FOURIER: Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk

• Sponsor: Amgen (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01764633
• Collaborator: (none)
• Enrollment: 27,564
• Locations: 1287
• Arms: 2
• Actual Duration (Months): 45.1
• Patients Per Site: 21.4
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

The primary objective was to evaluate the effect of treatment with evolocumab, compared with placebo, on the risk for cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization, whichever occurs first, in patients with clinically evident cardiovascular disease.

Condition or Disease	Intervention/Treatment	Phase
Dyslipidemia	Biological: Evolocumab; Drug: Placebo	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 27564 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Double-blind, Randomized, Placebo-controlled, Multicenter Study Assessing the Impact of Additional LDL-Cholesterol Reduction on Major Cardiovascular Events When Evolocumab (AMG 145) is Used in Combination With Statin Therapy In Patients With Clinically Evident Cardiovascular Disease
• Actual Study Start Date: Feb 8, 2013
• Actual Primary Completion Date: Nov 11, 2016
• Actual Study Completion Date: Nov 11, 2016

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo Participants received placebo subcutaneous injections either once every 2 weeks (Q2W) or once a month (QM) according to their own preference.	Drug: Placebo; Administered subcutaneously using a spring-based prefilled 1.0 mL autoinjector/pen.
Experimental: Evolocumab Participants received evolocumab 140 mg Q2W or 420 mg QM subcutaneous injections according to their own preference.	Biological: Evolocumab; Administered subcutaneously using a spring-based prefilled 1.0 mL autoinjector/pen.; Other Names: AMG 145 Repatha

Outcome Measures

Primary Outcome Measures

1. Time to Cardiovascular Death, Myocardial Infarction, Hospitalization for Unstable Angina, Stroke, or Coronary Revascularization [Events that occurred from randomization to the last confirmed survival status date; the median duration of follow-up was 26 months. KM estimates at 6, 12, 18, 24, 30 and 36 months are reported.]

   All deaths and potential endpoint events were adjudicated by an independent external Clinical Events Committee (CEC) led by the Thrombolysis in Myocardial Infarction (TIMI) Study Group, using standardized definitions based on the "Standardized Definitions for Cardiovascular and Stroke End Point Events in Clinical Trials and the Third Universal Definition of Myocardial Infarction". Time to cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization was defined as the time from randomization to the first occurrence of any component of the composite endpoint and was analyzed using Kaplan-Meier (KM) survival analysis. KM estimates of the percentage of participants with an event are reported. Participants with no event were censored based on last non-fatal potential endpoint collection date.

Secondary Outcome Measures

1. Time to Cardiovascular Death, Myocardial Infarction, or Stroke [Events that occurred from randomization to the last confirmed survival status date; the median duration of follow-up was 26 months. KM estimates at 6, 12, 18, 24, 30 and 36 months are reported.]

   All deaths and potential endpoint events were adjudicated by an independent external CEC led by the TIMI Study Group, using standardized definitions based on the "Standardized Definitions for Cardiovascular and Stroke End Point Events in Clinical Trials and the Third Universal Definition of Myocardial Infarction". Time to cardiovascular death, myocardial infarction, or stroke was defined as the time from randomization to the first occurrence of any component of the composite endpoint and was analyzed using Kaplan-Meier (KM) survival analysis. KM estimates of the percentage of participants with an event are reported. Participants with no event were censored based on last non-fatal potential endpoint collection date.

2. Time to Cardiovascular Death [Events that occurred from randomization to the last confirmed survival status date; the median duration of follow-up was 26 months. KM estimates at 6, 12, 18, 24, 30 and 36 months are reported.]

   All deaths and potential endpoint events were adjudicated by an independent external CEC led by the TIMI Study Group, using standardized definitions based on the "Standardized Definitions for Cardiovascular and Stroke End Point Events in Clinical Trials and the Third Universal Definition of Myocardial Infarction". Cardiovascular death includes death resulting from an acute myocardial infarction (MI), sudden cardiac death, death due to heart failure (HF), death due to stroke, death due to cardiovascular (CV) procedures, death due to CV hemorrhage, and death due to other CV causes. Time to cardiovascular death was defined as the time from randomization to the date of cardiovascular death and was analyzed using Kaplan-Meier (KM) survival analysis. KM estimates of the percentage of participants with an event are reported. Participants with no event were censored based on the last confirmed survival status date.

3. Time to All Cause Death [Events that occurred from randomization to the last confirmed survival status date; the median duration of follow-up was 26 months. KM estimates at 6, 12, 18, 24, 30 and 36 months are reported.]

   Time to all-cause death was defined as the time from randomization to the date of death and was analyzed using Kaplan-Meier (KM) survival analysis. KM estimates of the percentage of participants with an event are reported. Participants with no event were censored based on the last confirmed survival status date.

4. Time to First Myocardial Infarction [Events that occurred from randomization to the last confirmed survival status date; the median duration of follow-up was 26 months. KM estimates at 6, 12, 18, 24, 30 and 36 months are reported.]

   All deaths and potential endpoint events were adjudicated by an independent external CEC led by the TIMI Study Group, using standardized definitions based on the "Standardized Definitions for Cardiovascular and Stroke End Point Events in Clinical Trials and the Third Universal Definition of Myocardial Infarction". The diagnosis of myocardial infarction required the combination of: Evidence of myocardial necrosis (either changes in cardiac biomarkers or post-mortem pathological findings); and Supporting information derived from the clinical presentation, electrocardiographic changes, or the results of myocardial or coronary artery Imaging. Time to first myocardial infarction was defined as the time from randomization to the date of the first MI and was analyzed using Kaplan-Meier survival analysis. KM estimates of the percentage of participants with an event are reported. Participants with no event were censored based on last non-fatal potential endpoint collection date.

5. Time to First Stroke [Events that occurred from randomization to the last confirmed survival status date; the median duration of follow-up was 26 months. KM estimates at 6, 12, 18, 24, 30 and 36 months are reported.]

   All deaths and potential endpoint events were adjudicated by an independent external CEC led by the TIMI Study Group, using standardized definitions based on the "Standardized Definitions for Cardiovascular and Stroke End Point Events in Clinical Trials and the Third Universal Definition of Myocardial Infarction". Stroke was defined as an acute episode of focal or global neurological dysfunction caused by brain, spinal cord, or retinal vascular injury as a result of hemorrhage or infarction. Time to first stroke was defined as the time from randomization to the date of the stroke and was analyzed using Kaplan-Meier (KM) survival analysis. KM estimates of the percentage of participants with an event are reported. Participants with no event were censored based on last non-fatal potential endpoint collection date.

6. Time to First Coronary Revascularization [Events that occurred from randomization to the last confirmed survival status date; the median duration of follow-up was 26 months. KM estimates at 6, 12, 18, 24, 30 and 36 months are reported.]

   All deaths and potential endpoint events were adjudicated by an independent external CEC led by the TIMI Study Group, using standardized definitions based on the "Standardized Definitions for Cardiovascular and Stroke End Point Events in Clinical Trials and the Third Universal Definition of Myocardial Infarction". Time to first coronary revascularization was defined as the time from randomization to the date of the coronary revascularization and was analyzed using Kaplan-Meier (KM) survival analysis. KM estimates of the percentage of participants with an event are reported. Participants with no event were censored based on last non-fatal potential endpoint collection date.

7. Time to Cardiovascular Death or First Hospitalization for Worsening Heart Failure [Events that occurred from randomization to the last confirmed survival status date; the median duration of follow-up was 26 months. KM estimates at 6, 12, 18, 24, 30 and 36 months are reported.]

   All events were adjudicated by an independent external CEC led by the TIMI Study Group, using standardized definitions. HF hospitalization was defined as an event that met all of the following criteria: Admitted to hospital with a primary diagnosis of HF In hospital for at least 24 hours Documented new or worsening symptoms due to HF, including at least 1 of the following: Dyspnea Decreased exercise tolerance Fatigue Other symptoms of worsened end-organ perfusion or volume overload Evidence of new or worsening HF consisting of at least 2 physical exam findings or 1 physical exam finding and at least 1 laboratory criterion Received new or increased treatment for HF. Time to CV death or first hospitalization for worsening HF was defined as the time from randomization to the first occurrence of any component of the endpoint analyzed using KM survival analysis. Participants with no event were censored based on last non-fatal potential endpoint collection date.

8. Time to First Ischemic Fatal or Non-Fatal Stroke or Transient Ischemic Attack [Events that occurred from randomization to the last confirmed survival status date; the median duration of follow-up was 26 months. KM estimates at 6, 12, 18, 24, 30 and 36 months are reported.]

   All deaths and potential endpoint events were adjudicated by an independent external CEC led by the TIMI Study Group, using standardized definitions. Ischemic stroke was defined as an acute episode of focal cerebral, spinal, or retinal dysfunction caused by infarction of central nervous system tissue. Transient ischemic attack (TIA) was defined as a transient episode of focal neurological dysfunction caused by brain, spinal cord, or retinal ischemia, without acute infarction. Time to first ischemic fatal or non-fatal stroke or TIA was defined as the time from randomization to the first occurrence of any component of the composite endpoint and was analyzed using KM analysis. KM estimates of the percentage of participants with an event are reported. Participants with no event were censored based on last non-fatal potential endpoint collection date.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Male or female ≥ 40 to ≤ 85 years of age

• History of clinically evident cardiovascular disease at high risk for a recurrent event

• Fasting low-density lipoprotein cholesterol (LDL-C) ≥ 70 mg/dL (≥ 1.8 mmol/L) ) or non-high-density lipoprotein cholesterol (non-HDL-C) ≥ 100 mg/dL (> 2.6 mmol/L)

• Fasting triglycerides ≤ 400 mg/dL (4.5 mmol/L)

Exclusion Criteria:

• New York Heart Association (NYHA) class III or IV, or last known left ventricular ejection fraction < 30%

