JUPITER - Crestor 20mg Versus Placebo in Prevention of Cardiovascular (CV) Events

• Sponsor: AstraZeneca (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT00239681
• Collaborator: (none)
• Enrollment: 17,802
• Locations: 859
• Arms: 2
• Duration (Months): 67
• Patients Per Site: 20.7
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

The purpose of this study is to determine the safety and effectiveness of long-term therapy with rosuvastatin compared with a placebo, and to evaluate whether treatment with rosuvastatin might be effective in reducing the risk of major cardiovascular events.

Condition or Disease	Intervention/Treatment	Phase
Elevated High-sensitivity C-Reactive Protein (hsCRP)	Drug: Rosuvastatin; Other: Placebo	Phase 3

Detailed Description

AstraZeneca announced it has decided to stop the CRESTOR JUPITER clinical study early based on a recommendation from an Independent Data Monitoring Board and the JUPITER Steering Committee, which met on March 29, 2008. The study will be stopped early because there is unequivocal evidence of a reduction in cardiovascular morbidity and mortality amongst patients who received CRESTOR when compared to placebo.

Study Design

• Study Type: Interventional
• Actual Enrollment: 17802 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, Multicenter, Phase 3 Study of Rosuvastatin (CRESTOR®) 20 mg in the Prevention of Cardiovascular Events Among Subjects With Low Levels of Low Density Lipoprotein(LDL) Cholesterol & Elevated Levels of C-Reactive Protein
• Study Start Date: Feb 1, 2003
• Actual Primary Completion Date: Sep 1, 2008
• Actual Study Completion Date: Sep 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Rosuvastatin Rosuvastatin 20 mg once daily	Drug: Rosuvastatin; Oral; Other Names: Crestor
Placebo Comparator: Placebo Placebo once daily	Other: Placebo; Oral

Outcome Measures

Primary Outcome Measures

1. Time to Major Cardiac Event (Cardiovascular Death, Stroke, Myocardial Infarction, Hospitalization Due to Unstable Angina or Arterial Revascularization) [up to 5 years]

   Days from randomization to the first of CV death, stroke, MI, hospitalization for unstable angina or arterial revascularization. If no event, censoring occurs at earliest of termination date or efficacy cut-off date of 30 Mar 2008. Events were adjudicated by an endpoint committee. Kaplan-Meier estimate of the mean

Secondary Outcome Measures

1. Time to Death Due to Any Cause [up to 5 years]

   Days from randomization to death. If no death then censoring occurs at earliest of termination date or efficacy cutoff date of 30 Mar 2008. Kaplan-Meier estimate of the mean

2. Time to Non-cardiovascular Death [up to 5 years]

   Days from randomization to death from a non-cardiovascular cause. If no event, then censoring occurs at earliest of termination date or efficacy cutoff date of 30 Mar 2008. Events were adjudicated by an endpoint committee. Kaplan-Meier estimate of the mean

3. Time to Development of Diabetes Mellitus [up to 5 years]

   Days from randomization until development of diabetes. If no diabetes was developed censoring occurred at termination date. Kaplan-Meier estimate of the mean

4. Time to Venous Thromboembolic Event [up to 5 years]

   Time from randomization to the first venous thromboembolic event. Kaplan-Meier estimate of the mean

5. Time to Bone Fracture [Up to 5 years]

   Days from randomization until bone fracture. If no event, then censoring occurs at earliest of termination date or efficacy cutoff date of 30 Mar 2008. Kaplan-Meier estimate of the mean

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Men 50 years or older, women 60 years or older

• Low to normal levels of low density lipoprotein (LDL) cholesterol (< 130mg/dL)

• Elevated levels of C-Reactive Protein (CRP) > 2.0 mg/L

Exclusion Criteria:

