Ticagrelor 60 mg twice daily (BD)	Matching placebo
Period Title: Overall Study
STARTED	7050	7045	7067
COMPLETED	6995	6989	7014
NOT COMPLETED	55	56	53

Baseline Characteristics

Arm/Group Title	Ticagrelor 90 mg	Ticagrelor 60 mg	Placebo	Total
Arm/Group Description	Ticagrelor 90 mg twice daily (BD)	Ticagrelor 60 mg twice daily (BD)	Matching placebo	Total of all reporting groups
Overall Participants	7050	7045	7067	21162
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	65.4 (8.4)	65.2 (8.4)	65.4 (8.3)	65.3 (8.3)
Sex: Female, Male (Count of Participants)
Female	1682 23.9%	1661 23.6%	1717 24.3%	5060 23.9%
Male	5368 76.1%	5384 76.4%	5350 75.7%	16102 76.1%

Outcome Measures

1. Primary Outcome

Title	Kaplan-Meier Estimate of the Percentage of Patients Who Experienced Cardiovascular Death (CV Death), Myocardial Infarction (MI) or Stroke Within 3 Years From Randomization
Description	Participants with CV death, MI or Stroke. If no event, censoring occurs at the earliest of the efficacy cut-off date 14 Sep 2014, withdrawal of consent, non-CV death or at the last time point of complete clinical event assessment. Events were adjudicated by a blinded endpoint committee. The Kaplan-Meier estimate reports the percentage of patients who experienced CV Death, MI or stroke within 3 years from randomization
Time Frame	Randomization up to 47 months

Outcome Measure Data

Analysis Population Description
Intention to treat (ITT) population defined as all participants who were randomized to study treatment

Arm/Group Title	Ticagrelor 90 mg	Ticagrelor 60 mg	Placebo
Arm/Group Description	Ticagrelor 90 mg twice daily (BD)	Ticagrelor 60 mg twice daily (BD)	Matching placebo
Measure Participants	7050	7045	7067
Number [Percentage of Patients]	7.8	7.8	9.0

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Ticagrelor 90 mg, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0080
	Comments
	Method	Regression, Cox
	Comments

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.85
	Confidence Interval	(2-Sided) 95% 0.75 to 0.96
	Parameter Dispersion	Type: Value:
	Estimation Comments	The hazard ratio shows ticagrelor 90 mg hazard / placebo hazard

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Ticagrelor 60 mg, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0043
	Comments
	Method	Regression, Cox
	Comments

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.84
	Confidence Interval	(2-Sided) 95% 0.74 to 0.95
	Parameter Dispersion	Type: Value:
	Estimation Comments	The hazard ratio shows ticagrelor 60 mg hazard / placebo hazard

2. Secondary Outcome

Title	Kaplan-Meier Estimate of the Percentage of Patients Who Experienced Cardiovascular Death (CV Death) Within 3 Years From Randomization
Description	Participants with CV death. If no event, censoring occurs at the earliest of the efficacy cut-off date 14 Sep 2014, withdrawal of consent, non-CV death or at the last time point of complete clinical event assessment. Events were adjudicated by a blinded endpoint committee. The Kaplan-Meier estimate reports the percentage of patients who experienced CV Death within 3 years from randomization
Time Frame	Randomization up to 47 months

Outcome Measure Data

Analysis Population Description
Intention to treat (ITT) population defined as all participants who were randomized to study treatment

Arm/Group Title	Ticagrelor 90 mg	Ticagrelor 60 mg	Placebo
Arm/Group Description	Ticagrelor 90 mg twice daily (BD)	Ticagrelor 60 mg twice daily (BD)	Matching placebo
Measure Participants	7050	7045	7067
Number [Percentage of Patients]	2.9	2.9	3.4

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Ticagrelor 90 mg, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.1547
	Comments
	Method	Regression, Cox
	Comments

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.87
	Confidence Interval	(2-Sided) 95% 0.71 to 1.06
	Parameter Dispersion	Type: Value:
	Estimation Comments	The hazard ratio shows ticagrelor 90 mg hazard / placebo hazard

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Ticagrelor 60 mg, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0676
	Comments
	Method	Regression, Cox
	Comments

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.83
	Confidence Interval	(2-Sided) 95% 0.68 to 1.01
	Parameter Dispersion	Type: Value:
	Estimation Comments	The hazard ratio shows ticagrelor 60 mg hazard / placebo hazard

3. Secondary Outcome

Title	Kaplan-Meier Estimate of the Percentage of Patients Who Died From Any Cause Within 3 Years From Randomization
Description	Participants with death from any cause. If no event, censoring occurs at the earliest of the efficacy cut-off date 14 Sep 2014, withdrawal of consent or the last time point the particapant was known to be alive. Events were adjudicated by a blinded endpoint committee. The Kaplan-Meier estimate reports the percentage of patients who died from any cause within 3 years from randomization
Time Frame	Randomization up to 47 months

Outcome Measure Data

Analysis Population Description
Intention to treat (ITT) population defined as all participants who were randomized to study treatment

Arm/Group Title	Ticagrelor 90 mg	Ticagrelor 60 mg	Placebo
Arm/Group Description	Ticagrelor 90 mg twice daily (BD)	Ticagrelor 60 mg twice daily (BD)	Matching placebo
Measure Participants	7050	7045	7067
Number [Percentage of Patients]	5.1	4.7	5.2

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Ticagrelor 90 mg, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.9851
	Comments
	Method	Regression, Cox
	Comments

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.00
	Confidence Interval	(2-Sided) 95% 0.86 to 1.16
	Parameter Dispersion	Type: Value:
	Estimation Comments	The hazard ratio shows ticagrelor 90 mg hazard / placebo hazard

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Ticagrelor 60 mg, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.1350
	Comments
	Method	Regression, Cox
	Comments

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.89
	Confidence Interval	(2-Sided) 95% 0.76 to 1.04
	Parameter Dispersion	Type: Value:
	Estimation Comments	The hazard ratio shows ticagrelor 60 mg hazard / placebo hazard

4. Primary Outcome

Title	Kaplan-Meier Estimate of the Percentage of Patients Who Experienced a TIMI Major Bleeding Within 3 Years From First Dose of Study Drug Units: Percentage of Patients
Description	A Thrombolysis in Myocardial Infarction (TIMI) study group major bleeding is defined as any fatal bleeding (leading directly to death within 7 days), any intrcranial bleeding or any clinically overt signs of haemorrhage associated with a drop in Haemoglobin of >= 5g/dL. Events were adjudicated by a clinical events committee. Censoring ocurrs at 7 days following last dose of study drug. The Kaplan-Meier estimate reports the percentage of patients who experienced a TIMI Major bleeding within 3 years from first dose of study drug
Time Frame	First dosing up to 48 months

Outcome Measure Data

Analysis Population Description
The safety analysis set defined as all patients who took at least one dose of study drug

Arm/Group Title	Ticagrelor 90 mg	Ticagrelor 60 mg	Placebo
Arm/Group Description	Ticagrelor 90 mg twice daily (BD)	Ticagrelor 60 mg twice daily (BD)	Matching placebo
Measure Participants	6988	6958	6996
Number [Percentage of Patients]	2.6	2.3	1.1

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Ticagrelor 90 mg, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Regression, Cox
	Comments

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	2.69
	Confidence Interval	(2-Sided) 95% 1.96 to 3.70
	Parameter Dispersion	Type: Value:
	Estimation Comments	The hazard ratio shows ticagrelor 90 mg hazard / placebo hazard

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Ticagrelor 60 mg, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Regression, Cox
	Comments

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	2.32
	Confidence Interval	(2-Sided) 95% 1.68 to 3.21
	Parameter Dispersion	Type: Value:
	Estimation Comments	The hazard ratio shows ticagrelor 60 mg hazard / placebo hazard

Adverse Events

Arm/Group Description
Time Frame
Adverse Event Reporting Description	Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.