• Uncontrolled hypertension

• Uncontrolled or recurrent ventricular tachycardia

• Untreated hyperthyroidism or hypothyroidism

• Homozygous familial hypercholesterolemia

• LDL or plasma apheresis

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Site	Birmingham	Alabama	United States	35235
2	Research Site	Birmingham	Alabama	United States	35294
3	Research Site	Huntsville	Alabama	United States	35801
4	Research Site	Mobile	Alabama	United States	36608
5	Research Site	Anchorage	Alaska	United States	99508
6	Research Site	Glendale	Arizona	United States	85306
7	Research Site	Phoenix	Arizona	United States	85015
8	Research Site	Phoenix	Arizona	United States	85018
9	Research Site	Phoenix	Arizona	United States	85054
10	Research Site	Tucson	Arizona	United States	85712
11	Research Site	Tucson	Arizona	United States	85723
12	Research Site	Alhambra	California	United States	91801
13	Research Site	Banning	California	United States	92220
14	Research Site	Beverly Hills	California	United States	90211
15	Research Site	Encino	California	United States	91436
16	Research Site	Escondido	California	United States	92029
17	Research Site	Glendale	California	United States	91204
18	Research Site	Harbor City	California	United States	90710
19	Research Site	Huntington Beach	California	United States	92646
20	Research Site	Laguna Hills	California	United States	92653
21	Research Site	Long Beach	California	United States	90807
22	Research Site	Long Beach	California	United States	90822
23	Research Site	Los Alamitos	California	United States	90720
24	Research Site	Los Angeles	California	United States	90033
25	Research Site	Los Angeles	California	United States	90048
26	Research Site	Newport Beach	California	United States	92663
27	Research Site	Oceanside	California	United States	92056
28	Research Site	Oxnard	California	United States	93030
29	Research Site	Palm Springs	California	United States	92262
30	Research Site	Roseville	California	United States	95661
31	Research Site	Sacramento	California	United States	95816
32	Research Site	San Diego	California	United States	92103
33	Research Site	San Diego	California	United States	92161
34	Research Site	San Pedro	California	United States	90732
35	Research Site	Santa Ana	California	United States	92704
36	Research Site	Tarzana	California	United States	91356
37	Research Site	Thousand Oaks	California	United States	91360
38	Research Site	Torrance	California	United States	90502
39	Research Site	Torrance	California	United States	90503
40	Research Site	Valley Village	California	United States	91607
41	Research Site	Aurora	Colorado	United States	80012
42	Research Site	Colorado Springs	Colorado	United States	80907
43	Research Site	Colorado Springs	Colorado	United States	80909
44	Research Site	Denver	Colorado	United States	80218
45	Research Site	Greeley	Colorado	United States	80631
46	Research Site	Littleton	Colorado	United States	80120
47	Research Site	Longmont	Colorado	United States	80501
48	Research Site	Bridgeport	Connecticut	United States	06610
49	Research Site	Newark	Delaware	United States	19718
50	Research Site	Seaford	Delaware	United States	19973
51	Research Site	Wilmington	Delaware	United States	19803
52	Research Site	Washington	District of Columbia	United States	20037
53	Research Site	Atlantis	Florida	United States	33462
54	Research Site	Aventura	Florida	United States	33180
55	Research Site	Bay Pines	Florida	United States	33744
56	Research Site	Boynton Beach	Florida	United States	33472
57	Research Site	Bradenton	Florida	United States	34205
58	Research Site	Clearwater	Florida	United States	33756
59	Research Site	Crystal River	Florida	United States	34429
60	Research Site	Daytona Beach	Florida	United States	32117
61	Research Site	Deerfield Beach	Florida	United States	33442
62	Research Site	Delray Beach	Florida	United States	33484
63	Research Site	Edgewater	Florida	United States	32141
64	Research Site	Fleming Island	Florida	United States	32003
65	Research Site	Fort Lauderdale	Florida	United States	33308
66	Research Site	Hollywood	Florida	United States	33021
67	Research Site	Jacksonville Beach	Florida	United States	32250
68	Research Site	Jacksonville	Florida	United States	32216
69	Research Site	Lakeland	Florida	United States	33805
70	Research Site	Largo	Florida	United States	33777
71	Research Site	Melbourne	Florida	United States	32901
72	Research Site	Miami	Florida	United States	33144
73	Research Site	Miami	Florida	United States	33155
74	Research Site	Miami	Florida	United States	33173
75	Research Site	New Port Richey	Florida	United States	34653
76	Research Site	Orlando	Florida	United States	32806
77	Research Site	Palm Harbor	Florida	United States	34684
78	Research Site	Pembroke Pines	Florida	United States	33024
79	Research Site	Pembroke Pines	Florida	United States	33028
80	Research Site	Pensacola	Florida	United States	32501
81	Research Site	Ponte Vedra	Florida	United States	32081
82	Research Site	Port Charlotte	Florida	United States	33952
83	Research Site	Safety Harbor	Florida	United States	34695
84	Research Site	Saint Petersburg	Florida	United States	33709
85	Research Site	Saint Petersburg	Florida	United States	33713
86	Research Site	Sanford	Florida	United States	32771
87	Research Site	Sarasota	Florida	United States	34232
88	Research Site	Sarasota	Florida	United States	34239
89	Research Site	Tampa	Florida	United States	33614
90	Research Site	Wellington	Florida	United States	33449
91	Research Site	West Palm Beach	Florida	United States	33401
92	Research Site	Athens	Georgia	United States	30606
93	Research Site	Atlanta	Georgia	United States	30342
94	Research Site	Augusta	Georgia	United States	30909
95	Research Site	Dunwoody	Georgia	United States	30338
96	Research Site	East Point	Georgia	United States	30344
97	Research Site	Eatonton	Georgia	United States	31024
98	Research Site	Gainesville	Georgia	United States	30501
99	Research Site	Macon	Georgia	United States	31201
100	Research Site	Savannah	Georgia	United States	31406
101	Research Site	Suwanee	Georgia	United States	30024
102	Research Site	Boise	Idaho	United States	83704
103	Research Site	Boise	Idaho	United States	83706
104	Research Site	Coeur d'Alene	Idaho	United States	83814
105	Research Site	Meridian	Idaho	United States	83642
106	Research Site	Nampa	Idaho	United States	83686
107	Research Site	Addison	Illinois	United States	60101
108	Research Site	Belleville	Illinois	United States	62220
109	Research Site	Chicago	Illinois	United States	60616
110	Research Site	Hazel Crest	Illinois	United States	60429
111	Research Site	Jerseyville	Illinois	United States	62052
112	Research Site	Quincy	Illinois	United States	62301
113	Research Site	Evansville	Indiana	United States	47714
114	Research Site	Indianapolis	Indiana	United States	46227
115	Research Site	Indianapolis	Indiana	United States	46237
116	Research Site	Indianapolis	Indiana	United States	46260
117	Research Site	Munster	Indiana	United States	46321
118	Research Site	Valparaiso	Indiana	United States	46383
119	Research Site	Ames	Iowa	United States	50010
120	Research Site	Des Moines	Iowa	United States	50266
121	Research Site	Iowa City	Iowa	United States	52242
122	Research Site	Waterloo	Iowa	United States	50702
123	Research Site	Hutchinson	Kansas	United States	67502
124	Research Site	Kansas City	Kansas	United States	66160
125	Research Site	Overland Park	Kansas	United States	66210
126	Research Site	Wichita	Kansas	United States	67203
127	Research Site	Wichita	Kansas	United States	67214
128	Research Site	Lexington	Kentucky	United States	40504
129	Research Site	Owensboro	Kentucky	United States	42303
130	Research Site	Baton Rouge	Louisiana	United States	70808
131	Research Site	Covington	Louisiana	United States	70433
132	Research Site	Hammond	Louisiana	United States	70403
133	Research Site	Lafayette	Louisiana	United States	70508
134	Research Site	Metairie	Louisiana	United States	70006
135	Research Site	Monroe	Louisiana	United States	71203
136	Research Site	Natchitoches	Louisiana	United States	71457
137	Research Site	Slidell	Louisiana	United States	70458
138	Research Site	Auburn	Maine	United States	04210
139	Research Site	Bangor	Maine	United States	04401
140	Research Site	Biddeford	Maine	United States	04005
141	Research Site	Portland	Maine	United States	04101
142	Research Site	Annapolis	Maryland	United States	21401
143	Research Site	Baltimore	Maryland	United States	21201
144	Research Site	Baltimore	Maryland	United States	21204
145	Research Site	Baltimore	Maryland	United States	21236
146	Research Site	Baltimore	Maryland	United States	21237
147	Research Site	Charlotte Hall	Maryland	United States	20622
148	Research Site	Columbia	Maryland	United States	21044
149	Research Site	Columbia	Maryland	United States	21045
150	Research Site	Hollywood	Maryland	United States	20636
151	Research Site	Salisbury	Maryland	United States	21804
152	Research Site	Towson	Maryland	United States	21204
153	Research Site	Ayer	Massachusetts	United States	01432
154	Research Site	Billerica	Massachusetts	United States	01821
155	Research Site	Fall River	Massachusetts	United States	02720
156	Research Site	Haverhill	Massachusetts	United States	01830