• History of cardiovascular or cerebrovascular events

• Active liver disease

• Diabetes mellitus

• Uncontrolled hypertension or hypothyroidism

• History of certain malignancies

• Chronic inflammatory conditions

• History of alcohol or drug abuse

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Site	Birmingham	Alabama	United States
2	Research Site	Calera	Alabama	United States
3	Research Site	Columbiana	Alabama	United States
4	Research Site	Decatur	Alabama	United States
5	Research Site	Graysville	Alabama	United States
6	Research Site	Haleyville	Alabama	United States
7	Research Site	Hartselle	Alabama	United States
8	Research Site	Huntsville	Alabama	United States
9	Research Site	Mobile	Alabama	United States
10	Research Site	Montgomery	Alabama	United States
11	Research Site	Muscle Shoals	Alabama	United States
12	Research Site	South Birmingham	Alabama	United States
13	Research Site	Tuscumbia	Alabama	United States
14	Research Site	Mesa	Arizona	United States
15	Research Site	Phoenix	Arizona	United States
16	Research Site	Scottsdale	Arizona	United States
17	Research Site	Tucson	Arizona	United States
18	Research Site	Fayetteville	Arkansas	United States
19	Research Site	Hot Springs	Arkansas	United States
20	Research Site	Little Rock	Arkansas	United States
21	Research Site	Pine Bluff	Arkansas	United States
22	Research Site	Alhambra	California	United States
23	Research Site	Azusa	California	United States
24	Research Site	Berkeley	California	United States
25	Research Site	Beverly Hills	California	United States
26	Research Site	Burlingame	California	United States
27	Research Site	Carmichael	California	United States
28	Research Site	Concord	California	United States
29	Research Site	Culver City	California	United States
30	Research Site	Daly City	California	United States
31	Research Site	Folsom	California	United States
32	Research Site	Foothill Ranch	California	United States
33	Research Site	Fountain Valley	California	United States
34	Research Site	Fresno	California	United States
35	Research Site	Garden Grove	California	United States
36	Research Site	Inglewood	California	United States
37	Research Site	Irvine	California	United States
38	Research Site	La Jolla	California	United States
39	Research Site	La Mesa	California	United States
40	Research Site	Languna Niguel	California	United States
41	Research Site	Long Beach	California	United States
42	Research Site	Los Angeles	California	United States
43	Research Site	Los Gatos	California	United States
44	Research Site	Mission Hills	California	United States
45	Research Site	Mission Viejo	California	United States
46	Research Site	Modesto	California	United States
47	Research Site	Newport Beach	California	United States
48	Research Site	Norwalk	California	United States
49	Research Site	Orangevale	California	United States
50	Research Site	Orange	California	United States
51	Research Site	Palm Desert	California	United States
52	Research Site	Pasadena	California	United States
53	Research Site	Pismo Beach	California	United States
54	Research Site	Pomona	California	United States
55	Research Site	Riverside	California	United States
56	Research Site	Roseville	California	United States
57	Research Site	Sacramento	California	United States
58	Research Site	San Diego	California	United States
59	Research Site	San Jose	California	United States
60	Research Site	San Ramon	California	United States
61	Research Site	Santa Ana	California	United States
62	Research Site	Santa Monica	California	United States
63	Research Site	Thousand Oaks	California	United States
64	Research Site	Torrance	California	United States
65	Research Site	Upland	California	United States
66	Research Site	Ventura	California	United States
67	Research Site	Vista	California	United States
68	Research Site	Walnut Creek	California	United States
69	Research Site	Westlake Village	California	United States
70	Research Site	Aurora	Colorado	United States
71	Research Site	Colorado Springs	Colorado	United States
72	Research Site	Denver	Colorado	United States
73	Research Site	Fort Collins	Colorado	United States
74	Research Site	Golden	Colorado	United States
75	Research Site	Highlands Ranch	Colorado	United States
76	Research Site	Littleton	Colorado	United States
77	Research Site	Loveland	Colorado	United States
78	Research Site	Avon	Connecticut	United States
79	Research Site	Bristol	Connecticut	United States
80	Research Site	Hartford	Connecticut	United States
81	Research Site	Stamford	Connecticut	United States
82	Research Site	Trumbull	Connecticut	United States
83	Research Site	West Hartford	Connecticut	United States
84	Research Site	Newark	Delaware	United States
85	Research Site	Wlimington	Delaware	United States
86	Research Site	Washington	District of Columbia	United States
87	Research Site	Apopka	Florida	United States
88	Research Site	Beverly Hills	Florida	United States
89	Research Site	Cape Coral	Florida	United States
90	Research Site	Clearwater	Florida	United States
91	Research Site	Cooper City	Florida	United States
92	Research Site	Crystal River	Florida	United States
93	Research Site	Davie	Florida	United States
94	Research Site	Deerfield Beach	Florida	United States
95	Research Site	Delray Beach	Florida	United States
96	Research Site	Fort Lauderdale	Florida	United States
97	Research Site	Gainesville	Florida	United States
98	Research Site	Jacksonville	Florida	United States
99	Research Site	Lakeland	Florida	United States
100	Research Site	Largo	Florida	United States
101	Research Site	Margate	Florida	United States
102	Research Site	Miami	Florida	United States
103	Research Site	North Miami Beach	Florida	United States
104	Research Site	Orlando	Florida	United States
105	Research Site	Ormond Beach	Florida	United States
106	Research Site	Palm Harbor	Florida	United States
107	Research Site	Pensacola	Florida	United States
108	Research Site	Port Charlotte	Florida	United States
109	Research Site	Port Orange	Florida	United States
110	Research Site	Sarasota	Florida	United States
111	Research Site	Sebastian	Florida	United States
112	Research Site	Tamarac	Florida	United States
113	Research Site	Tampa	Florida	United States
114	Research Site	Vero Beach	Florida	United States
115	Research Site	West Palm Beach	Florida	United States
116	Research Site	Atlanta	Georgia	United States
117	Research Site	Augusta	Georgia	United States
118	Research Site	Blue Ridge	Georgia	United States
119	Research Site	Brunswick	Georgia	United States
120	Research Site	Columbus	Georgia	United States
121	Research Site	Conyers	Georgia	United States
122	Research Site	Decatur	Georgia	United States
123	Research Site	Fayetteville	Georgia	United States
124	Research Site	Suwanee	Georgia	United States
125	Research Site	Woodstock	Georgia	United States
126	Research Site	Idaho Falls	Idaho	United States
127	Research Site	Meridian	Idaho	United States
128	Research Site	Aurora	Illinois	United States
129	Research Site	Champaign	Illinois	United States
130	Research Site	Chicago	Illinois	United States
131	Research Site	Gurnee	Illinois	United States
132	Research Site	Lake Road	Illinois	United States
133	Research Site	Melrose Park	Illinois	United States
134	Research Site	Morton	Illinois	United States
135	Research Site	O'fallon	Illinois	United States
136	Research Site	Orland Park	Illinois	United States
137	Research Site	Springfield	Illinois	United States
138	Research Site	Sterling	Illinois	United States
139	Research Site	Vernon Hills	Illinois	United States
140	Research Site	Avon	Indiana	United States
141	Research Site	Evansville	Indiana	United States
142	Research Site	Granger	Indiana	United States
143	Research Site	Indianapolis	Indiana	United States
144	Research Site	Jeffersonville	Indiana	United States
145	Research Site	Munster	Indiana	United States
146	Research Site	Newburgh	Indiana	United States
147	Research Site	Valparaiso	Indiana	United States
148	Research Site	Des Moines	Iowa	United States
149	Research Site	Dubuque	Iowa	United States
150	Research Site	Iowa City	Iowa	United States
151	Research Site	West Des Moines	Iowa	United States
152	Research Site	Leavenworth	Kansas	United States
153	Research Site	Olathe	Kansas	United States
154	Research Site	Overland Park	Kansas	United States
155	Research Site	Shawnee Mission	Kansas	United States
156	Research Site	Topeka	Kansas	United States
157	Research Site	Wichita	Kansas	United States
158	Research Site	Evansville	Kentucky	United States
159	Research Site	Lexington	Kentucky	United States
160	Research Site	Louisville	Kentucky	United States
161	Research Site	Baton Rouge	Louisiana	United States
162	Research Site	Covington	Louisiana	United States
163	Research Site	Houma	Louisiana	United States
164	Research Site	Lake Charles	Louisiana	United States
165	Research Site	Marrero	Louisiana	United States
166	Research Site	New Orleans	Louisiana	United States
167	Research Site	Shreveport	Louisiana	United States
168	Research Site	Auburn	Maine	United States
169	Research Site	Bangor	Maine	United States
170	Research Site	Portland	Maine	United States
171	Research Site	S Portland	Maine	United States
172	Research Site	Sanford	Maine	United States
173	Research Site	Baltimore	Maryland	United States
174	Research Site	Charlotte Hall	Maryland	United States
175	Research Site	Glen Burnie	Maryland	United States
176	Research Site	Hagerstown	Maryland	United States
177	Research Site	Prince Frederick	Maryland	United States
178	Research Site	Rockville	Maryland	United States
179	Research Site	Towson	Maryland	United States
180	Research Site	Ayer	Massachusetts	United States
181	Research Site	Boston	Massachusetts	United States
182	Research Site	Burlington	Massachusetts	United States
183	Research Site	East Bridgewater	Massachusetts	United States
184	Research Site	Haverhill	Massachusetts	United States
185	Research Site	Natick	Massachusetts	United States
186	Research Site	Newton	Massachusetts	United States
187	Research Site	Springfield	Massachusetts	United States
188	Research Site	West Yarmouth	Massachusetts	United States
189	Research Site	Worcester	Massachusetts	United States
190	Research Site	Berkley	Michigan	United States
191	Research Site	Dearborn	Michigan	United States
192	Research Site	Grand Rapids	Michigan	United States
193	Research Site	Livonia	Michigan	United States
194	Research Site	Petoskey	Michigan	United States
195	Research Site	Portage	Michigan	United States
196	Research Site	St. Joseph	Michigan	United States
197	Research Site	Troy	Michigan	United States
198	Research Site	Warren	Michigan	United States
199	Research Site	Chaska	Minnesota	United States
200	Research Site	Duluth	Minnesota	United States
201	Research Site	Minneapolis	Minnesota	United States
202	Research Site	Rochester	Minnesota	United States
203	Research Site	St. Paul	Minnesota	United States
204	Research Site	Gulfport	Mississippi	United States
205	Research Site	Jackson	Mississippi	United States
206	Research Site	Olive Branch	Mississippi	United States
207	Research Site	Picayune	Mississippi	United States
208	Research Site	Port Gibson	Mississippi	United States
209	Research Site	Chesterfield	Missouri	United States
210	Research Site	Excelsior Springs	Missouri	United States
211	Research Site	Jefferson City	Missouri	United States
212	Research Site	Kansas City	Missouri	United States
213	Research Site	Manchester	Missouri	United States
214	Research Site	Mexico	Missouri	United States
215	Research Site	Rolla	Missouri	United States
216	Research Site	Shawnee Mission	Missouri	United States
217	Research Site	Springfield	Missouri	United States
218	Research Site	St Charles	Missouri	United States
219	Research Site	St Louis	Missouri	United States
220	Research Site	Washington	Missouri	United States
221	Research Site	Wentzville	Missouri	United States
222	Research Site	Anaconda	Montana	United States
223	Research Site	Butte	Montana	United States
224	Research Site	Kalispell	Montana	United States
225	Research Site	Missoula	Montana	United States
226	Research Site	Grand Island	Nebraska	United States
227	Research Site	Omaha	Nebraska	United States
228	Research Site	Henderson	Nevada	United States
229	Research Site	Las Vegas	Nevada	United States
230	Research Site	Pahrump	Nevada	United States
231	Research Site	Nashua	New Hampshire	United States
232	Research Site	Bloomfield	New Jersey	United States
233	Research Site	Brick	New Jersey	United States
234	Research Site	Cherry Hill	New Jersey	United States
235	Research Site	Elizabeth	New Jersey	United States
236	Research Site	Englewood Cliffs	New Jersey	United States
237	Research Site	Morristown	New Jersey	United States
238	Research Site	Newark	New Jersey	United States
239	Research Site	Northbrunswick	New Jersey	United States
240	Research Site	Passaic	New Jersey	United States
241	Research Site	Teaneck	New Jersey	United States
242	Research Site	Trenton	New Jersey	United States
243	Research Site	West Caldwell	New Jersey	United States
244	Research Site	Albuquerque	New Mexico	United States
245	Research Site	Los Alamos	New Mexico	United States
246	Research Site	Rio Rancho	New Mexico	United States
247	Research Site	Albany	New York	United States
248	Research Site	Binghamton	New York	United States
249	Research Site	Bowmansville	New York	United States
250	Research Site	Bronxville	New York	United States
251	Research Site	Bronx	New York	United States
252	Research Site	Brooklyn	New York	United States
253	Research Site	Buffalo	New York	United States
254	Research Site	Camillus	New York	United States
255	Research Site	E Syracuse	New York	United States
256	Research Site	East Islip	New York	United States
257	Research Site	Fayetteville	New York	United States
258	Research Site	Lake Success	New York	United States
259	Research Site	Mamaroneck	New York	United States
260	Research Site	Mount Vernon	New York	United States
261	Research Site	New Hartford	New York	United States
262	Research Site	New Hyde Park	New York	United States
263	Research Site	New York	New York	United States
264	Research Site	Niagara Falls	New York	United States
265	Research Site	Poughkeepsie	New York	United States
266	Research Site	Riverhead	New York	United States
267	Research Site	Rochester	New York	United States
268	Research Site	Syracuse	New York	United States
269	Research Site	Tonawanda	New York	United States
270	Research Site	Williamsville	New York	United States
271	Research Site	Asheville	North Carolina	United States
272	Research Site	Burlington	North Carolina	United States
273	Research Site	Cary	North Carolina	United States
274	Research Site	Chapel Hill	North Carolina	United States
275	Research Site	Charlotte	North Carolina	United States
276	Research Site	Durham	North Carolina	United States
277	Research Site	Fayetteville	North Carolina	United States
278	Research Site	Lenoir	North Carolina	United States
279	Research Site	Lexington	North Carolina	United States
280	Research Site	Raleigh	North Carolina	United States
281	Research Site	Statesville	North Carolina	United States
282	Research Site	Winston-salem	North Carolina	United States
283	Research Site	Fargo	North Dakota	United States
284	Research Site	Akron	Ohio	United States
285	Research Site	Athens	Ohio	United States
286	Research Site	Bellbrook	Ohio	United States
287	Research Site	Canal Fulton	Ohio	United States
288	Research Site	Centerville	Ohio	United States
289	Research Site	Chesterland	Ohio	United States
290	Research Site	Cincinnati	Ohio	United States
291	Research Site	Columbus	Ohio	United States
292	Research Site	Dayton	Ohio	United States
293	Research Site	Mansfield	Ohio	United States
294	Research Site	Massillon	Ohio	United States
295	Research Site	Maumee	Ohio	United States
296	Research Site	Wadsworth	Ohio	United States
297	Research Site	Warren	Ohio	United States
298	Research Site	Zanesville	Ohio	United States
299	Research Site	Guthrie	Oklahoma	United States
300	Research Site	Muskogee	Oklahoma	United States
301	Research Site	Oklahoma City	Oklahoma	United States
302	Research Site	Tulsa	Oklahoma	United States
303	Research Site	Yukon	Oklahoma	United States
304	Research Site	Corvallis	Oregon	United States
305	Research Site	Dallas	Oregon	United States
306	Research Site	Eugene	Oregon	United States
307	Research Site	Lake Oswego	Oregon	United States
308	Research Site	Medford	Oregon	United States
309	Research Site	Milwaukie	Oregon	United States
310	Research Site	Portland	Oregon	United States
311	Research Site	Springfield	Oregon	United States
312	Research Site	Altoona	Pennsylvania	United States
313	Research Site	Beaver	Pennsylvania	United States
314	Research Site	Bloomsburg	Pennsylvania	United States
315	Research Site	Broomall	Pennsylvania	United States
316	Research Site	Camp Hill	Pennsylvania	United States
317	Research Site	Connellsville	Pennsylvania	United States
318	Research Site	Downingtown	Pennsylvania	United States
319	Research Site	Erie	Pennsylvania	United States
320	Research Site	Feasterville	Pennsylvania	United States
321	Research Site	Fleetwood	Pennsylvania	United States
322	Research Site	Harleysville	Pennsylvania	United States
323	Research Site	Harrisburg	Pennsylvania	United States
324	Research Site	Jersey Shore	Pennsylvania	United States
325	Research Site	King of Prussia	Pennsylvania	United States
326	Research Site	Lansdale	Pennsylvania	United States
327	Research Site	Lansdowne	Pennsylvania	United States
328	Research Site	Lewisburg	Pennsylvania	United States
329	Research Site	Lewistown	Pennsylvania	United States
330	Research Site	Lock Haven	Pennsylvania	United States
331	Research Site	McMurry	Pennsylvania	United States
332	Research Site	Melrose Park	Pennsylvania	United States
333	Research Site	Norristown	Pennsylvania	United States
334	Research Site	Philadelphia	Pennsylvania	United States
335	Research Site	Pittsburgh	Pennsylvania	United States
336	Research Site	Plymouth Meeting	Pennsylvania	United States
337	Research Site	Reading	Pennsylvania	United States
338	Research Site	Scotland	Pennsylvania	United States
339	Research Site	Sellersville	Pennsylvania	United States
340	Research Site	Souderton	Pennsylvania	United States
341	Research Site	Springfield	Pennsylvania	United States
342	Research Site	State College	Pennsylvania	United States
343	Research Site	Stoneboro	Pennsylvania	United States
344	Research Site	Tipton	Pennsylvania	United States
345	Research Site	Uniontown	Pennsylvania	United States
346	Research Site	Upland	Pennsylvania	United States
347	Research Site	Wallingford	Pennsylvania	United States
348	Research Site	Warminster	Pennsylvania	United States
349	Research Site	West Grove	Pennsylvania	United States
350	Research Site	West Reading	Pennsylvania	United States
351	Research Site	Wilkes-barre	Pennsylvania	United States
352	Research Site	York	Pennsylvania	United States
353	Research Site	Cranston	Rhode Island	United States
354	Research Site	Johnston	Rhode Island	United States
355	Research Site	Pawtucket	Rhode Island	United States
356	Research Site	Providence	Rhode Island	United States
357	Research Site	Charleston	South Carolina	United States
358	Research Site	Greenville	South Carolina	United States
359	Research Site	Greer	South Carolina	United States
360	Research Site	Hampton	South Carolina	United States
361	Research Site	Moncks Corner	South Carolina	United States
362	Research Site	Mt Pleasant	South Carolina	United States
363	Research Site	Orangeburg	South Carolina	United States
364	Research Site	Simpsonville	South Carolina	United States
365	Research Site	Sioux Falls	South Dakota	United States
366	Research Site	Bristol	Tennessee	United States
367	Research Site	Chattanooga	Tennessee	United States
368	Research Site	Clarksville	Tennessee	United States
369	Research Site	Fayetteville	Tennessee	United States
370	Research Site	Germantown	Tennessee	United States
371	Research Site	Hendersonville	Tennessee	United States
372	Research Site	Jefferson City	Tennessee	United States
373	Research Site	Johnson City	Tennessee	United States
374	Research Site	Memphis	Tennessee	United States
375	Research Site	Morristown	Tennessee	United States
376	Research Site	Nashville	Tennessee	United States
377	Research Site	Arlington	Texas	United States
378	Research Site	Austin	Texas	United States
379	Research Site	Carrollton	Texas	United States
380	Research Site	Colleyville	Texas	United States
381	Research Site	Corpus Christi	Texas	United States
382	Research Site	Dallas	Texas	United States
383	Research Site	El Paso	Texas	United States