Arm/Group Title	Placebo		Ticagrelor 60mg bd		Ticagrelor 90mg bd
All Cause Mortality
	Placebo		Ticagrelor 60mg bd		Ticagrelor 90mg bd
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Placebo		Ticagrelor 60mg bd		Ticagrelor 90mg bd
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1757/6996 (25.1%)		1853/6958 (26.6%)		1918/6988 (27.4%)
Blood and lymphatic system disorders
Anaemia	9/6996 (0.1%)	9	5/6958 (0.1%)	5	12/6988 (0.2%)	12
Anaemia macrocytic	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Anaemia megaloblastic	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Anaemia of chronic disease	1/6996 (0%)	1	0/6958 (0%)	0	1/6988 (0%)	1
Anaemia of malignant disease	0/6996 (0%)	0	1/6958 (0%)	1	2/6988 (0%)	7
Anaemia vitamin B12 deficiency	1/6996 (0%)	1	0/6958 (0%)	0	1/6988 (0%)	1
Aplastic anaemia	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Coagulation factor deficiency	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Coagulopathy	0/6996 (0%)	0	1/6958 (0%)	1	1/6988 (0%)	1
Febrile neutropenia	0/6996 (0%)	0	1/6958 (0%)	1	1/6988 (0%)	1
Haemolysis	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Haemorrhagic anaemia	2/6996 (0%)	2	7/6958 (0.1%)	7	4/6988 (0.1%)	4
Heparin-induced thrombocytopenia	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Hypercoagulation	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Hypochromic anaemia	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Immune thrombocytopenic purpura	0/6996 (0%)	0	2/6958 (0%)	2	0/6988 (0%)	0
Increased tendency to bruise	0/6996 (0%)	0	1/6958 (0%)	1	2/6988 (0%)	2
Iron deficiency anaemia	3/6996 (0%)	3	11/6958 (0.2%)	11	24/6988 (0.3%)	25
Leukocytosis	1/6996 (0%)	1	0/6958 (0%)	0	1/6988 (0%)	1
Leukopenia	0/6996 (0%)	0	1/6958 (0%)	1	2/6988 (0%)	2
Lymphadenopathy	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Microcytic anaemia	2/6996 (0%)	2	5/6958 (0.1%)	5	4/6988 (0.1%)	4
Nephrogenic anaemia	0/6996 (0%)	0	2/6958 (0%)	2	2/6988 (0%)	2
Neutropenia	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Normochromic normocytic anaemia	0/6996 (0%)	0	0/6958 (0%)	0	3/6988 (0%)	3
Pancytopenia	0/6996 (0%)	0	3/6958 (0%)	3	2/6988 (0%)	2
Pernicious anaemia	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Splenic haemorrhage	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Splenomegaly	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Spontaneous haematoma	3/6996 (0%)	3	1/6958 (0%)	1	2/6988 (0%)	2
Spontaneous haemorrhage	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Thrombocytopenia	6/6996 (0.1%)	6	2/6958 (0%)	2	8/6988 (0.1%)	8
Cardiac disorders
Acute coronary syndrome	3/6996 (0%)	3	1/6958 (0%)	1	0/6988 (0%)	0
Acute left ventricular failure	5/6996 (0.1%)	6	1/6958 (0%)	1	3/6988 (0%)	3
Acute myocardial infarction	28/6996 (0.4%)	28	20/6958 (0.3%)	20	19/6988 (0.3%)	19
Adams-Stokes syndrome	1/6996 (0%)	1	1/6958 (0%)	1	0/6988 (0%)	0
Angina pectoris	51/6996 (0.7%)	53	45/6958 (0.6%)	47	51/6988 (0.7%)	55
Angina unstable	3/6996 (0%)	3	2/6958 (0%)	2	4/6988 (0.1%)	4
Aortic valve disease	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Aortic valve stenosis	2/6996 (0%)	2	2/6958 (0%)	3	3/6988 (0%)	3
Arrhythmia	1/6996 (0%)	1	3/6958 (0%)	3	2/6988 (0%)	2
Arrhythmia supraventricular	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Arteriosclerosis coronary artery	2/6996 (0%)	2	2/6958 (0%)	2	1/6988 (0%)	1
Atrial fibrillation	67/6996 (1%)	73	94/6958 (1.4%)	104	74/6988 (1.1%)	88
Atrial flutter	16/6996 (0.2%)	20	14/6958 (0.2%)	15	13/6988 (0.2%)	13
Atrial tachycardia	4/6996 (0.1%)	4	2/6958 (0%)	2	0/6988 (0%)	0
Atrial thrombosis	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Atrioventricular block	1/6996 (0%)	1	5/6958 (0.1%)	5	3/6988 (0%)	3
Atrioventricular block complete	13/6996 (0.2%)	14	6/6958 (0.1%)	6	3/6988 (0%)	3
Atrioventricular block second degree	5/6996 (0.1%)	5	3/6958 (0%)	3	4/6988 (0.1%)	4
Bifascicular block	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Bradyarrhythmia	0/6996 (0%)	0	1/6958 (0%)	1	2/6988 (0%)	2
Bradycardia	2/6996 (0%)	2	7/6958 (0.1%)	7	7/6988 (0.1%)	7
Bundle branch block left	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Bundle branch block right	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Cardiac arrest	6/6996 (0.1%)	6	8/6958 (0.1%)	8	7/6988 (0.1%)	8
Cardiac asthma	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Cardiac failure	58/6996 (0.8%)	73	53/6958 (0.8%)	70	54/6988 (0.8%)	69
Cardiac failure acute	6/6996 (0.1%)	6	6/6958 (0.1%)	6	4/6988 (0.1%)	4
Cardiac failure chronic	14/6996 (0.2%)	16	11/6958 (0.2%)	19	19/6988 (0.3%)	25
Cardiac failure congestive	51/6996 (0.7%)	60	53/6958 (0.8%)	79	70/6988 (1%)	97
Cardiac hypertrophy	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Cardiac perforation	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Cardiac tamponade	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Cardiac valve disease	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Cardiac ventricular thrombosis	3/6996 (0%)	3	2/6958 (0%)	2	1/6988 (0%)	1
Cardio-respiratory arrest	7/6996 (0.1%)	7	6/6958 (0.1%)	6	6/6988 (0.1%)	7
Cardiogenic shock	10/6996 (0.1%)	10	9/6958 (0.1%)	9	4/6988 (0.1%)	5
Cardiomyopathy	1/6996 (0%)	1	2/6958 (0%)	2	2/6988 (0%)	2
Cardiopulmonary failure	1/6996 (0%)	1	1/6958 (0%)	1	0/6988 (0%)	0
Cardiovascular insufficiency	1/6996 (0%)	1	0/6958 (0%)	0	1/6988 (0%)	1
Conduction disorder	1/6996 (0%)	1	0/6958 (0%)	0	1/6988 (0%)	1
Cor pulmonale chronic	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Coronary artery disease	6/6996 (0.1%)	6	8/6958 (0.1%)	8	6/6988 (0.1%)	6
Coronary artery occlusion	1/6996 (0%)	1	1/6958 (0%)	1	0/6988 (0%)	0
Coronary artery stenosis	3/6996 (0%)	3	2/6958 (0%)	2	6/6988 (0.1%)	6
Coronary artery thrombosis	0/6996 (0%)	0	2/6958 (0%)	2	0/6988 (0%)	0
Dressler's syndrome	0/6996 (0%)	0	0/6958 (0%)	0	2/6988 (0%)	2
Gastrocardiac syndrome	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Heart valve incompetence	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Intracardiac thrombus	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Ischaemic cardiomyopathy	2/6996 (0%)	2	1/6958 (0%)	1	8/6988 (0.1%)	8
Left ventricular dysfunction	1/6996 (0%)	1	2/6958 (0%)	2	1/6988 (0%)	1
Left ventricular failure	4/6996 (0.1%)	4	1/6958 (0%)	1	4/6988 (0.1%)	4
Low cardiac output syndrome	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Mitral valve calcification	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Mitral valve incompetence	4/6996 (0.1%)	4	7/6958 (0.1%)	8	0/6988 (0%)	0
Mitral valve prolapse	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Myocardial fibrosis	1/6996 (0%)	1	0/6958 (0%)	0	1/6988 (0%)	1
Myocardial infarction	11/6996 (0.2%)	11	9/6958 (0.1%)	9	10/6988 (0.1%)	10
Myocardial ischaemia	3/6996 (0%)	3	1/6958 (0%)	1	3/6988 (0%)	4
Myocardial oedema	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Myocardial rupture	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Myocarditis	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Nodal arrhythmia	2/6996 (0%)	2	1/6958 (0%)	2	0/6988 (0%)	0
Nodal rhythm	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Palpitations	3/6996 (0%)	3	3/6958 (0%)	3	2/6988 (0%)	2
Pericardial effusion	4/6996 (0.1%)	4	2/6958 (0%)	2	0/6988 (0%)	0
Pericardial haemorrhage	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Pericarditis	2/6996 (0%)	2	1/6958 (0%)	1	3/6988 (0%)	4
Pulseless electrical activity	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Right ventricular failure	1/6996 (0%)	1	0/6958 (0%)	0	1/6988 (0%)	1
Sick sinus syndrome	7/6996 (0.1%)	8	7/6958 (0.1%)	7	8/6988 (0.1%)	9
Sinoatrial block	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Sinus arrest	0/6996 (0%)	0	1/6958 (0%)	1	1/6988 (0%)	1
Sinus arrhythmia	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Sinus bradycardia	7/6996 (0.1%)	7	7/6958 (0.1%)	7	12/6988 (0.2%)	12
Sinus tachycardia	2/6996 (0%)	2	1/6958 (0%)	1	0/6988 (0%)	0
Subendocardial ischaemia	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Supraventricular extrasystoles	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Supraventricular tachycardia	5/6996 (0.1%)	5	4/6958 (0.1%)	4	4/6988 (0.1%)	4
Systolic dysfunction	0/6996 (0%)	0	0/6958 (0%)	0	3/6988 (0%)	4
Tachyarrhythmia	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Tachycardia	5/6996 (0.1%)	5	0/6958 (0%)	0	0/6988 (0%)	0
Tachycardia paroxysmal	2/6996 (0%)	2	0/6958 (0%)	0	0/6988 (0%)	0
Ventricular arrhythmia	3/6996 (0%)	3	2/6958 (0%)	3	1/6988 (0%)	1
Ventricular dysfunction	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Ventricular extrasystoles	4/6996 (0.1%)	4	4/6958 (0.1%)	6	3/6988 (0%)	3
Ventricular fibrillation	9/6996 (0.1%)	9	11/6958 (0.2%)	11	4/6988 (0.1%)	4
Ventricular tachycardia	12/6996 (0.2%)	12	17/6958 (0.2%)	20	17/6988 (0.2%)	20
Congenital, familial and genetic disorders
Atrial septal defect	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Ear and labyrinth disorders
Acute vestibular syndrome	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Auricular perichondritis	0/6996 (0%)	0	1/6958 (0%)	1	1/6988 (0%)	1
Deafness	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Deafness unilateral	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Inner ear disorder	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Meniere's disease	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Middle ear effusion	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Presbyacusis	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Sudden hearing loss	1/6996 (0%)	1	2/6958 (0%)	2	1/6988 (0%)	1
Tympanic membrane perforation	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Vertigo	7/6996 (0.1%)	8	3/6958 (0%)	3	4/6988 (0.1%)	5
Vertigo labyrinthine	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Vertigo positional	3/6996 (0%)	3	5/6958 (0.1%)	5	6/6988 (0.1%)	7
Endocrine disorders
Autoimmune thyroiditis	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Goitre	2/6996 (0%)	2	0/6958 (0%)	0	3/6988 (0%)	3
Hyperthyroidism	1/6996 (0%)	1	1/6958 (0%)	1	0/6988 (0%)	0
Hypothyroidism	0/6996 (0%)	0	1/6958 (0%)	1	1/6988 (0%)	1
Inappropriate antidiuretic hormone secretion	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Toxic nodular goitre	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Eye disorders
Age-related macular degeneration	1/6996 (0%)	1	0/6958 (0%)	0	1/6988 (0%)	1
Angle closure glaucoma	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Blindness unilateral	0/6996 (0%)	0	0/6958 (0%)	0	2/6988 (0%)	2
Cataract	14/6996 (0.2%)	17	16/6958 (0.2%)	18	10/6988 (0.1%)	11
Cataract nuclear	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Conjunctival haemorrhage	1/6996 (0%)	2	0/6958 (0%)	0	0/6988 (0%)	0
Diabetic retinopathy	3/6996 (0%)	3	1/6958 (0%)	1	1/6988 (0%)	1
Diplopia	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Endocrine ophthalmopathy	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Extraocular muscle paresis	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Eye haemorrhage	0/6996 (0%)	0	2/6958 (0%)	2	0/6988 (0%)	0
Eyelid ptosis	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Glaucoma	1/6996 (0%)	1	2/6958 (0%)	2	1/6988 (0%)	1
Macular degeneration	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Macular fibrosis	0/6996 (0%)	0	1/6958 (0%)	1	2/6988 (0%)	2
Open angle glaucoma	0/6996 (0%)	0	1/6958 (0%)	1	1/6988 (0%)	1
Opsoclonus myoclonus	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Optic ischaemic neuropathy	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Pterygium	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Retinal artery embolism	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Retinal artery occlusion	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Retinal degeneration	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Retinal detachment	4/6996 (0.1%)	5	1/6958 (0%)	1	3/6988 (0%)	3
Retinal haemorrhage	1/6996 (0%)	1	1/6958 (0%)	1	1/6988 (0%)	1
Retinal vein occlusion	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Strabismus	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Tolosa-Hunt syndrome	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Vitreous haemorrhage	2/6996 (0%)	2	3/6958 (0%)	3	1/6988 (0%)	1
Gastrointestinal disorders
Abdominal adhesions	2/6996 (0%)	2	0/6958 (0%)	0	1/6988 (0%)	1
Abdominal discomfort	1/6996 (0%)	1	1/6958 (0%)	1	1/6988 (0%)	1
Abdominal hernia	1/6996 (0%)	1	3/6958 (0%)	3	5/6988 (0.1%)	5
Abdominal hernia obstructive	1/6996 (0%)	1	1/6958 (0%)	1	1/6988 (0%)	1
Abdominal pain	4/6996 (0.1%)	4	5/6958 (0.1%)	6	7/6988 (0.1%)	7
Abdominal pain lower	2/6996 (0%)	2	0/6958 (0%)	0	0/6988 (0%)	0
Abdominal pain upper	2/6996 (0%)	2	1/6958 (0%)	1	1/6988 (0%)	1
Abdominal wall haematoma	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Acute abdomen	2/6996 (0%)	2	1/6958 (0%)	1	1/6988 (0%)	1
Anal fissure	0/6996 (0%)	0	1/6958 (0%)	1	1/6988 (0%)	1
Anal fistula	2/6996 (0%)	2	2/6958 (0%)	2	2/6988 (0%)	2
Anal haemorrhage	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Anal polyp	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Anal stenosis	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Appendiceal mucocoele	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Ascites	1/6996 (0%)	1	0/6958 (0%)	0	1/6988 (0%)	1
Barrett's oesophagus	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Colitis	4/6996 (0.1%)	4	5/6958 (0.1%)	7	2/6988 (0%)	2
Colitis ischaemic	1/6996 (0%)	1	3/6958 (0%)	3	1/6988 (0%)	1
Colitis ulcerative	1/6996 (0%)	1	1/6958 (0%)	1	1/6988 (0%)	1
Constipation	1/6996 (0%)	1	4/6958 (0.1%)	4	9/6988 (0.1%)	9
Crohn's disease	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	4
Dental caries	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Diaphragmatic hernia	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Diarrhoea	1/6996 (0%)	1	2/6958 (0%)	2	7/6988 (0.1%)	7
Dieulafoy's vascular malformation	0/6996 (0%)	0	0/6958 (0%)	0	2/6988 (0%)	2
Diverticular perforation	0/6996 (0%)	0	0/6958 (0%)	0	3/6988 (0%)	3
Diverticulitis intestinal haemorrhagic	4/6996 (0.1%)	5	2/6958 (0%)	2	1/6988 (0%)	1
Diverticulum	1/6996 (0%)	1	3/6958 (0%)	3	8/6988 (0.1%)	9
Diverticulum intestinal	3/6996 (0%)	3	2/6958 (0%)	2	2/6988 (0%)	2
Diverticulum intestinal haemorrhagic	2/6996 (0%)	2	12/6958 (0.2%)	15	11/6988 (0.2%)	12
Duodenal stenosis	1/6996 (0%)	2	0/6958 (0%)	0	0/6988 (0%)	0
Duodenal ulcer	1/6996 (0%)	1	4/6958 (0.1%)	4	5/6988 (0.1%)	5
Duodenal ulcer haemorrhage	4/6996 (0.1%)	4	7/6958 (0.1%)	7	7/6988 (0.1%)	7
Duodenitis	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Dyspepsia	5/6996 (0.1%)	5	1/6958 (0%)	1	1/6988 (0%)	1
Dysphagia	0/6996 (0%)	0	1/6958 (0%)	1	2/6988 (0%)	2
Enteritis	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Enterocolitis	2/6996 (0%)	2	0/6958 (0%)	0	0/6988 (0%)	0
Enterocolitis haemorrhagic	1/6996 (0%)	1	3/6958 (0%)	3	1/6988 (0%)	1
Enterovesical fistula	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Erosive duodenitis	0/6996 (0%)	0	1/6958 (0%)	1	1/6988 (0%)	1
Erosive oesophagitis	0/6996 (0%)	0	0/6958 (0%)	0	2/6988 (0%)	2
Faecalith	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Femoral hernia, obstructive	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Food poisoning	4/6996 (0.1%)	4	1/6958 (0%)	1	0/6988 (0%)	0
Gastric haemorrhage	1/6996 (0%)	1	1/6958 (0%)	1	2/6988 (0%)	2
Gastric perforation	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Gastric polyps	1/6996 (0%)	1	1/6958 (0%)	1	0/6988 (0%)	0
Gastric ulcer	4/6996 (0.1%)	4	6/6958 (0.1%)	7	13/6988 (0.2%)	14
Gastric ulcer haemorrhage	7/6996 (0.1%)	7	14/6958 (0.2%)	14	18/6988 (0.3%)	18
Gastric ulcer perforation	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Gastritis	10/6996 (0.1%)	11	8/6958 (0.1%)	9	17/6988 (0.2%)	18
Gastritis atrophic	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Gastritis erosive	1/6996 (0%)	1	3/6958 (0%)	3	4/6988 (0.1%)	4
Gastritis haemorrhagic	1/6996 (0%)	1	3/6958 (0%)	3	3/6988 (0%)	3
Gastritis hypertrophic	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Gastroduodenitis	0/6996 (0%)	0	0/6958 (0%)	0	2/6988 (0%)	2
Gastroduodenitis haemorrhagic	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Gastrointestinal angiodysplasia haemorrhagic	1/6996 (0%)	1	0/6958 (0%)	0	3/6988 (0%)	3
Gastrointestinal erosion	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Gastrointestinal haemorrhage	8/6996 (0.1%)	9	15/6958 (0.2%)	15	26/6988 (0.4%)	27
Gastrointestinal mucosal disorder	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Gastrointestinal necrosis	2/6996 (0%)	2	0/6958 (0%)	0	0/6988 (0%)	0
Gastrointestinal pain	0/6996 (0%)	0	1/6958 (0%)	1	1/6988 (0%)	1
Gastrointestinal perforation	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Gastrointestinal polyp haemorrhage	3/6996 (0%)	3	5/6958 (0.1%)	5	2/6988 (0%)	2