157	Research Site	Hyannis	Massachusetts	United States	02601
158	Research Site	Newton	Massachusetts	United States	02459
159	Research Site	Quincy	Massachusetts	United States	02169
160	Research Site	Springfield	Massachusetts	United States	01199
161	Research Site	Watertown	Massachusetts	United States	02472
162	Research Site	Ann Arbor	Michigan	United States	48106
163	Research Site	Dearborn	Michigan	United States	48124
164	Research Site	Flint	Michigan	United States	48532
165	Research Site	Grandville	Michigan	United States	49418
166	Research Site	Lansing	Michigan	United States	48912
167	Research Site	Muskegon	Michigan	United States	49444
168	Research Site	Novi	Michigan	United States	48374
169	Research Site	Saginaw	Michigan	United States	48601
170	Research Site	Saginaw	Michigan	United States	48604
171	Research Site	Traverse City	Michigan	United States	49684
172	Research Site	Minneapolis	Minnesota	United States	55417
173	Research Site	Saint Cloud	Minnesota	United States	56303
174	Research Site	Saint Paul	Minnesota	United States	55102
175	Research Site	Olive Branch	Mississippi	United States	38654
176	Research Site	Tupelo	Mississippi	United States	38801
177	Research Site	Columbia	Missouri	United States	65212
178	Research Site	Jefferson City	Missouri	United States	65109
179	Research Site	Kansas City	Missouri	United States	64128
180	Research Site	Saint Louis	Missouri	United States	63117
181	Research Site	Saint Louis	Missouri	United States	63128
182	Research Site	Billings	Montana	United States	59101
183	Research Site	Billings	Montana	United States	59102
184	Research Site	Great Falls	Montana	United States	59405
185	Research Site	Kalispell	Montana	United States	59901
186	Research Site	Missoula	Montana	United States	59802
187	Research Site	Lincoln	Nebraska	United States	68506
188	Research Site	Omaha	Nebraska	United States	68131
189	Research Site	Las Vegas	Nevada	United States	89128
190	Research Site	Elizabeth	New Jersey	United States	07202
191	Research Site	Voorhees	New Jersey	United States	08043
192	Research Site	Westwood	New Jersey	United States	07675
193	Research Site	Albany	New York	United States	12208
194	Research Site	Buffalo	New York	United States	14203
195	Research Site	Buffalo	New York	United States	14215
196	Research Site	Cortlandt Manor	New York	United States	10567
197	Research Site	Kingston	New York	United States	12401
198	Research Site	New Hyde Park	New York	United States	11042
199	Research Site	New Windsor	New York	United States	12553
200	Research Site	New York	New York	United States	10021
201	Research Site	New York	New York	United States	10029
202	Research Site	New York	New York	United States	10033
203	Research Site	New York	New York	United States	10036
204	Research Site	Rochester	New York	United States	14609
205	Research Site	Stony Brook	New York	United States	11794
206	Research Site	Syracuse	New York	United States	13202
207	Research Site	Troy	New York	United States	12180
208	Research Site	West Seneca	New York	United States	14224
209	Research Site	Williamsville	New York	United States	14221
210	Research Site	Asheville	North Carolina	United States	28801
211	Research Site	Asheville	North Carolina	United States	28805
212	Research Site	Calabash	North Carolina	United States	28467
213	Research Site	Cary	North Carolina	United States	27518
214	Research Site	Charlotte	North Carolina	United States	28204
215	Research Site	Charlotte	North Carolina	United States	28277
216	Research Site	Durham	North Carolina	United States	27710
217	Research Site	Greensboro	North Carolina	United States	27408
218	Research Site	Hickory	North Carolina	United States	28601
219	Research Site	High Point	North Carolina	United States	27262
220	Research Site	Lenoir	North Carolina	United States	28645
221	Research Site	Mooresville	North Carolina	United States	28117
222	Research Site	Raleigh	North Carolina	United States	27609
223	Research Site	Statesville	North Carolina	United States	28625
224	Research Site	Tabor City	North Carolina	United States	28463
225	Research Site	Wilmington	North Carolina	United States	28401
226	Research Site	Winston-Salem	North Carolina	United States	27103
227	Research Site	Winston-Salem	North Carolina	United States	27127
228	Research Site	Fargo	North Dakota	United States	58122
229	Research Site	Grand Forks	North Dakota	United States	58201
230	Research Site	Canton	Ohio	United States	44710
231	Research Site	Cincinnati	Ohio	United States	45219
232	Research Site	Cincinnati	Ohio	United States	45224
233	Research Site	Cleveland	Ohio	United States	44195
234	Research Site	Columbus	Ohio	United States	43201
235	Research Site	Columbus	Ohio	United States	43215
236	Research Site	Dayton	Ohio	United States	45414
237	Research Site	Elyria	Ohio	United States	44035
238	Research Site	Garfield Heights	Ohio	United States	44125
239	Research Site	Marion	Ohio	United States	43302
240	Research Site	Sandusky	Ohio	United States	44870
241	Research Site	Springfield	Ohio	United States	45505
242	Research Site	Toledo	Ohio	United States	43608
243	Research Site	Toledo	Ohio	United States	43615
244	Research Site	Toledo	Ohio	United States	43623
245	Research Site	Westlake	Ohio	United States	44145
246	Research Site	Willoughby	Ohio	United States	44094
247	Research Site	Oklahoma City	Oklahoma	United States	73135
248	Research Site	Pryor	Oklahoma	United States	74362
249	Research Site	Tulsa	Oklahoma	United States	74133
250	Research Site	Bend	Oregon	United States	97701
251	Research Site	Portland	Oregon	United States	97225
252	Research Site	Portland	Oregon	United States	97239
253	Research Site	Abington	Pennsylvania	United States	19001
254	Research Site	Altoona	Pennsylvania	United States	16602
255	Research Site	Camp Hill	Pennsylvania	United States	17011
256	Research Site	Chambersburg	Pennsylvania	United States	17201
257	Research Site	Feasterville	Pennsylvania	United States	19053
258	Research Site	Indiana	Pennsylvania	United States	15701
259	Research Site	Jersey Shore	Pennsylvania	United States	17740
260	Research Site	Norristown	Pennsylvania	United States	19401
261	Research Site	Philadelphia	Pennsylvania	United States	19104
262	Research Site	Philadelphia	Pennsylvania	United States	19107
263	Research Site	Philadelphia	Pennsylvania	United States	19152
264	Research Site	Pittsburgh	Pennsylvania	United States	15206
265	Research Site	Sellersville	Pennsylvania	United States	18960
266	Research Site	Uniontown	Pennsylvania	United States	15401
267	Research Site	York	Pennsylvania	United States	17405
268	Research Site	Cranston	Rhode Island	United States	02920
269	Research Site	Cumberland	Rhode Island	United States	02864
270	Research Site	Johnston	Rhode Island	United States	02919
271	Research Site	Pawtucket	Rhode Island	United States	02860
272	Research Site	Anderson	South Carolina	United States	29621
273	Research Site	Charleston	South Carolina	United States	29407
274	Research Site	Charleston	South Carolina	United States	29425
275	Research Site	Columbia	South Carolina	United States	29204
276	Research Site	Fountain Inn	South Carolina	United States	29644
277	Research Site	Indian Land	South Carolina	United States	29707
278	Research Site	Moncks Corner	South Carolina	United States	29461
279	Research Site	Mount Pleasant	South Carolina	United States	29464
280	Research Site	North Myrtle Beach	South Carolina	United States	29582
281	Research Site	Orangeburg	South Carolina	United States	29118
282	Research Site	Rapid City	South Dakota	United States	57701
283	Research Site	Germantown	Tennessee	United States	38138
284	Research Site	Jackson	Tennessee	United States	38305
285	Research Site	Memphis	Tennessee	United States	38112
286	Research Site	Nashville	Tennessee	United States	37203
287	Research Site	Nashville	Tennessee	United States	37205
288	Research Site	Nashville	Tennessee	United States	37208
289	Research Site	Tullahoma	Tennessee	United States	37388
290	Research Site	Arlington	Texas	United States	76012
291	Research Site	Austin	Texas	United States	78758
292	Research Site	Dallas	Texas	United States	75216
293	Research Site	Grapevine	Texas	United States	76051
294	Research Site	Houston	Texas	United States	77025
295	Research Site	Houston	Texas	United States	77030
296	Research Site	Houston	Texas	United States	77070
297	Research Site	Houston	Texas	United States	77074
298	Research Site	Kerrville	Texas	United States	78028
299	Research Site	Longview	Texas	United States	75605
300	Research Site	Odessa	Texas	United States	79761
301	Research Site	Plano	Texas	United States	75023
302	Research Site	Plano	Texas	United States	75024
303	Research Site	San Antonio	Texas	United States	78229
304	Research Site	Sugar Land	Texas	United States	77478
305	Research Site	Tomball	Texas	United States	77375
306	Research Site	Wichita Falls	Texas	United States	76301
307	Research Site	Layton	Utah	United States	84041
308	Research Site	Murray	Utah	United States	84107
309	Research Site	West Jordan	Utah	United States	84088
310	Research Site	White River Junction	Vermont	United States	05009
311	Research Site	Burke	Virginia	United States	22015
312	Research Site	Danville	Virginia	United States	24541
313	Research Site	Falls Church	Virginia	United States	22042