384	Research Site	Fort Worth	Texas	United States
385	Research Site	Friendswood	Texas	United States
386	Research Site	Ft Worth	Texas	United States
387	Research Site	Grapevine	Texas	United States
388	Research Site	Houston	Texas	United States
389	Research Site	Irving	Texas	United States
390	Research Site	Lake Jackson	Texas	United States
391	Research Site	Lubbock	Texas	United States
392	Research Site	N Richland Hills	Texas	United States
393	Research Site	New Braunfels	Texas	United States
394	Research Site	Pharr	Texas	United States
395	Research Site	Plano	Texas	United States
396	Research Site	San Antonio	Texas	United States
397	Research Site	Seguin	Texas	United States
398	Research Site	Sugar Land	Texas	United States
399	Research Site	The Woodlands	Texas	United States
400	Research Site	Tyler	Texas	United States
401	Research Site	Bountiful	Utah	United States
402	Research Site	Nephi	Utah	United States
403	Research Site	Salt Lake City	Utah	United States
404	Research Site	Burlington	Vermont	United States
405	Research Site	Alexandria	Virginia	United States
406	Research Site	Arlington	Virginia	United States
407	Research Site	Burke	Virginia	United States
408	Research Site	Charlottesville	Virginia	United States
409	Research Site	Hampton	Virginia	United States
410	Research Site	Hayes	Virginia	United States
411	Research Site	Norfolk	Virginia	United States
412	Research Site	Quinton	Virginia	United States
413	Research Site	Richmond	Virginia	United States
414	Research Site	Springfield	Virginia	United States
415	Research Site	Stuart	Virginia	United States
416	Research Site	Suffolk	Virginia	United States
417	Research Site	Weber City	Virginia	United States
418	Research Site	Yorktown	Virginia	United States
419	Research Site	Burien	Washington	United States
420	Research Site	Everett	Washington	United States
421	Research Site	Gig Harbor	Washington	United States
422	Research Site	Olympia	Washington	United States
423	Research Site	Seattle	Washington	United States
424	Research Site	Spokane	Washington	United States
425	Research Site	Wenatchee	Washington	United States
426	Research Site	Charleston	West Virginia	United States
427	Research Site	Lewisburg	West Virginia	United States
428	Research Site	Beloit	Wisconsin	United States
429	Research Site	Green Bay	Wisconsin	United States
430	Research Site	Madison	Wisconsin	United States
431	Research Site	Menomonee Falls	Wisconsin	United States
432	Research Site	Milwaukee	Wisconsin	United States
433	Research Site	Quilmes	Buenos Aires - Argentina	Argentina
434	Research Site	Ramos Mejia	Buenos Aires Argentina	Argentina
435	Research Site	San Isidro	Buenos Aires- Argentina	Argentina
436	Research Site	Capital Federal	Buenos Aires	Argentina
437	Research Site	Pilar	Buenos Aires	Argentina
438	Research Site	Cordoba	Cordoba - Argentina	Argentina
439	Research Site	Rosario	Santa Fe- Argentina	Argentina
440	Research Site	San Miguel de Tucuman	Tucuman / Argentina	Argentina
441	Research Site	Tucuman	Tucuman-argentina	Argentina
442	Research Site	Salta		Argentina
443	Research Site	Alsemberg		Belgium
444	Research Site	ANS		Belgium
445	Research Site	Anthee		Belgium
446	Research Site	Auvelais		Belgium
447	Research Site	Baisy-thy		Belgium
448	Research Site	Bertrix		Belgium
449	Research Site	Betekom		Belgium
450	Research Site	Boechout		Belgium
451	Research Site	Braine-l 'alleud		Belgium
452	Research Site	Brussels		Belgium
453	Research Site	Burdinne		Belgium
454	Research Site	Cerexhe-heuseux		Belgium
455	Research Site	Champion		Belgium
456	Research Site	Chenee		Belgium
457	Research Site	De Pinte		Belgium
458	Research Site	Deurne (antwerpen)		Belgium
459	Research Site	Dour		Belgium
460	Research Site	Ekeren		Belgium
461	Research Site	Embourg		Belgium
462	Research Site	Evergem		Belgium
463	Research Site	Genk		Belgium
464	Research Site	Genly		Belgium
465	Research Site	Gozee		Belgium
466	Research Site	Grivegnee		Belgium
467	Research Site	Halen		Belgium
468	Research Site	Hasselt		Belgium
469	Research Site	Heurne		Belgium
470	Research Site	Heusden		Belgium
471	Research Site	Hove		Belgium
472	Research Site	Kessel-lo		Belgium
473	Research Site	Komen		Belgium
474	Research Site	Kraainem		Belgium
475	Research Site	Landen		Belgium
476	Research Site	Lauwe		Belgium
477	Research Site	Leopoldsburg		Belgium
478	Research Site	Leuven		Belgium
479	Research Site	Libin		Belgium
480	Research Site	Linkebeek		Belgium
481	Research Site	Lommel		Belgium
482	Research Site	Marchienne-au-pont		Belgium
483	Research Site	Marchovelette		Belgium
484	Research Site	Massemen		Belgium
485	Research Site	Mechelen-aan-de-maas		Belgium
486	Research Site	Melsbroek		Belgium
487	Research Site	Moerkerke		Belgium
488	Research Site	Mont-sur-marchienne		Belgium
489	Research Site	Moorsel		Belgium
490	Research Site	Mouscron		Belgium
491	Research Site	Natoye		Belgium
492	Research Site	Oostham		Belgium
493	Research Site	Opgrimbie (maasmechelen)		Belgium
494	Research Site	Oudenaarde		Belgium
495	Research Site	Paal		Belgium
496	Research Site	Puurs		Belgium
497	Research Site	Ronquieres		Belgium
498	Research Site	Ronse		Belgium
499	Research Site	Rumst		Belgium
500	Research Site	Saint-medard		Belgium
501	Research Site	Schoonaarde		Belgium
502	Research Site	Schuiferskapelle		Belgium
503	Research Site	Sint-gillis-waas		Belgium
504	Research Site	Steenokkerzeel		Belgium
505	Research Site	Tavier		Belgium
506	Research Site	Tessenderlo		Belgium
507	Research Site	Thuin		Belgium
508	Research Site	Tielt		Belgium
509	Research Site	Tremelo		Belgium
510	Research Site	Trois-ponts		Belgium
511	Research Site	Turnhout		Belgium
512	Research Site	Vilvoorde		Belgium
513	Research Site	Waremme		Belgium
514	Research Site	Weerde		Belgium
515	Research Site	Wezembeek- Oppem		Belgium
516	Research Site	Zoersel		Belgium
517	Research Site	Maceio	Alagoas	Brazil
518	Research Site	Salvador	BA	Brazil
519	Research Site	Fortaleza	CE	Brazil
520	Research Site	Goiagoianiania	Goias	Brazil
521	Research Site	Belo Horizonte	MG	Brazil
522	Research Site	Passo Fundo	Rio Grande Do Sul	Brazil
523	Research Site	Rio de Janeiro	RJ	Brazil
524	Research Site	Porto Alegre	RS	Brazil
525	Research Site	Santos	Sao Paulo	Brazil
526	Research Site	Sao Jose Do Rio Preto	Sao Paulo	Brazil
527	Research Site	Botucatu	SP	Brazil
528	Research Site	S.j.rio Preto	SP	Brazil
529	Research Site	Campinas		Brazil
530	Research Site	Sao Paulo		Brazil
531	Research Site	Dimitrovgrad		Bulgaria
532	Research Site	Haskovo		Bulgaria
533	Research Site	Pleven		Bulgaria
534	Research Site	Plovdiv		Bulgaria
535	Research Site	Russe		Bulgaria
536	Research Site	Sofia		Bulgaria
537	Research Site	Varna		Bulgaria
538	Research Site	Veliko Tarnovo		Bulgaria
539	Research Site	Calgary	Alberta	Canada
540	Research Site	Edmonton	Alberta	Canada
541	Research Site	Chilliwack	British Columbia	Canada
542	Research Site	Coquitlam	British Columbia	Canada
543	Research Site	Kelowna	British Columbia	Canada
544	Research Site	Langley	British Columbia	Canada
545	Research Site	New Westminister	British Columbia	Canada
546	Research Site	Penticton	British Columbia	Canada
547	Research Site	Surrey	British Columbia	Canada
548	Research Site	Victoria	British Columbia	Canada
549	Research Site	Portage La Prairie	Manitoba	Canada
550	Research Site	Winnipeg	Manitoba	Canada
551	Research Site	Grand Bay - Westfield	New Brunswick	Canada
552	Research Site	Moncton	New Brunswick	Canada
553	Research Site	Nackawic	New Brunswick	Canada
554	Research Site	Saint John	New Brunswick	Canada
555	Research Site	Woodstock	New Brunswick	Canada
556	Research Site	Bay Roberts	Newfoundland and Labrador	Canada
557	Research Site	Carbonear	Newfoundland and Labrador	Canada
558	Research Site	Conception Bay South	Newfoundland and Labrador	Canada
559	Research Site	Holyrood	Newfoundland and Labrador	Canada
560	Research Site	Mount Pearl	Newfoundland and Labrador	Canada
561	Research Site	St. John's	Newfoundland and Labrador	Canada
562	Research Site	Amherst	Nova Scotia	Canada
563	Research Site	Antigonish	Nova Scotia	Canada
564	Research Site	Digby	Nova Scotia	Canada
565	Research Site	Halifax	Nova Scotia	Canada
566	Research Site	Windsor	Nova Scotia	Canada
567	Research Site	Bolton	Ontario	Canada
568	Research Site	Brampton	Ontario	Canada
569	Research Site	Burlington	Ontario	Canada
570	Research Site	Cambridge	Ontario	Canada
571	Research Site	Corunna	Ontario	Canada
572	Research Site	Courtice	Ontario	Canada
573	Research Site	Etobicoke	Ontario	Canada
574	Research Site	Exeter	Ontario	Canada
575	Research Site	Hamilton	Ontario	Canada
576	Research Site	Ingersoll	Ontario	Canada
577	Research Site	Kingston	Ontario	Canada
578	Research Site	London	Ontario	Canada
579	Research Site	Markham	Ontario	Canada
580	Research Site	Newmarket	Ontario	Canada
581	Research Site	Niagara Falls	Ontario	Canada
582	Research Site	North Bay	Ontario	Canada
583	Research Site	North York	Ontario	Canada
584	Research Site	Orleans	Ontario	Canada
585	Research Site	Oshawa	Ontario	Canada
586	Research Site	Ottawa	Ontario	Canada
587	Research Site	Perth	Ontario	Canada
588	Research Site	Peterborough	Ontario	Canada
589	Research Site	Renfrew	Ontario	Canada
590	Research Site	Sarnia	Ontario	Canada
591	Research Site	Scarborough	Ontario	Canada
592	Research Site	Smith Falls	Ontario	Canada
593	Research Site	St Catherines	Ontario	Canada
594	Research Site	Stirling	Ontario	Canada
595	Research Site	Sudbury	Ontario	Canada
596	Research Site	Thornhill	Ontario	Canada
597	Research Site	Thunder Bay	Ontario	Canada
598	Research Site	Tillsonburg	Ontario	Canada
599	Research Site	Toronto	Ontario	Canada
600	Research Site	Windsor	Ontario	Canada
601	Research Site	Woodstock	Ontario	Canada
602	Research Site	Charlottetown	Prince Edward Island	Canada
603	Research Site	Chicoutimi	Quebec	Canada
604	Research Site	Courcelette	Quebec	Canada
605	Research Site	Drummonville	Quebec	Canada
606	Research Site	Gatineau	Quebec	Canada
607	Research Site	Granby	Quebec	Canada
608	Research Site	Greenfield Park	Quebec	Canada
609	Research Site	Lasalle	Quebec	Canada
610	Research Site	Laval	Quebec	Canada
611	Research Site	Longueuil	Quebec	Canada
612	Research Site	Montreal	Quebec	Canada
613	Research Site	Pointe-claire	Quebec	Canada
614	Research Site	Saint-georges	Quebec	Canada
615	Research Site	Saint-marc-des-carrieres	Quebec	Canada
616	Research Site	Sainte-catherine	Quebec	Canada
617	Research Site	Sainte-julie	Quebec	Canada
618	Research Site	Sherbrooke	Quebec	Canada
619	Research Site	Trois-rivieres	Quebec	Canada
620	Research Site	Vanier	Quebec	Canada
621	Research Site	Regina	Saskatchewan	Canada
622	Research Site	Saskatoon	Saskatchewan	Canada
623	Research Site	Quebec		Canada
624	Research Site	Temuco	Novena Region	Chile
625	Research Site	Santiago	Region Metropolitana	Chile
626	Research Site	Medellin	Antioquia	Colombia
627	Research Site	Barranquilla	Atlantico	Colombia
628	Research Site	Cartagena	Bolivar	Colombia
629	Research Site	Pereira	Risaralda	Colombia
630	Research Site	Bucaramanga	Santander	Colombia
631	Research Site	Floridablanca	Santander	Colombia
632	Research Site	Cali	Valle	Colombia
633	Research Site	Bogota		Colombia
634	Research Site	Desamparados	San Jose	Costa Rica
635	Research Site	Escazu	San Jose	Costa Rica
636	Research Site	San Pedro de Montes de Oca	San Jose	Costa Rica
637	Research Site	Heredia		Costa Rica
638	Research Site	Gentofte		Denmark
639	Research Site	Glostrup		Denmark
640	Research Site	Herlev		Denmark
641	Research Site	Hillerod		Denmark
642	Research Site	Odense C		Denmark
643	Research Site	El Salvador	San Salvador	El Salvador
644	Research Site	Salvador		El Salvador
645	Research Site	San Salvador		El Salvador
646	Research Site	Saku	Harju County	Estonia
647	Research Site	Parnu		Estonia
648	Research Site	Rakvere		Estonia
649	Research Site	Tallinn		Estonia
650	Research Site	Tartu		Estonia
651	Research Site	Viljandi County		Estonia
652	Research Site	Berlin		Germany
653	Research Site	Bochum		Germany
654	Research Site	Chemnitz		Germany
655	Research Site	Dortmund		Germany
656	Research Site	Dresden		Germany
657	Research Site	Frankfurt		Germany
658	Research Site	Gorlitz		Germany
659	Research Site	Hamburg		Germany
660	Research Site	Kunzing		Germany
661	Research Site	Leipzig		Germany
662	Research Site	Magdeburg		Germany
663	Research Site	Nurnberg		Germany
664	Research Site	ULM		Germany
665	Research Site	Witten		Germany
666	Research Site	Kiryat Hadassah	Jerusalem	Israel
667	Research Site	Ashkelon Shore		Israel
668	Research Site	Beer Yakov		Israel
669	Research Site	Haifa		Israel
670	Research Site	Holon		Israel
671	Research Site	Jerusalem		Israel
672	Research Site	Kfar-saba		Israel
673	Research Site	Safed		Israel
674	Research Site	Tel Aviv		Israel
675	Research Site	Tel-hashomer		Israel
676	Research Site	Zrifin		Israel
677	Research Site	Mexico City	D.F	Mexico
678	Research Site	Guadalajara	Jalisco	Mexico
679	Research Site	Monterrey	Nuevo Leon	Mexico
680	Research Site	Culiacan	Sinaloa	Mexico
681	Research Site	San Luis Potosi	SLP	Mexico
682	Research Site	Aguascalientes		Mexico
683	Research Site	Alkmaar		Netherlands
684	Research Site	Amersfoort		Netherlands
685	Research Site	Amsterdam		Netherlands
686	Research Site	Breda		Netherlands
687	Research Site	Den Haag		Netherlands
688	Research Site	Deventer		Netherlands
689	Research Site	Eindhoven		Netherlands
690	Research Site	Gouda		Netherlands
691	Research Site	Groningen		Netherlands
692	Research Site	Hoorn		Netherlands
693	Research Site	Leiden		Netherlands
694	Research Site	Nijmegen		Netherlands
695	Research Site	Rotterdam		Netherlands
696	Research Site	Tilburg		Netherlands
697	Research Site	Utrecht		Netherlands
698	Research Site	Velp		Netherlands
699	Research Site	Zoetermeer		Netherlands
700	Research Site	Bekkestua		Norway
701	Research Site	Bergen		Norway
702	Research Site	Boverbru		Norway
703	Research Site	Elverum		Norway
704	Research Site	Flatasen		Norway
705	Research Site	Fredrikstad		Norway
706	Research Site	Halden		Norway
707	Research Site	Heimdal		Norway
708	Research Site	Kristiansand		Norway
709	Research Site	Laksevag		Norway
710	Research Site	Lena		Norway
711	Research Site	Lierskogen		Norway
712	Research Site	Lovenstad		Norway
713	Research Site	Lysaker		Norway
714	Research Site	Moelv		Norway
715	Research Site	Moss		Norway
716	Research Site	Oslo		Norway
717	Research Site	Osteras		Norway
718	Research Site	Paradis		Norway
719	Research Site	Radal		Norway
720	Research Site	Randaberg		Norway
721	Research Site	Skedsmokorset		Norway
722	Research Site	Skiptvet		Norway
723	Research Site	SKI		Norway
724	Research Site	Snaroya		Norway
725	Research Site	Sogndal		Norway
726	Research Site	Spikkestad		Norway
727	Research Site	Stavanger		Norway
728	Research Site	Strommen		Norway
729	Research Site	Svelvik		Norway
730	Research Site	Trollasen		Norway
731	Research Site	Trondheim		Norway
732	Research Site	Panama		Panama
733	Research Site	Aleksandrow Lodzki		Poland
734	Research Site	Bydgoszcz		Poland
735	Research Site	Bytom		Poland
736	Research Site	Chodziez		Poland
737	Research Site	Chorzow		Poland
738	Research Site	Gdansk		Poland
739	Research Site	Gliwice		Poland
740	Research Site	Jelcz-laskowice		Poland
741	Research Site	Karpacz		Poland
742	Research Site	Katowice		Poland
743	Research Site	Koluszki		Poland
744	Research Site	Krakow		Poland
745	Research Site	Linia		Poland
746	Research Site	Lodz		Poland
747	Research Site	Lublin		Poland
748	Research Site	Nowogard		Poland
749	Research Site	Olawa		Poland
750	Research Site	Olsztyn		Poland
751	Research Site	Opalenica		Poland
752	Research Site	Opole		Poland
753	Research Site	Ostrow Wielkopolski		Poland
754	Research Site	Piekary Slaskie		Poland
755	Research Site	Poznan		Poland
756	Research Site	Pulawy		Poland
757	Research Site	Radom		Poland
758	Research Site	Radziejow		Poland
759	Research Site	Rybnik		Poland
760	Research Site	Sieradz		Poland
761	Research Site	Skierniewice		Poland
762	Research Site	Slupca		Poland
763	Research Site	Sobotka		Poland
764	Research Site	Sopot		Poland
765	Research Site	Szczecin		Poland
766	Research Site	Tarnow		Poland
767	Research Site	Torun		Poland
768	Research Site	Trzcianka		Poland
769	Research Site	Turek		Poland
770	Research Site	Wabrzezno		Poland
771	Research Site	Warszawa		Poland
772	Research Site	Wejherowo		Poland
773	Research Site	Wroclaw		Poland
774	Research Site	Zabrze		Poland
775	Research Site	Aguas Buenas		Puerto Rico
776	Research Site	Caguas		Puerto Rico
777	Research Site	Cidra		Puerto Rico
778	Research Site	Levittown-toa Baja		Puerto Rico
779	Research Site	Ponce		Puerto Rico
780	Research Site	San Juan		Puerto Rico
781	Research Site	Cluj Napoca	Cluj	Romania
782	Research Site	Timisoara	Timis	Romania
783	Research Site	Brasov		Romania
784	Research Site	Bucharest		Romania
785	Research Site	Bucuresti		Romania
786	Research Site	Ekaterinburg		Russian Federation
787	Research Site	Kemerovo		Russian Federation
788	Research Site	Krasnoyarsk		Russian Federation
789	Research Site	Moscow		Russian Federation
790	Research Site	Novosibirsk		Russian Federation
791	Research Site	Saratov		Russian Federation
792	Research Site	St-petersburg		Russian Federation
793	Research Site	Toliatti		Russian Federation
794	Research Site	Tomsk		Russian Federation
795	Research Site	Tyumen		Russian Federation
796	Research Site	Voronezh		Russian Federation
797	Research Site	Yaroslavl		Russian Federation
798	Research Site	Claremont	Cape Province	South Africa
799	Research Site	Athlone	Cape Town	South Africa
800	Research Site	Florida Park	Gauteng	South Africa
801	Research Site	Lenasia	Gauteng	South Africa
802	Research Site	Pretoria	Gauteng	South Africa
803	Research Site	Witbank	Gauteng	South Africa
804	Research Site	Durban	Kwazulu Natal	South Africa
805	Research Site	Umkomaas	Kwazulu Natal	South Africa
806	Research Site	Morningside Manor	Morningside	South Africa
807	Research Site	Korsten	Port Elizabeth	South Africa
808	Research Site	Hillcrest	Pretoria	South Africa
809	Research Site	Benoni		South Africa
810	Research Site	Halfway House		South Africa
811	Research Site	Johannesburg		South Africa
812	Research Site	Lakeview, Retreat		South Africa
813	Research Site	Rustenburg		South Africa
814	Research Site	Somerset West		South Africa
815	Research Site	Vanderbijlpark		South Africa
816	Research Site	Worcester		South Africa
817	Research Site	Olten	Schweiz	Switzerland
818	Research Site	Reading	Berkshire	United Kingdom
819	Research Site	Annan	Dumfries and Galloway	United Kingdom
820	Research Site	Blantyre	Lanarkshire	United Kingdom
821	Research Site	Hamilton	Lanarkshire	United Kingdom
822	Research Site	Strathaven	Lanarkshire	United Kingdom
823	Research Site	Wishaw	Lanarkshire	United Kingdom
824	Research Site	Paisley	Renfrewshire	United Kingdom
825	Research Site	Airdrie	Scotland	United Kingdom
826	Research Site	Glasgow	Scotland	United Kingdom
827	Research Site	Barrhead		United Kingdom
828	Research Site	Bellshill		United Kingdom
829	Research Site	Birmingham		United Kingdom
830	Research Site	Cambuslang		United Kingdom
831	Research Site	Cardiff		United Kingdom
832	Research Site	Chorley		United Kingdom
833	Research Site	Cumbernauld		United Kingdom
834	Research Site	Gourock		United Kingdom
835	Research Site	Greenock		United Kingdom
836	Research Site	Helensburgh		United Kingdom
837	Research Site	Kirkintilloch		United Kingdom
838	Research Site	Liverpool		United Kingdom
839	Research Site	Lockerbie		United Kingdom
840	Research Site	Manchester		United Kingdom
841	Research Site	New Stevenson		United Kingdom
842	Research Site	Renfrew		United Kingdom
843	Research Site	Stranraer		United Kingdom
844	Research Site	Strathblane		United Kingdom
845	Research Site	Thornhill		United Kingdom
846	Research Site	Wolverhampton		United Kingdom
847	Research Site	Montevideo		Uruguay
848	Research Site	Maracay, Municipio Girardot	Estado Aragua	Venezuela
849	Research Site	Barinas	Estado Barinas	Venezuela
850	Research Site	Ciudad Bolivar	Estado Bolivar	Venezuela
851	Research Site	Puerto Ordaz	Estado Bolivar	Venezuela
852	Research Site	Valencia	Estado Carabobo	Venezuela
853	Research Site	Barquisimeto	Estado Lara	Venezuela
854	Research Site	Merida	Estado Merida	Venezuela
855	Research Site	Porlamar	Estado Nueva Esparta	Venezuela
856	Research Site	Maracaibo	Estado Zulia	Venezuela
857	Research Site	Latrinidad Caracas	Municipio Baruta	Venezuela
858	Research Site	Caracas		Venezuela
859	Research Site	Punto Fijo, Estado Falcon		Venezuela