Gastrointestinal ulcer haemorrhage	0/6996 (0%)	0	0/6958 (0%)	0	5/6988 (0.1%)	5
Gastrointestinal vascular malformation	0/6996 (0%)	0	1/6958 (0%)	1	3/6988 (0%)	3
Gastrooesophageal reflux disease	10/6996 (0.1%)	11	6/6958 (0.1%)	7	11/6988 (0.2%)	11
Gingival bleeding	0/6996 (0%)	0	1/6958 (0%)	1	2/6988 (0%)	2
Haematemesis	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Haematochezia	0/6996 (0%)	0	2/6958 (0%)	2	2/6988 (0%)	2
Haemorrhagic erosive gastritis	3/6996 (0%)	3	2/6958 (0%)	2	3/6988 (0%)	3
Haemorrhoidal haemorrhage	3/6996 (0%)	3	2/6958 (0%)	2	4/6988 (0.1%)	4
Haemorrhoids	2/6996 (0%)	2	5/6958 (0.1%)	5	3/6988 (0%)	3
Hiatus hernia	0/6996 (0%)	0	4/6958 (0.1%)	4	1/6988 (0%)	1
Ileus	4/6996 (0.1%)	4	4/6958 (0.1%)	5	4/6988 (0.1%)	4
Ileus paralytic	2/6996 (0%)	2	0/6958 (0%)	0	2/6988 (0%)	2
Impaired gastric emptying	1/6996 (0%)	1	1/6958 (0%)	1	1/6988 (0%)	12
Inguinal hernia	21/6996 (0.3%)	22	26/6958 (0.4%)	27	25/6988 (0.4%)	25
Inguinal hernia strangulated	1/6996 (0%)	1	2/6958 (0%)	2	1/6988 (0%)	1
Inguinal hernia, obstructive	2/6996 (0%)	2	1/6958 (0%)	1	0/6988 (0%)	0
Intestinal haemorrhage	0/6996 (0%)	0	4/6958 (0.1%)	4	0/6988 (0%)	0
Intestinal infarction	1/6996 (0%)	1	1/6958 (0%)	1	0/6988 (0%)	0
Intestinal ischaemia	2/6996 (0%)	2	3/6958 (0%)	3	2/6988 (0%)	2
Intestinal obstruction	3/6996 (0%)	3	3/6958 (0%)	3	5/6988 (0.1%)	5
Intestinal perforation	0/6996 (0%)	0	3/6958 (0%)	3	0/6988 (0%)	0
Intussusception	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Irritable bowel syndrome	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Large intestinal ulcer haemorrhage	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Large intestine perforation	2/6996 (0%)	2	1/6958 (0%)	1	0/6988 (0%)	0
Large intestine polyp	8/6996 (0.1%)	8	5/6958 (0.1%)	5	12/6988 (0.2%)	12
Lower gastrointestinal haemorrhage	2/6996 (0%)	2	2/6958 (0%)	2	3/6988 (0%)	3
Mallory-Weiss syndrome	0/6996 (0%)	0	3/6958 (0%)	3	4/6988 (0.1%)	4
Mechanical ileus	0/6996 (0%)	0	0/6958 (0%)	0	2/6988 (0%)	2
Melaena	2/6996 (0%)	2	2/6958 (0%)	2	4/6988 (0.1%)	4
Mouth haemorrhage	0/6996 (0%)	0	1/6958 (0%)	1	2/6988 (0%)	2
Nausea	0/6996 (0%)	0	0/6958 (0%)	0	2/6988 (0%)	2
Oesophageal achalasia	3/6996 (0%)	3	0/6958 (0%)	0	0/6988 (0%)	0
Oesophageal haemorrhage	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Oesophageal obstruction	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Oesophageal pain	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Oesophageal rupture	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Oesophageal stenosis	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Oesophageal ulcer	1/6996 (0%)	1	1/6958 (0%)	1	0/6988 (0%)	0
Oesophageal ulcer haemorrhage	0/6996 (0%)	0	0/6958 (0%)	0	2/6988 (0%)	2
Oesophageal varices haemorrhage	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Oesophagitis	3/6996 (0%)	3	1/6958 (0%)	1	3/6988 (0%)	3
Oesophagitis haemorrhagic	1/6996 (0%)	1	0/6958 (0%)	0	1/6988 (0%)	1
Pancreatic duct obstruction	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Pancreatic fistula	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Pancreatic mass	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Pancreatitis	7/6996 (0.1%)	7	6/6958 (0.1%)	7	7/6988 (0.1%)	8
Pancreatitis acute	7/6996 (0.1%)	7	10/6958 (0.1%)	10	8/6988 (0.1%)	8
Pancreatitis chronic	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Pancreatitis haemorrhagic	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Papilla of Vater stenosis	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Parotid gland inflammation	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Peptic ulcer haemorrhage	1/6996 (0%)	1	3/6958 (0%)	3	4/6988 (0.1%)	4
Peritoneal haemorrhage	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Proctitis	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Proctitis haemorrhagic	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Rectal haemorrhage	1/6996 (0%)	1	3/6958 (0%)	3	5/6988 (0.1%)	5
Rectal polyp	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Reflux gastritis	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Small intestinal haemorrhage	0/6996 (0%)	0	0/6958 (0%)	0	2/6988 (0%)	2
Small intestinal obstruction	6/6996 (0.1%)	6	0/6958 (0%)	0	1/6988 (0%)	1
Small intestinal perforation	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Thrombosis mesenteric vessel	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Tongue blistering	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Tooth disorder	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Toothache	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Umbilical hernia	3/6996 (0%)	3	8/6958 (0.1%)	8	3/6988 (0%)	3
Umbilical hernia, obstructive	0/6996 (0%)	0	1/6958 (0%)	1	3/6988 (0%)	3
Upper gastrointestinal haemorrhage	1/6996 (0%)	1	7/6958 (0.1%)	7	7/6988 (0.1%)	7
Volvulus	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Volvulus of small bowel	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Vomiting	1/6996 (0%)	1	2/6958 (0%)	2	1/6988 (0%)	1
General disorders
Asthenia	1/6996 (0%)	1	7/6958 (0.1%)	9	2/6988 (0%)	2
Cardiac death	1/6996 (0%)	1	1/6958 (0%)	1	1/6988 (0%)	1
Catheter site haemorrhage	2/6996 (0%)	2	0/6958 (0%)	0	3/6988 (0%)	4
Chest discomfort	2/6996 (0%)	2	4/6958 (0.1%)	4	2/6988 (0%)	2
Chest pain	4/6996 (0.1%)	4	2/6958 (0%)	2	6/6988 (0.1%)	6
Death	42/6996 (0.6%)	42	34/6958 (0.5%)	34	42/6988 (0.6%)	42
Device battery issue	0/6996 (0%)	0	1/6958 (0%)	1	1/6988 (0%)	1
Device breakage	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Device defective	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Device dislocation	1/6996 (0%)	1	0/6958 (0%)	0	3/6988 (0%)	3
Device lead damage	0/6996 (0%)	0	0/6958 (0%)	0	2/6988 (0%)	2
Device lead issue	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Device malfunction	2/6996 (0%)	2	0/6958 (0%)	0	3/6988 (0%)	3
Device material issue	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Device occlusion	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Drowning	1/6996 (0%)	1	1/6958 (0%)	1	0/6988 (0%)	0
Drug withdrawal syndrome	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Euthanasia	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Fatigue	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Gait disturbance	0/6996 (0%)	0	1/6958 (0%)	1	1/6988 (0%)	1
General physical health deterioration	1/6996 (0%)	1	2/6958 (0%)	2	0/6988 (0%)	0
Hernia obstructive	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Hypothermia	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Impaired healing	2/6996 (0%)	2	1/6958 (0%)	1	3/6988 (0%)	3
Implant site pain	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Injection site bruising	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Malaise	1/6996 (0%)	1	2/6958 (0%)	2	1/6988 (0%)	1
Medical device complication	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Multi-organ failure	1/6996 (0%)	1	2/6958 (0%)	2	0/6988 (0%)	0
Non-cardiac chest pain	109/6996 (1.6%)	118	113/6958 (1.6%)	124	115/6988 (1.6%)	122
Oedema peripheral	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Pain	1/6996 (0%)	1	1/6958 (0%)	1	0/6988 (0%)	0
Pyrexia	3/6996 (0%)	3	0/6958 (0%)	0	3/6988 (0%)	3
Stent-graft endoleak	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Sudden cardiac death	33/6996 (0.5%)	33	27/6958 (0.4%)	27	27/6988 (0.4%)	27
Sudden death	9/6996 (0.1%)	9	11/6958 (0.2%)	11	6/6988 (0.1%)	6
Systemic inflammatory response syndrome	1/6996 (0%)	1	0/6958 (0%)	0	1/6988 (0%)	1
Vessel puncture site haemorrhage	1/6996 (0%)	1	1/6958 (0%)	1	0/6988 (0%)	0
Hepatobiliary disorders
Acute hepatic failure	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Bile duct stenosis	2/6996 (0%)	2	0/6958 (0%)	0	1/6988 (0%)	1
Bile duct stone	8/6996 (0.1%)	10	7/6958 (0.1%)	8	1/6988 (0%)	1
Biliary colic	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Biliary dyskinesia	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Biliary fistula	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Biloma	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Cholangitis	3/6996 (0%)	3	2/6958 (0%)	2	3/6988 (0%)	3
Cholangitis sclerosing	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Cholecystitis	5/6996 (0.1%)	5	17/6958 (0.2%)	17	10/6988 (0.1%)	10
Cholecystitis acute	11/6996 (0.2%)	11	11/6958 (0.2%)	13	7/6988 (0.1%)	7
Cholecystitis chronic	1/6996 (0%)	1	4/6958 (0.1%)	4	2/6988 (0%)	2
Cholelithiasis	31/6996 (0.4%)	31	18/6958 (0.3%)	18	15/6988 (0.2%)	15
Cholestasis	3/6996 (0%)	3	1/6958 (0%)	1	0/6988 (0%)	0
Chronic hepatitis	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Cirrhosis alcoholic	0/6996 (0%)	0	1/6958 (0%)	1	1/6988 (0%)	1
Drug-induced liver injury	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Gallbladder disorder	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Hepatic cirrhosis	2/6996 (0%)	2	0/6958 (0%)	0	1/6988 (0%)	1
Hepatic failure	3/6996 (0%)	3	0/6958 (0%)	0	1/6988 (0%)	1
Hepatic vein thrombosis	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Hepatomegaly	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Hepatorenal failure	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Hydrocholecystis	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Hyperplastic cholecystopathy	0/6996 (0%)	0	1/6958 (0%)	1	1/6988 (0%)	1
Jaundice	0/6996 (0%)	0	1/6958 (0%)	1	1/6988 (0%)	1
Jaundice cholestatic	1/6996 (0%)	1	1/6958 (0%)	1	0/6988 (0%)	0
Liver disorder	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Non-alcoholic steatohepatitis	0/6996 (0%)	0	2/6958 (0%)	2	0/6988 (0%)	0
Portal vein thrombosis	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Immune system disorders
Allergy to arthropod sting	1/6996 (0%)	1	0/6958 (0%)	0	1/6988 (0%)	1
Anaphylactic reaction	2/6996 (0%)	2	0/6958 (0%)	0	1/6988 (0%)	1
Anaphylactic shock	0/6996 (0%)	0	0/6958 (0%)	0	2/6988 (0%)	2
Anti-neutrophil cytoplasmic antibody positive vasculitis	1/6996 (0%)	1	1/6958 (0%)	1	0/6988 (0%)	0
Contrast media allergy	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Drug hypersensitivity	1/6996 (0%)	1	2/6958 (0%)	2	0/6988 (0%)	0
Hypersensitivity	1/6996 (0%)	1	2/6958 (0%)	2	0/6988 (0%)	0
Reaction to food additive	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Sarcoidosis	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Infections and infestations
Abdominal abscess	0/6996 (0%)	0	3/6958 (0%)	3	2/6988 (0%)	2
Abdominal sepsis	0/6996 (0%)	0	0/6958 (0%)	0	2/6988 (0%)	2
Abdominal wall abscess	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Abdominal wall infection	0/6996 (0%)	0	1/6958 (0%)	2	0/6988 (0%)	0
Abscess	0/6996 (0%)	0	1/6958 (0%)	1	1/6988 (0%)	1
Abscess limb	0/6996 (0%)	0	1/6958 (0%)	1	4/6988 (0.1%)	4
Abscess neck	2/6996 (0%)	2	0/6958 (0%)	0	0/6988 (0%)	0
Acquired immunodeficiency syndrome	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Acute sinusitis	0/6996 (0%)	0	1/6958 (0%)	1	1/6988 (0%)	1
Amoebiasis	1/6996 (0%)	1	0/6958 (0%)	0	1/6988 (0%)	1
Anal abscess	1/6996 (0%)	1	2/6958 (0%)	2	1/6988 (0%)	1
Appendicitis	9/6996 (0.1%)	9	8/6958 (0.1%)	8	7/6988 (0.1%)	7
Appendicitis perforated	1/6996 (0%)	1	1/6958 (0%)	1	1/6988 (0%)	1
Arthritis infective	2/6996 (0%)	2	3/6958 (0%)	3	0/6988 (0%)	0
Atypical pneumonia	0/6996 (0%)	0	0/6958 (0%)	0	2/6988 (0%)	2
Avian influenza	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Bacteraemia	0/6996 (0%)	0	2/6958 (0%)	2	1/6988 (0%)	1
Bacterial infection	0/6996 (0%)	0	0/6958 (0%)	0	3/6988 (0%)	3
Bacterial prostatitis	1/6996 (0%)	1	0/6958 (0%)	0	1/6988 (0%)	1
Bacterial pyelonephritis	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Bartholin's abscess	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Biliary sepsis	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Breast abscess	0/6996 (0%)	0	1/6958 (0%)	1	1/6988 (0%)	1
Bronchitis	19/6996 (0.3%)	20	10/6958 (0.1%)	14	22/6988 (0.3%)	27
Bronchitis bacterial	0/6996 (0%)	0	1/6958 (0%)	3	0/6988 (0%)	0
Bronchopneumonia	8/6996 (0.1%)	8	6/6958 (0.1%)	6	12/6988 (0.2%)	12
Bronchopulmonary aspergillosis	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Bursitis infective	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Campylobacter gastroenteritis	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Cellulitis	14/6996 (0.2%)	15	17/6958 (0.2%)	19	12/6988 (0.2%)	13
Cellulitis laryngeal	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Cellulitis of male external genital organ	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Cerebral toxoplasmosis	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Chest wall abscess	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Cholangitis suppurative	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Cholecystitis infective	1/6996 (0%)	1	0/6958 (0%)	0	1/6988 (0%)	1
Chronic sinusitis	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Clostridium colitis	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Clostridium difficile colitis	3/6996 (0%)	3	1/6958 (0%)	1	1/6988 (0%)	1
Clostridium difficile infection	3/6996 (0%)	3	1/6958 (0%)	1	0/6988 (0%)	0
Clostridium difficile sepsis	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Colonic abscess	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Congo-Crimean haemorrhagic fever	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Cystitis	1/6996 (0%)	1	3/6958 (0%)	3	3/6988 (0%)	3
Dengue fever	1/6996 (0%)	1	1/6958 (0%)	1	0/6988 (0%)	0
Device related infection	4/6996 (0.1%)	4	4/6958 (0.1%)	5	2/6988 (0%)	2
Device related sepsis	0/6996 (0%)	0	1/6958 (0%)	1	1/6988 (0%)	1
Diabetic foot infection	3/6996 (0%)	4	2/6958 (0%)	2	0/6988 (0%)	0
Diabetic gangrene	1/6996 (0%)	1	0/6958 (0%)	0	1/6988 (0%)	1
Diverticulitis	12/6996 (0.2%)	12	8/6958 (0.1%)	8	11/6988 (0.2%)	12
Ear infection	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Emphysematous cholecystitis	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Encephalitis brain stem	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Endocarditis	1/6996 (0%)	1	0/6958 (0%)	0	1/6988 (0%)	1
Endocarditis bacterial	1/6996 (0%)	1	0/6958 (0%)	0	1/6988 (0%)	1
Enteritis infectious	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Enterococcal sepsis	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Enterocolitis infectious	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Epididymitis	1/6996 (0%)	1	1/6958 (0%)	1	4/6988 (0.1%)	4
Epiglottitis	1/6996 (0%)	1	1/6958 (0%)	1	0/6988 (0%)	0
Erysipelas	7/6996 (0.1%)	7	4/6958 (0.1%)	4	4/6988 (0.1%)	5
Escherichia bacteraemia	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Escherichia pyelonephritis	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Escherichia sepsis	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Escherichia urinary tract infection	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Extradural abscess	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Eye infection	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Furuncle	1/6996 (0%)	1	1/6958 (0%)	1	0/6988 (0%)	0
Gangrene	8/6996 (0.1%)	8	5/6958 (0.1%)	8	5/6988 (0.1%)	5
Gastritis viral	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Gastroenteritis	18/6996 (0.3%)	18	15/6958 (0.2%)	16	18/6988 (0.3%)	18
Gastroenteritis bacterial	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	2
Gastroenteritis norovirus	1/6996 (0%)	1	0/6958 (0%)	0	2/6988 (0%)	2
Gastroenteritis rotavirus	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Gastroenteritis salmonella	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Gastroenteritis viral	4/6996 (0.1%)	4	2/6958 (0%)	2	1/6988 (0%)	1
Gastrointestinal infection	2/6996 (0%)	2	0/6958 (0%)	0	0/6988 (0%)	0
Gingivitis	1/6996 (0%)	1	1/6958 (0%)	1	0/6988 (0%)	0
Groin abscess	0/6996 (0%)	0	2/6958 (0%)	2	0/6988 (0%)	0
Groin infection	0/6996 (0%)	0	0/6958 (0%)	0	2/6988 (0%)	2
H1N1 influenza	1/6996 (0%)	1	1/6958 (0%)	1	0/6988 (0%)	0
Haematoma infection	0/6996 (0%)	0	1/6958 (0%)	1	2/6988 (0%)	2
Helicobacter gastritis	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Helicobacter infection	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Hepatitis A	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Hepatitis viral	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Herpes simplex meningoencephalitis	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Herpes zoster	3/6996 (0%)	3	2/6958 (0%)	2	2/6988 (0%)	2
Incision site infection	1/6996 (0%)	1	1/6958 (0%)	1	0/6988 (0%)	0
Infected dermal cyst	1/6996 (0%)	1	1/6958 (0%)	1	0/6988 (0%)	0
Infected fistula	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Infected skin ulcer	2/6996 (0%)	2	1/6958 (0%)	1	1/6988 (0%)	1
Infection	0/6996 (0%)	0	0/6958 (0%)	0	4/6988 (0.1%)	4