314	Research Site	Hopewell	Virginia	United States	23860
315	Research Site	Richmond	Virginia	United States	23219
316	Research Site	Richmond	Virginia	United States	23294
317	Research Site	Roanoke	Virginia	United States	24014
318	Research Site	Suffolk	Virginia	United States	23435
319	Research Site	Virginia Beach	Virginia	United States	23455
320	Research Site	Federal Way	Washington	United States	98003
321	Research Site	Seattle	Washington	United States	98104
322	Research Site	Seattle	Washington	United States	98195
323	Research Site	Selah	Washington	United States	98942
324	Research Site	Green Bay	Wisconsin	United States	54301
325	Research Site	Madison	Wisconsin	United States	53713
326	Research Site	Marshfield	Wisconsin	United States	54449
327	Research Site	Bahia Blanca	Buenos Aires	Argentina	B8000FTD
328	Research Site	Ciudad Autonoma de Buenos Aires	Buenos Aires	Argentina	1209
329	Research Site	Ciudad Autonoma de Buenos Aires	Buenos Aires	Argentina	C1093AAS
330	Research Site	Ciudad Autonoma de Buenos Aires	Buenos Aires	Argentina	C1128AAF
331	Research Site	Ciudad Autonoma de Buenos Aires	Buenos Aires	Argentina	C1426EGR
332	Research Site	Ciudad Autonoma de Buenos Aires	Buenos Aires	Argentina	C1428AQK
333	Research Site	Ciudad Autonoma de Buenos Aires	Buenos Aires	Argentina	C1430CKE
334	Research Site	La Plata	Buenos Aires	Argentina	B1902AGY
335	Research Site	La Plata	Buenos Aires	Argentina	B1902COS
336	Research Site	Mar del Plata	Buenos Aires	Argentina	B7600FZN
337	Research Site	Mar del Plata	Buenos Aires	Argentina	B7602CBM
338	Research Site	Quilmes	Buenos Aires	Argentina	B1878GEG
339	Research Site	Cordoba	Córdoba	Argentina	X5000BNB
340	Research Site	Cordoba	Córdoba	Argentina	X5000EPU
341	Research Site	Cordoba	Córdoba	Argentina	X5002AOQ
342	Research Site	Cordoba	Córdoba	Argentina	X5016KEH
343	Research Site	Rosario	Santa Fe	Argentina	S2000CVD
344	Research Site	San Miguel de Tucuman	Tucuman	Argentina	T4000IAF
345	Research Site	San Miguel de Tucuman	Tucuman	Argentina	T4000ICL
346	Research Site	Corrientes		Argentina	W3400AMZ
347	Research Site	Córdoba		Argentina	X5003DCE
348	Research Site	Salta		Argentina	A4400ANG
349	Research Site	Salta		Argentina	A4400CRC
350	Research Site	Woden	Australian Capital Territory	Australia	2605
351	Research Site	Camperdown	New South Wales	Australia	2050
352	Research Site	Concord	New South Wales	Australia	2139
353	Research Site	Kogarah	New South Wales	Australia	2217
354	Research Site	Liverpool	New South Wales	Australia	2170
355	Research Site	Woolloongabba	New South Wales	Australia	4102
356	Research Site	Auchenflower	Queensland	Australia	4066
357	Research Site	Herston	Queensland	Australia	4029
358	Research Site	Woolloongabba	Queensland	Australia	4102
359	Research Site	Adelaide	South Australia	Australia	5000
360	Research Site	Ashford	South Australia	Australia	5035
361	Research Site	Ashford	South Australia	Australia	5036
362	Research Site	Fullarton	South Australia	Australia	5063
363	Research Site	Woodville South	South Australia	Australia	5011
364	Research Site	Hobart	Tasmania	Australia	7000
365	Research Site	Box Hill	Victoria	Australia	3128
366	Research Site	Epping	Victoria	Australia	3076
367	Research Site	Footscray	Victoria	Australia	3011
368	Research Site	Geelong	Victoria	Australia	3220
369	Research Site	Heidelberg	Victoria	Australia	3084
370	Research Site	Nedlands	Western Australia	Australia	6009
371	Research Site	Graz		Austria	8036
372	Research Site	Innsbruck		Austria	6020
373	Research Site	Linz		Austria	4010
374	Research Site	Salzburg		Austria	5020
375	Research Site	Wels		Austria	4600
376	Research Site	Wien		Austria	1060
377	Research Site	Wien		Austria	1090
378	Research Site	Wien		Austria	1130
379	Research Site	Wien		Austria	1160
380	Research Site	Wien		Austria	1190
381	Research Site	Aalst		Belgium	9300
382	Research Site	Antwerpen		Belgium	2020
383	Research Site	Antwerpen		Belgium	2060
384	Research Site	Blankenberge		Belgium	8370
385	Research Site	Bonheiden		Belgium	2820
386	Research Site	Brussels		Belgium	1020
387	Research Site	Brussels		Belgium	1070
388	Research Site	Bruxelles		Belgium	1200
389	Research Site	Gent		Belgium	9000
390	Research Site	Gozee		Belgium	6534
391	Research Site	Ieper		Belgium	8900
392	Research Site	La Louviere		Belgium	7100
393	Research Site	La Louvière		Belgium	7100
394	Research Site	Liege		Belgium	4000
395	Research Site	Liège		Belgium	4000
396	Research Site	Lodelinsart		Belgium	6042
397	Research Site	Natoye		Belgium	5360
398	Research Site	Turnhout		Belgium	2300
399	Research Site	Fortaleza	Ceará	Brazil	60430-350
400	Research Site	Brasília	Distrito Federal	Brazil	71625-009
401	Research Site	Vitória	Espírito Santo	Brazil	29042-751
402	Research Site	Goiania	Goiás	Brazil	74223-130
403	Research Site	Belo Horizonte	Minas Gerais	Brazil	30150-240
404	Research Site	Campina Grande do Sul	Paraná	Brazil	83430-000
405	Research Site	Curitiba	Paraná	Brazil	80010-030
406	Research Site	Curitiba	Paraná	Brazil	80730-150
407	Research Site	Canoas	Rio Grande Do Sul	Brazil	92425-900
408	Research Site	Passo Fundo	Rio Grande Do Sul	Brazil	99010-080
409	Research Site	Porto Alegre	Rio Grande Do Sul	Brazil	90020-090
410	Research Site	Porto Alegre	Rio Grande Do Sul	Brazil	90035-001
411	Research Site	Porto Alegre	Rio Grande Do Sul	Brazil	90035-903
412	Research Site	Porto Alegre	Rio Grande Do Sul	Brazil	90610-000
413	Research Site	Porto Alegre	Rio Grande Do Sul	Brazil	90620-001
414	Research Site	Porto Alegre	Rio Grande Do Sul	Brazil	90880-480
415	Research Site	Porto Alegre	Rio Grande Do Sul	Brazil	91350-200
416	Research Site	Campinas	São Paulo	Brazil	13010-001
417	Research Site	Campinas	São Paulo	Brazil	13059-740
418	Research Site	Sao Jose do Rio Preto	São Paulo	Brazil	15015-210
419	Research Site	Sao Paulo	São Paulo	Brazil	01244-030
420	Research Site	Sao Paulo	São Paulo	Brazil	04004-030
421	Research Site	Rio De Janeiro		Brazil	22271-100
422	Research Site	São Paulo		Brazil	04040-000
423	Research Site	São Paulo		Brazil	04266-010
424	Research Site	São Paulo		Brazil	05403-000
425	Research Site	Haskovo		Bulgaria	6300
426	Research Site	Kazanlak		Bulgaria	6100
427	Research Site	Pazardzhik		Bulgaria	4700
428	Research Site	Pleven		Bulgaria	5800
429	Research Site	Plovdiv		Bulgaria	4002
430	Research Site	Sofia		Bulgaria	1309
431	Research Site	Sofia		Bulgaria	1407
432	Research Site	Sofia		Bulgaria	1431
433	Research Site	Sofia		Bulgaria	1527
434	Research Site	Sofia		Bulgaria	1606
435	Research Site	Sofia		Bulgaria	1784
436	Research Site	Varna		Bulgaria	9010
437	Research Site	Calgary	Alberta	Canada	T2N 4Z6
438	Research Site	Kelowna	British Columbia	Canada	V1Y 1V6
439	Research Site	New Westminster	British Columbia	Canada	V3L 3W4
440	Research Site	Vancouver	British Columbia	Canada	V6Z 1Y6
441	Research Site	St. John's	Newfoundland and Labrador	Canada	A1A 3R5
442	Research Site	St. Johns	Newfoundland and Labrador	Canada	A1B 3V6
443	Research Site	Halifax	Nova Scotia	Canada	B3H 3A7
444	Research Site	Brampton	Ontario	Canada	L6Z 4N5
445	Research Site	Cambridge	Ontario	Canada	N1R 6V6
446	Research Site	Hamilton	Ontario	Canada	L8L 2X2
447	Research Site	London	Ontario	Canada	N6A 5K8
448	Research Site	London	Ontario	Canada	N6C 0A7
449	Research Site	Newmarket	Ontario	Canada	L3Y 5G8
450	Research Site	Newmarket	Ontario	Canada	L3Y 8C3
451	Research Site	Oshawa	Ontario	Canada	L1J 2J9
452	Research Site	Oshawa	Ontario	Canada	L1J 2K1
453	Research Site	Ottawa	Ontario	Canada	K1Y 4W7
454	Research Site	Peterborough	Ontario	Canada	K9J 0B2
455	Research Site	Sarnia	Ontario	Canada	N7T 4X3
456	Research Site	Scarborough	Ontario	Canada	M1E 5E9
457	Research Site	Scarborough	Ontario	Canada	M1P 2T7
458	Research Site	Strathroy	Ontario	Canada	N7G 1Y7
459	Research Site	Thunder Bay	Ontario	Canada	P7B 6V4
460	Research Site	Toronto	Ontario	Canada	M5C 2T2
461	Research Site	Toronto	Ontario	Canada	M5T 3A9
462	Research Site	Chicoutimi	Quebec	Canada	G7H 7K9
463	Research Site	Gatineau	Quebec	Canada	J8Y 6S8
464	Research Site	Granby	Quebec	Canada	J2G 8Z9
465	Research Site	Greenfield Park	Quebec	Canada	J4V 2G8
466	Research Site	Lachine	Quebec	Canada	H8S 2E4
467	Research Site	Longueuil	Quebec	Canada	J4M 2X1
468	Research Site	Montreal	Quebec	Canada	H1T 3Y7
469	Research Site	Montreal	Quebec	Canada	H1Y 3L1
470	Research Site	Montreal	Quebec	Canada	H2W 1R7
471	Research Site	Montreal	Quebec	Canada	H2W 1T8
472	Research Site	Montreal	Quebec	Canada	H3G 1A4
473	Research Site	Montreal	Quebec	Canada	H4A 3J1
474	Research Site	Pointe-Claire	Quebec	Canada	H9R 3J1
475	Research Site	Québec	Quebec	Canada	G1V 4G5
476	Research Site	St Jean sur Richelieu	Quebec	Canada	J3A 1C3
477	Research Site	St-Charles-Borromee	Quebec	Canada	J6E 6J2
478	Research Site	St-Jérôme	Quebec	Canada	J7Z 5T3
479	Research Site	Terrebonne	Quebec	Canada	J6V 2H2
480	Research Site	Westmout	Quebec	Canada	H3Z 1E5
481	Research Site	Regina	Saskatchewan	Canada	S4P 0W5
482	Research Site	Quebec		Canada	G1V 4W2
483	Research Site	Temuco	Cautín	Chile	4781156
484	Research Site	Temuco	Cautín	Chile	4813299
485	Research Site	Osorno		Chile	5311092
486	Research Site	Santiago		Chile	7500520
487	Research Site	Santiago		Chile	7650018