Sponsors and Collaborators

• AstraZeneca

Investigators

• Study Director: Judith Hsia, MD, AstraZeneca
• Study Chair: Paul Ridker, MD, Brigham and Women's Hospital

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Related Info

Publications

None provided.

• Responsible Party: AstraZeneca
• ClinicalTrials.gov Identifier: NCT00239681
• Other Study ID Numbers: D3560L00030; Jupiter; 4522US/0011
• First Posted: Oct 17, 2005
• Last Update Posted: Mar 24, 2014
• Last Verified: Feb 1, 2014

• Keywords provided by AstraZeneca: Primary prevention; Cardiovascular disease; Statin therapy; C-reactive protein
• Additional relevant MeSH terms: Hypersensitivity; Rosuvastatin Calcium

Study Results

Participant Flow

Recruitment Details	The first subject was enrolled on 05 February 2003. The last subject completed on 20 August 2008. Study subjects were randomized at 1348 centers in 26 countries. Enrolled subjects participated in an initial 4-week, run-in phase and received placebo therapy.
Pre-assignment Detail	If found eligible for the main study on the basis of appropriate levels of baseline Low Density Lipoprotein (LDL), High-sensitivity C-Reactive Protein (hsCRP), and run-in phase compliance (>80% of pills taken), subjects were randomized to either rosuvastatin 20 mg or placebo once daily

Arm/Group Title	Rosuvastatin	Placebo
Arm/Group Description	Rosuvastatin 20 mg once daily	Placebo once daily
Period Title: Overall Study
STARTED	8901	8901
Randomized and Treated (Safety Pop)	8869	8864
COMPLETED	8208	8186
NOT COMPLETED	693	715

Baseline Characteristics

Arm/Group Title	Rosuvastatin	Placebo	Total
Arm/Group Description	Rosuvastatin 20 mg once daily	Placebo once daily	Total of all reporting groups
Overall Participants	8901	8901	17802
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	66.1 (7.64)	66.1 (7.8)	66.1 (7.72)
Sex: Female, Male (Count of Participants)
Female	3426 38.5%	3375 37.9%	6801 38.2%
Male	5475 61.5%	5526 62.1%	11001 61.8%

Outcome Measures

1. Primary Outcome

Title	Time to Major Cardiac Event (Cardiovascular Death, Stroke, Myocardial Infarction, Hospitalization Due to Unstable Angina or Arterial Revascularization)
Description	Days from randomization to the first of CV death, stroke, MI, hospitalization for unstable angina or arterial revascularization. If no event, censoring occurs at earliest of termination date or efficacy cut-off date of 30 Mar 2008. Events were adjudicated by an endpoint committee. Kaplan-Meier estimate of the mean
Time Frame	up to 5 years

Outcome Measure Data

Analysis Population Description

Intention to treat population

Arm/Group Title	Rosuvastatin	Placebo
Arm/Group Description	Rosuvastatin 20 mg once daily	Placebo once daily
Measure Participants	8901	8901
Mean (Standard Error) [Days]	1646.4 (2.76)	1578.3 (3.49)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Rosuvastatin, 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	0.56
	Confidence Interval	() 95%; 0.46 to 0.69
	Parameter Dispersion	Type: Value:
	Estimation Comments	The hazard ratio shows (Rosuvastatin hazard/Placebo hazard)

2. Secondary Outcome

Title	Time to Death Due to Any Cause
Description	Days from randomization to death. If no death then censoring occurs at earliest of termination date or efficacy cutoff date of 30 Mar 2008. Kaplan-Meier estimate of the mean
Time Frame	up to 5 years

Outcome Measure Data

Analysis Population Description

Intention to treat population

Arm/Group Title	Rosuvastatin	Placebo
Arm/Group Description	Rosuvastatin 20 mg once daily	Placebo once daily
Measure Participants	8901	8901
Mean (Standard Error) [days]	1543.3 (2.48)	1619.1 (3.10)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Rosuvastatin, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.021
	Comments
	Method	Regression, Cox
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.80
	Confidence Interval	() 95%; 0.67 to 0.97
	Parameter Dispersion	Type: Value:
	Estimation Comments	The hazard ratio shows (Rosuvastatin hazard/Placebo hazard)

3. Secondary Outcome

Title	Time to Non-cardiovascular Death
Description	Days from randomization to death from a non-cardiovascular cause. If no event, then censoring occurs at earliest of termination date or efficacy cutoff date of 30 Mar 2008. Events were adjudicated by an endpoint committee. Kaplan-Meier estimate of the mean
Time Frame	up to 5 years

Outcome Measure Data

Analysis Population Description

Intention to treat population

Arm/Group Title	Rosuvastatin	Placebo
Arm/Group Description	Rosuvastatin 20 mg once daily	Placebo once daily
Measure Participants	8901	8901
Mean (Standard Error) [Days]	1558.5 (1.90)	1640.5 (2.44)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Rosuvastatin, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.172
	Comments
	Method	Regression, Cox
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.84
	Confidence Interval	() 95%; 0.65 to 1.08
	Parameter Dispersion	Type: Value:
	Estimation Comments	The hazard ratio shows (Rosuvastatin hazard/Placebo hazard)

4. Secondary Outcome

Title	Time to Development of Diabetes Mellitus
Description	Days from randomization until development of diabetes. If no diabetes was developed censoring occurred at termination date. Kaplan-Meier estimate of the mean
Time Frame	up to 5 years

Outcome Measure Data

Analysis Population Description

Intention to treat population

Arm/Group Title	Rosuvastatin	Placebo
Arm/Group Description	Rosuvastatin 20 mg once daily	Placebo once daily
Measure Participants	8901	8901
Mean (Standard Error) [Days]	1687.0 (3.92)	1517.0 (2.46)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Rosuvastatin, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.015
	Comments
	Method	Regression, Cox
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.27
	Confidence Interval	() 95%; 1.05 to 1.53
	Parameter Dispersion	Type: Value:
	Estimation Comments	The hazard ratio shows (Rosuvastatin hazard/Placebo hazard)

5. Secondary Outcome

Title	Time to Venous Thromboembolic Event
Description	Time from randomization to the first venous thromboembolic event. Kaplan-Meier estimate of the mean
Time Frame	up to 5 years

Outcome Measure Data

Analysis Population Description

Intention to treat population

Arm/Group Title	Rosuvastatin	Placebo
Arm/Group Description	Rosuvastatin 20 mg once daily	Placebo once daily
Measure Participants	8901	8901
Mean (Standard Error) [Days]	1147.4 (0.54)	1377.2 (1.05)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Rosuvastatin, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.018
	Comments
	Method	Regression, Cox
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.57
	Confidence Interval	() 95%; 0.35 to 0.91
	Parameter Dispersion	Type: Value:
	Estimation Comments	The hazard ratio shows (Rosuvastatin hazard/Placebo hazard)

6. Secondary Outcome

Title	Time to Bone Fracture
Description	Days from randomization until bone fracture. If no event, then censoring occurs at earliest of termination date or efficacy cutoff date of 30 Mar 2008. Kaplan-Meier estimate of the mean
Time Frame	Up to 5 years

Outcome Measure Data

Analysis Population Description

Intention to treat population

Arm/Group Title	Rosuvastatin	Placebo
Arm/Group Description	Rosuvastatin 20 mg once daily	Placebo once daily
Measure Participants	8901	8901
Mean (Standard Error) [Days]	1662.7 (3.35)	1546.9 (2.78)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Rosuvastatin, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.548
	Comments
	Method	Regression, Cox
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.06
	Confidence Interval	() 95%; 0.88 to 1.28
	Parameter Dispersion	Type: Value:
	Estimation Comments	The hazard ratio shows (Rosuvastatin hazard/Placebo hazard)