Infectious colitis	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Infectious pleural effusion	1/6996 (0%)	1	0/6958 (0%)	0	3/6988 (0%)	3
Infective exacerbation of chronic obstructive airways disease	6/6996 (0.1%)	6	3/6958 (0%)	4	2/6988 (0%)	2
Influenza	4/6996 (0.1%)	4	0/6958 (0%)	0	2/6988 (0%)	2
Intervertebral discitis	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Klebsiella sepsis	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Labyrinthitis	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Laryngitis	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Leishmaniasis	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Listeria sepsis	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Liver abscess	1/6996 (0%)	1	0/6958 (0%)	0	2/6988 (0%)	2
Lobar pneumonia	4/6996 (0.1%)	4	2/6958 (0%)	2	3/6988 (0%)	3
Localised infection	1/6996 (0%)	1	2/6958 (0%)	2	2/6988 (0%)	2
Lower respiratory tract infection	4/6996 (0.1%)	4	6/6958 (0.1%)	7	4/6988 (0.1%)	4
Lower respiratory tract infection bacterial	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Lung abscess	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Lung infection	1/6996 (0%)	1	2/6958 (0%)	2	0/6988 (0%)	0
Lyme disease	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Malaria	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Meningitis	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Meningitis bacterial	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Muscle abscess	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Myringitis	0/6996 (0%)	0	1/6958 (0%)	1	1/6988 (0%)	1
Nasal abscess	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Nasopharyngitis	0/6996 (0%)	0	0/6958 (0%)	0	2/6988 (0%)	2
Necrotising fasciitis	0/6996 (0%)	0	1/6958 (0%)	1	1/6988 (0%)	1
Neutropenic sepsis	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Ophthalmic herpes zoster	1/6996 (0%)	1	0/6958 (0%)	0	1/6988 (0%)	1
Orchitis	1/6996 (0%)	1	1/6958 (0%)	1	1/6988 (0%)	1
Osteomyelitis	5/6996 (0.1%)	5	7/6958 (0.1%)	7	5/6988 (0.1%)	5
Otitis externa	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Otitis media acute	0/6996 (0%)	0	2/6958 (0%)	2	0/6988 (0%)	0
Otitis media chronic	1/6996 (0%)	1	1/6958 (0%)	1	0/6988 (0%)	0
Pancreatic abscess	1/6996 (0%)	2	0/6958 (0%)	0	0/6988 (0%)	0
Paraspinal abscess	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Parotitis	0/6996 (0%)	0	1/6958 (0%)	1	1/6988 (0%)	1
Pelvic abscess	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Periodontitis	1/6996 (0%)	1	0/6958 (0%)	0	2/6988 (0%)	2
Perirectal abscess	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Peritonitis	3/6996 (0%)	3	3/6958 (0%)	3	6/6988 (0.1%)	6
Peritonsillar abscess	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Pharyngeal abscess	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Pilonidal cyst	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Pneumococcal sepsis	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Pneumocystis jirovecii pneumonia	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Pneumonia	76/6996 (1.1%)	83	69/6958 (1%)	72	77/6988 (1.1%)	86
Pneumonia bacterial	11/6996 (0.2%)	12	15/6958 (0.2%)	15	6/6988 (0.1%)	6
Pneumonia cytomegaloviral	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Pneumonia haemophilus	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Pneumonia influenzal	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Pneumonia legionella	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Pneumonia necrotising	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Pneumonia pneumococcal	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Pneumonia pseudomonal	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Pneumonia streptococcal	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Pneumonia viral	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Post procedural infection	5/6996 (0.1%)	5	1/6958 (0%)	1	1/6988 (0%)	1
Post procedural pneumonia	1/6996 (0%)	1	0/6958 (0%)	0	1/6988 (0%)	1
Postoperative wound infection	2/6996 (0%)	2	8/6958 (0.1%)	9	2/6988 (0%)	3
Proctitis infectious	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Pseudomembranous colitis	1/6996 (0%)	1	1/6958 (0%)	1	0/6988 (0%)	0
Pseudomonal sepsis	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Pseudomonas infection	1/6996 (0%)	1	2/6958 (0%)	2	0/6988 (0%)	0
Pulmonary sepsis	3/6996 (0%)	3	0/6958 (0%)	0	1/6988 (0%)	1
Pulmonary tuberculosis	0/6996 (0%)	0	1/6958 (0%)	1	1/6988 (0%)	1
Pyelonephritis	5/6996 (0.1%)	5	5/6958 (0.1%)	5	4/6988 (0.1%)	4
Pyelonephritis acute	2/6996 (0%)	4	2/6958 (0%)	2	3/6988 (0%)	4
Pyopneumothorax	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Rectal abscess	3/6996 (0%)	3	0/6958 (0%)	0	1/6988 (0%)	1
Respiratory tract infection	4/6996 (0.1%)	4	3/6958 (0%)	3	4/6988 (0.1%)	4
Respiratory tract infection viral	0/6996 (0%)	0	1/6958 (0%)	1	1/6988 (0%)	1
Retroperitoneal abscess	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Rhinitis	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Salmonellosis	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Scrotal abscess	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Sepsis	15/6996 (0.2%)	16	20/6958 (0.3%)	20	17/6988 (0.2%)	18
Septic necrosis	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Septic shock	6/6996 (0.1%)	6	7/6958 (0.1%)	7	12/6988 (0.2%)	12
Sialoadenitis	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Sinusitis	1/6996 (0%)	1	2/6958 (0%)	2	4/6988 (0.1%)	4
Skin infection	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Soft tissue infection	1/6996 (0%)	1	1/6958 (0%)	1	0/6988 (0%)	0
Staphylococcal sepsis	1/6996 (0%)	1	0/6958 (0%)	0	1/6988 (0%)	1
Streptococcal abscess	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Streptococcal infection	0/6996 (0%)	0	0/6958 (0%)	0	2/6988 (0%)	2
Subacute endocarditis	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Subcutaneous abscess	1/6996 (0%)	1	1/6958 (0%)	1	0/6988 (0%)	0
Tonsillitis	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Toxoplasmosis	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Tracheitis	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Tracheobronchitis	0/6996 (0%)	0	1/6958 (0%)	1	1/6988 (0%)	1
Tuberculosis	2/6996 (0%)	2	1/6958 (0%)	1	3/6988 (0%)	3
Upper respiratory tract infection	2/6996 (0%)	2	6/6958 (0.1%)	6	1/6988 (0%)	1
Urethritis	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Urinary bladder abscess	1/6996 (0%)	1	0/6958 (0%)	0	1/6988 (0%)	1
Urinary tract infection	15/6996 (0.2%)	15	27/6958 (0.4%)	30	28/6988 (0.4%)	30
Urinary tract infection pseudomonal	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Urosepsis	5/6996 (0.1%)	5	5/6958 (0.1%)	5	19/6988 (0.3%)	19
Vestibular neuronitis	2/6996 (0%)	2	2/6958 (0%)	2	2/6988 (0%)	2
Viral diarrhoea	1/6996 (0%)	1	0/6958 (0%)	0	1/6988 (0%)	1
Viral infection	2/6996 (0%)	2	1/6958 (0%)	1	2/6988 (0%)	2
Wound abscess	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Wound infection	3/6996 (0%)	3	5/6958 (0.1%)	5	6/6988 (0.1%)	7
Wound infection bacterial	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Wound infection staphylococcal	1/6996 (0%)	1	1/6958 (0%)	1	0/6988 (0%)	0
Yersinia infection	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Injury, poisoning and procedural complications
Abdominal wound dehiscence	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Accidental overdose	0/6996 (0%)	0	1/6958 (0%)	1	2/6988 (0%)	2
Acetabulum fracture	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Alcohol poisoning	2/6996 (0%)	2	2/6958 (0%)	3	0/6988 (0%)	0
Anaemia postoperative	3/6996 (0%)	3	1/6958 (0%)	1	1/6988 (0%)	1
Anaesthetic complication	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Anastomotic complication	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Anastomotic stenosis	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Anastomotic ulcer haemorrhage	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Ankle fracture	4/6996 (0.1%)	4	11/6958 (0.2%)	11	5/6988 (0.1%)	5
Arterial injury	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Arterial restenosis	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Arthropod sting	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Back injury	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Bone contusion	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Bone fissure	0/6996 (0%)	0	1/6958 (0%)	1	1/6988 (0%)	1
Brain contusion	1/6996 (0%)	1	3/6958 (0%)	3	1/6988 (0%)	1
Brain herniation	1/6996 (0%)	2	0/6958 (0%)	0	1/6988 (0%)	1
Burns second degree	1/6996 (0%)	1	0/6958 (0%)	0	1/6988 (0%)	1
Burns third degree	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Carbon monoxide poisoning	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Carotid artery restenosis	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Cervical vertebral fracture	2/6996 (0%)	2	0/6958 (0%)	0	2/6988 (0%)	2
Chemical peritonitis	0/6996 (0%)	0	1/6958 (0%)	1	1/6988 (0%)	1
Chest injury	1/6996 (0%)	1	1/6958 (0%)	1	0/6988 (0%)	0
Clavicle fracture	2/6996 (0%)	2	0/6958 (0%)	0	1/6988 (0%)	1
Concussion	3/6996 (0%)	3	1/6958 (0%)	1	2/6988 (0%)	2
Contusion	2/6996 (0%)	2	6/6958 (0.1%)	6	1/6988 (0%)	1
Craniocerebral injury	1/6996 (0%)	1	3/6958 (0%)	3	1/6988 (0%)	1
Cystitis radiation	0/6996 (0%)	0	1/6958 (0%)	2	1/6988 (0%)	1
Extradural haematoma	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Face injury	0/6996 (0%)	0	2/6958 (0%)	2	2/6988 (0%)	2
Facial bones fracture	0/6996 (0%)	0	1/6958 (0%)	1	2/6988 (0%)	2
Fall	1/6996 (0%)	1	3/6958 (0%)	3	4/6988 (0.1%)	4
Femoral neck fracture	7/6996 (0.1%)	7	7/6958 (0.1%)	7	4/6988 (0.1%)	4
Femur fracture	10/6996 (0.1%)	11	11/6958 (0.2%)	11	11/6988 (0.2%)	11
Fibula fracture	2/6996 (0%)	2	2/6958 (0%)	2	0/6988 (0%)	0
Foot fracture	3/6996 (0%)	3	4/6958 (0.1%)	4	2/6988 (0%)	2
Forearm fracture	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Foreign body	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Fractured ischium	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Gas poisoning	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Gastrointestinal injury	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Gastrointestinal stoma complication	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Gun shot wound	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Haematuria traumatic	0/6996 (0%)	0	0/6958 (0%)	0	2/6988 (0%)	2
Hand fracture	1/6996 (0%)	1	4/6958 (0.1%)	5	0/6988 (0%)	0
Head injury	2/6996 (0%)	2	1/6958 (0%)	1	2/6988 (0%)	2
Heat exhaustion	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Heat stroke	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Hip fracture	7/6996 (0.1%)	7	8/6958 (0.1%)	8	5/6988 (0.1%)	5
Humerus fracture	4/6996 (0.1%)	4	7/6958 (0.1%)	7	5/6988 (0.1%)	5
Incisional hernia	1/6996 (0%)	1	1/6958 (0%)	1	4/6988 (0.1%)	4
Incisional hernia, obstructive	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Inflammation of wound	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Intestinal anastomosis complication	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Joint capsule rupture	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Joint dislocation	2/6996 (0%)	2	7/6958 (0.1%)	7	5/6988 (0.1%)	6
Joint injury	1/6996 (0%)	1	3/6958 (0%)	3	4/6988 (0.1%)	4
Laceration	0/6996 (0%)	0	1/6958 (0%)	1	2/6988 (0%)	2
Ligament injury	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Ligament rupture	1/6996 (0%)	1	2/6958 (0%)	2	0/6988 (0%)	0
Ligament sprain	0/6996 (0%)	0	1/6958 (0%)	1	1/6988 (0%)	1
Limb crushing injury	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Limb injury	2/6996 (0%)	2	6/6958 (0.1%)	6	1/6988 (0%)	1
Limb traumatic amputation	1/6996 (0%)	1	0/6958 (0%)	0	1/6988 (0%)	1
Lip injury	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Lower limb fracture	1/6996 (0%)	1	2/6958 (0%)	2	3/6988 (0%)	3
Lumbar vertebral fracture	1/6996 (0%)	1	1/6958 (0%)	1	1/6988 (0%)	1
Meniscus injury	6/6996 (0.1%)	6	1/6958 (0%)	1	5/6988 (0.1%)	5
Multiple fractures	3/6996 (0%)	3	1/6958 (0%)	1	2/6988 (0%)	2
Multiple injuries	1/6996 (0%)	1	1/6958 (0%)	1	0/6988 (0%)	0
Muscle rupture	1/6996 (0%)	1	1/6958 (0%)	1	0/6988 (0%)	0
Muscle strain	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Neck injury	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Osteoradionecrosis	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Overdose	1/6996 (0%)	1	2/6958 (0%)	2	1/6988 (0%)	1
Pancreatic leak	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Patella fracture	1/6996 (0%)	1	1/6958 (0%)	1	0/6988 (0%)	0
Pelvic fracture	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Peripheral arterial reocclusion	2/6996 (0%)	2	1/6958 (0%)	2	0/6988 (0%)	0
Peripheral artery restenosis	1/6996 (0%)	1	0/6958 (0%)	0	1/6988 (0%)	1
Periprosthetic fracture	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Pneumothorax traumatic	0/6996 (0%)	0	2/6958 (0%)	2	2/6988 (0%)	2
Poisoning	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Post gastric surgery syndrome	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Post procedural complication	1/6996 (0%)	1	2/6958 (0%)	2	0/6988 (0%)	0
Post procedural fistula	1/6996 (0%)	1	2/6958 (0%)	2	1/6988 (0%)	1
Post procedural haematoma	1/6996 (0%)	1	7/6958 (0.1%)	7	4/6988 (0.1%)	4
Post procedural haematuria	0/6996 (0%)	0	6/6958 (0.1%)	7	1/6988 (0%)	1
Post procedural haemorrhage	10/6996 (0.1%)	11	8/6958 (0.1%)	8	11/6988 (0.2%)	12
Post procedural persistent drain fluid	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Post-traumatic pain	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Postoperative ileus	2/6996 (0%)	2	0/6958 (0%)	0	2/6988 (0%)	2
Postoperative respiratory failure	1/6996 (0%)	1	0/6958 (0%)	0	2/6988 (0%)	2
Postoperative thoracic procedure complication	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Postoperative wound complication	0/6996 (0%)	0	3/6958 (0%)	3	0/6988 (0%)	0
Postpericardiotomy syndrome	2/6996 (0%)	2	0/6958 (0%)	0	0/6988 (0%)	0
Procedural haemorrhage	4/6996 (0.1%)	4	5/6958 (0.1%)	5	6/6988 (0.1%)	7
Procedural hypotension	1/6996 (0%)	1	1/6958 (0%)	1	0/6988 (0%)	0
Procedural pain	2/6996 (0%)	2	0/6958 (0%)	0	1/6988 (0%)	1
Pubis fracture	1/6996 (0%)	1	1/6958 (0%)	1	2/6988 (0%)	2
Pulmonary contusion	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Radial nerve injury	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Radiation dysphagia	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Radius fracture	2/6996 (0%)	2	5/6958 (0.1%)	5	5/6988 (0.1%)	5
Remnant gastritis	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Renal haematoma	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Rib fracture	8/6996 (0.1%)	8	5/6958 (0.1%)	5	8/6988 (0.1%)	8
Road traffic accident	2/6996 (0%)	2	5/6958 (0.1%)	5	2/6988 (0%)	2
Scapula fracture	2/6996 (0%)	2	1/6958 (0%)	1	1/6988 (0%)	1
Seroma	0/6996 (0%)	0	1/6958 (0%)	1	1/6988 (0%)	1
Skull fracture	0/6996 (0%)	0	1/6958 (0%)	1	1/6988 (0%)	1
Soft tissue injury	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	2
Spinal compression fracture	10/6996 (0.1%)	10	2/6958 (0%)	2	4/6988 (0.1%)	4
Spinal cord injury cervical	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Spinal fracture	3/6996 (0%)	3	0/6958 (0%)	0	1/6988 (0%)	1
Splenic rupture	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Sternal fracture	2/6996 (0%)	2	0/6958 (0%)	0	1/6988 (0%)	1
Subdural haematoma	1/6996 (0%)	1	2/6958 (0%)	2	5/6988 (0.1%)	5
Subdural haemorrhage	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Suture related complication	0/6996 (0%)	0	1/6958 (0%)	1	1/6988 (0%)	1
Tendon injury	1/6996 (0%)	1	1/6958 (0%)	1	1/6988 (0%)	1
Tendon rupture	2/6996 (0%)	2	4/6958 (0.1%)	5	4/6988 (0.1%)	4
Thermal burn	0/6996 (0%)	0	0/6958 (0%)	0	2/6988 (0%)	2
Thoracic vertebral fracture	0/6996 (0%)	0	3/6958 (0%)	3	1/6988 (0%)	1
Tibia fracture	1/6996 (0%)	1	1/6958 (0%)	1	6/6988 (0.1%)	6
Toxicity to various agents	1/6996 (0%)	1	0/6958 (0%)	0	2/6988 (0%)	2
Traumatic haematoma	4/6996 (0.1%)	4	10/6958 (0.1%)	10	13/6988 (0.2%)	14
Traumatic haemorrhage	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Traumatic haemothorax	3/6996 (0%)	3	0/6958 (0%)	0	0/6988 (0%)	0
Traumatic intracranial haemorrhage	11/6996 (0.2%)	13	17/6958 (0.2%)	19	18/6988 (0.3%)	20
Traumatic spinal cord compression	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Ulna fracture	1/6996 (0%)	1	2/6958 (0%)	2	0/6988 (0%)	0
Upper limb fracture	3/6996 (0%)	3	5/6958 (0.1%)	5	2/6988 (0%)	2
Urinary retention postoperative	0/6996 (0%)	0	1/6958 (0%)	1	1/6988 (0%)	1
Urinary tract injury	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