488	Research Site	Santiago		Chile	8350595
489	Research Site	Santiago		Chile
490	Research Site	Beijing	Beijing	China	100037
491	Research Site	Beijing	Beijing	China	100191
492	Research Site	Guangzhou	Guangdong	China	510080
493	Research Site	Harbin	Heilongjiang	China	150001
494	Research Site	Zhengzhou	Henan	China	450052
495	Research Site	Wuhan	Hubei	China	430014
496	Research Site	Wuhan	Hubei	China	430030
497	Research Site	Changde	Hunan	China	415003
498	Research Site	Changsha	Hunan	China	410004
499	Research Site	Changsha	Hunan	China	410005
500	Research Site	Changsha	Hunan	China	410008
501	Research Site	Changsha	Hunan	China	410013
502	Research Site	Xiangtan	Hunan	China	411100
503	Research Site	Zhuzhou	Hunan	China	412000
504	Research Site	Baotou	Inner Mongolia	China	014010
505	Research Site	Hohhot	Inner Mongolia	China	010020
506	Research Site	Suzhou	Jiangsu	China	215000
507	Research Site	Wuxi	Jiangsu	China	214023
508	Research Site	Xuzhou	Jiangsu	China	221006
509	Research Site	Changchun	Jilin	China	130011
510	Research Site	Changchun	Jilin	China	130021
511	Research Site	Changchun	Jilin	China	130033
512	Research Site	Siping	Jilin	China	136000
513	Research Site	Dalian	Liaoning	China	116027
514	Research Site	Shenyang	Liaoning	China	110016
515	Research Site	Yinchuan	Ningxia	China	750004
516	Research Site	Qingdao	Shandong	China	266003
517	Research Site	Taiyuan	Shanxi	China	030009
518	Research Site	Tianjin	Tianjin	China	300052
519	Research Site	Tianjin	Tianjin	China	300120
520	Research Site	Urumqi	Xinjiang	China	830054
521	Research Site	Hangzhou	Zhejiang	China	310013
522	Research Site	Linhai	Zhejiang	China	317000
523	Research Site	Ningbo	Zhejiang	China	315010
524	Research Site	Wenzhou	Zhejiang	China	325000
525	Research Site	Beijing		China	100020
526	Research Site	Tianjin		China	300211
527	Research Site	Medellin	Antioquia	Colombia	050012
528	Research Site	Medellin	Antioquia	Colombia	050021
529	Research Site	Barranquilla	Atlántico	Colombia	08001000
530	Research Site	Barranquilla	Atlántico	Colombia	080020
531	Research Site	Cartagena	Bolívar	Colombia	130010
532	Research Site	Manizales	Caldas	Colombia
533	Research Site	Bogota	Cundinamarca	Colombia	11001000
534	Research Site	Bogota	Cundinamarca	Colombia	110221
535	Research Site	Bogota	Cundinamarca	Colombia
536	Research Site	Armenia	Quindío	Colombia
537	Research Site	Floridablanca	Santander	Colombia
538	Research Site	Santiago de Cali	Valle Del Cauca	Colombia	760032
539	Research Site	Benatky nad Jizerou		Czechia	294 71
540	Research Site	Benesov		Czechia	256 01
541	Research Site	Beroun		Czechia	266 01
542	Research Site	Bilovec		Czechia	743 01
543	Research Site	Brandys nad Labem		Czechia	250 01
544	Research Site	Brno		Czechia	602 00
545	Research Site	Brno		Czechia	603 00
546	Research Site	Brno		Czechia	625 00
547	Research Site	Brno		Czechia	636 00
548	Research Site	Brno		Czechia	638 00
549	Research Site	Brno		Czechia	656 91
550	Research Site	Ceske Budejovice		Czechia	370 04
551	Research Site	Cesky Krumlov		Czechia	381 01
552	Research Site	Chomutov		Czechia	430 02
553	Research Site	Havlickuv Brod		Czechia	580 22
554	Research Site	Hodonin		Czechia	695 01
555	Research Site	Hradec Kralove		Czechia	500 02
556	Research Site	Hranice na Morave		Czechia	753 22
557	Research Site	Jihlava		Czechia	586 01
558	Research Site	Kladno		Czechia	272 59
559	Research Site	Klatovy IV		Czechia	339 01
560	Research Site	Kutna Hora		Czechia	284 01
561	Research Site	Liberec		Czechia	460 63
562	Research Site	Litomerice		Czechia	412 01
563	Research Site	Litomysl		Czechia	570 14
564	Research Site	Milevsko		Czechia	399 01
565	Research Site	Mlada Boleslav		Czechia	293 01
566	Research Site	Mohelnice		Czechia	789 85
567	Research Site	Moravske Budejovice		Czechia	676 02
568	Research Site	Nymburk		Czechia	288 01
569	Research Site	Olomouc		Czechia	779 00
570	Research Site	Ostrava - Zabreh		Czechia	700 30
571	Research Site	Ostrava-Poruba		Czechia	708 00
572	Research Site	Ostrava		Czechia	728 80
573	Research Site	Pardubice		Czechia	530 02
574	Research Site	Plzen		Czechia	305 99
575	Research Site	Policka		Czechia	572 01
576	Research Site	Prachatice		Czechia	383 01
577	Research Site	Praha 10		Czechia	101 00
578	Research Site	Praha 2		Czechia	128 08
579	Research Site	Praha 3		Czechia	130 00
580	Research Site	Praha 4		Czechia	140 21
581	Research Site	Praha 4		Czechia	140 59
582	Research Site	Praha 5 - Smichov		Czechia	150 00
583	Research Site	Praha 5		Czechia	150 06
584	Research Site	Praha 5		Czechia	158 00
585	Research Site	Prerov		Czechia	750 02
586	Research Site	Pribram VIII		Czechia	261 01
587	Research Site	Svitavy		Czechia	568 25
588	Research Site	Teplice		Czechia	415 01
589	Research Site	Uherske Hradiste		Czechia	686 01
590	Research Site	Znojmo		Czechia	669 02
591	Research Site	Aalborg		Denmark	9000
592	Research Site	Aarhus N		Denmark	8200
593	Research Site	Ballerup		Denmark	2750
594	Research Site	Esbjerg		Denmark	6700
595	Research Site	Glostrup		Denmark	2600
596	Research Site	Hvidovre		Denmark	2650
597	Research Site	København S		Denmark	2300
598	Research Site	København		Denmark	2400
599	Research Site	Køge		Denmark	4600
600	Research Site	Odense		Denmark	5000
601	Research Site	Roskilde		Denmark	4000
602	Research Site	Svendborg		Denmark	5700
603	Research Site	Vejle		Denmark	7100
604	Research Site	Viborg		Denmark	8800
605	Research Site	Harjumaa		Estonia	74001
606	Research Site	Paide		Estonia	72713
607	Research Site	Tallinn		Estonia	10128
608	Research Site	Tallinn		Estonia	10138
609	Research Site	Tallinn		Estonia	13419
610	Research Site	Helsinki		Finland	00180
611	Research Site	Helsinki		Finland	00290
612	Research Site	Hämeenlinna		Finland	13100
613	Research Site	Jyväskylä		Finland	40100
614	Research Site	Kokkola		Finland	67100
615	Research Site	Kuopio		Finland	70100
616	Research Site	Oulo		Finland	90029
617	Research Site	Oulu		Finland	90100
618	Research Site	Tampere		Finland	33100
619	Research Site	Tampere		Finland	33521
620	Research Site	Turku		Finland	20100
621	Research Site	Besançon Cedex		France	25030
622	Research Site	Brest Cedex 2		France	29200
623	Research Site	Chambray les Tours		France	37170
624	Research Site	Clermont Ferrand		France	63000
625	Research Site	Créteil		France	94010
626	Research Site	Dijon cedex		France	21079
627	Research Site	Le Coudray		France	28630
628	Research Site	Lille Cedex		France	59037
629	Research Site	Lyon		France	69007
630	Research Site	Marseille Cedex 08		France	13285
631	Research Site	Metz cedex 03		France	57085
632	Research Site	Montpellier cedex 05		France	34295
633	Research Site	Montpellier cedex 5		France	34094
634	Research Site	Nantes Cedex 1		France	44093
635	Research Site	Nantes Cedex 2		France	44202
636	Research Site	Nice		France	06000
637	Research Site	Nimes		France	30029
638	Research Site	Orleans		France	45067
639	Research Site	Paris		France	75010
640	Research Site	Paris		France	75013
641	Research Site	Paris		France	75015
642	Research Site	Pau		France	64000
643	Research Site	Perpignan Cedex		France	66046
644	Research Site	Pessac Cedex		France	33604
645	Research Site	Poitiers		France	86000
646	Research Site	Reims cedex		France	51092
647	Research Site	Rennes		France	35033
648	Research Site	Saint Priest en Jarez		France	42270
649	Research Site	Strasbourg		France	67091
650	Research Site	Toulouse Cedex 9		France	31059
651	Research Site	Vandoeuvre les Nancy		France	54511
652	Research Site	Vesoul		France	70014
653	Research Site	Bad Krozingen		Germany	79189
654	Research Site	Berlin		Germany	10787
655	Research Site	Berlin		Germany	12351
656	Research Site	Berlin		Germany	12559
657	Research Site	Berlin		Germany	13353
658	Research Site	Bochum		Germany	44787
659	Research Site	Demmin		Germany	17109
660	Research Site	Dortmund		Germany	44137
661	Research Site	Dresden		Germany	01307
662	Research Site	Düsseldorf		Germany	40210
663	Research Site	Frankfurt am Main		Germany	60596
664	Research Site	Giessen		Germany	35392
665	Research Site	Hamburg		Germany	20099
666	Research Site	Hamburg		Germany	20246
667	Research Site	Hannover		Germany	30159
668	Research Site	Heidelberg		Germany	69120
669	Research Site	Ingelheim		Germany	55218
670	Research Site	Kassel		Germany	34121
671	Research Site	Köln		Germany	50937
672	Research Site	Lahr		Germany	77933
673	Research Site	Leipzig		Germany	04103
674	Research Site	Limburg		Germany	65549
675	Research Site	Magdeburg		Germany	39120
676	Research Site	Mainz		Germany	55131
677	Research Site	Mannheim		Germany	68165
678	Research Site	Marburg		Germany	35043
679	Research Site	München		Germany	80636
680	Research Site	München		Germany	80638
681	Research Site	Regensburg		Germany	93053
682	Research Site	Stuttgart		Germany	70376
683	Research Site	Ulm		Germany	89081
684	Research Site	Witten		Germany	58455
685	Research Site	Wuppertal		Germany	42117
686	Research Site	Alexandroupoli		Greece	68100
687	Research Site	Athens		Greece	10676
688	Research Site	Athens		Greece	11521
689	Research Site	Athens		Greece	11527
690	Research Site	Athens		Greece	12462
691	Research Site	Athens		Greece	14233
692	Research Site	Athens		Greece	14561
693	Research Site	Athens		Greece	15123
694	Research Site	Athens		Greece	16673