Adverse Events

Arm/Group Title	PLACEBO		ROSUVASTATIN 20 MG
Arm/Group Description
All Cause Mortality
	PLACEBO		ROSUVASTATIN 20 MG
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	PLACEBO		ROSUVASTATIN 20 MG
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1216/8864 (13.7%)		1205/8869 (13.6%)
Blood and lymphatic system disorders
Anaemia	11/8864 (0.1%)	11	15/8869 (0.2%)	15
Anaemia megaloblastic	1/8864 (0%)	1	0/8869 (0%)	0
Anaemia of chronic disease	1/8864 (0%)	1	0/8869 (0%)	0
Aplastic anaemia	1/8864 (0%)	1	0/8869 (0%)	0
Bone marrow failure	0/8864 (0%)	0	1/8869 (0%)	1
Febrile neutropenia	0/8864 (0%)	0	1/8869 (0%)	1
Haemolytic anaemia	1/8864 (0%)	1	0/8869 (0%)	0
Haemorrhagic anaemia	1/8864 (0%)	1	1/8869 (0%)	1
Iron deficiency anaemia	1/8864 (0%)	1	2/8869 (0%)	2
Leukocytosis	2/8864 (0%)	2	4/8869 (0%)	4
Leukopenia	1/8864 (0%)	1	0/8869 (0%)	0
Lymphadenopathy mediastinal	1/8864 (0%)	1	0/8869 (0%)	0
Normochromic normocytic anaemia	1/8864 (0%)	1	1/8869 (0%)	1
Pancytopenia	0/8864 (0%)	0	1/8869 (0%)	1
Pernicious anaemia	0/8864 (0%)	0	1/8869 (0%)	1
Splenic haemorrhage	1/8864 (0%)	1	0/8869 (0%)	0
Splenic infarction	0/8864 (0%)	0	1/8869 (0%)	1
Splenomegaly	1/8864 (0%)	1	1/8869 (0%)	1
Thrombocytopenia	2/8864 (0%)	2	1/8869 (0%)	1
Thrombocytopenic purpura	1/8864 (0%)	1	0/8869 (0%)	0
Cardiac disorders
AV dissociation	1/8864 (0%)	1	0/8869 (0%)	0
Acute coronary syndrome	3/8864 (0%)	3	0/8869 (0%)	0
Angina pectoris	10/8864 (0.1%)	10	10/8869 (0.1%)	10
Angina unstable	6/8864 (0.1%)	6	3/8869 (0%)	3
Aortic valve incompetence	1/8864 (0%)	1	2/8869 (0%)	2
Arrhythmia	0/8864 (0%)	0	4/8869 (0%)	4
Atrial fibrillation	65/8864 (0.7%)	65	56/8869 (0.6%)	56
Atrial flutter	9/8864 (0.1%)	9	5/8869 (0.1%)	5
Atrial tachycardia	3/8864 (0%)	3	0/8869 (0%)	0
Atrioventricular block	0/8864 (0%)	0	1/8869 (0%)	1
Atrioventricular block complete	0/8864 (0%)	0	5/8869 (0.1%)	5
Atrioventricular block first degree	1/8864 (0%)	1	0/8869 (0%)	0
Atrioventricular block second degree	1/8864 (0%)	1	0/8869 (0%)	0
Bradyarrhythmia	0/8864 (0%)	0	1/8869 (0%)	1
Bradycardia	6/8864 (0.1%)	6	10/8869 (0.1%)	10
Bundle branch block left	1/8864 (0%)	1	0/8869 (0%)	0
Cardiac arrest	1/8864 (0%)	1	0/8869 (0%)	0
Cardiac asthma	0/8864 (0%)	0	1/8869 (0%)	1
Cardiac failure	5/8864 (0.1%)	5	6/8869 (0.1%)	6
Cardiac failure congestive	19/8864 (0.2%)	19	16/8869 (0.2%)	16
Cardiac valve sclerosis	0/8864 (0%)	0	1/8869 (0%)	1
Cardiomyopathy	3/8864 (0%)	3	2/8869 (0%)	2
Congestive cardiomyopathy	2/8864 (0%)	2	0/8869 (0%)	0
Coronary artery disease	3/8864 (0%)	3	3/8869 (0%)	3
Coronary artery occlusion	1/8864 (0%)	1	0/8869 (0%)	0
Coronary artery stenosis	0/8864 (0%)	0	1/8869 (0%)	1
Extrasystoles	1/8864 (0%)	1	1/8869 (0%)	1
Intracardiac thrombus	1/8864 (0%)	1	0/8869 (0%)	0
Ischaemic cardiomyopathy	0/8864 (0%)	0	1/8869 (0%)	1
Left ventricular failure	1/8864 (0%)	1	1/8869 (0%)	1
Mitral valve disease	0/8864 (0%)	0	1/8869 (0%)	1
Mitral valve incompetence	3/8864 (0%)	3	3/8869 (0%)	3
Myocardial infarction	7/8864 (0.1%)	7	3/8869 (0%)	3
Myocardial ischaemia	3/8864 (0%)	3	2/8869 (0%)	2
Myocarditis	0/8864 (0%)	0	1/8869 (0%)	1
Palpitations	3/8864 (0%)	3	3/8869 (0%)	3
Pericardial effusion	1/8864 (0%)	1	1/8869 (0%)	1
Pericarditis	1/8864 (0%)	1	2/8869 (0%)	2
Sick sinus syndrome	6/8864 (0.1%)	6	5/8869 (0.1%)	5
Sinus bradycardia	2/8864 (0%)	2	0/8869 (0%)	0
Sinus tachycardia	0/8864 (0%)	0	3/8869 (0%)	3
Supraventricular extrasystoles	0/8864 (0%)	0	1/8869 (0%)	1
Supraventricular tachycardia	3/8864 (0%)	3	3/8869 (0%)	3
Tachycardia	1/8864 (0%)	1	1/8869 (0%)	1
Tachycardia paroxysmal	0/8864 (0%)	0	1/8869 (0%)	1
Tricuspid valve incompetence	0/8864 (0%)	0	1/8869 (0%)	1
Ventricular arrhythmia	1/8864 (0%)	1	0/8869 (0%)	0
Ventricular extrasystoles	1/8864 (0%)	1	1/8869 (0%)	1
Ventricular fibrillation	0/8864 (0%)	0	2/8869 (0%)	2
Ventricular flutter	0/8864 (0%)	0	1/8869 (0%)	1
Ventricular tachycardia	1/8864 (0%)	1	1/8869 (0%)	1
Wolff-Parkinson-White syndrome	0/8864 (0%)	0	1/8869 (0%)	1
Congenital, familial and genetic disorders
Congenital intestinal malformation	0/8864 (0%)	0	1/8869 (0%)	1
Duchenne muscular dystrophy	0/8864 (0%)	0	1/8869 (0%)	1
Hereditary haemorrhagic telangiectasia	1/8864 (0%)	1	0/8869 (0%)	0
Hydrocele	0/8864 (0%)	0	2/8869 (0%)	2
Lymphangioma	1/8864 (0%)	1	0/8869 (0%)	0
Phimosis	1/8864 (0%)	1	0/8869 (0%)	0
Ear and labyrinth disorders
Auricular swelling	1/8864 (0%)	1	0/8869 (0%)	0
Deafness unilateral	2/8864 (0%)	2	0/8869 (0%)	0
Meniere's disease	1/8864 (0%)	1	0/8869 (0%)	0
Tympanic membrane perforation	0/8864 (0%)	0	1/8869 (0%)	1
Vertigo	3/8864 (0%)	3	4/8869 (0%)	4
Vertigo positional	2/8864 (0%)	2	2/8869 (0%)	2
Vestibular neuronitis	1/8864 (0%)	1	0/8869 (0%)	0
Endocrine disorders
Addison's disease	0/8864 (0%)	0	1/8869 (0%)	1
Hyperparathyroidism	1/8864 (0%)	1	1/8869 (0%)	1
Hyperthyroidism	2/8864 (0%)	2	4/8869 (0%)	4
Inappropriate antidiuretic hormone secretion	0/8864 (0%)	0	1/8869 (0%)	1
Pituitary cyst	1/8864 (0%)	1	0/8869 (0%)	0
Thyroid disorder	0/8864 (0%)	0	2/8869 (0%)	2
Thyroid mass	2/8864 (0%)	2	0/8869 (0%)	0
Eye disorders
Amaurosis fugax	1/8864 (0%)	1	0/8869 (0%)	0
Blindness	1/8864 (0%)	1	0/8869 (0%)	0
Cataract	8/8864 (0.1%)	8	3/8869 (0%)	3
Diplopia	1/8864 (0%)	1	0/8869 (0%)	0
Ectropion	0/8864 (0%)	0	1/8869 (0%)	1
Endophthalmitis	0/8864 (0%)	0	2/8869 (0%)	2
Eye haemorrhage	0/8864 (0%)	0	1/8869 (0%)	1
Eyelid ptosis	0/8864 (0%)	0	1/8869 (0%)	1
Lacrimal disorder	0/8864 (0%)	0	1/8869 (0%)	1
Lenticular opacities	0/8864 (0%)	0	1/8869 (0%)	1
Macular degeneration	1/8864 (0%)	1	0/8869 (0%)	0
Retinal detachment	3/8864 (0%)	3	3/8869 (0%)	3
Retinal tear	2/8864 (0%)	2	0/8869 (0%)	0
Visual acuity reduced	0/8864 (0%)	0	1/8869 (0%)	1
Visual disturbance	1/8864 (0%)	1	0/8869 (0%)	0
Vitreous detachment	1/8864 (0%)	1	0/8869 (0%)	0
Gastrointestinal disorders
Abdominal discomfort	1/8864 (0%)	1	0/8869 (0%)	0
Abdominal distension	0/8864 (0%)	0	1/8869 (0%)	1
Abdominal hernia	1/8864 (0%)	1	3/8869 (0%)	3
Abdominal pain	7/8864 (0.1%)	7	9/8869 (0.1%)	9
Abdominal pain upper	5/8864 (0.1%)	5	4/8869 (0%)	4
Abdominal strangulated hernia	0/8864 (0%)	0	1/8869 (0%)	1
Abdominal wall disorder	1/8864 (0%)	1	0/8869 (0%)	0
Abdominal wall haematoma	0/8864 (0%)	0	1/8869 (0%)	1
Anal fistula	2/8864 (0%)	2	0/8869 (0%)	0
Appendicitis perforated	1/8864 (0%)	1	0/8869 (0%)	0
Barrett's oesophagus	1/8864 (0%)	1	0/8869 (0%)	0
Colitis	4/8864 (0%)	4	0/8869 (0%)	0
Colitis ischaemic	1/8864 (0%)	1	2/8869 (0%)	2
Colitis ulcerative	2/8864 (0%)	2	2/8869 (0%)	2
Colonic polyp	3/8864 (0%)	3	4/8869 (0%)	4
Colonic stenosis	1/8864 (0%)	1	1/8869 (0%)	1
Constipation	0/8864 (0%)	0	1/8869 (0%)	1
Crohn's disease	1/8864 (0%)	1	3/8869 (0%)	3
Diarrhoea	8/8864 (0.1%)	8	5/8869 (0.1%)	5
Diverticulum	2/8864 (0%)	2	4/8869 (0%)	4
Diverticulum intestinal	0/8864 (0%)	0	2/8869 (0%)	2
Duodenal ulcer	2/8864 (0%)	2	1/8869 (0%)	1
Duodenal ulcer haemorrhage	0/8864 (0%)	0	1/8869 (0%)	1
Duodenal ulcer perforation	1/8864 (0%)	1	0/8869 (0%)	0
Duodenitis	1/8864 (0%)	1	0/8869 (0%)	0
Dyspepsia	1/8864 (0%)	1	0/8869 (0%)	0
Dysphagia	1/8864 (0%)	1	0/8869 (0%)	0
Enterocele	0/8864 (0%)	0	1/8869 (0%)	1
Enterovesical fistula	1/8864 (0%)	1	2/8869 (0%)	2
Erosive oesophagitis	1/8864 (0%)	1	2/8869 (0%)	2
Faecaloma	1/8864 (0%)	1	0/8869 (0%)	0
Food poisoning	0/8864 (0%)	0	1/8869 (0%)	1
Gastric perforation	0/8864 (0%)	0	1/8869 (0%)	1
Gastric polyps	0/8864 (0%)	0	1/8869 (0%)	1
Gastric ulcer	6/8864 (0.1%)	6	2/8869 (0%)	2
Gastric ulcer haemorrhage	2/8864 (0%)	2	3/8869 (0%)	3
Gastric ulcer perforation	0/8864 (0%)	0	1/8869 (0%)	1
Gastritis	4/8864 (0%)	4	3/8869 (0%)	3
Gastritis erosive	0/8864 (0%)	0	1/8869 (0%)	1
Gastritis haemorrhagic	2/8864 (0%)	2	0/8869 (0%)	0
Gastrointestinal disorder	1/8864 (0%)	1	0/8869 (0%)	0
Gastrointestinal haemorrhage	13/8864 (0.1%)	13	20/8869 (0.2%)	20
Gastrointestinal inflammation	1/8864 (0%)	1	0/8869 (0%)	0
Gastrointestinal pain	0/8864 (0%)	0	1/8869 (0%)	1
Gastrooesophageal reflux disease	4/8864 (0%)	4	2/8869 (0%)	2
Haematemesis	2/8864 (0%)	2	1/8869 (0%)	1
Haemorrhoidal haemorrhage	0/8864 (0%)	0	1/8869 (0%)	1
Haemorrhoids	2/8864 (0%)	2	3/8869 (0%)	3
Hiatus hernia	2/8864 (0%)	2	4/8869 (0%)	4
Ileus	1/8864 (0%)	1	1/8869 (0%)	1
Ileus paralytic	0/8864 (0%)	0	2/8869 (0%)	2
Impaired gastric emptying	1/8864 (0%)	1	0/8869 (0%)	0
Inguinal hernia	15/8864 (0.2%)	15	17/8869 (0.2%)	17
Inguinal hernia, obstructive	0/8864 (0%)	0	1/8869 (0%)	1
Intestinal obstruction	7/8864 (0.1%)	7	11/8869 (0.1%)	11
Intestinal perforation	2/8864 (0%)	2	0/8869 (0%)	0
Intestinal stenosis	1/8864 (0%)	1	0/8869 (0%)	0
Intra-abdominal haematoma	1/8864 (0%)	1	0/8869 (0%)	0
Intra-abdominal haemorrhage	0/8864 (0%)	0	2/8869 (0%)	2
Irritable bowel syndrome	0/8864 (0%)	0	2/8869 (0%)	2
Large intestinal haemorrhage	0/8864 (0%)	0	1/8869 (0%)	1
Large intestine perforation	0/8864 (0%)	0	1/8869 (0%)	1
Nausea	2/8864 (0%)	2	1/8869 (0%)	1
Odynophagia	1/8864 (0%)	1	0/8869 (0%)	0
Oesophageal achalasia	1/8864 (0%)	1	0/8869 (0%)	0
Oesophageal haemorrhage	0/8864 (0%)	0	1/8869 (0%)	1
Oesophageal rupture	0/8864 (0%)	0	1/8869 (0%)	1
Oesophageal varices haemorrhage	1/8864 (0%)	1	0/8869 (0%)	0
Oesophagitis	1/8864 (0%)	1	0/8869 (0%)	0
Oesophagitis haemorrhagic	0/8864 (0%)	0	1/8869 (0%)	1
Pancreatitis	6/8864 (0.1%)	6	3/8869 (0%)	3
Pancreatitis acute	6/8864 (0.1%)	6	9/8869 (0.1%)	9
Pancreatolithiasis	1/8864 (0%)	1	0/8869 (0%)	0
Peptic ulcer	1/8864 (0%)	1	2/8869 (0%)	2
Peptic ulcer haemorrhage	1/8864 (0%)	1	1/8869 (0%)	1
Peritonitis	3/8864 (0%)	3	4/8869 (0%)	4
Proctalgia	1/8864 (0%)	1	0/8869 (0%)	0
Rectal haemorrhage	4/8864 (0%)	4	1/8869 (0%)	1
Rectal polyp	0/8864 (0%)	0	2/8869 (0%)	2
Rectal prolapse	0/8864 (0%)	0	2/8869 (0%)	2
Retroperitoneal haematoma	1/8864 (0%)	1	0/8869 (0%)	0
Salivary gland calculus	0/8864 (0%)	0	1/8869 (0%)	1
Salivary gland cyst	0/8864 (0%)	0	2/8869 (0%)	2
Small intestinal haemorrhage	1/8864 (0%)	1	1/8869 (0%)	1
Small intestinal obstruction	7/8864 (0.1%)	7	5/8869 (0.1%)	5
Spigelian hernia	0/8864 (0%)	0	1/8869 (0%)	1
Swollen tongue	0/8864 (0%)	0	1/8869 (0%)	1
Umbilical hernia	5/8864 (0.1%)	5	8/8869 (0.1%)	8
Umbilical hernia, obstructive	1/8864 (0%)	1	0/8869 (0%)	0
Volvulus	1/8864 (0%)	1	0/8869 (0%)	0
Vomiting	0/8864 (0%)	0	2/8869 (0%)	2
General disorders
Adhesion	1/8864 (0%)	1	0/8869 (0%)	0
Adverse drug reaction	0/8864 (0%)	0	1/8869 (0%)	1
Asthenia	2/8864 (0%)	2	0/8869 (0%)	0
Calcinosis	0/8864 (0%)	0	1/8869 (0%)	1
Chest discomfort	0/8864 (0%)	0	2/8869 (0%)	2
Chest pain	7/8864 (0.1%)	7	9/8869 (0.1%)	9
Death	34/8864 (0.4%)	34	30/8869 (0.3%)	30
Deformity	1/8864 (0%)	1	0/8869 (0%)	0
Dysplasia	1/8864 (0%)	1	0/8869 (0%)	0
Fatigue	1/8864 (0%)	1	0/8869 (0%)	0
General physical health deterioration	1/8864 (0%)	1	0/8869 (0%)	0
Hernia	2/8864 (0%)	2	2/8869 (0%)	2
Hernia obstructive	1/8864 (0%)	1	0/8869 (0%)	0
Malaise	1/8864 (0%)	1	0/8869 (0%)	0
Mucosal inflammation	1/8864 (0%)	1	0/8869 (0%)	0
Multi-organ failure	1/8864 (0%)	1	2/8869 (0%)	2
Non-cardiac chest pain	22/8864 (0.2%)	22	29/8869 (0.3%)	29
Oedema peripheral	5/8864 (0.1%)	5	1/8869 (0%)	1