VIIIth nerve injury	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Vascular graft complication	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Vascular graft occlusion	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Vascular graft thrombosis	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Vascular injury	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Vascular procedure complication	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Vascular pseudoaneurysm	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Venous injury	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Wound	1/6996 (0%)	1	0/6958 (0%)	0	2/6988 (0%)	2
Wound dehiscence	0/6996 (0%)	0	3/6958 (0%)	3	1/6988 (0%)	1
Wound haemorrhage	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Wrist fracture	0/6996 (0%)	0	4/6958 (0.1%)	4	0/6988 (0%)	0
Investigations
Blood electrolytes decreased	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Blood glucose decreased	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Blood pressure increased	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Blood urine present	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Cardiac stress test abnormal	0/6996 (0%)	0	0/6958 (0%)	0	2/6988 (0%)	2
Clostridium test positive	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	2
Ejection fraction decreased	1/6996 (0%)	1	0/6958 (0%)	0	1/6988 (0%)	1
Electrocardiogram abnormal	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Glycosylated haemoglobin increased	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Haematocrit decreased	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Liver function test abnormal	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Lymph node palpable	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Occult blood positive	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Scan myocardial perfusion abnormal	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Weight increased	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Metabolism and nutrition disorders
Abnormal loss of weight	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Decreased appetite	1/6996 (0%)	1	0/6958 (0%)	0	1/6988 (0%)	1
Dehydration	8/6996 (0.1%)	8	9/6958 (0.1%)	9	11/6988 (0.2%)	13
Diabetes mellitus	13/6996 (0.2%)	15	15/6958 (0.2%)	15	15/6988 (0.2%)	17
Diabetes mellitus inadequate control	13/6996 (0.2%)	13	12/6958 (0.2%)	13	11/6988 (0.2%)	14
Diabetic complication	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Diabetic ketoacidosis	1/6996 (0%)	1	1/6958 (0%)	1	1/6988 (0%)	2
Electrolyte imbalance	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Failure to thrive	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Gout	2/6996 (0%)	2	2/6958 (0%)	2	1/6988 (0%)	1
Hypercalcaemia	1/6996 (0%)	2	0/6958 (0%)	0	1/6988 (0%)	1
Hyperglycaemia	2/6996 (0%)	2	4/6958 (0.1%)	4	5/6988 (0.1%)	5
Hyperkalaemia	1/6996 (0%)	1	5/6958 (0.1%)	5	3/6988 (0%)	3
Hypocalcaemia	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Hypoglycaemia	5/6996 (0.1%)	6	6/6958 (0.1%)	6	5/6988 (0.1%)	5
Hypokalaemia	2/6996 (0%)	2	1/6958 (0%)	1	1/6988 (0%)	1
Hypomagnesaemia	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Hyponatraemia	2/6996 (0%)	2	2/6958 (0%)	2	3/6988 (0%)	4
Hypovolaemia	1/6996 (0%)	2	0/6958 (0%)	0	1/6988 (0%)	1
Lactic acidosis	0/6996 (0%)	0	1/6958 (0%)	1	1/6988 (0%)	1
Lactose intolerance	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Malnutrition	2/6996 (0%)	2	0/6958 (0%)	0	0/6988 (0%)	0
Metabolic acidosis	2/6996 (0%)	2	0/6958 (0%)	0	2/6988 (0%)	2
Obesity	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Type 1 diabetes mellitus	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Type 2 diabetes mellitus	5/6996 (0.1%)	5	3/6958 (0%)	3	6/6988 (0.1%)	6
Musculoskeletal and connective tissue disorders
Ankylosing spondylitis	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Arthralgia	2/6996 (0%)	2	1/6958 (0%)	1	3/6988 (0%)	3
Arthritis	9/6996 (0.1%)	9	5/6958 (0.1%)	5	10/6988 (0.1%)	10
Arthropathy	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Back pain	2/6996 (0%)	2	8/6958 (0.1%)	10	8/6988 (0.1%)	8
Bone pain	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Bursitis	0/6996 (0%)	0	1/6958 (0%)	1	2/6988 (0%)	2
Cervical spinal stenosis	2/6996 (0%)	2	2/6958 (0%)	3	1/6988 (0%)	1
Chondrocalcinosis pyrophosphate	0/6996 (0%)	0	1/6958 (0%)	1	1/6988 (0%)	1
Chondropathy	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Costochondritis	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Dupuytren's contracture	1/6996 (0%)	1	0/6958 (0%)	0	1/6988 (0%)	1
Facet joint syndrome	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Fibromyalgia	1/6996 (0%)	1	1/6958 (0%)	1	0/6988 (0%)	0
Foot deformity	1/6996 (0%)	1	0/6958 (0%)	0	2/6988 (0%)	2
Fracture malunion	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Fracture nonunion	1/6996 (0%)	1	1/6958 (0%)	1	0/6988 (0%)	0
Gouty arthritis	0/6996 (0%)	0	1/6958 (0%)	1	2/6988 (0%)	3
Groin pain	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Haemarthrosis	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Hand deformity	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Intervertebral disc compression	1/6996 (0%)	1	0/6958 (0%)	0	1/6988 (0%)	1
Intervertebral disc degeneration	2/6996 (0%)	2	2/6958 (0%)	2	1/6988 (0%)	1
Intervertebral disc disorder	0/6996 (0%)	0	1/6958 (0%)	1	2/6988 (0%)	2
Intervertebral disc protrusion	14/6996 (0.2%)	15	10/6958 (0.1%)	10	8/6988 (0.1%)	11
Jaw cyst	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Jaw disorder	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Joint ankylosis	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Joint effusion	0/6996 (0%)	0	1/6958 (0%)	1	1/6988 (0%)	1
Lumbar spinal stenosis	4/6996 (0.1%)	4	7/6958 (0.1%)	7	5/6988 (0.1%)	5
Meniscal degeneration	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Mobility decreased	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Monarthritis	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Muscle haemorrhage	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Muscle hypertrophy	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Muscle spasms	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Muscular weakness	1/6996 (0%)	1	0/6958 (0%)	0	1/6988 (0%)	1
Musculoskeletal chest pain	20/6996 (0.3%)	20	22/6958 (0.3%)	23	16/6988 (0.2%)	17
Musculoskeletal pain	6/6996 (0.1%)	6	2/6958 (0%)	2	3/6988 (0%)	3
Myalgia	1/6996 (0%)	1	2/6958 (0%)	2	1/6988 (0%)	1
Myalgia intercostal	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Myopathy	0/6996 (0%)	0	0/6958 (0%)	0	2/6988 (0%)	2
Myositis	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Neck pain	2/6996 (0%)	2	0/6958 (0%)	0	0/6988 (0%)	0
Osteoarthritis	59/6996 (0.8%)	62	54/6958 (0.8%)	59	54/6988 (0.8%)	57
Osteonecrosis	0/6996 (0%)	0	2/6958 (0%)	2	1/6988 (0%)	1
Osteoporosis	1/6996 (0%)	1	0/6958 (0%)	0	1/6988 (0%)	1
Pain in extremity	0/6996 (0%)	0	2/6958 (0%)	2	1/6988 (0%)	1
Pain in jaw	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Periarthritis	0/6996 (0%)	0	0/6958 (0%)	0	2/6988 (0%)	2
Polyarthritis	1/6996 (0%)	1	1/6958 (0%)	1	2/6988 (0%)	2
Polymyalgia rheumatica	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Polymyositis	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Psoriatic arthropathy	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Resorption bone increased	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Rhabdomyolysis	1/6996 (0%)	1	1/6958 (0%)	1	1/6988 (0%)	1
Rheumatoid arthritis	2/6996 (0%)	2	4/6958 (0.1%)	4	2/6988 (0%)	2
Rotator cuff syndrome	7/6996 (0.1%)	7	3/6958 (0%)	3	12/6988 (0.2%)	12
Sacroiliitis	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Spinal column stenosis	2/6996 (0%)	3	9/6958 (0.1%)	9	3/6988 (0%)	3
Spinal disorder	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Spinal osteoarthritis	4/6996 (0.1%)	4	3/6958 (0%)	3	7/6988 (0.1%)	8
Spinal pain	2/6996 (0%)	3	3/6958 (0%)	3	3/6988 (0%)	3
Spondylolisthesis	4/6996 (0.1%)	4	0/6958 (0%)	0	1/6988 (0%)	1
Spondylolysis	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Sympathetic posterior cervical syndrome	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Synovial cyst	1/6996 (0%)	1	2/6958 (0%)	2	0/6988 (0%)	0
Systemic lupus erythematosus	1/6996 (0%)	1	0/6958 (0%)	0	1/6988 (0%)	1
Tendon calcification	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Tendon disorder	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Tendonitis	0/6996 (0%)	0	0/6958 (0%)	0	2/6988 (0%)	2
Trigger finger	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acinic cell carcinoma of salivary gland	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Acute myeloid leukaemia	3/6996 (0%)	4	1/6958 (0%)	1	2/6988 (0%)	2
Adenocarcinoma	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Adenocarcinoma gastric	4/6996 (0.1%)	4	5/6958 (0.1%)	5	3/6988 (0%)	3
Adenocarcinoma of colon	7/6996 (0.1%)	7	7/6958 (0.1%)	7	7/6988 (0.1%)	7
Adenolymphoma	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Adrenal adenoma	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Ameloblastoma	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Anal cancer	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Anal cancer metastatic	0/6996 (0%)	0	1/6958 (0%)	2	0/6988 (0%)	0
Anaplastic large cell lymphoma T- and null-cell types	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Anogenital warts	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	2
Astrocytoma malignant	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Atypical fibroxanthoma	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
B-cell lymphoma	0/6996 (0%)	0	3/6958 (0%)	3	1/6988 (0%)	1
Basal cell carcinoma	6/6996 (0.1%)	9	4/6958 (0.1%)	4	9/6988 (0.1%)	12
Benign neoplasm of bladder	1/6996 (0%)	1	2/6958 (0%)	2	1/6988 (0%)	1
Benign neoplasm of thyroid gland	0/6996 (0%)	0	1/6958 (0%)	1	2/6988 (0%)	2
Benign neoplasm of ureter	1/6996 (0%)	2	0/6958 (0%)	0	0/6988 (0%)	0
Benign ovarian tumour	1/6996 (0%)	1	1/6958 (0%)	1	0/6988 (0%)	0
Benign pancreatic neoplasm	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Benign renal neoplasm	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Benign salivary gland neoplasm	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Benign soft tissue neoplasm	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Bile duct adenocarcinoma	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Bile duct cancer	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Biliary neoplasm	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Bladder cancer	11/6996 (0.2%)	12	15/6958 (0.2%)	15	5/6988 (0.1%)	5
Bladder cancer recurrent	0/6996 (0%)	0	3/6958 (0%)	5	1/6988 (0%)	1
Bladder neoplasm	3/6996 (0%)	3	7/6958 (0.1%)	7	4/6988 (0.1%)	4
Bladder papilloma	0/6996 (0%)	0	1/6958 (0%)	1	1/6988 (0%)	1
Bladder transitional cell carcinoma	5/6996 (0.1%)	5	4/6958 (0.1%)	4	3/6988 (0%)	3
Bladder transitional cell carcinoma metastatic	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Bladder transitional cell carcinoma recurrent	2/6996 (0%)	3	0/6958 (0%)	0	0/6988 (0%)	0
Bone cancer	0/6996 (0%)	0	2/6958 (0%)	2	0/6988 (0%)	0
Bone cancer metastatic	0/6996 (0%)	0	1/6958 (0%)	1	1/6988 (0%)	1
Bone sarcoma	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Bowen's disease	0/6996 (0%)	0	1/6958 (0%)	1	1/6988 (0%)	1
Brain cancer metastatic	0/6996 (0%)	0	2/6958 (0%)	2	0/6988 (0%)	0
Brain neoplasm	0/6996 (0%)	0	2/6958 (0%)	2	1/6988 (0%)	1
Brain neoplasm malignant	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Breast cancer female	7/6996 (0.1%)	7	4/6958 (0.1%)	4	7/6988 (0.1%)	7
Breast cancer male	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Breast cancer metastatic	4/6996 (0.1%)	4	1/6958 (0%)	3	4/6988 (0.1%)	4
Breast cancer recurrent	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Brenner tumour	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Bronchial carcinoma	2/6996 (0%)	2	1/6958 (0%)	1	0/6988 (0%)	0
Bronchioloalveolar carcinoma	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Cervix cancer metastatic	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Cervix carcinoma	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Cervix carcinoma stage 0	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Cholangiocarcinoma	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Cholesteatoma	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Choroid melanoma	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Chronic lymphocytic leukaemia	2/6996 (0%)	3	0/6958 (0%)	0	2/6988 (0%)	2
Chronic myeloid leukaemia	1/6996 (0%)	1	1/6958 (0%)	1	0/6988 (0%)	0
Clear cell renal cell carcinoma	1/6996 (0%)	1	1/6958 (0%)	1	0/6988 (0%)	0
Colon adenoma	6/6996 (0.1%)	6	3/6958 (0%)	4	7/6988 (0.1%)	7
Colon cancer	7/6996 (0.1%)	7	14/6958 (0.2%)	14	14/6988 (0.2%)	14
Colon cancer metastatic	8/6996 (0.1%)	8	5/6958 (0.1%)	5	7/6988 (0.1%)	9
Colon neoplasm	1/6996 (0%)	1	1/6958 (0%)	1	2/6988 (0%)	2
Colorectal adenocarcinoma	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Colorectal cancer	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Diffuse large B-cell lymphoma	2/6996 (0%)	3	1/6958 (0%)	1	2/6988 (0%)	2
Endometrial adenocarcinoma	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Endometrial cancer	2/6996 (0%)	2	1/6958 (0%)	1	0/6988 (0%)	0
Endometrial cancer stage I	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Epithelioid mesothelioma	1/6996 (0%)	2	0/6958 (0%)	0	0/6988 (0%)	0
Essential thrombocythaemia	0/6996 (0%)	0	1/6958 (0%)	1	1/6988 (0%)	1
Fallopian tube cancer	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Fibroma	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Follicle centre lymphoma, follicular grade I, II, III stage IV	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Gallbladder adenocarcinoma	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Gallbladder cancer	0/6996 (0%)	0	1/6958 (0%)	2	2/6988 (0%)	2
Gallbladder cancer metastatic	0/6996 (0%)	0	2/6958 (0%)	2	0/6988 (0%)	0
Gastric adenoma	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Gastric cancer	8/6996 (0.1%)	9	6/6958 (0.1%)	6	8/6988 (0.1%)	10
Gastrointestinal cancer metastatic	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Gastrointestinal carcinoma	2/6996 (0%)	2	0/6958 (0%)	0	0/6988 (0%)	0
Gastrointestinal stromal cancer	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Gastrointestinal stromal tumour	0/6996 (0%)	0	2/6958 (0%)	3	0/6988 (0%)	0
Gastrointestinal tract adenoma	1/6996 (0%)	1	1/6958 (0%)	1	2/6988 (0%)	2
Gastrooesophageal cancer	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Glioblastoma	3/6996 (0%)	3	0/6958 (0%)	0	1/6988 (0%)	1
Glioblastoma multiforme	1/6996 (0%)	1	3/6958 (0%)	3	0/6988 (0%)	0
Haemangioma	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Hepatic cancer	1/6996 (0%)	1	1/6958 (0%)	1	1/6988 (0%)	1
Hepatic cancer metastatic	1/6996 (0%)	1	0/6958 (0%)	0	1/6988 (0%)	2
Hepatic neoplasm	0/6996 (0%)	0	0/6958 (0%)	0	2/6988 (0%)	2
Hepatocellular carcinoma	2/6996 (0%)	2	2/6958 (0%)	3	0/6988 (0%)	0
Hodgkin's disease	1/6996 (0%)	1	1/6958 (0%)	1	1/6988 (0%)	1
Hypergammaglobulinaemia benign monoclonal	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Inflammatory pseudotumour	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Intestinal adenocarcinoma	1/6996 (0%)	1	0/6958 (0%)	0	2/6988 (0%)	2
Invasive ductal breast carcinoma	0/6996 (0%)	0	0/6958 (0%)	0	2/6988 (0%)	2
Large intestine benign neoplasm	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Laryngeal cancer	1/6996 (0%)	1	0/6958 (0%)	0	2/6988 (0%)	2
Laryngeal neoplasm	0/6996 (0%)	0	2/6958 (0%)	2	0/6988 (0%)	0
Laryngeal squamous cell carcinoma	1/6996 (0%)	1	1/6958 (0%)	1	0/6988 (0%)	0
Leiomyoma	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Leiomyosarcoma	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Lentigo maligna	2/6996 (0%)	2	0/6958 (0%)	0	1/6988 (0%)	1
Leukaemia	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Lip and/or oral cavity cancer	0/6996 (0%)	0	2/6958 (0%)	2	0/6988 (0%)	0
Lip neoplasm malignant stage unspecified	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Lipoma	1/6996 (0%)	1	2/6958 (0%)	2	0/6988 (0%)	0
Lung adenocarcinoma	5/6996 (0.1%)	5	0/6958 (0%)	0	4/6988 (0.1%)	4
Lung adenocarcinoma metastatic	0/6996 (0%)	0	2/6958 (0%)	2	3/6988 (0%)	4
Lung cancer metastatic	10/6996 (0.1%)	10	11/6958 (0.2%)	11	14/6988 (0.2%)	14
Lung carcinoma cell type unspecified recurrent	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Lung carcinoma cell type unspecified stage I	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Lung carcinoma cell type unspecified stage IV	2/6996 (0%)	2	0/6958 (0%)	0	0/6988 (0%)	0
Lung neoplasm	2/6996 (0%)	2	1/6958 (0%)	1	1/6988 (0%)	1
Lung neoplasm malignant	10/6996 (0.1%)	10	10/6958 (0.1%)	10	17/6988 (0.2%)	17