695	Research Site	Athens		Greece	17674
696	Research Site	Chalkida		Greece	34100
697	Research Site	Heraklion		Greece	71110
698	Research Site	Ioannina		Greece	45500
699	Research Site	Larissa		Greece	41110
700	Research Site	Nikaia, Piraeus		Greece	18454
701	Research Site	Piraeus		Greece	18536
702	Research Site	Rhodes		Greece	85100
703	Research Site	Thessaloniki		Greece	54636
704	Research Site	Thessaloniki		Greece	54642
705	Research Site	Hong Kong		Hong Kong
706	Research Site	New Territories		Hong Kong
707	Research Site	Balatonfured		Hungary	8230
708	Research Site	Bekescsaba		Hungary	5600
709	Research Site	Berettyoujfalu		Hungary	4100
710	Research Site	Budapest		Hungary	1027
711	Research Site	Budapest		Hungary	1036
712	Research Site	Budapest		Hungary	1085
713	Research Site	Budapest		Hungary	1096
714	Research Site	Budapest		Hungary	1122
715	Research Site	Budapest		Hungary	1125
716	Research Site	Budapest		Hungary	1134
717	Research Site	Cegled		Hungary	2700
718	Research Site	Debrecen		Hungary	4032
719	Research Site	Gyongyos		Hungary	3200
720	Research Site	Gyula		Hungary	5700
721	Research Site	Kaposvar		Hungary	7400
722	Research Site	Kecskemet		Hungary	6000
723	Research Site	Komarom		Hungary	2921
724	Research Site	Miskolc		Hungary	3529
725	Research Site	Nyiregyhaza		Hungary	4400
726	Research Site	Pecs		Hungary	7624
727	Research Site	Szeged		Hungary	6725
728	Research Site	Szekszard		Hungary	7100
729	Research Site	Szolnok		Hungary	5004
730	Research Site	Zalaegerszeg		Hungary	8900
731	Research Site	Kopavogur		Iceland	201
732	Research Site	Reykjavik		Iceland	101
733	Research Site	Vijayawada	Andhra Pradesh	India	520 008
734	Research Site	New Delhi	Delhi	India	110 002
735	Research Site	Ahmedabad	Gujarat	India	380 008
736	Research Site	Ahmedabad	Gujarat	India	380 016
737	Research Site	Ahmedabad	Gujarat	India	380 054
738	Research Site	Ahmedabad	Gujarat	India	380 060
739	Research Site	Vadodara	Gujarat	India	390 001
740	Research Site	Gurgaon	Haryana	India	122 001
741	Research Site	Belgaum	Karnataka	India	590 010
742	Research Site	Mysore	Karnataka	India	570 001
743	Research Site	Mumbai	Maharashtra	India	400 007
744	Research Site	Mumbai	Maharashtra	India	400 008
745	Research Site	Mumbai	Maharashtra	India	400 022
746	Research Site	Nagpur	Maharashtra	India	440 003
747	Research Site	Pune	Maharashtra	India	411 005
748	Research Site	Pune	Maharashtra	India	411 006
749	Research Site	Pune	Maharashtra	India	411 019
750	Research Site	Lucknow	Uttar Pradesh	India	226 003
751	Research Site	Kolkata	West Bengal	India	700 020
752	Research Site	Ballinasloe		Ireland
753	Research Site	Dublin		Ireland	8
754	Research Site	Dublin		Ireland	9
755	Research Site	Galway		Ireland
756	Research Site	Hadera		Israel	38100
757	Research Site	Haifa		Israel	31048
758	Research Site	Haifa		Israel	34362
759	Research Site	Herzliya-on-sea		Israel	46851
760	Research Site	Holon		Israel	58100
761	Research Site	Jerusalem		Israel	91031
762	Research Site	Nahariya		Israel	22100
763	Research Site	Netanya		Israel	42470
764	Research Site	Rehovot		Israel	76100
765	Research Site	Tel Aviv		Israel	64239
766	Research Site	Tel Hashomer		Israel	52621
767	Research Site	Ascoli Piceno		Italy	63100
768	Research Site	Bergamo		Italy	24127
769	Research Site	Bologna		Italy	40138
770	Research Site	Chieti		Italy	66100
771	Research Site	Colleferro RM		Italy	00034
772	Research Site	Cortona AR		Italy	52044
773	Research Site	Firenze		Italy	50139
774	Research Site	L' Aquila		Italy	67100
775	Research Site	Milano		Italy	20138
776	Research Site	Milano		Italy	20162
777	Research Site	Napoli		Italy	80131
778	Research Site	Palermo		Italy	90126
779	Research Site	Parma		Italy	43100
780	Research Site	Pavia		Italy	27100
781	Research Site	Perugia		Italy	06129
782	Research Site	Pisa		Italy	56124
783	Research Site	Roma		Italy	00161
784	Research Site	Roma		Italy	00168
785	Research Site	Sanremo (IM)		Italy	18038
786	Research Site	Siena		Italy	53100
787	Research Site	Ichinomiya-shi	Aichi	Japan	491-8551
788	Research Site	Kasugai-shi	Aichi	Japan	487-0031
789	Research Site	Nagoya-shi	Aichi	Japan	451-8511
790	Research Site	Nagoya-shi	Aichi	Japan	455-8530
791	Research Site	Nagoya-shi	Aichi	Japan	457-8511
792	Research Site	Nagoya-shi	Aichi	Japan	460-0001
793	Research Site	Toyohashi-shi	Aichi	Japan	440-8510
794	Research Site	Chiba-shi	Chiba	Japan	260-8606
795	Research Site	Matsudo-shi	Chiba	Japan	271-0077
796	Research Site	Niihama-shi	Ehime	Japan	792-8586
797	Research Site	Saijo-shi	Ehime	Japan	793-0030
798	Research Site	Chikushi-gun	Fukuoka	Japan	811-1244
799	Research Site	Chikushino-shi	Fukuoka	Japan	818-8516
800	Research Site	Fukuoka-shi	Fukuoka	Japan	814-0180
801	Research Site	Fukuoka-shi	Fukuoka	Japan	814-8522
802	Research Site	Itoshima-shi	Fukuoka	Japan	819-1104
803	Research Site	Koga-shi	Fukuoka	Japan	811-3195
804	Research Site	Kurume-shi	Fukuoka	Japan	830-0011
805	Research Site	Kurume-shi	Fukuoka	Japan	830-8577
806	Research Site	Okawa-shi	Fukuoka	Japan	831-0016
807	Research Site	Koriyama-shi	Fukushima	Japan	963-8052
808	Research Site	Kure-shi	Hiroshima	Japan	737-0023
809	Research Site	Otake-shi	Hiroshima	Japan	739-0651
810	Research Site	Asahikawa-shi	Hokkaido	Japan	070-0054
811	Research Site	Sapporo-shi	Hokkaido	Japan	060-0031
812	Research Site	Himeji-shi	Hyogo	Japan	672-8043
813	Research Site	Kobe-shi	Hyogo	Japan	654-0155
814	Research Site	Toride-shi	Ibaraki	Japan	302-0022
815	Research Site	Tsukuba-city	Ibaraki	Japan	305-8558
816	Research Site	Kanazawa-shi	Ishikawa	Japan	920-8650
817	Research Site	Sanuki-shi	Kagawa	Japan	769-2393
818	Research Site	Fujisawa-shi	Kanagawa	Japan	251-8550
819	Research Site	Odawara-shi	Kanagawa	Japan	250-8558
820	Research Site	Sagamihara-shi	Kanagawa	Japan	252-0375
821	Research Site	Yokohama-shi	Kanagawa	Japan	245-8575
822	Research Site	Kumamoto-shi	Kumamoto	Japan	860-8556
823	Research Site	Kyoto-shi	Kyoto	Japan	615-0035
824	Research Site	Sendai-shi	Miyagi	Japan	983-8520
825	Research Site	Higashisonogi-gun	Nagasaki	Japan	859-3615
826	Research Site	Nagasaki-shi	Nagasaki	Japan	850-8555
827	Research Site	Omura-shi	Nagasaki	Japan	856-8562
828	Research Site	Oita-shi	Oita	Japan	870-0263
829	Research Site	Okayama-shi	Okayama	Japan	702-8055
830	Research Site	Okinawa-shi	Okinawa	Japan	904-8585
831	Research Site	Shimajiri-gun	Okinawa	Japan	901-0493
832	Research Site	Urasoe-shi	Okinawa	Japan	901-2132
833	Research Site	Osaka-shi	Osaka	Japan	530-0001
834	Research Site	Osaka-shi	Osaka	Japan	530-8480
835	Research Site	Osaka-shi	Osaka	Japan	543-0035
836	Research Site	Osaka-shi	Osaka	Japan	550-0022
837	Research Site	Saga-shi	Saga	Japan	840-8571
838	Research Site	Saga-shi	Saga	Japan	849-0917
839	Research Site	Kawaguchi-shi	Saitama	Japan	332-8558
840	Research Site	Kusatsu-shi	Shiga	Japan	525-8585
841	Research Site	Hamada-shi	Shimane	Japan	697-8511
842	Research Site	Sunto-gun	Shizuoka	Japan	411-8611
843	Research Site	Komatsushima-shi	Tokushima	Japan	773-8502
844	Research Site	Bunkyo-ku	Tokyo	Japan	113-8431
845	Research Site	Chuo-ku	Tokyo	Japan	103-0027
846	Research Site	Hachioji-shi	Tokyo	Japan	192-0918
847	Research Site	Itabashi-ku	Tokyo	Japan	173-8606
848	Research Site	Itabashi-ku	Tokyo	Japan	173-8610
849	Research Site	Musashimurayama-shi	Tokyo	Japan	208-0011
850	Research Site	Tachikawa-shi	Tokyo	Japan	190-0014
851	Research Site	Chuo-shi	Yamanashi	Japan	409-3898
852	Research Site	Busan, Seo-gu		Korea, Republic of	602-715
853	Research Site	Daejeon		Korea, Republic of	301-723
854	Research Site	Daejeon		Korea, Republic of	371-718
855	Research Site	Goyang-si, Gyeonggi-do		Korea, Republic of	411-706
856	Research Site	Gwangju		Korea, Republic of	501-757
857	Research Site	Seongnam-si		Korea, Republic of	463-707
858	Research Site	Seoul		Korea, Republic of	110-746
859	Research Site	Seoul		Korea, Republic of	120-752
860	Research Site	Seoul		Korea, Republic of	130-872
861	Research Site	Seoul		Korea, Republic of	135-700
862	Research Site	Seoul		Korea, Republic of	135-710
863	Research Site	Seoul		Korea, Republic of	137-701
864	Research Site	Seoul		Korea, Republic of	138-736
865	Research Site	Seoul		Korea, Republic of	152-703
866	Research Site	Seoul		Korea, Republic of	156-707
867	Research Site	Seoul		Korea, Republic of	158-710
868	Research Site	Suwon-si		Korea, Republic of	443-380
869	Research Site	Daugavpils		Latvia	5417
870	Research Site	Daugavpils		Latvia	LV-5410
871	Research Site	Kuldiga		Latvia	LV-3301
872	Research Site	Liepaja		Latvia	LV-3414
873	Research Site	Ogre		Latvia	5001
874	Research Site	Ogre		Latvia	LV-5003
875	Research Site	Riga		Latvia	1002
876	Research Site	Riga		Latvia	1012
877	Research Site	Riga		Latvia	LV-1001
878	Research Site	Kaunas		Lithuania	48259
879	Research Site	Kaunas		Lithuania	50009
880	Research Site	Klaipeda		Lithuania	94231
881	Research Site	Vilnius		Lithuania	08661
882	Research Site	Vilnius		Lithuania	10323
883	Research Site	Johor Bahru	Johor	Malaysia	80100
884	Research Site	Taiping	Perak	Malaysia	34000
885	Research Site	Kota Kinabalu	Sabah	Malaysia	88300
886	Research Site	Kuala Lumpur	Wilayah Persekutuan	Malaysia	50400
887	Research Site	Kuala Lumpur	Wilayah Persekutuan	Malaysia	56000