Pyrexia	1/8864 (0%)	1	4/8869 (0%)	4
Sudden death	1/8864 (0%)	1	0/8869 (0%)	0
Systemic inflammatory response syndrome	1/8864 (0%)	1	0/8869 (0%)	0
Ulcer	1/8864 (0%)	1	0/8869 (0%)	0
Ulcer haemorrhage	0/8864 (0%)	0	1/8869 (0%)	1
Hepatobiliary disorders
Bile duct stone	5/8864 (0.1%)	5	4/8869 (0%)	4
Biliary colic	1/8864 (0%)	1	2/8869 (0%)	2
Biliary dyskinesia	1/8864 (0%)	1	1/8869 (0%)	1
Cholangitis	0/8864 (0%)	0	1/8869 (0%)	1
Cholangitis sclerosing	1/8864 (0%)	1	0/8869 (0%)	0
Cholecystitis	9/8864 (0.1%)	9	10/8869 (0.1%)	10
Cholecystitis acute	5/8864 (0.1%)	5	4/8869 (0%)	4
Cholecystitis chronic	4/8864 (0%)	4	0/8869 (0%)	0
Cholelithiasis	23/8864 (0.3%)	23	22/8869 (0.2%)	22
Cirrhosis alcoholic	1/8864 (0%)	1	0/8869 (0%)	0
Gallbladder polyp	0/8864 (0%)	0	1/8869 (0%)	1
Hepatic cirrhosis	1/8864 (0%)	1	0/8869 (0%)	0
Hepatic cyst	1/8864 (0%)	1	1/8869 (0%)	1
Hepatic cyst ruptured	0/8864 (0%)	0	1/8869 (0%)	1
Hepatic failure	2/8864 (0%)	2	0/8869 (0%)	0
Hepatic function abnormal	0/8864 (0%)	0	1/8869 (0%)	1
Hepatic mass	1/8864 (0%)	1	0/8869 (0%)	0
Hepatic pain	0/8864 (0%)	0	1/8869 (0%)	1
Hepatitis	0/8864 (0%)	0	2/8869 (0%)	2
Hepatitis cholestatic	1/8864 (0%)	1	0/8869 (0%)	0
Hydrocholecystis	0/8864 (0%)	0	1/8869 (0%)	1
Jaundice	1/8864 (0%)	1	1/8869 (0%)	1
Jaundice cholestatic	2/8864 (0%)	2	0/8869 (0%)	0
Immune system disorders
Allergy to arthropod sting	1/8864 (0%)	1	0/8869 (0%)	0
Anaphylactic reaction	0/8864 (0%)	0	2/8869 (0%)	2
Drug hypersensitivity	0/8864 (0%)	0	4/8869 (0%)	4
Sarcoidosis	1/8864 (0%)	1	1/8869 (0%)	1
Infections and infestations
Abdominal sepsis	1/8864 (0%)	1	0/8869 (0%)	0
Abdominal wall abscess	1/8864 (0%)	1	0/8869 (0%)	0
Abscess	1/8864 (0%)	1	0/8869 (0%)	0
Abscess intestinal	0/8864 (0%)	0	1/8869 (0%)	1
Abscess limb	1/8864 (0%)	1	1/8869 (0%)	1
Abscess rupture	1/8864 (0%)	1	0/8869 (0%)	0
Appendicitis	7/8864 (0.1%)	7	5/8869 (0.1%)	5
Arthritis bacterial	0/8864 (0%)	0	1/8869 (0%)	1
Arthritis infective	3/8864 (0%)	3	1/8869 (0%)	1
Aspergillosis	1/8864 (0%)	1	0/8869 (0%)	0
Atypical mycobacterial infection	1/8864 (0%)	1	0/8869 (0%)	0
Bacteraemia	3/8864 (0%)	3	1/8869 (0%)	1
Bacterial infection	1/8864 (0%)	1	1/8869 (0%)	1
Bronchiectasis	1/8864 (0%)	1	2/8869 (0%)	2
Bronchitis	5/8864 (0.1%)	5	7/8869 (0.1%)	7
Bronchitis bacterial	0/8864 (0%)	0	1/8869 (0%)	1
Bronchopneumonia	3/8864 (0%)	3	2/8869 (0%)	2
Campylobacter gastroenteritis	1/8864 (0%)	1	0/8869 (0%)	0
Cellulitis	20/8864 (0.2%)	20	13/8869 (0.1%)	13
Cholecystitis infective	1/8864 (0%)	1	1/8869 (0%)	1
Chronic sinusitis	0/8864 (0%)	0	1/8869 (0%)	1
Clostridial infection	1/8864 (0%)	1	0/8869 (0%)	0
Clostridium difficile colitis	1/8864 (0%)	1	1/8869 (0%)	1
Corneal abscess	0/8864 (0%)	0	1/8869 (0%)	1
Cystitis	1/8864 (0%)	1	0/8869 (0%)	0
Device related infection	1/8864 (0%)	1	0/8869 (0%)	0
Diarrhoea infectious	0/8864 (0%)	0	1/8869 (0%)	1
Diverticulitis	16/8864 (0.2%)	16	13/8869 (0.1%)	13
Empyema	1/8864 (0%)	1	1/8869 (0%)	1
Endocarditis	0/8864 (0%)	0	1/8869 (0%)	1
Enterocolitis infectious	0/8864 (0%)	0	2/8869 (0%)	2
Epiglottitis	1/8864 (0%)	1	0/8869 (0%)	0
Erysipelas	2/8864 (0%)	2	1/8869 (0%)	1
Gangrene	1/8864 (0%)	1	0/8869 (0%)	0
Gastroenteritis	11/8864 (0.1%)	11	8/8869 (0.1%)	8
Gastroenteritis clostridial	0/8864 (0%)	0	1/8869 (0%)	1
Gastroenteritis viral	1/8864 (0%)	1	1/8869 (0%)	1
HIV infection	1/8864 (0%)	1	1/8869 (0%)	1
Haematoma infection	0/8864 (0%)	0	1/8869 (0%)	1
Hepatitis A	1/8864 (0%)	1	1/8869 (0%)	1
Hepatitis C	0/8864 (0%)	0	1/8869 (0%)	1
Herpes zoster	1/8864 (0%)	1	0/8869 (0%)	0
Incision site cellulitis	0/8864 (0%)	0	1/8869 (0%)	1
Infected cyst	1/8864 (0%)	1	0/8869 (0%)	0
Infected skin ulcer	0/8864 (0%)	0	1/8869 (0%)	1
Infection	2/8864 (0%)	2	0/8869 (0%)	0
Infectious mononucleosis	0/8864 (0%)	0	1/8869 (0%)	1
Infective exacerbation of chronic obstructive airways disease	0/8864 (0%)	0	1/8869 (0%)	1
Influenza	0/8864 (0%)	0	3/8869 (0%)	3
Labyrinthitis	1/8864 (0%)	1	0/8869 (0%)	0
Laryngitis	0/8864 (0%)	0	1/8869 (0%)	1
Liver abscess	1/8864 (0%)	1	1/8869 (0%)	1
Localised infection	1/8864 (0%)	1	1/8869 (0%)	1
Lower respiratory tract infection	9/8864 (0.1%)	9	4/8869 (0%)	4
Lung abscess	2/8864 (0%)	2	0/8869 (0%)	0
Lung infection	2/8864 (0%)	2	0/8869 (0%)	0
Lymphangitis	0/8864 (0%)	0	1/8869 (0%)	1
Meningitis pneumococcal	1/8864 (0%)	1	0/8869 (0%)	0
Meningococcal sepsis	0/8864 (0%)	0	1/8869 (0%)	1
Nasopharyngitis	0/8864 (0%)	0	3/8869 (0%)	3
Oral herpes	0/8864 (0%)	0	1/8869 (0%)	1
Orchitis	1/8864 (0%)	1	0/8869 (0%)	0
Osteomyelitis	3/8864 (0%)	3	0/8869 (0%)	0
Otitis media	0/8864 (0%)	0	1/8869 (0%)	1
Parotid abscess	1/8864 (0%)	1	0/8869 (0%)	0
Pelvic abscess	0/8864 (0%)	0	1/8869 (0%)	1
Perianal abscess	1/8864 (0%)	1	0/8869 (0%)	0
Pneumococcal sepsis	0/8864 (0%)	0	2/8869 (0%)	2
Pneumonia	57/8864 (0.6%)	57	56/8869 (0.6%)	56
Pneumonia bacterial	2/8864 (0%)	2	2/8869 (0%)	2
Pneumonia chlamydial	1/8864 (0%)	1	0/8869 (0%)	0
Pneumonia viral	1/8864 (0%)	1	0/8869 (0%)	0
Postoperative wound infection	2/8864 (0%)	2	2/8869 (0%)	2
Prostate infection	0/8864 (0%)	0	1/8869 (0%)	1
Pseudomonas infection	0/8864 (0%)	0	1/8869 (0%)	1
Pulmonary tuberculosis	3/8864 (0%)	3	2/8869 (0%)	2
Pyelonephritis	1/8864 (0%)	1	2/8869 (0%)	2
Pyelonephritis acute	1/8864 (0%)	1	0/8869 (0%)	0
Rash pustular	1/8864 (0%)	1	0/8869 (0%)	0
Rectal abscess	1/8864 (0%)	1	0/8869 (0%)	0
Respiratory tract infection	0/8864 (0%)	0	1/8869 (0%)	1
Scrotal infection	1/8864 (0%)	1	0/8869 (0%)	0
Sepsis	5/8864 (0.1%)	5	11/8869 (0.1%)	11
Septic shock	2/8864 (0%)	2	4/8869 (0%)	4
Sialoadenitis	0/8864 (0%)	0	1/8869 (0%)	1
Sinusitis	1/8864 (0%)	1	1/8869 (0%)	1
Staphylococcal bacteraemia	1/8864 (0%)	1	0/8869 (0%)	0
Staphylococcal infection	1/8864 (0%)	1	1/8869 (0%)	1
Subacute endocarditis	1/8864 (0%)	1	0/8869 (0%)	0
Subcutaneous abscess	1/8864 (0%)	1	3/8869 (0%)	3
Tooth abscess	1/8864 (0%)	1	0/8869 (0%)	0
Tracheitis	1/8864 (0%)	1	0/8869 (0%)	0
Upper respiratory tract infection	1/8864 (0%)	1	0/8869 (0%)	0
Urinary tract infection	6/8864 (0.1%)	6	15/8869 (0.2%)	15
Urosepsis	4/8864 (0%)	4	0/8869 (0%)	0
Viral infection	2/8864 (0%)	2	2/8869 (0%)	2
Viral pericarditis	2/8864 (0%)	2	0/8869 (0%)	0
Viral upper respiratory tract infection	1/8864 (0%)	1	0/8869 (0%)	0
Vulvitis	0/8864 (0%)	0	1/8869 (0%)	1
Wound infection	4/8864 (0%)	4	1/8869 (0%)	1
Wound sepsis	0/8864 (0%)	0	1/8869 (0%)	1
Injury, poisoning and procedural complications
Alcohol poisoning	1/8864 (0%)	1	0/8869 (0%)	0
Anaemia postoperative	1/8864 (0%)	1	2/8869 (0%)	2
Animal bite	0/8864 (0%)	0	1/8869 (0%)	1
Ankle fracture	9/8864 (0.1%)	9	14/8869 (0.2%)	14
Back injury	2/8864 (0%)	2	1/8869 (0%)	1
Bone fissure	1/8864 (0%)	1	0/8869 (0%)	0
Brain contusion	1/8864 (0%)	1	1/8869 (0%)	1
Cartilage injury	0/8864 (0%)	0	1/8869 (0%)	1
Caustic injury	0/8864 (0%)	0	1/8869 (0%)	1
Cervical vertebral fracture	3/8864 (0%)	3	0/8869 (0%)	0
Clavicle fracture	3/8864 (0%)	3	1/8869 (0%)	1
Concussion	3/8864 (0%)	3	0/8869 (0%)	0
Contusion	1/8864 (0%)	1	3/8869 (0%)	3
Crush injury	0/8864 (0%)	0	1/8869 (0%)	1
Device dislocation	0/8864 (0%)	0	1/8869 (0%)	1
Dislocation of joint prosthesis	0/8864 (0%)	0	2/8869 (0%)	2
Drug toxicity	1/8864 (0%)	1	3/8869 (0%)	3
Eye injury	1/8864 (0%)	1	2/8869 (0%)	2
Facial bones fracture	0/8864 (0%)	0	1/8869 (0%)	1
Fall	3/8864 (0%)	3	3/8869 (0%)	3
Femoral neck fracture	2/8864 (0%)	2	3/8869 (0%)	3
Femur fracture	6/8864 (0.1%)	6	8/8869 (0.1%)	8
Fibula fracture	2/8864 (0%)	2	2/8869 (0%)	2
Foot fracture	3/8864 (0%)	3	2/8869 (0%)	2
Forearm fracture	3/8864 (0%)	3	3/8869 (0%)	3
Foreign body in eye	0/8864 (0%)	0	1/8869 (0%)	1
Fracture	2/8864 (0%)	2	0/8869 (0%)	0
Gun shot wound	1/8864 (0%)	1	0/8869 (0%)	0
Hand fracture	4/8864 (0%)	4	2/8869 (0%)	2
Head injury	5/8864 (0.1%)	5	2/8869 (0%)	2
Hip fracture	14/8864 (0.2%)	14	15/8869 (0.2%)	15
Humerus fracture	3/8864 (0%)	3	1/8869 (0%)	1
Incisional hernia	3/8864 (0%)	3	0/8869 (0%)	0
Injury	1/8864 (0%)	1	1/8869 (0%)	1
Joint dislocation	5/8864 (0.1%)	5	5/8869 (0.1%)	5
Joint injury	3/8864 (0%)	3	4/8869 (0%)	4
Laceration	3/8864 (0%)	3	0/8869 (0%)	0
Ligament injury	0/8864 (0%)	0	1/8869 (0%)	1
Ligament rupture	1/8864 (0%)	1	2/8869 (0%)	2
Limb injury	1/8864 (0%)	1	2/8869 (0%)	2
Lower limb fracture	4/8864 (0%)	4	5/8869 (0.1%)	5
Lumbar vertebral fracture	1/8864 (0%)	1	2/8869 (0%)	2
Lung injury	1/8864 (0%)	1	0/8869 (0%)	0
Medical device complication	0/8864 (0%)	0	4/8869 (0%)	4
Meniscus lesion	2/8864 (0%)	2	2/8869 (0%)	2
Multiple fractures	1/8864 (0%)	1	2/8869 (0%)	2
Multiple injuries	0/8864 (0%)	0	1/8869 (0%)	1
Muscle injury	0/8864 (0%)	0	1/8869 (0%)	1
Neck injury	0/8864 (0%)	0	1/8869 (0%)	1
Nerve injury	0/8864 (0%)	0	1/8869 (0%)	1
Overdose	0/8864 (0%)	0	1/8869 (0%)	1
Patella fracture	1/8864 (0%)	1	0/8869 (0%)	0
Periorbital haematoma	1/8864 (0%)	1	0/8869 (0%)	0
Post procedural haematoma	1/8864 (0%)	1	1/8869 (0%)	1
Post procedural haemorrhage	3/8864 (0%)	3	1/8869 (0%)	1
Post-traumatic pain	1/8864 (0%)	1	0/8869 (0%)	0
Postoperative ileus	0/8864 (0%)	0	2/8869 (0%)	2
Procedural pain	1/8864 (0%)	1	0/8869 (0%)	0
Pubic rami fracture	1/8864 (0%)	1	0/8869 (0%)	0
Radius fracture	2/8864 (0%)	2	4/8869 (0%)	4
Retinal injury	0/8864 (0%)	0	1/8869 (0%)	1
Rib fracture	8/8864 (0.1%)	8	4/8869 (0%)	4
Road traffic accident	4/8864 (0%)	4	3/8869 (0%)	3
Scrotal haematoma	1/8864 (0%)	1	0/8869 (0%)	0
Skin laceration	1/8864 (0%)	1	3/8869 (0%)	3
Skull fracture	1/8864 (0%)	1	0/8869 (0%)	0
Spinal compression fracture	2/8864 (0%)	2	1/8869 (0%)	1
Spinal fracture	2/8864 (0%)	2	1/8869 (0%)	1
Splenic rupture	0/8864 (0%)	0	1/8869 (0%)	1
Sternal fracture	2/8864 (0%)	2	3/8869 (0%)	3
Subdural haematoma	2/8864 (0%)	2	4/8869 (0%)	4
Synovial rupture	0/8864 (0%)	0	1/8869 (0%)	1
Tendon injury	2/8864 (0%)	2	1/8869 (0%)	1
Tendon rupture	3/8864 (0%)	3	2/8869 (0%)	2
Thermal burn	0/8864 (0%)	0	1/8869 (0%)	1
Thoracic vertebral fracture	1/8864 (0%)	1	3/8869 (0%)	3
Tibia fracture	3/8864 (0%)	3	2/8869 (0%)	2
Traumatic brain injury	1/8864 (0%)	1	1/8869 (0%)	1
Ulna fracture	1/8864 (0%)	1	1/8869 (0%)	1
Upper limb fracture	5/8864 (0.1%)	5	3/8869 (0%)	3
Urinary retention postoperative	0/8864 (0%)	0	2/8869 (0%)	2
Wound	0/8864 (0%)	0	1/8869 (0%)	1
Wound dehiscence	0/8864 (0%)	0	2/8869 (0%)	2
Wrist fracture	3/8864 (0%)	3	4/8869 (0%)	4
Investigations
Alanine aminotransferase increased	3/8864 (0%)	3	0/8869 (0%)	0
Anticonvulsant drug level increased	0/8864 (0%)	0	1/8869 (0%)	1
Blood creatine phosphokinase increased	0/8864 (0%)	0	1/8869 (0%)	1
Blood creatinine increased	0/8864 (0%)	0	1/8869 (0%)	1
Blood pressure increased	1/8864 (0%)	1	1/8869 (0%)	1
Electrocardiogram T wave inversion	1/8864 (0%)	1	0/8869 (0%)	0
Gamma-glutamyltransferase increased	1/8864 (0%)	1	0/8869 (0%)	0
Heart rate increased	1/8864 (0%)	1	0/8869 (0%)	0
Heart rate irregular	0/8864 (0%)	0	1/8869 (0%)	1
International normalised ratio increased	0/8864 (0%)	0	1/8869 (0%)	1
Oxygen saturation decreased	0/8864 (0%)	0	1/8869 (0%)	1
Prostatic specific antigen increased	1/8864 (0%)	1	0/8869 (0%)	0
Weight decreased	0/8864 (0%)	0	1/8869 (0%)	1
White blood cell count increased	0/8864 (0%)	0	1/8869 (0%)	1