Lymphoma	1/6996 (0%)	1	1/6958 (0%)	1	4/6988 (0.1%)	4
Lymphoma cutis	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Lymphoplasmacytoid lymphoma/immunocytoma	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Malignant anorectal neoplasm	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Malignant ascites	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Malignant fibrous histiocytoma	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Malignant melanoma	10/6996 (0.1%)	12	7/6958 (0.1%)	7	5/6988 (0.1%)	5
Malignant neoplasm of ampulla of Vater	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	2
Malignant neoplasm of unknown primary site	3/6996 (0%)	3	0/6958 (0%)	0	2/6988 (0%)	2
Malignant peritoneal neoplasm	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Malignant pleural effusion	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Mediastinum neoplasm	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Melanocytic naevus	1/6996 (0%)	1	1/6958 (0%)	1	0/6988 (0%)	0
Meningioma	2/6996 (0%)	2	2/6958 (0%)	2	0/6988 (0%)	0
Meningioma benign	0/6996 (0%)	0	2/6958 (0%)	2	1/6988 (0%)	1
Metastases to bone	1/6996 (0%)	1	1/6958 (0%)	1	0/6988 (0%)	0
Metastases to central nervous system	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Metastases to liver	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Metastases to lung	1/6996 (0%)	1	0/6958 (0%)	0	1/6988 (0%)	1
Metastases to lymph nodes	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Metastases to pancreas	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	2
Metastases to peritoneum	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Metastatic bronchial carcinoma	3/6996 (0%)	4	1/6958 (0%)	1	1/6988 (0%)	1
Metastatic carcinoma of the bladder	0/6996 (0%)	0	2/6958 (0%)	2	0/6988 (0%)	0
Metastatic gastric cancer	6/6996 (0.1%)	6	1/6958 (0%)	1	2/6988 (0%)	2
Metastatic malignant melanoma	0/6996 (0%)	0	1/6958 (0%)	1	4/6988 (0.1%)	4
Metastatic neoplasm	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Metastatic pain	1/6996 (0%)	2	0/6958 (0%)	0	0/6988 (0%)	0
Metastatic salivary gland cancer	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Metastatic squamous cell carcinoma	0/6996 (0%)	0	2/6958 (0%)	2	1/6988 (0%)	1
Monoclonal gammopathy	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Myelofibrosis	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Myeloproliferative disorder	0/6996 (0%)	0	1/6958 (0%)	1	1/6988 (0%)	1
Nasal neoplasm benign	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Neoplasm	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Neoplasm malignant	1/6996 (0%)	1	2/6958 (0%)	2	0/6988 (0%)	0
Neoplasm prostate	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Neoplasm skin	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Neuroendocrine carcinoma	0/6996 (0%)	0	2/6958 (0%)	2	0/6988 (0%)	0
Neuroendocrine carcinoma metastatic	1/6996 (0%)	1	0/6958 (0%)	0	2/6988 (0%)	2
Neuroendocrine tumour	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Non-Hodgkin's lymphoma	2/6996 (0%)	2	1/6958 (0%)	1	2/6988 (0%)	2
Non-Hodgkin's lymphoma recurrent	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Non-Hodgkin's lymphoma stage I	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Non-Hodgkin's lymphoma stage II	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Non-Hodgkin's lymphoma unspecified histology aggressive	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Non-small cell lung cancer	0/6996 (0%)	0	0/6958 (0%)	0	3/6988 (0%)	3
Non-small cell lung cancer metastatic	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Oesophageal adenocarcinoma	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Oesophageal adenocarcinoma metastatic	1/6996 (0%)	1	0/6958 (0%)	0	1/6988 (0%)	1
Oesophageal cancer metastatic	1/6996 (0%)	1	1/6958 (0%)	1	1/6988 (0%)	1
Oesophageal carcinoma	2/6996 (0%)	2	4/6958 (0.1%)	4	5/6988 (0.1%)	6
Oncocytoma	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Oral cavity cancer metastatic	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Oropharyngeal cancer recurrent	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Ovarian cancer	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Ovarian cancer metastatic	0/6996 (0%)	0	1/6958 (0%)	1	1/6988 (0%)	1
Ovarian cancer stage III	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Ovarian germ cell teratoma benign	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Pancoast's tumour	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Pancreatic carcinoma	3/6996 (0%)	3	2/6958 (0%)	3	6/6988 (0.1%)	7
Pancreatic carcinoma metastatic	6/6996 (0.1%)	7	4/6958 (0.1%)	5	5/6988 (0.1%)	5
Pancreatic neoplasm	1/6996 (0%)	1	1/6958 (0%)	1	0/6988 (0%)	0
Paranasal sinus neoplasm	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Parathyroid tumour benign	2/6996 (0%)	2	0/6958 (0%)	0	0/6988 (0%)	0
Pelvic neoplasm	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Penile squamous cell carcinoma	0/6996 (0%)	0	2/6958 (0%)	3	0/6988 (0%)	0
Penis carcinoma metastatic	0/6996 (0%)	0	1/6958 (0%)	3	0/6988 (0%)	0
Peritoneal neoplasm	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Pharyngeal cancer	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Pharyngeal cancer metastatic	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Pituitary tumour benign	1/6996 (0%)	1	2/6958 (0%)	2	2/6988 (0%)	2
Plasma cell myeloma	2/6996 (0%)	2	0/6958 (0%)	0	1/6988 (0%)	1
Pleomorphic adenoma	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Pleural mesothelioma	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Pleural mesothelioma malignant	1/6996 (0%)	1	0/6958 (0%)	0	1/6988 (0%)	1
Polycythaemia vera	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Prostate cancer	37/6996 (0.5%)	37	29/6958 (0.4%)	29	38/6988 (0.5%)	38
Prostate cancer metastatic	2/6996 (0%)	2	5/6958 (0.1%)	5	8/6988 (0.1%)	8
Prostate cancer recurrent	0/6996 (0%)	0	1/6958 (0%)	1	1/6988 (0%)	1
Prostate cancer stage II	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Prostatic adenoma	2/6996 (0%)	2	1/6958 (0%)	1	2/6988 (0%)	2
Rectal adenocarcinoma	1/6996 (0%)	1	3/6958 (0%)	3	3/6988 (0%)	3
Rectal adenoma	1/6996 (0%)	1	0/6958 (0%)	0	1/6988 (0%)	1
Rectal cancer	1/6996 (0%)	1	5/6958 (0.1%)	5	3/6988 (0%)	3
Rectal cancer metastatic	0/6996 (0%)	0	1/6958 (0%)	1	2/6988 (0%)	2
Rectosigmoid cancer	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Renal cancer	1/6996 (0%)	1	5/6958 (0.1%)	5	4/6988 (0.1%)	4
Renal cancer metastatic	1/6996 (0%)	1	0/6958 (0%)	0	1/6988 (0%)	1
Renal cell carcinoma	4/6996 (0.1%)	4	2/6958 (0%)	2	5/6988 (0.1%)	5
Renal cell carcinoma recurrent	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Renal neoplasm	0/6996 (0%)	0	0/6958 (0%)	0	3/6988 (0%)	3
Renal oncocytoma	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Salivary gland adenoma	0/6996 (0%)	0	2/6958 (0%)	2	1/6988 (0%)	1
Salivary gland cancer	1/6996 (0%)	1	1/6958 (0%)	1	1/6988 (0%)	1
Salivary gland cancer recurrent	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Salivary gland neoplasm	0/6996 (0%)	0	1/6958 (0%)	1	2/6988 (0%)	2
Sarcoma	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Sarcomatoid mesothelioma	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Skin cancer	2/6996 (0%)	5	1/6958 (0%)	1	0/6988 (0%)	0
Small cell lung cancer	2/6996 (0%)	2	2/6958 (0%)	2	4/6988 (0.1%)	4
Small cell lung cancer metastatic	0/6996 (0%)	0	0/6958 (0%)	0	2/6988 (0%)	2
Small intestine carcinoma	1/6996 (0%)	1	1/6958 (0%)	1	0/6988 (0%)	0
Spinal cord neoplasm	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Splenic marginal zone lymphoma	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Squamous cell carcinoma	1/6996 (0%)	1	4/6958 (0.1%)	4	1/6988 (0%)	1
Squamous cell carcinoma of lung	0/6996 (0%)	0	2/6958 (0%)	2	4/6988 (0.1%)	4
Squamous cell carcinoma of pharynx	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Squamous cell carcinoma of skin	1/6996 (0%)	1	1/6958 (0%)	1	2/6988 (0%)	2
Thyroid adenoma	0/6996 (0%)	0	2/6958 (0%)	2	1/6988 (0%)	1
Thyroid cancer	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Thyroid cancer metastatic	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Thyroid neoplasm	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Tongue cancer metastatic	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Tongue neoplasm malignant stage unspecified	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Tonsil cancer	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Tonsillar neoplasm	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Transitional cell carcinoma	3/6996 (0%)	4	6/6958 (0.1%)	6	6/6988 (0.1%)	6
Transitional cell carcinoma metastatic	0/6996 (0%)	0	2/6958 (0%)	2	0/6988 (0%)	0
Tumour associated fever	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Tumour haemorrhage	2/6996 (0%)	2	2/6958 (0%)	2	0/6988 (0%)	0
Tumour pain	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Undifferentiated nasopharyngeal carcinoma	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Ureteric cancer	0/6996 (0%)	0	1/6958 (0%)	1	1/6988 (0%)	1
Urethral cancer	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Urinary tract neoplasm	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Uterine leiomyoma	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Nervous system disorders
Amyotrophic lateral sclerosis	1/6996 (0%)	1	1/6958 (0%)	1	0/6988 (0%)	0
Brain injury	1/6996 (0%)	1	2/6958 (0%)	2	0/6988 (0%)	0
Brain oedema	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Brain stem infarction	1/6996 (0%)	1	0/6958 (0%)	0	1/6988 (0%)	1
Brain stem syndrome	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Carotid arteriosclerosis	2/6996 (0%)	2	2/6958 (0%)	2	0/6988 (0%)	0
Carotid artery aneurysm	1/6996 (0%)	1	0/6958 (0%)	0	1/6988 (0%)	1
Carotid artery disease	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Carotid artery stenosis	5/6996 (0.1%)	5	7/6958 (0.1%)	7	15/6988 (0.2%)	17
Carotid sinus syndrome	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Carpal tunnel syndrome	0/6996 (0%)	0	3/6958 (0%)	3	0/6988 (0%)	0
Cauda equina syndrome	0/6996 (0%)	0	1/6958 (0%)	1	1/6988 (0%)	1
Central nervous system lesion	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Cerebellar ataxia	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Cerebral arteriosclerosis	1/6996 (0%)	1	1/6958 (0%)	2	1/6988 (0%)	1
Cerebral cyst	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Cerebral haemorrhage	5/6996 (0.1%)	5	5/6958 (0.1%)	5	2/6988 (0%)	2
Cerebral infarction	2/6996 (0%)	2	1/6958 (0%)	1	2/6988 (0%)	2
Cerebral ischaemia	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Cerebral microangiopathy	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Cerebrospinal fluid leakage	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Cerebrovascular accident	1/6996 (0%)	1	2/6958 (0%)	2	3/6988 (0%)	3
Cerebrovascular disorder	1/6996 (0%)	1	1/6958 (0%)	1	0/6988 (0%)	0
Cervical cord compression	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Cervical myelopathy	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Cervical radiculopathy	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Cervicobrachial syndrome	1/6996 (0%)	1	1/6958 (0%)	1	0/6988 (0%)	0
Cluster headache	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Cognitive disorder	1/6996 (0%)	1	1/6958 (0%)	1	1/6988 (0%)	1
Complex regional pain syndrome	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Convulsion	3/6996 (0%)	3	1/6958 (0%)	1	1/6988 (0%)	1
Dementia	4/6996 (0.1%)	4	0/6958 (0%)	0	0/6988 (0%)	0
Dementia Alzheimer's type	2/6996 (0%)	2	1/6958 (0%)	1	1/6988 (0%)	1
Demyelinating polyneuropathy	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Diabetic neuropathy	1/6996 (0%)	1	1/6958 (0%)	1	1/6988 (0%)	1
Dizziness	2/6996 (0%)	2	6/6958 (0.1%)	6	9/6988 (0.1%)	10
Encephalopathy	0/6996 (0%)	0	3/6958 (0%)	3	1/6988 (0%)	1
Epilepsy	1/6996 (0%)	1	1/6958 (0%)	1	5/6988 (0.1%)	6
Extrapyramidal disorder	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Grand mal convulsion	0/6996 (0%)	0	0/6958 (0%)	0	2/6988 (0%)	2
Guillain-Barre syndrome	1/6996 (0%)	1	0/6958 (0%)	0	2/6988 (0%)	2
Haemorrhage intracranial	0/6996 (0%)	0	0/6958 (0%)	0	2/6988 (0%)	2
Haemorrhagic stroke	10/6996 (0.1%)	10	3/6958 (0%)	3	5/6988 (0.1%)	5
Haemorrhagic transformation stroke	4/6996 (0.1%)	4	1/6958 (0%)	1	0/6988 (0%)	0
Headache	2/6996 (0%)	2	0/6958 (0%)	0	4/6988 (0.1%)	4
Hypercapnic coma	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Hypertensive encephalopathy	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Hypoxic-ischaemic encephalopathy	2/6996 (0%)	2	0/6958 (0%)	0	2/6988 (0%)	2
IIIrd nerve paralysis	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Intracranial aneurysm	1/6996 (0%)	1	1/6958 (0%)	1	1/6988 (0%)	1
Intraventricular haemorrhage	0/6996 (0%)	0	2/6958 (0%)	2	0/6988 (0%)	0
Ischaemic cerebral infarction	1/6996 (0%)	1	1/6958 (0%)	1	1/6988 (0%)	1
Ischaemic stroke	18/6996 (0.3%)	19	11/6958 (0.2%)	11	11/6988 (0.2%)	11
Leukoencephalopathy	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Loss of consciousness	1/6996 (0%)	1	1/6958 (0%)	1	1/6988 (0%)	1
Lumbar radiculopathy	2/6996 (0%)	2	1/6958 (0%)	1	0/6988 (0%)	0
Metabolic encephalopathy	0/6996 (0%)	0	2/6958 (0%)	2	0/6988 (0%)	0
Migraine	2/6996 (0%)	2	0/6958 (0%)	0	1/6988 (0%)	1
Mononeuritis	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Monoparesis	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Multiple sclerosis relapse	0/6996 (0%)	0	1/6958 (0%)	1	1/6988 (0%)	1
Muscle contractions involuntary	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Myelopathy	0/6996 (0%)	0	1/6958 (0%)	1	1/6988 (0%)	1
Myoclonus	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Nerve root compression	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Neuralgia	1/6996 (0%)	1	0/6958 (0%)	0	1/6988 (0%)	1
Neuritis cranial	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Neuropathy peripheral	1/6996 (0%)	1	1/6958 (0%)	1	1/6988 (0%)	1
Normal pressure hydrocephalus	0/6996 (0%)	0	3/6958 (0%)	3	0/6988 (0%)	0
Occipital neuralgia	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Orthostatic intolerance	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Paraesthesia	0/6996 (0%)	0	0/6958 (0%)	0	2/6988 (0%)	2
Parkinson's disease	1/6996 (0%)	1	0/6958 (0%)	0	1/6988 (0%)	1
Parkinsonism	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Peripheral nerve paresis	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Polyneuropathy	1/6996 (0%)	1	1/6958 (0%)	1	0/6988 (0%)	0
Presyncope	6/6996 (0.1%)	6	8/6958 (0.1%)	8	3/6988 (0%)	3
Psychomotor hyperactivity	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Quadriparesis	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Radiculopathy	1/6996 (0%)	1	1/6958 (0%)	1	1/6988 (0%)	1
Ruptured cerebral aneurysm	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Sciatica	3/6996 (0%)	3	1/6958 (0%)	1	3/6988 (0%)	4
Senile dementia	2/6996 (0%)	2	1/6958 (0%)	1	0/6988 (0%)	0
Serotonin syndrome	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Somnolence	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Spinal claudication	0/6996 (0%)	0	0/6958 (0%)	0	2/6988 (0%)	3
Spinal cord compression	0/6996 (0%)	0	1/6958 (0%)	1	2/6988 (0%)	2
Status epilepticus	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Subarachnoid haemorrhage	1/6996 (0%)	1	1/6958 (0%)	1	1/6988 (0%)	1
Syncope	28/6996 (0.4%)	30	31/6958 (0.4%)	33	37/6988 (0.5%)	39
Temporal lobe epilepsy	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Tension headache	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Toxic encephalopathy	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Transient global amnesia	1/6996 (0%)	1	2/6958 (0%)	2	1/6988 (0%)	1
Transient ischaemic attack	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Trigeminal neuralgia	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Uraemic encephalopathy	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
VIIth nerve paralysis	2/6996 (0%)	2	2/6958 (0%)	2	1/6988 (0%)	1
VIth nerve paresis	1/6996 (0%)	1	1/6958 (0%)	1	0/6988 (0%)	0
Vagus nerve disorder	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Vascular encephalopathy	0/6996 (0%)	0	3/6958 (0%)	3	1/6988 (0%)	1
Vascular parkinsonism	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Vertebral artery stenosis	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Vertebrobasilar insufficiency	1/6996 (0%)	1	0/6958 (0%)	0	1/6988 (0%)	1
Psychiatric disorders
Affective disorder	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Alcohol abuse	0/6996 (0%)	0	0/6958 (0%)	0	3/6988 (0%)	3
Alcoholism	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Anxiety	2/6996 (0%)	3	4/6958 (0.1%)	4	1/6988 (0%)	1