888	Research Site	Georgetown		Malaysia	10400
889	Research Site	Kuala Lumpur		Malaysia	59100
890	Research Site	Melaka		Malaysia	75400
891	Research Site	Penang		Malaysia	10050
892	Research Site	Torreon	Coahuila	Mexico	27000
893	Research Site	Mexico	Distrito Federal	Mexico	03800
894	Research Site	Mexico	Distrito Federal	Mexico	14380
895	Research Site	Leon	Guanajuato	Mexico	37520
896	Research Site	Guadalajara	Jalisco	Mexico	44150
897	Research Site	Guadalajara	Jalisco	Mexico	44210
898	Research Site	Guadalajara	Jalisco	Mexico	44340
899	Research Site	Guadalajara	Jalisco	Mexico	44380
900	Research Site	Guadalajara	Jalisco	Mexico	44600
901	Research Site	Monterrey	Nuevo León	Mexico	64718
902	Research Site	Queretaro	Querétaro	Mexico	76000
903	Research Site	San Luis Potosi	San Luis Potosí	Mexico	78240
904	Research Site	Culiacan	Sinaloa	Mexico	80230
905	Research Site	Tampico	Tamaulipas	Mexico	89000
906	Research Site	Xalapa	Veracruz	Mexico	91193
907	Research Site	Aguascalientes		Mexico	20230
908	Research Site	Chihuahua		Mexico	31217
909	Research Site	Alkmaar		Netherlands	1815 JD
910	Research Site	Almelo		Netherlands	7609 PP
911	Research Site	Amstelveen		Netherlands	1186 AM
912	Research Site	Amsterdam		Netherlands	1061 AE
913	Research Site	Amsterdam		Netherlands	1091 AC
914	Research Site	Arnhem		Netherlands	6815 AD
915	Research Site	Beverwijk		Netherlands	1942 LE
916	Research Site	Den Helder		Netherlands	1782 GZ
917	Research Site	Deventer		Netherlands	7416 SE
918	Research Site	Doetinchem		Netherlands	7009 BL
919	Research Site	Ede		Netherlands	6716 RP
920	Research Site	Eindhoven		Netherlands	5623 EJ
921	Research Site	Eindhoven		Netherlands	5631 BM
922	Research Site	Goes		Netherlands	4462 RA
923	Research Site	Gorinchem		Netherlands	4204 AA
924	Research Site	Gouda		Netherlands	2803 HH
925	Research Site	Harderwijk		Netherlands	3844 DG
926	Research Site	Helmond		Netherlands	5707 HA
927	Research Site	Hoogeveen		Netherlands	7909 AA
928	Research Site	Hoorn		Netherlands	1624 NP
929	Research Site	Leiden		Netherlands	2333 ZA
930	Research Site	Leiden		Netherlands	2334 CK
931	Research Site	Nieuwegein		Netherlands	3435 CM
932	Research Site	Nijmegen		Netherlands	6532 SZ
933	Research Site	Purmerend		Netherlands	1440 AG
934	Research Site	Rotterdam		Netherlands	3045 PM
935	Research Site	Rotterdam		Netherlands	3079 DZ
936	Research Site	Sneek		Netherlands	8601 ZK
937	Research Site	Tiel		Netherlands	4002 WP
938	Research Site	Tilburg		Netherlands	5042 AD
939	Research Site	Uden		Netherlands	5406 PT
940	Research Site	Veldhoven		Netherlands	5504 DB
941	Research Site	Venlo		Netherlands	5912 BL
942	Research Site	Christchurch		New Zealand	8011
943	Research Site	Papatoetoe, Auckland		New Zealand	2025
944	Research Site	Tauranga		New Zealand	3143
945	Research Site	Bekkestua		Norway	1357
946	Research Site	Bodø		Norway	8092
947	Research Site	Hamar		Norway	2317
948	Research Site	Lierskogen		Norway	3420
949	Research Site	Oslo		Norway	0450
950	Research Site	Skedsmokorset		Norway	2020
951	Research Site	Skien		Norway	3710
952	Research Site	Stavanger		Norway	4005
953	Research Site	Ålesund		Norway	6003
954	Research Site	Davao City	Davao	Philippines	8000
955	Research Site	Angeles		Philippines	2009
956	Research Site	Baguio City		Philippines	2600
957	Research Site	Dasmariñas Cavite		Philippines	4114
958	Research Site	Iloilo		Philippines	5000
959	Research Site	Makati City		Philippines	1218
960	Research Site	Manila		Philippines	1113
961	Research Site	Marikiina		Philippines	1800
962	Research Site	Quezon City		Philippines	1100
963	Research Site	Quezon City		Philippines	1102
964	Research Site	Bielsko-Biala		Poland	43-316
965	Research Site	Bydgoszcz		Poland	85-094
966	Research Site	Gdansk		Poland	80-542
967	Research Site	Gdansk		Poland	80-952
968	Research Site	Gdynia		Poland	81-384
969	Research Site	Gdynia		Poland	81-402
970	Research Site	Gdynia		Poland	81-472
971	Research Site	Gizycko		Poland	11-500
972	Research Site	Jelenia Gora		Poland	58-506
973	Research Site	Katowice		Poland	40-018
974	Research Site	Katowice		Poland	40-040
975	Research Site	Katowice		Poland	40-084
976	Research Site	Kielce		Poland	25-020
977	Research Site	Krakow		Poland	30-001
978	Research Site	Krakow		Poland	30-347
979	Research Site	Krakow		Poland	31-202
980	Research Site	Krakow		Poland	31-216
981	Research Site	Krakow		Poland	31-315
982	Research Site	Krakow		Poland	32-082
983	Research Site	Lodz		Poland	90-368
984	Research Site	Lodz		Poland	90-549
985	Research Site	Lodz		Poland	91-347
986	Research Site	Lodz		Poland	93-530
987	Research Site	Lublin		Poland	20-045
988	Research Site	Lublin		Poland	20-080
989	Research Site	Lublin		Poland	20-857
990	Research Site	Nowa Sol		Poland	67-100
991	Research Site	Nysa		Poland	48-300
992	Research Site	Olsztyn		Poland	10-010
993	Research Site	Plock		Poland	09-402
994	Research Site	Poznan		Poland	60-702
995	Research Site	Poznan		Poland	61-113
996	Research Site	Poznan		Poland	61-853
997	Research Site	Pszczyna		Poland	43-200
998	Research Site	Pulawy		Poland	24-100
999	Research Site	Ruda Slaska		Poland	41-709
1000	Research Site	Skierniewice		Poland	96-100
1001	Research Site	Starogard Gdanski		Poland	83-200
1002	Research Site	Staszow		Poland	28-200
1003	Research Site	Swidnik		Poland	21-040
1004	Research Site	Tarnow		Poland	33-100
1005	Research Site	Torun		Poland	87-100
1006	Research Site	Warszawa		Poland	01-192
1007	Research Site	Warszawa		Poland	01-809
1008	Research Site	Warszawa		Poland	02-097
1009	Research Site	Warszawa		Poland	02-507
1010	Research Site	Warszawa		Poland	04-628
1011	Research Site	Warszawa		Poland	04-730
1012	Research Site	Warszawa		Poland	04-749
1013	Research Site	Wloclawek		Poland	87-800
1014	Research Site	Wroclaw		Poland	50-088
1015	Research Site	Wroclaw		Poland	50-349
1016	Research Site	Wroclaw		Poland	51-685
1017	Research Site	Zamosc		Poland	22-400
1018	Research Site	Almada		Portugal	2801-951
1019	Research Site	Amadora		Portugal	2720-276
1020	Research Site	Carnaxide		Portugal	2790-134
1021	Research Site	Coimbra		Portugal	3000-075
1022	Research Site	Covilha		Portugal	6200-251
1023	Research Site	Lisboa		Portugal	1169-024
1024	Research Site	Lisboa		Portugal	1350-070
1025	Research Site	Lisboa		Portugal	1449-005
1026	Research Site	Porto		Portugal	4100-180
1027	Research Site	Setubal		Portugal	2910-446
1028	Research Site	Bucharest		Romania	010242
1029	Research Site	Bucharest		Romania	011601
1030	Research Site	Bucharest		Romania	020125
1031	Research Site	Bucuresti		Romania	020054
1032	Research Site	Bucuresti		Romania	021659
1033	Research Site	Bucuresti		Romania	030463
1034	Research Site	Bucuresti		Romania	042122
1035	Research Site	Cluj-Napoca		Romania	400347
1036	Research Site	Craiova		Romania	200147
1037	Research Site	Iasi		Romania	700503
1038	Research Site	Iasi		Romania	700547
1039	Research Site	Iasi		Romania	700661
1040	Research Site	Oradea		Romania	410169
1041	Research Site	Timisoara		Romania	300079
1042	Research Site	Timisoara		Romania	300158
1043	Research Site	Timisoara		Romania	300736
1044	Research Site	Barnaul		Russian Federation	656038
1045	Research Site	Barnaul		Russian Federation	656055
1046	Research Site	Ekaterinburg		Russian Federation	620102
1047	Research Site	Ekaterinburg		Russian Federation	620144
1048	Research Site	Ivanovo		Russian Federation	153012
1049	Research Site	Izhevsk		Russian Federation	426063
1050	Research Site	Kemerovo		Russian Federation	650002
1051	Research Site	Kemerovo		Russian Federation	650099
1052	Research Site	Kirov		Russian Federation	610014
1053	Research Site	Moscow		Russian Federation	101990
1054	Research Site	Moscow		Russian Federation	111020
1055	Research Site	Moscow		Russian Federation	111539
1056	Research Site	Moscow		Russian Federation	117292
1057	Research Site	Moscow		Russian Federation	117342
1058	Research Site	Moscow		Russian Federation	119620
1059	Research Site	Moscow		Russian Federation	121552
1060	Research Site	Moscow		Russian Federation	129090
1061	Research Site	Nizhniy Novgorod		Russian Federation	603076
1062	Research Site	Novosibirsk		Russian Federation	630047
1063	Research Site	Novosibirsk		Russian Federation	630089
1064	Research Site	Omsk		Russian Federation	644018
1065	Research Site	Pushkin		Russian Federation	196601
1066	Research Site	Saint Petersburg		Russian Federation	192289
1067	Research Site	Saint Petersburg		Russian Federation	195112
1068	Research Site	Saint Petersburg		Russian Federation	197022
1069	Research Site	Saint Petersburg		Russian Federation	197341
1070	Research Site	Saint Petersburg		Russian Federation	198205
1071	Research Site	Saint-Petersburg		Russian Federation	194156
1072	Research Site	Saint-Petersburg		Russian Federation	197022
1073	Research Site	Saint-Petersburg		Russian Federation	199106
1074	Research Site	Saratov		Russian Federation	410054
1075	Research Site	St. Petersburg		Russian Federation	191015
1076	Research Site	Tomsk		Russian Federation	634012
1077	Research Site	Tyumen		Russian Federation	625000
1078	Research Site	Singapore		Singapore	169609
1079	Research Site	Singapore		Singapore	529889
1080	Research Site	Singapore		Singapore	768828
1081	Research Site	Banovce nad Bebravou		Slovakia	957 01