Metabolism and nutrition disorders
Dehydration	8/8864 (0.1%)	8	5/8869 (0.1%)	5
Diabetes mellitus	13/8864 (0.1%)	13	14/8869 (0.2%)	14
Electrolyte imbalance	1/8864 (0%)	1	2/8869 (0%)	2
Gout	1/8864 (0%)	1	1/8869 (0%)	1
Hypercalcaemia	2/8864 (0%)	2	1/8869 (0%)	1
Hyperglycaemia	0/8864 (0%)	0	1/8869 (0%)	1
Hyperkalaemia	0/8864 (0%)	0	1/8869 (0%)	1
Hypermagnesaemia	0/8864 (0%)	0	1/8869 (0%)	1
Hypernatraemia	0/8864 (0%)	0	1/8869 (0%)	1
Hyperphosphataemia	0/8864 (0%)	0	1/8869 (0%)	1
Hypoalbuminaemia	0/8864 (0%)	0	1/8869 (0%)	1
Hypocalcaemia	0/8864 (0%)	0	1/8869 (0%)	1
Hypoglycaemia	0/8864 (0%)	0	3/8869 (0%)	3
Hypokalaemia	0/8864 (0%)	0	5/8869 (0.1%)	5
Hypomagnesaemia	0/8864 (0%)	0	1/8869 (0%)	1
Hyponatraemia	4/8864 (0%)	4	3/8869 (0%)	3
Lipomatosis	1/8864 (0%)	1	0/8869 (0%)	0
Metabolic acidosis	0/8864 (0%)	0	2/8869 (0%)	2
Obesity	0/8864 (0%)	0	1/8869 (0%)	1
Musculoskeletal and connective tissue disorders
Ankylosing spondylitis	0/8864 (0%)	0	1/8869 (0%)	1
Arthralgia	0/8864 (0%)	0	7/8869 (0.1%)	7
Arthritis	53/8864 (0.6%)	53	48/8869 (0.5%)	48
Arthropathy	0/8864 (0%)	0	3/8869 (0%)	3
Back pain	6/8864 (0.1%)	6	8/8869 (0.1%)	8
Bone pain	3/8864 (0%)	3	6/8869 (0.1%)	6
Bunion	0/8864 (0%)	0	1/8869 (0%)	1
Bursitis	0/8864 (0%)	0	1/8869 (0%)	1
Cervical spinal stenosis	1/8864 (0%)	1	0/8869 (0%)	0
Foot deformity	1/8864 (0%)	1	1/8869 (0%)	1
Intervertebral disc degeneration	1/8864 (0%)	1	3/8869 (0%)	3
Intervertebral disc disorder	1/8864 (0%)	1	1/8869 (0%)	1
Intervertebral disc protrusion	12/8864 (0.1%)	12	9/8869 (0.1%)	9
Joint contracture	0/8864 (0%)	0	1/8869 (0%)	1
Joint crepitation	0/8864 (0%)	0	1/8869 (0%)	1
Joint effusion	0/8864 (0%)	0	1/8869 (0%)	1
Lumbar spinal stenosis	4/8864 (0%)	4	6/8869 (0.1%)	6
Muscle atrophy	0/8864 (0%)	0	1/8869 (0%)	1
Muscle disorder	1/8864 (0%)	1	0/8869 (0%)	0
Muscle haemorrhage	0/8864 (0%)	0	1/8869 (0%)	1
Muscle spasms	1/8864 (0%)	1	1/8869 (0%)	1
Muscle swelling	0/8864 (0%)	0	1/8869 (0%)	1
Muscular weakness	0/8864 (0%)	0	1/8869 (0%)	1
Musculoskeletal chest pain	0/8864 (0%)	0	1/8869 (0%)	1
Musculoskeletal pain	3/8864 (0%)	3	6/8869 (0.1%)	6
Myalgia	1/8864 (0%)	1	5/8869 (0.1%)	5
Neck pain	0/8864 (0%)	0	1/8869 (0%)	1
Osteoarthritis	15/8864 (0.2%)	15	17/8869 (0.2%)	17
Osteolysis	1/8864 (0%)	1	0/8869 (0%)	0
Osteonecrosis	0/8864 (0%)	0	3/8869 (0%)	3
Pain in extremity	1/8864 (0%)	1	1/8869 (0%)	1
Polymyalgia rheumatica	0/8864 (0%)	0	1/8869 (0%)	1
Polymyositis	1/8864 (0%)	1	0/8869 (0%)	0
Pseudarthrosis	0/8864 (0%)	0	1/8869 (0%)	1
Rotator cuff syndrome	6/8864 (0.1%)	6	6/8869 (0.1%)	6
Spinal column stenosis	4/8864 (0%)	4	2/8869 (0%)	2
Spinal osteoarthritis	0/8864 (0%)	0	1/8869 (0%)	1
Spondylolisthesis	1/8864 (0%)	1	4/8869 (0%)	4
Tendonitis	1/8864 (0%)	1	1/8869 (0%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia	0/8864 (0%)	0	1/8869 (0%)	1
Acute myelomonocytic leukaemia	0/8864 (0%)	0	1/8869 (0%)	1
Adenocarcinoma	0/8864 (0%)	0	1/8869 (0%)	1
Adenoma benign	1/8864 (0%)	1	0/8869 (0%)	0
Adrenal neoplasm	0/8864 (0%)	0	1/8869 (0%)	1
Anal cancer	1/8864 (0%)	1	0/8869 (0%)	0
Astrocytoma	1/8864 (0%)	1	0/8869 (0%)	0
Astrocytoma malignant	1/8864 (0%)	1	0/8869 (0%)	0
Basal cell carcinoma	5/8864 (0.1%)	5	11/8869 (0.1%)	11
Benign breast neoplasm	0/8864 (0%)	0	1/8869 (0%)	1
Benign neoplasm of bladder	1/8864 (0%)	1	0/8869 (0%)	0
Benign neoplasm of thyroid gland	1/8864 (0%)	1	0/8869 (0%)	0
Benign renal neoplasm	1/8864 (0%)	1	0/8869 (0%)	0
Benign salivary gland neoplasm	0/8864 (0%)	0	1/8869 (0%)	1
Bile duct cancer	1/8864 (0%)	1	0/8869 (0%)	0
Bile duct cancer recurrent	1/8864 (0%)	1	0/8869 (0%)	0
Bladder cancer	8/8864 (0.1%)	8	5/8869 (0.1%)	5
Bladder neoplasm	7/8864 (0.1%)	7	2/8869 (0%)	2
Bladder papilloma	1/8864 (0%)	1	1/8869 (0%)	1
Bowen's disease	1/8864 (0%)	1	1/8869 (0%)	1
Brain cancer metastatic	1/8864 (0%)	1	0/8869 (0%)	0
Brain neoplasm	0/8864 (0%)	0	2/8869 (0%)	2
Breast cancer	22/8864 (0.2%)	22	20/8869 (0.2%)	20
Breast cancer in situ	1/8864 (0%)	1	2/8869 (0%)	2
Breast cancer metastatic	1/8864 (0%)	1	0/8869 (0%)	0
Bronchial carcinoma	0/8864 (0%)	0	5/8869 (0.1%)	5
Bronchial neoplasm	1/8864 (0%)	1	0/8869 (0%)	0
Carcinoid tumour of the small bowel	0/8864 (0%)	0	1/8869 (0%)	1
Carcinoid tumour of the stomach	1/8864 (0%)	1	0/8869 (0%)	0
Carcinoma in situ of bladder	1/8864 (0%)	1	0/8869 (0%)	0
Cervix carcinoma stage III	0/8864 (0%)	0	1/8869 (0%)	1
Cervix neoplasm	1/8864 (0%)	1	0/8869 (0%)	0
Cholesteatoma	0/8864 (0%)	0	1/8869 (0%)	1
Chronic lymphocytic leukaemia	2/8864 (0%)	2	2/8869 (0%)	2
Colon adenoma	2/8864 (0%)	2	2/8869 (0%)	2
Colon cancer	20/8864 (0.2%)	20	16/8869 (0.2%)	16
Colon cancer metastatic	2/8864 (0%)	2	1/8869 (0%)	1
Colon cancer stage I	0/8864 (0%)	0	1/8869 (0%)	1
Colon cancer stage III	1/8864 (0%)	1	0/8869 (0%)	0
Colon neoplasm	1/8864 (0%)	1	3/8869 (0%)	3
Endometrial cancer	0/8864 (0%)	0	5/8869 (0.1%)	5
Ganglioneuroma	0/8864 (0%)	0	1/8869 (0%)	1
Gastric cancer	4/8864 (0%)	4	4/8869 (0%)	4
Gastrointestinal cancer metastatic	1/8864 (0%)	1	1/8869 (0%)	1
Gastrointestinal carcinoma	5/8864 (0.1%)	5	4/8869 (0%)	4
Gastrointestinal neoplasm	2/8864 (0%)	2	0/8869 (0%)	0
Gastrointestinal stromal tumour	0/8864 (0%)	0	1/8869 (0%)	1
Gastrooesophageal cancer	1/8864 (0%)	1	1/8869 (0%)	1
Glioblastoma	1/8864 (0%)	1	0/8869 (0%)	0
Glioblastoma multiforme	1/8864 (0%)	1	0/8869 (0%)	0
Glioma	1/8864 (0%)	1	0/8869 (0%)	0
Head and neck cancer	0/8864 (0%)	0	1/8869 (0%)	1
Hepatic cancer metastatic	1/8864 (0%)	1	1/8869 (0%)	1
Hepatic neoplasm malignant	1/8864 (0%)	1	1/8869 (0%)	1
Hodgkin's disease	0/8864 (0%)	0	1/8869 (0%)	1
Hypopharyngeal cancer	1/8864 (0%)	1	0/8869 (0%)	0
Large cell carcinoma of the respiratory tract stage unspecified	0/8864 (0%)	0	1/8869 (0%)	1
Laryngeal cancer	0/8864 (0%)	0	1/8869 (0%)	1
Leiomyosarcoma metastatic	0/8864 (0%)	0	1/8869 (0%)	1
Leukaemia	2/8864 (0%)	2	1/8869 (0%)	1
Lip and/or oral cavity cancer	0/8864 (0%)	0	1/8869 (0%)	1
Lipoma	2/8864 (0%)	2	1/8869 (0%)	1
Liposarcoma	1/8864 (0%)	1	0/8869 (0%)	0
Lung adenocarcinoma	1/8864 (0%)	1	4/8869 (0%)	4
Lung adenocarcinoma metastatic	1/8864 (0%)	1	0/8869 (0%)	0
Lung cancer metastatic	3/8864 (0%)	3	3/8869 (0%)	3
Lung neoplasm	7/8864 (0.1%)	7	2/8869 (0%)	2
Lung neoplasm malignant	13/8864 (0.1%)	13	10/8869 (0.1%)	10
Lung squamous cell carcinoma stage unspecified	2/8864 (0%)	2	2/8869 (0%)	2
Lymphoma	3/8864 (0%)	3	4/8869 (0%)	4
Lymphoplasmacytoid lymphoma/immunocytoma	1/8864 (0%)	1	0/8869 (0%)	0
Malignant melanoma	4/8864 (0%)	4	4/8869 (0%)	4
Mantle cell lymphoma	1/8864 (0%)	1	0/8869 (0%)	0
Melanocytic naevus	1/8864 (0%)	1	0/8869 (0%)	0
Meningioma	1/8864 (0%)	1	2/8869 (0%)	2
Mesothelioma	0/8864 (0%)	0	1/8869 (0%)	1
Metastases to bone	1/8864 (0%)	1	2/8869 (0%)	2
Metastases to central nervous system	1/8864 (0%)	1	0/8869 (0%)	0
Metastases to liver	0/8864 (0%)	0	2/8869 (0%)	2
Metastases to lung	1/8864 (0%)	1	0/8869 (0%)	0
Metastatic malignant melanoma	0/8864 (0%)	0	2/8869 (0%)	2
Metastatic neoplasm	0/8864 (0%)	0	2/8869 (0%)	2
Metastatic squamous cell carcinoma	1/8864 (0%)	1	0/8869 (0%)	0
Multiple myeloma	2/8864 (0%)	2	3/8869 (0%)	3
Mycosis fungoides	1/8864 (0%)	1	0/8869 (0%)	0
Myelodysplastic syndrome	0/8864 (0%)	0	2/8869 (0%)	2
Myelofibrosis	1/8864 (0%)	1	0/8869 (0%)	0
Nasopharyngeal cancer	0/8864 (0%)	0	1/8869 (0%)	1
Neoplasm malignant	1/8864 (0%)	1	1/8869 (0%)	1
Neoplasm prostate	1/8864 (0%)	1	0/8869 (0%)	0
Neuroendocrine carcinoma of the skin	0/8864 (0%)	0	1/8869 (0%)	1
Neurofibroma	0/8864 (0%)	0	1/8869 (0%)	1
Non-Hodgkin's lymphoma	2/8864 (0%)	2	7/8869 (0.1%)	7
Non-small cell lung cancer	2/8864 (0%)	2	6/8869 (0.1%)	6
Non-small cell lung cancer metastatic	1/8864 (0%)	1	0/8869 (0%)	0
Ocular neoplasm	0/8864 (0%)	0	1/8869 (0%)	1
Oesophageal adenocarcinoma	1/8864 (0%)	1	2/8869 (0%)	2
Oesophageal cancer metastatic	1/8864 (0%)	1	0/8869 (0%)	0
Oesophageal carcinoma	6/8864 (0.1%)	6	3/8869 (0%)	3
Oesophageal squamous cell carcinoma	0/8864 (0%)	0	1/8869 (0%)	1
Ovarian adenoma	0/8864 (0%)	0	1/8869 (0%)	1
Ovarian cancer	4/8864 (0%)	4	2/8869 (0%)	2
Ovarian cancer metastatic	1/8864 (0%)	1	0/8869 (0%)	0
Ovarian fibroma	1/8864 (0%)	1	0/8869 (0%)	0
Ovarian neoplasm	1/8864 (0%)	1	1/8869 (0%)	1
Pancreatic carcinoma	6/8864 (0.1%)	6	4/8869 (0%)	4
Pancreatic carcinoma metastatic	2/8864 (0%)	2	0/8869 (0%)	0
Pancreatic neoplasm	1/8864 (0%)	1	0/8869 (0%)	0
Papillary thyroid cancer	2/8864 (0%)	2	0/8869 (0%)	0
Papilloma	1/8864 (0%)	1	0/8869 (0%)	0
Parathyroid tumour benign	1/8864 (0%)	1	0/8869 (0%)	0
Penis carcinoma	0/8864 (0%)	0	1/8869 (0%)	1
Phaeochromocytoma	1/8864 (0%)	1	0/8869 (0%)	0
Pharyngeal cancer stage unspecified	1/8864 (0%)	1	0/8869 (0%)	0
Pituitary tumour benign	0/8864 (0%)	0	2/8869 (0%)	2
Plasmacytoma	1/8864 (0%)	1	0/8869 (0%)	0
Polycythaemia vera	0/8864 (0%)	0	1/8869 (0%)	1
Prostate cancer	38/8864 (0.4%)	38	34/8869 (0.4%)	34
Prostate cancer recurrent	0/8864 (0%)	0	1/8869 (0%)	1
Prostatic adenoma	0/8864 (0%)	0	1/8869 (0%)	1
Pseudomyxoma peritonei	0/8864 (0%)	0	1/8869 (0%)	1
Rectal cancer	6/8864 (0.1%)	6	1/8869 (0%)	1
Rectal neoplasm	1/8864 (0%)	1	0/8869 (0%)	0
Rectosigmoid cancer	0/8864 (0%)	0	1/8869 (0%)	1
Renal cancer	0/8864 (0%)	0	2/8869 (0%)	2
Renal cancer metastatic	0/8864 (0%)	0	2/8869 (0%)	2
Renal cell carcinoma	5/8864 (0.1%)	5	5/8869 (0.1%)	5
Renal neoplasm	0/8864 (0%)	0	1/8869 (0%)	1
Renal oncocytoma	1/8864 (0%)	1	0/8869 (0%)	0
Rhabdomyosarcoma	0/8864 (0%)	0	1/8869 (0%)	1
Salivary gland cancer	1/8864 (0%)	1	0/8869 (0%)	0
Sarcoma	2/8864 (0%)	2	0/8869 (0%)	0
Signet-ring cell carcinoma	0/8864 (0%)	0	1/8869 (0%)	1
Skin cancer	0/8864 (0%)	0	1/8869 (0%)	1
Skin neoplasm bleeding	1/8864 (0%)	1	0/8869 (0%)	0
Small cell lung cancer metastatic	1/8864 (0%)	1	0/8869 (0%)	0
Small cell lung cancer stage unspecified	2/8864 (0%)	2	1/8869 (0%)	1
Squamous cell carcinoma	1/8864 (0%)	1	2/8869 (0%)	2
Squamous cell carcinoma of skin	0/8864 (0%)	0	4/8869 (0%)	4
Squamous cell carcinoma of the cervix	1/8864 (0%)	1	0/8869 (0%)	0
T-cell lymphoma	0/8864 (0%)	0	1/8869 (0%)	1
Testis cancer	0/8864 (0%)	0	1/8869 (0%)	1
Throat cancer	0/8864 (0%)	0	1/8869 (0%)	1
Thyroid adenoma	1/8864 (0%)	1	0/8869 (0%)	0
Thyroid cancer	2/8864 (0%)	2	1/8869 (0%)	1
Thyroid neoplasm	1/8864 (0%)	1	2/8869 (0%)	2
Tongue neoplasm malignant stage unspecified	1/8864 (0%)	1	1/8869 (0%)	1
Tonsil cancer	2/8864 (0%)	2	0/8869 (0%)	0
Transitional cell carcinoma	1/8864 (0%)	1	3/8869 (0%)	3
Ureteric cancer	1/8864 (0%)	1	2/8869 (0%)	2
Ureteric cancer metastatic	0/8864 (0%)	0	1/8869 (0%)	1
Uterine cancer	0/8864 (0%)	0	4/8869 (0%)	4
Uterine leiomyoma	1/8864 (0%)	1	0/8869 (0%)	0
Waldenstrom's macroglobulinaemia	2/8864 (0%)	2	1/8869 (0%)	1
Nervous system disorders
Amyotrophic lateral sclerosis	2/8864 (0%)	2	1/8869 (0%)	1
Anoxic encephalopathy	1/8864 (0%)	1	0/8869 (0%)	0
Anticholinergic syndrome	1/8864 (0%)	1	0/8869 (0%)	0
Carotid artery stenosis	1/8864 (0%)	1	0/8869 (0%)	0
Carotid sinus syndrome	1/8864 (0%)	1	1/8869 (0%)	1
Carpal tunnel syndrome	1/8864 (0%)	1	1/8869 (0%)	1
Cerebellar atrophy	0/8864 (0%)	0	1/8869 (0%)	1
Cerebral haemorrhage	1/8864 (0%)	1	0/8869 (0%)	0