Bipolar I disorder	1/6996 (0%)	1	1/6958 (0%)	1	0/6988 (0%)	0
Completed suicide	2/6996 (0%)	2	0/6958 (0%)	0	3/6988 (0%)	3
Confusional state	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Conversion disorder	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Delirium	0/6996 (0%)	0	1/6958 (0%)	1	1/6988 (0%)	1
Depressed mood	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Depression	8/6996 (0.1%)	11	8/6958 (0.1%)	8	11/6988 (0.2%)	13
Insomnia	0/6996 (0%)	0	1/6958 (0%)	1	1/6988 (0%)	1
Major depression	2/6996 (0%)	2	1/6958 (0%)	1	1/6988 (0%)	1
Mental status changes	3/6996 (0%)	3	2/6958 (0%)	2	3/6988 (0%)	3
Panic attack	1/6996 (0%)	1	0/6958 (0%)	0	3/6988 (0%)	3
Panic disorder	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Post-traumatic stress disorder	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Psychiatric decompensation	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Psychiatric symptom	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Psychotic behaviour	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Somatoform disorder cardiovascular	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Suicidal ideation	0/6996 (0%)	0	2/6958 (0%)	2	0/6988 (0%)	0
Suicide attempt	0/6996 (0%)	0	2/6958 (0%)	2	2/6988 (0%)	2
Renal and urinary disorders
Acute prerenal failure	1/6996 (0%)	1	1/6958 (0%)	1	1/6988 (0%)	1
Bladder diverticulum	1/6996 (0%)	1	0/6958 (0%)	0	1/6988 (0%)	1
Bladder neck sclerosis	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Bladder prolapse	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Bladder tamponade	0/6996 (0%)	0	2/6958 (0%)	2	0/6988 (0%)	0
Calculus bladder	2/6996 (0%)	2	3/6958 (0%)	3	2/6988 (0%)	2
Calculus ureteric	4/6996 (0.1%)	4	6/6958 (0.1%)	6	5/6988 (0.1%)	5
Calculus urethral	1/6996 (0%)	1	1/6958 (0%)	1	4/6988 (0.1%)	4
Calculus urinary	1/6996 (0%)	1	3/6958 (0%)	3	2/6988 (0%)	2
Cystitis haemorrhagic	0/6996 (0%)	0	0/6958 (0%)	0	2/6988 (0%)	2
Cystitis noninfective	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Diabetic nephropathy	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Glomerulonephritis membranoproliferative	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Glomerulonephritis membranous	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Haematuria	3/6996 (0%)	3	8/6958 (0.1%)	11	9/6988 (0.1%)	9
Haemorrhage urinary tract	0/6996 (0%)	0	0/6958 (0%)	0	2/6988 (0%)	2
Hydronephrosis	0/6996 (0%)	0	1/6958 (0%)	1	4/6988 (0.1%)	4
Hypertensive nephropathy	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Nephritis	0/6996 (0%)	0	2/6958 (0%)	2	1/6988 (0%)	1
Nephrolithiasis	8/6996 (0.1%)	12	10/6958 (0.1%)	11	21/6988 (0.3%)	22
Neurogenic bladder	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Obstructive uropathy	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Pelvi-ureteric obstruction	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Renal artery stenosis	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Renal colic	1/6996 (0%)	1	3/6958 (0%)	3	4/6988 (0.1%)	4
Renal cyst	1/6996 (0%)	1	2/6958 (0%)	2	1/6988 (0%)	1
Renal cyst ruptured	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Renal failure	15/6996 (0.2%)	18	8/6958 (0.1%)	9	6/6988 (0.1%)	6
Renal failure acute	28/6996 (0.4%)	34	32/6958 (0.5%)	32	32/6988 (0.5%)	34
Renal failure chronic	6/6996 (0.1%)	6	7/6958 (0.1%)	8	5/6988 (0.1%)	6
Renal haemorrhage	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Renal impairment	4/6996 (0.1%)	4	4/6958 (0.1%)	4	1/6988 (0%)	1
Renal tubular acidosis	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Stress urinary incontinence	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Tubulointerstitial nephritis	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Ureteric rupture	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Ureteric stenosis	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Urethral stenosis	2/6996 (0%)	2	1/6958 (0%)	1	3/6988 (0%)	3
Urinary bladder haemorrhage	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Urinary bladder polyp	2/6996 (0%)	2	4/6958 (0.1%)	4	1/6988 (0%)	1
Urinary incontinence	0/6996 (0%)	0	1/6958 (0%)	1	2/6988 (0%)	2
Urinary retention	4/6996 (0.1%)	4	3/6958 (0%)	3	1/6988 (0%)	1
Urinary tract disorder	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Urinoma	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Reproductive system and breast disorders
Acquired hydrocele	4/6996 (0.1%)	5	4/6958 (0.1%)	4	2/6988 (0%)	2
Acquired phimosis	0/6996 (0%)	0	3/6958 (0%)	3	1/6988 (0%)	1
Benign prostatic hyperplasia	26/6996 (0.4%)	26	25/6958 (0.4%)	26	20/6988 (0.3%)	20
Breast fibrosis	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Calculus prostatic	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Cervical cyst	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Cervical dysplasia	0/6996 (0%)	0	1/6958 (0%)	1	1/6988 (0%)	1
Cystocele	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Endometrial hyperplasia	0/6996 (0%)	0	1/6958 (0%)	1	2/6988 (0%)	2
Gynaecomastia	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Menorrhagia	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Metrorrhagia	1/6996 (0%)	1	1/6958 (0%)	1	1/6988 (0%)	1
Ovarian cyst	0/6996 (0%)	0	2/6958 (0%)	2	0/6988 (0%)	0
Ovarian necrosis	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Postmenopausal haemorrhage	1/6996 (0%)	2	0/6958 (0%)	0	0/6988 (0%)	0
Prostatic mass	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Prostatism	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Prostatitis	7/6996 (0.1%)	7	5/6958 (0.1%)	5	5/6988 (0.1%)	5
Prostatomegaly	1/6996 (0%)	1	0/6958 (0%)	0	2/6988 (0%)	2
Uterine cyst	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Uterine haemorrhage	2/6996 (0%)	2	0/6958 (0%)	0	0/6988 (0%)	0
Uterine polyp	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Uterine prolapse	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Uterovaginal prolapse	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Vaginal prolapse	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Varicocele	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema	5/6996 (0.1%)	5	3/6958 (0%)	3	2/6988 (0%)	3
Acute respiratory distress syndrome	1/6996 (0%)	1	1/6958 (0%)	1	1/6988 (0%)	1
Acute respiratory failure	7/6996 (0.1%)	7	2/6958 (0%)	2	6/6988 (0.1%)	7
Aspiration	0/6996 (0%)	0	1/6958 (0%)	1	1/6988 (0%)	1
Asthma	4/6996 (0.1%)	6	6/6958 (0.1%)	6	9/6988 (0.1%)	12
Atelectasis	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Bronchial haemorrhage	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Bronchial hyperreactivity	2/6996 (0%)	2	0/6958 (0%)	0	0/6988 (0%)	0
Bronchial obstruction	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Bronchiectasis	1/6996 (0%)	1	1/6958 (0%)	1	0/6988 (0%)	0
Bronchitis chronic	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Bronchospasm	2/6996 (0%)	2	0/6958 (0%)	0	0/6988 (0%)	0
Choking	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Chronic obstructive pulmonary disease	45/6996 (0.6%)	65	39/6958 (0.6%)	62	54/6988 (0.8%)	74
Chronic respiratory failure	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Cough	2/6996 (0%)	2	0/6958 (0%)	0	0/6988 (0%)	0
Diaphragmatic paralysis	2/6996 (0%)	2	0/6958 (0%)	0	0/6988 (0%)	0
Diffuse panbronchiolitis	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Dyspnoea	12/6996 (0.2%)	12	23/6958 (0.3%)	24	29/6988 (0.4%)	30
Dyspnoea exertional	1/6996 (0%)	1	3/6958 (0%)	3	1/6988 (0%)	1
Emphysema	1/6996 (0%)	1	0/6958 (0%)	0	1/6988 (0%)	1
Epiglottic cyst	0/6996 (0%)	0	1/6958 (0%)	2	0/6988 (0%)	0
Epiglottic oedema	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Epistaxis	2/6996 (0%)	2	15/6958 (0.2%)	17	20/6988 (0.3%)	21
Haemoptysis	1/6996 (0%)	1	3/6958 (0%)	3	5/6988 (0.1%)	6
Haemothorax	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Hydrothorax	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Hypoxia	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Idiopathic pulmonary fibrosis	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	2
Interstitial lung disease	4/6996 (0.1%)	4	1/6958 (0%)	1	5/6988 (0.1%)	5
Laryngeal oedema	0/6996 (0%)	0	1/6958 (0%)	1	1/6988 (0%)	1
Lung consolidation	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Lung disorder	1/6996 (0%)	1	0/6958 (0%)	0	1/6988 (0%)	1
Nasal polyps	0/6996 (0%)	0	4/6958 (0.1%)	4	1/6988 (0%)	1
Nasal septum deviation	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Nocturnal dyspnoea	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Obstructive airways disorder	2/6996 (0%)	2	1/6958 (0%)	1	0/6988 (0%)	0
Organising pneumonia	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Pharyngeal haemorrhage	0/6996 (0%)	0	0/6958 (0%)	0	2/6988 (0%)	3
Pharyngeal oedema	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Pleural adhesion	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Pleural effusion	16/6996 (0.2%)	18	6/6958 (0.1%)	7	2/6988 (0%)	3
Pleurisy	0/6996 (0%)	0	3/6958 (0%)	3	2/6988 (0%)	2
Pleuritic pain	0/6996 (0%)	0	2/6958 (0%)	2	3/6988 (0%)	3
Pneumonia aspiration	5/6996 (0.1%)	5	0/6958 (0%)	0	5/6988 (0.1%)	5
Pneumothorax	6/6996 (0.1%)	8	5/6958 (0.1%)	5	5/6988 (0.1%)	5
Pneumothorax spontaneous	1/6996 (0%)	1	3/6958 (0%)	3	0/6988 (0%)	0
Pulmonary arterial hypertension	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Pulmonary congestion	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Pulmonary embolism	17/6996 (0.2%)	17	17/6958 (0.2%)	17	21/6988 (0.3%)	23
Pulmonary fibrosis	0/6996 (0%)	0	2/6958 (0%)	2	3/6988 (0%)	3
Pulmonary haemorrhage	2/6996 (0%)	2	0/6958 (0%)	0	0/6988 (0%)	0
Pulmonary hypertension	1/6996 (0%)	1	2/6958 (0%)	2	3/6988 (0%)	3
Pulmonary mass	2/6996 (0%)	2	0/6958 (0%)	0	3/6988 (0%)	3
Pulmonary oedema	1/6996 (0%)	3	5/6958 (0.1%)	5	5/6988 (0.1%)	5
Respiratory arrest	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Respiratory distress	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Respiratory failure	3/6996 (0%)	3	7/6958 (0.1%)	7	6/6988 (0.1%)	6
Respiratory tract haemorrhage	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Respiratory tract inflammation	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Sleep apnoea syndrome	5/6996 (0.1%)	5	3/6958 (0%)	3	3/6988 (0%)	3
Thoracic haemorrhage	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Tonsillar hypertrophy	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Vocal cord leukoplakia	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Skin and subcutaneous tissue disorders
Actinic keratosis	1/6996 (0%)	1	1/6958 (0%)	1	0/6988 (0%)	0
Angioedema	3/6996 (0%)	3	2/6958 (0%)	3	2/6988 (0%)	2
Cutaneous sarcoidosis	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Decubitus ulcer	3/6996 (0%)	3	0/6958 (0%)	0	1/6988 (0%)	1
Dermal cyst	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Dermatitis allergic	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Diabetic foot	2/6996 (0%)	2	3/6958 (0%)	3	4/6988 (0.1%)	4
Drug eruption	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Dry gangrene	0/6996 (0%)	0	0/6958 (0%)	0	2/6988 (0%)	2
Ecchymosis	0/6996 (0%)	0	1/6958 (0%)	1	1/6988 (0%)	1
Eczema	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Hyperhidrosis	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Hyperkeratosis	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Hypersensitivity vasculitis	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Panniculitis	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Psoriasis	0/6996 (0%)	0	1/6958 (0%)	1	1/6988 (0%)	1
Pyoderma gangrenosum	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	2
Rash	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Rash generalised	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Skin haemorrhage	1/6996 (0%)	1	1/6958 (0%)	1	0/6988 (0%)	0
Skin ulcer	3/6996 (0%)	4	0/6958 (0%)	0	2/6988 (0%)	2
Stevens-Johnson syndrome	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Urticaria	1/6996 (0%)	1	1/6958 (0%)	1	0/6988 (0%)	0
Vascular disorders
Accelerated hypertension	1/6996 (0%)	1	1/6958 (0%)	1	2/6988 (0%)	2
Angiodysplasia	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Aortic aneurysm	13/6996 (0.2%)	13	19/6958 (0.3%)	19	19/6988 (0.3%)	20
Aortic aneurysm rupture	0/6996 (0%)	0	0/6958 (0%)	0	4/6988 (0.1%)	4
Aortic dissection	0/6996 (0%)	0	1/6958 (0%)	1	1/6988 (0%)	1
Aortic dissection rupture	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Aortic rupture	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Aortic stenosis	8/6996 (0.1%)	8	2/6958 (0%)	2	2/6988 (0%)	2
Aortic thrombosis	2/6996 (0%)	2	1/6958 (0%)	1	1/6988 (0%)	1
Aorto-duodenal fistula	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Arterial rupture	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Arteriosclerosis	2/6996 (0%)	2	1/6958 (0%)	1	0/6988 (0%)	0
Arteriovenous fistula	1/6996 (0%)	1	0/6958 (0%)	0	1/6988 (0%)	1
Circulatory collapse	1/6996 (0%)	1	1/6958 (0%)	1	0/6988 (0%)	0
Deep vein thrombosis	10/6996 (0.1%)	10	4/6958 (0.1%)	5	10/6988 (0.1%)	11
Diabetic vascular disorder	3/6996 (0%)	3	0/6958 (0%)	0	1/6988 (0%)	1
Essential hypertension	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Extremity necrosis	1/6996 (0%)	2	0/6958 (0%)	0	1/6988 (0%)	1
Femoral artery aneurysm	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Femoral artery embolism	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Femoral artery occlusion	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Hot flush	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Hypertension	18/6996 (0.3%)	18	15/6958 (0.2%)	15	8/6988 (0.1%)	8
Hypertensive crisis	12/6996 (0.2%)	14	8/6958 (0.1%)	8	10/6988 (0.1%)	11
Hypertensive emergency	1/6996 (0%)	1	4/6958 (0.1%)	5	0/6988 (0%)	0
Hypotension	10/6996 (0.1%)	10	9/6958 (0.1%)	9	10/6988 (0.1%)	10
Hypothenar hammer syndrome	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Hypovolaemic shock	0/6996 (0%)	0	1/6958 (0%)	1	1/6988 (0%)	1
Iliac artery occlusion	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Intermittent claudication	5/6996 (0.1%)	5	4/6958 (0.1%)	4	4/6988 (0.1%)	4
Leriche syndrome	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Lymphoedema	0/6996 (0%)	0	1/6958 (0%)	1	1/6988 (0%)	1
Malignant hypertension	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Orthostatic hypotension	4/6996 (0.1%)	4	4/6958 (0.1%)	4	5/6988 (0.1%)	5
Penetrating atherosclerotic ulcer	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Peripheral arterial occlusive disease	15/6996 (0.2%)	18	10/6958 (0.1%)	10	17/6988 (0.2%)	17
Peripheral artery aneurysm	3/6996 (0%)	3	4/6958 (0.1%)	4	1/6988 (0%)	1
Peripheral artery stenosis	17/6996 (0.2%)	22	5/6958 (0.1%)	7	5/6988 (0.1%)	6
Peripheral artery thrombosis	5/6996 (0.1%)	5	3/6958 (0%)	4	4/6988 (0.1%)	4
Peripheral circulatory failure	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Peripheral embolism	1/6996 (0%)	1	3/6958 (0%)	3	1/6988 (0%)	2
Peripheral ischaemia	9/6996 (0.1%)	13	3/6958 (0%)	3	5/6988 (0.1%)	6
Peripheral vascular disorder	8/6996 (0.1%)	8	1/6958 (0%)	1	4/6988 (0.1%)	5
Poor peripheral circulation	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Shock	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Shock haemorrhagic	1/6996 (0%)	1	1/6958 (0%)	1	0/6988 (0%)	0
Steal syndrome	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Subclavian artery occlusion	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Subclavian artery stenosis	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Superior vena cava syndrome	0/6996 (0%)	0	0/6958 (0%)	0	1/6988 (0%)	1
Temporal arteritis	0/6996 (0%)	0	2/6958 (0%)	2	1/6988 (0%)	1
Thrombophlebitis	0/6996 (0%)	0	1/6958 (0%)	1	2/6988 (0%)	2
Thrombosis	2/6996 (0%)	2	0/6958 (0%)	0	0/6988 (0%)	0
Varicose vein	1/6996 (0%)	1	5/6958 (0.1%)	6	2/6988 (0%)	2
Vasculitis	0/6996 (0%)	0	1/6958 (0%)	1	0/6988 (0%)	0
Vena cava thrombosis	1/6996 (0%)	1	0/6958 (0%)	0	1/6988 (0%)	1
Venous insufficiency	1/6996 (0%)	2	1/6958 (0%)	1	0/6988 (0%)	0
Venous thrombosis	1/6996 (0%)	1	0/6958 (0%)	0	0/6988 (0%)	0
Other (Not Including Serious) Adverse Events
	Placebo		Ticagrelor 60mg bd		Ticagrelor 90mg bd
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	945/6996 (13.5%)		1992/6958 (28.6%)		2245/6988 (32.1%)
Blood and lymphatic system disorders
Increased tendency to bruise	65/6996 (0.9%)	70	419/6958 (6%)	520	464/6988 (6.6%)	575
Infections and infestations
Nasopharyngitis	377/6996 (5.4%)	469	364/6958 (5.2%)	486	368/6988 (5.3%)	490
Injury, poisoning and procedural complications
Contusion	111/6996 (1.6%)	122	353/6958 (5.1%)	471	385/6988 (5.5%)	473
Respiratory, thoracic and mediastinal disorders
Dyspnoea	329/6996 (4.7%)	362	876/6958 (12.6%)	1036	1091/6988 (15.6%)	1340
Epistaxis	165/6996 (2.4%)	221	420/6958 (6%)	623	505/6988 (7.2%)	668

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/Title	Anders Himmelmann, MD PhD
Organization	AstraZeneca AB
Phone	+46 31 7761000
Email	ClinicalTrialTransparency@astrazeneca.com

Responsible Party:

AstraZeneca

ClinicalTrials.gov Identifier:

NCT01225562

Other Study ID Numbers:

D5132C00001
2009-017242-30

First Posted:

Oct 21, 2010

Last Update Posted:

Jan 25, 2016

Last Verified:

Dec 1, 2015

PEGASUS: Prevention of Cardiovascular Events (eg, Death From Heart or Vascular Disease, Heart Attack, or Stroke) in Patients With Prior Heart Attack Using Ticagrelor Compared to Placebo on a Background of Aspirin

Study Details

Study Description

Brief Summary

Study Design

Arms and Interventions

Outcome Measures

Primary Outcome Measures

Secondary Outcome Measures

Eligibility Criteria

Criteria

Inclusion Criteria:

Exclusion Criteria:

Contacts and Locations

Locations

Sponsors and Collaborators

Investigators

Study Documents (Full-Text)

More Information

Additional Information:

Publications

Study Results

Participant Flow

Baseline Characteristics

Outcome Measures

Outcome Measure Data

Statistical Analysis 1

Statistical Analysis 2

Outcome Measure Data

Statistical Analysis 1

Statistical Analysis 2

Outcome Measure Data

Statistical Analysis 1

Statistical Analysis 2

Outcome Measure Data

Statistical Analysis 1

Statistical Analysis 2

Adverse Events

All Cause Mortality

Serious Adverse Events

Other (Not Including Serious) Adverse Events

Limitations/Caveats

More Information

Certain Agreements

Results Point of Contact