Cerebral ischaemia	1/8864 (0%)	1	1/8869 (0%)	1
Cerebrovascular accident	5/8864 (0.1%)	5	9/8869 (0.1%)	9
Cerebrovascular disorder	1/8864 (0%)	1	0/8869 (0%)	0
Cervical myelopathy	0/8864 (0%)	0	1/8869 (0%)	1
Cervicobrachial syndrome	1/8864 (0%)	1	0/8869 (0%)	0
Cognitive disorder	1/8864 (0%)	1	0/8869 (0%)	0
Convulsion	0/8864 (0%)	0	2/8869 (0%)	2
Dementia Alzheimer's type	2/8864 (0%)	2	0/8869 (0%)	0
Demyelinating polyneuropathy	0/8864 (0%)	0	1/8869 (0%)	1
Dizziness	7/8864 (0.1%)	7	3/8869 (0%)	3
Drop attacks	1/8864 (0%)	1	0/8869 (0%)	0
Drug withdrawal convulsions	1/8864 (0%)	1	0/8869 (0%)	0
Dysaesthesia	0/8864 (0%)	0	1/8869 (0%)	1
Encephalitis	1/8864 (0%)	1	0/8869 (0%)	0
Encephalopathy	1/8864 (0%)	1	0/8869 (0%)	0
Epilepsy	2/8864 (0%)	2	3/8869 (0%)	3
Facial neuralgia	0/8864 (0%)	0	1/8869 (0%)	1
Facial palsy	1/8864 (0%)	1	2/8869 (0%)	2
Grand mal convulsion	0/8864 (0%)	0	2/8869 (0%)	2
Headache	3/8864 (0%)	3	3/8869 (0%)	3
Hemicephalalgia	1/8864 (0%)	1	0/8869 (0%)	0
Hemiparesis	0/8864 (0%)	0	1/8869 (0%)	1
Hydrocephalus	1/8864 (0%)	1	0/8869 (0%)	0
Hypertensive encephalopathy	1/8864 (0%)	1	0/8869 (0%)	0
Hypertonia	1/8864 (0%)	1	0/8869 (0%)	0
Hypoaesthesia	0/8864 (0%)	0	1/8869 (0%)	1
Hypoglycaemic coma	0/8864 (0%)	0	1/8869 (0%)	1
Intracranial aneurysm	1/8864 (0%)	1	0/8869 (0%)	0
Intracranial pressure increased	1/8864 (0%)	1	0/8869 (0%)	0
Ischaemic stroke	1/8864 (0%)	1	1/8869 (0%)	1
Lacunar infarction	2/8864 (0%)	2	1/8869 (0%)	1
Loss of consciousness	0/8864 (0%)	0	2/8869 (0%)	2
Lumbar radiculopathy	1/8864 (0%)	1	0/8869 (0%)	0
Migraine	0/8864 (0%)	0	1/8869 (0%)	1
Myasthenia gravis	0/8864 (0%)	0	1/8869 (0%)	1
Myxoedema coma	0/8864 (0%)	0	1/8869 (0%)	1
Nerve compression	2/8864 (0%)	2	1/8869 (0%)	1
Nerve root compression	1/8864 (0%)	1	0/8869 (0%)	0
Neuropathy peripheral	0/8864 (0%)	0	1/8869 (0%)	1
Optic neuritis	0/8864 (0%)	0	1/8869 (0%)	1
Paralysis	0/8864 (0%)	0	1/8869 (0%)	1
Paraplegia	0/8864 (0%)	0	1/8869 (0%)	1
Peripheral paralysis	0/8864 (0%)	0	1/8869 (0%)	1
Pneumocephalus	1/8864 (0%)	1	0/8869 (0%)	0
Polyneuropathy	0/8864 (0%)	0	1/8869 (0%)	1
Presyncope	0/8864 (0%)	0	5/8869 (0.1%)	5
Radiculitis	0/8864 (0%)	0	1/8869 (0%)	1
Radiculopathy	2/8864 (0%)	2	0/8869 (0%)	0
Ruptured cerebral aneurysm	1/8864 (0%)	1	0/8869 (0%)	0
Sciatica	3/8864 (0%)	3	2/8869 (0%)	2
Senile dementia	1/8864 (0%)	1	0/8869 (0%)	0
Sensory loss	1/8864 (0%)	1	0/8869 (0%)	0
Spinal cord compression	0/8864 (0%)	0	1/8869 (0%)	1
Syncope	15/8864 (0.2%)	15	11/8869 (0.1%)	11
Transient ischaemic attack	10/8864 (0.1%)	10	9/8869 (0.1%)	9
Tremor	0/8864 (0%)	0	1/8869 (0%)	1
Vertebral artery stenosis	1/8864 (0%)	1	0/8869 (0%)	0
Vocal cord paralysis	0/8864 (0%)	0	2/8869 (0%)	2
Psychiatric disorders
Aggression	1/8864 (0%)	1	0/8869 (0%)	0
Alcohol abuse	1/8864 (0%)	1	0/8869 (0%)	0
Alcoholism	1/8864 (0%)	1	0/8869 (0%)	0
Anxiety	2/8864 (0%)	2	2/8869 (0%)	2
Completed suicide	1/8864 (0%)	1	1/8869 (0%)	1
Confusional state	1/8864 (0%)	1	7/8869 (0.1%)	7
Delirium	1/8864 (0%)	1	2/8869 (0%)	2
Depression	2/8864 (0%)	2	7/8869 (0.1%)	7
Insomnia	0/8864 (0%)	0	2/8869 (0%)	2
Major depression	0/8864 (0%)	0	2/8869 (0%)	2
Mental status changes	1/8864 (0%)	1	2/8869 (0%)	2
Panic attack	1/8864 (0%)	1	0/8869 (0%)	0
Psychotic disorder	1/8864 (0%)	1	0/8869 (0%)	0
Suicidal ideation	0/8864 (0%)	0	2/8869 (0%)	2
Suicide attempt	0/8864 (0%)	0	1/8869 (0%)	1
Renal and urinary disorders
Azotaemia	0/8864 (0%)	0	1/8869 (0%)	1
Bladder diverticulum	1/8864 (0%)	1	0/8869 (0%)	0
Bladder obstruction	1/8864 (0%)	1	0/8869 (0%)	0
Bladder prolapse	5/8864 (0.1%)	5	0/8869 (0%)	0
Bladder stenosis	0/8864 (0%)	0	1/8869 (0%)	1
Calculus bladder	1/8864 (0%)	1	1/8869 (0%)	1
Calculus urinary	1/8864 (0%)	1	0/8869 (0%)	0
Cystitis interstitial	1/8864 (0%)	1	0/8869 (0%)	0
Dysuria	1/8864 (0%)	1	0/8869 (0%)	0
Glomerulonephritis	1/8864 (0%)	1	0/8869 (0%)	0
Haematuria	6/8864 (0.1%)	6	11/8869 (0.1%)	11
Hydronephrosis	0/8864 (0%)	0	1/8869 (0%)	1
Nephrolithiasis	12/8864 (0.1%)	12	7/8869 (0.1%)	7
Pollakiuria	0/8864 (0%)	0	1/8869 (0%)	1
Renal artery stenosis	0/8864 (0%)	0	1/8869 (0%)	1
Renal colic	4/8864 (0%)	4	1/8869 (0%)	1
Renal cyst	1/8864 (0%)	1	1/8869 (0%)	1
Renal failure	7/8864 (0.1%)	7	6/8869 (0.1%)	6
Renal failure acute	6/8864 (0.1%)	6	6/8869 (0.1%)	6
Renal failure chronic	1/8864 (0%)	1	1/8869 (0%)	1
Renal haemorrhage	0/8864 (0%)	0	1/8869 (0%)	1
Renal mass	1/8864 (0%)	1	0/8869 (0%)	0
Renal pain	0/8864 (0%)	0	1/8869 (0%)	1
Renal tubular necrosis	1/8864 (0%)	1	0/8869 (0%)	0
Stress urinary incontinence	1/8864 (0%)	1	1/8869 (0%)	1
Urethral obstruction	1/8864 (0%)	1	0/8869 (0%)	0
Urethral polyp	0/8864 (0%)	0	1/8869 (0%)	1
Urethral stenosis	3/8864 (0%)	3	0/8869 (0%)	0
Urinary bladder haemorrhage	2/8864 (0%)	2	0/8869 (0%)	0
Urinary bladder polyp	0/8864 (0%)	0	1/8869 (0%)	1
Urinary incontinence	0/8864 (0%)	0	1/8869 (0%)	1
Urinary retention	5/8864 (0.1%)	5	7/8869 (0.1%)	7
Urinary tract obstruction	2/8864 (0%)	2	2/8869 (0%)	2
Vesical fistula	1/8864 (0%)	1	0/8869 (0%)	0
Reproductive system and breast disorders
Benign prostatic hyperplasia	17/8864 (0.2%)	17	12/8869 (0.1%)	12
Cervical polyp	1/8864 (0%)	1	0/8869 (0%)	0
Cystocele	3/8864 (0%)	3	0/8869 (0%)	0
Endometrial hypertrophy	0/8864 (0%)	0	1/8869 (0%)	1
Epididymitis	0/8864 (0%)	0	1/8869 (0%)	1
Erectile dysfunction	0/8864 (0%)	0	2/8869 (0%)	2
Female genital tract fistula	0/8864 (0%)	0	1/8869 (0%)	1
Genital cyst	1/8864 (0%)	1	0/8869 (0%)	0
Ovarian cyst	1/8864 (0%)	1	3/8869 (0%)	3
Ovarian mass	1/8864 (0%)	1	0/8869 (0%)	0
Pelvic pain	0/8864 (0%)	0	1/8869 (0%)	1
Postmenopausal haemorrhage	0/8864 (0%)	0	1/8869 (0%)	1
Prostatic disorder	2/8864 (0%)	2	1/8869 (0%)	1
Prostatism	1/8864 (0%)	1	0/8869 (0%)	0
Prostatitis	2/8864 (0%)	2	2/8869 (0%)	2
Prostatomegaly	5/8864 (0.1%)	5	3/8869 (0%)	3
Rectocele	2/8864 (0%)	2	1/8869 (0%)	1
Testicular swelling	0/8864 (0%)	0	1/8869 (0%)	1
Uterine cervical erosion	1/8864 (0%)	1	0/8869 (0%)	0
Uterine polyp	0/8864 (0%)	0	1/8869 (0%)	1
Uterine prolapse	4/8864 (0%)	4	7/8869 (0.1%)	7
Uterovaginal prolapse	0/8864 (0%)	0	1/8869 (0%)	1
Vaginal fistula	0/8864 (0%)	0	1/8869 (0%)	1
Vaginal prolapse	2/8864 (0%)	2	0/8869 (0%)	0
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema	2/8864 (0%)	2	0/8869 (0%)	0
Acute respiratory failure	2/8864 (0%)	2	0/8869 (0%)	0
Alveolitis allergic	2/8864 (0%)	2	0/8869 (0%)	0
Aspiration	1/8864 (0%)	1	0/8869 (0%)	0
Asthma	3/8864 (0%)	3	6/8869 (0.1%)	6
Atelectasis	1/8864 (0%)	1	1/8869 (0%)	1
Bronchitis chronic	2/8864 (0%)	2	1/8869 (0%)	1
Bronchospasm	0/8864 (0%)	0	3/8869 (0%)	3
Chronic obstructive pulmonary disease	33/8864 (0.4%)	33	25/8869 (0.3%)	25
Cough	2/8864 (0%)	2	0/8869 (0%)	0
Dysphonia	0/8864 (0%)	0	1/8869 (0%)	1
Dyspnoea	6/8864 (0.1%)	6	8/8869 (0.1%)	8
Emphysema	5/8864 (0.1%)	5	0/8869 (0%)	0
Eosinophilic pneumonia chronic	0/8864 (0%)	0	1/8869 (0%)	1
Epistaxis	0/8864 (0%)	0	4/8869 (0%)	4
Foreign body aspiration	0/8864 (0%)	0	1/8869 (0%)	1
Haemoptysis	1/8864 (0%)	1	1/8869 (0%)	1
Haemothorax	1/8864 (0%)	1	0/8869 (0%)	0
Hydrothorax	0/8864 (0%)	0	1/8869 (0%)	1
Hypoventilation	0/8864 (0%)	0	1/8869 (0%)	1
Hypoxia	2/8864 (0%)	2	2/8869 (0%)	2
Idiopathic pulmonary fibrosis	0/8864 (0%)	0	1/8869 (0%)	1
Interstitial lung disease	0/8864 (0%)	0	3/8869 (0%)	3
Laryngeal leukoplakia	1/8864 (0%)	1	0/8869 (0%)	0
Lung infiltration	0/8864 (0%)	0	1/8869 (0%)	1
Nasal polyps	0/8864 (0%)	0	3/8869 (0%)	3
Obstructive airways disorder	1/8864 (0%)	1	0/8869 (0%)	0
Pharyngolaryngeal pain	0/8864 (0%)	0	1/8869 (0%)	1
Pleural effusion	7/8864 (0.1%)	7	4/8869 (0%)	4
Pleuritic pain	0/8864 (0%)	0	1/8869 (0%)	1
Pneumonia aspiration	2/8864 (0%)	2	1/8869 (0%)	1
Pneumonitis	1/8864 (0%)	1	0/8869 (0%)	0
Pneumothorax	7/8864 (0.1%)	7	4/8869 (0%)	4
Pulmonary embolism	14/8864 (0.2%)	14	11/8869 (0.1%)	11
Pulmonary fibrosis	3/8864 (0%)	3	0/8869 (0%)	0
Pulmonary hypertension	0/8864 (0%)	0	1/8869 (0%)	1
Pulmonary oedema	4/8864 (0%)	4	0/8869 (0%)	0
Respiratory arrest	2/8864 (0%)	2	1/8869 (0%)	1
Respiratory disorder	1/8864 (0%)	1	1/8869 (0%)	1
Respiratory distress	1/8864 (0%)	1	1/8869 (0%)	1
Respiratory failure	12/8864 (0.1%)	12	12/8869 (0.1%)	12
Sinus disorder	1/8864 (0%)	1	1/8869 (0%)	1
Sleep apnoea syndrome	0/8864 (0%)	0	2/8869 (0%)	2
Skin and subcutaneous tissue disorders
Angioedema	2/8864 (0%)	2	2/8869 (0%)	2
Decubitus ulcer	1/8864 (0%)	1	0/8869 (0%)	0
Dermatitis	1/8864 (0%)	1	0/8869 (0%)	0
Dermatitis exfoliative	0/8864 (0%)	0	1/8869 (0%)	1
Facial hemiatrophy	0/8864 (0%)	0	1/8869 (0%)	1
Psoriasis	0/8864 (0%)	0	1/8869 (0%)	1
Rash	0/8864 (0%)	0	1/8869 (0%)	1
Rash erythematous	0/8864 (0%)	0	1/8869 (0%)	1
Skin disorder	0/8864 (0%)	0	1/8869 (0%)	1
Skin nodule	0/8864 (0%)	0	1/8869 (0%)	1
Skin ulcer	1/8864 (0%)	1	2/8869 (0%)	2
Stevens-Johnson syndrome	1/8864 (0%)	1	0/8869 (0%)	0
Telangiectasia	1/8864 (0%)	1	0/8869 (0%)	0
Urticaria	0/8864 (0%)	0	1/8869 (0%)	1
Surgical and medical procedures
Cholecystectomy	0/8864 (0%)	0	1/8869 (0%)	1
Hip arthroplasty	0/8864 (0%)	0	1/8869 (0%)	1
Pancreatectomy	0/8864 (0%)	0	1/8869 (0%)	1
Vascular disorders
Aortic aneurysm	5/8864 (0.1%)	5	3/8869 (0%)	3
Aortic aneurysm rupture	1/8864 (0%)	1	0/8869 (0%)	0
Aortic dissection	1/8864 (0%)	1	0/8869 (0%)	0
Aortic stenosis	2/8864 (0%)	2	4/8869 (0%)	4
Arterial occlusive disease	1/8864 (0%)	1	0/8869 (0%)	0
Arterial thrombosis limb	1/8864 (0%)	1	0/8869 (0%)	0
Arteriosclerosis	1/8864 (0%)	1	1/8869 (0%)	1
Circulatory collapse	1/8864 (0%)	1	2/8869 (0%)	2
Deep vein thrombosis	13/8864 (0.1%)	13	7/8869 (0.1%)	7
Embolism	0/8864 (0%)	0	1/8869 (0%)	1
Haematoma	3/8864 (0%)	3	2/8869 (0%)	2
Hypertension	7/8864 (0.1%)	7	9/8869 (0.1%)	9
Hypertensive crisis	0/8864 (0%)	0	2/8869 (0%)	2
Hypertensive emergency	1/8864 (0%)	1	0/8869 (0%)	0
Hypotension	2/8864 (0%)	2	0/8869 (0%)	0
Hypovolaemic shock	1/8864 (0%)	1	1/8869 (0%)	1
Intermittent claudication	2/8864 (0%)	2	0/8869 (0%)	0
Lymphoedema	1/8864 (0%)	1	0/8869 (0%)	0
Orthostatic hypotension	2/8864 (0%)	2	0/8869 (0%)	0
Peripheral artery aneurysm	1/8864 (0%)	1	2/8869 (0%)	2
Peripheral embolism	1/8864 (0%)	1	0/8869 (0%)	0
Peripheral ischaemia	1/8864 (0%)	1	0/8869 (0%)	0
Phlebitis	1/8864 (0%)	1	1/8869 (0%)	1
Thrombophlebitis	2/8864 (0%)	2	2/8869 (0%)	2
Thrombosis	1/8864 (0%)	1	0/8869 (0%)	0
Varicose vein	2/8864 (0%)	2	2/8869 (0%)	2
Vascular pseudoaneurysm	0/8864 (0%)	0	2/8869 (0%)	2
Venous thrombosis	1/8864 (0%)	1	0/8869 (0%)	0
Other (Not Including Serious) Adverse Events
	PLACEBO		ROSUVASTATIN 20 MG
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3170/8864 (35.8%)		3228/8869 (36.4%)
Infections and infestations
Bronchitis	571/8864 (6.4%)	571	596/8869 (6.7%)	596
Nasopharyngitis	607/8864 (6.8%)	607	632/8869 (7.1%)	632
Upper respiratory tract infection	637/8864 (7.2%)	637	580/8869 (6.5%)	580
Urinary tract infection	686/8864 (7.7%)	686	699/8869 (7.9%)	699
Musculoskeletal and connective tissue disorders
Back pain	576/8864 (6.5%)	576	631/8869 (7.1%)	631
Myalgia	559/8864 (6.3%)	559	653/8869 (7.4%)	653
Vascular disorders
Hypertension	628/8864 (7.1%)	628	557/8869 (6.3%)	557

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.