1082	Research Site	Bardejov		Slovakia	085 01
1083	Research Site	Bratislava		Slovakia	811 04
1084	Research Site	Bratislava		Slovakia	811 08
1085	Research Site	Bratislava		Slovakia	833 48
1086	Research Site	Brezno		Slovakia	977 42
1087	Research Site	Dolny Kubin		Slovakia	026 01
1088	Research Site	Kosice		Slovakia	040 01
1089	Research Site	Kosice		Slovakia	040 22
1090	Research Site	Lucenec		Slovakia	984 01
1091	Research Site	Martin		Slovakia	036 59
1092	Research Site	Moldava nad Bodvou		Slovakia	045 01
1093	Research Site	Nitra		Slovakia	949 01
1094	Research Site	Nove Zamky		Slovakia	940 01
1095	Research Site	Presov		Slovakia	080 01
1096	Research Site	Rimavska Sobota		Slovakia	979 01
1097	Research Site	Roznava		Slovakia	048 01
1098	Research Site	Snina		Slovakia	069 01
1099	Research Site	Svidnik		Slovakia	089 01
1100	Research Site	Trencin		Slovakia	911 01
1101	Research Site	Trnava		Slovakia	917 01
1102	Research Site	Port Elizabeth	Eastern Cape	South Africa	6001
1103	Research Site	Bloemfontein	Free State	South Africa	9301
1104	Research Site	Alberton	Gauteng	South Africa	1449
1105	Research Site	Alberton	Gauteng	South Africa	1450
1106	Research Site	Boksburg	Gauteng	South Africa	1459
1107	Research Site	Centurion	Gauteng	South Africa	0157
1108	Research Site	Johannesburg	Gauteng	South Africa	1724
1109	Research Site	Johannesburg	Gauteng	South Africa	2196
1110	Research Site	Midrand	Gauteng	South Africa	1685
1111	Research Site	Pretoria west	Gauteng	South Africa	0183
1112	Research Site	Pretoria	Gauteng	South Africa	0040
1113	Research Site	Pretoria	Gauteng	South Africa	0087
1114	Research Site	Pretoria	Gauteng	South Africa	0158
1115	Research Site	Pretoria	Gauteng	South Africa	0184
1116	Research Site	Soweto	Gauteng	South Africa	2013
1117	Research Site	Sunninghill	Gauteng	South Africa	2157
1118	Research Site	Amanzimtoti	KwaZulu-Natal	South Africa	4126
1119	Research Site	Durban	KwaZulu-Natal	South Africa	4001
1120	Research Site	Durban	KwaZulu-Natal	South Africa	4321
1121	Research Site	Tongaat	KwaZulu-Natal	South Africa	4400
1122	Research Site	Kuils River	Western Cape	South Africa	7580
1123	Research Site	Paarl	Western Cape	South Africa	7646
1124	Research Site	Parow	Western Cape	South Africa	7505
1125	Research Site	Somerset West	Western Cape	South Africa	7130
1126	Research Site	Worcester	Western Cape	South Africa	6850
1127	Research Site	Cape Town		South Africa	7405
1128	Research Site	Cape Town		South Africa	7530
1129	Research Site	Kempton Park		South Africa	1619
1130	Research Site	Almeria	Andalucía	Spain	04120
1131	Research Site	Cordoba	Andalucía	Spain	14004
1132	Research Site	Zaragoza	Aragón	Spain	50009
1133	Research Site	L'Hospitalet de Llobregat	Cataluña	Spain	08907
1134	Research Site	San Juan de Alicante	Comunidad Valenciana	Spain	03550
1135	Research Site	Valencia	Comunidad Valenciana	Spain	46010
1136	Research Site	Santiago de Compostela	Galicia	Spain	15706
1137	Research Site	Vigo	Galicia	Spain	36312
1138	Research Site	El Palmar	Murcia	Spain	30120
1139	Research Site	Galdakao	País Vasco	Spain	48960
1140	Research Site	Madrid		Spain	28007
1141	Research Site	Madrid		Spain	28034
1142	Research Site	Bollnäs		Sweden	821 81
1143	Research Site	Eksjö		Sweden	575 81
1144	Research Site	Eskilstuna		Sweden	631 88
1145	Research Site	Falun		Sweden	791 82
1146	Research Site	Helsingborg		Sweden	251 87
1147	Research Site	Jönköping		Sweden	551 85
1148	Research Site	Linköping		Sweden	581 85
1149	Research Site	Luleå		Sweden	971 80
1150	Research Site	Lund		Sweden	221 85
1151	Research Site	Lund		Sweden	222 21
1152	Research Site	Stockholm		Sweden	111 57
1153	Research Site	Stockholm		Sweden	118 83
1154	Research Site	Stockholm		Sweden	141 86
1155	Research Site	Stockholm		Sweden	171 76
1156	Research Site	Uddevalla		Sweden	451 50
1157	Research Site	Umeå		Sweden	901 85
1158	Research Site	Västerås		Sweden	721 89
1159	Research Site	Örebro		Sweden	701 85
1160	Research Site	Östersund		Sweden	831 83
1161	Research Site	Baden		Switzerland	5404
1162	Research Site	Basel		Switzerland	4031
1163	Research Site	Bern		Switzerland	3010
1164	Research Site	Geneva 14		Switzerland	1211
1165	Research Site	Lausanne		Switzerland	1011
1166	Research Site	Lugano		Switzerland	6900
1167	Research Site	Sion		Switzerland	1950
1168	Research Site	Winterthur		Switzerland	8401
1169	Research Site	Zurich		Switzerland	8063
1170	Research Site	New Taipei City	Taipei	Taiwan	251
1171	Research Site	Changhua		Taiwan	50006
1172	Research Site	Kaohsiung		Taiwan	807
1173	Research Site	Kaohsiung		Taiwan	83301
1174	Research Site	Taichung City		Taiwan	402
1175	Research Site	Tainan		Taiwan	710
1176	Research Site	Taipei		Taiwan	100
1177	Research Site	Taipei		Taiwan	10630
1178	Research Site	Taipei		Taiwan	11217
1179	Research Site	Taoyuan		Taiwan	33305
1180	Research Site	Adana		Turkey	01330
1181	Research Site	Ankara		Turkey	06100
1182	Research Site	Ankara		Turkey	06490
1183	Research Site	Istanbul		Turkey	34096
1184	Research Site	Istanbul		Turkey	34865
1185	Research Site	Izmir		Turkey	35000
1186	Research Site	Izmir		Turkey	35100
1187	Research Site	Kocaeli		Turkey	41380
1188	Research Site	Konya		Turkey	42080
1189	Research Site	Sivas		Turkey	58140
1190	Research Site	Cherkasy		Ukraine	18009
1191	Research Site	Ivano-Frankivsk		Ukraine	76018
1192	Research Site	Kharkiv		Ukraine	61002
1193	Research Site	Kharkiv		Ukraine	61018
1194	Research Site	Kharkiv		Ukraine	61039
1195	Research Site	Kharkiv		Ukraine	61106
1196	Research Site	Kharkiv		Ukraine	61176
1197	Research Site	Kyiv		Ukraine	01023
1198	Research Site	Kyiv		Ukraine	02002
1199	Research Site	Kyiv		Ukraine	02091
1200	Research Site	Kyiv		Ukraine	02232
1201	Research Site	Kyiv		Ukraine	02660
1202	Research Site	Kyiv		Ukraine	03049
1203	Research Site	Kyiv		Ukraine	03680
1204	Research Site	Kyiv		Ukraine	04114
1205	Research Site	Lugansk		Ukraine	91045
1206	Research Site	Uzhgorod		Ukraine	88000
1207	Research Site	Vinnytsia		Ukraine	21018
1208	Research Site	Vinnytsia		Ukraine	21029
1209	Research Site	Zaporizhzhia		Ukraine	69000
1210	Research Site	Zaporizhzhia		Ukraine	69035
1211	Research Site	Zaporizhzhya		Ukraine	69600
1212	Research Site	Aberdeen		United Kingdom	AB25 2ZN
1213	Research Site	Addlestone		United Kingdom	KT15 2BH
1214	Research Site	Arnsley		United Kingdom	S75 2EP
1215	Research Site	Basildon		United Kingdom	SS16 5NL
1216	Research Site	Belfast		United Kingdom	BT12 6BA
1217	Research Site	Belfast		United Kingdom	BT13 3BW
1218	Research Site	Belfast		United Kingdom	BT16 1RH
1219	Research Site	Belfast		United Kingdom	BT7 2EB
1220	Research Site	Birmingham		United Kingdom	B15 2SQ
1221	Research Site	Birmingham		United Kingdom	B18 7QH
1222	Research Site	Blackpool		United Kingdom	FY3 8NR
1223	Research Site	Bournemouth		United Kingdom	BH7 7DW
1224	Research Site	Bury St Edmunds		United Kingdom	IP33 2QZ
1225	Research Site	Canterbury		United Kingdom	CT1 3NG
1226	Research Site	Cardiff		United Kingdom	CF14 5GJ
1227	Research Site	Cardiff		United Kingdom	CF4 4XW
1228	Research Site	Chesterfield		United Kingdom	S40 4AA
1229	Research Site	Chippenham		United Kingdom	SN15 2SB
1230	Research Site	Chorley		United Kingdom	PR7 7NA
1231	Research Site	Colchester		United Kingdom	CO4 5JL
1232	Research Site	Cottingham		United Kingdom	HU16 5JQ
1233	Research Site	Coventry		United Kingdom	CV4 7AL
1234	Research Site	Dundee		United Kingdom	DD1 9SY
1235	Research Site	Edinburgh		United Kingdom	EH16 4SB
1236	Research Site	Glasgow		United Kingdom	G20 0SP
1237	Research Site	Glasgow		United Kingdom	G45 9AW
1238	Research Site	Glasgow		United Kingdom	G51 4TF
1239	Research Site	Harrow		United Kingdom	HA1 3UJ
1240	Research Site	Haxey, Doncaster		United Kingdom	DN9 2HY
1241	Research Site	Hayle		United Kingdom	TR27 5DT
1242	Research Site	Hexham		United Kingdom	NE46 1QJ
1243	Research Site	Hitchin		United Kingdom	SG4 9TH
1244	Research Site	Inverness		United Kingdom	IV2 3JH
1245	Research Site	Leamington Spa		United Kingdom	CV34 4RA
1246	Research Site	Leeds		United Kingdom	LS1 3EX
1247	Research Site	Leicester		United Kingdom	LE3 9QP
1248	Research Site	Liverpool		United Kingdom	L22 0LG
1249	Research Site	Liverpool		United Kingdom	L7 8XP
1250	Research Site	Liverpool		United Kingdom	L9 7AL
1251	Research Site	London		United Kingdom	EC1M 6BQ
1252	Research Site	London		United Kingdom	SE1 7EH
1253	Research Site	London		United Kingdom	W12 0HS
1254	Research Site	Luton		United Kingdom	LU4 0DZ
1255	Research Site	Manchester		United Kingdom	M15 6SX
1256	Research Site	Manchester		United Kingdom	M23 9LT
1257	Research Site	Middlesbrough		United Kingdom	TS4 3BW
1258	Research Site	Newport		United Kingdom	PO30 5TG
1259	Research Site	Northampton		United Kingdom	NN1 5BD
1260	Research Site	Nottingham		United Kingdom	NG5 1PB
1261	Research Site	Nuneaton		United Kingdom	CV10 7DJ
1262	Research Site	Penzance		United Kingdom	TR18 2RE
1263	Research Site	Penzance		United Kingdom	TR18 4EL
1264	Research Site	Penzance		United Kingdom	TR19 7HX
1265	Research Site	Plymouth		United Kingdom	PL6 8DH
1266	Research Site	Portsmouth		United Kingdom	PO6 3LY
1267	Research Site	Reading		United Kingdom	RG2 0TF
1268	Research Site	Rotherham		United Kingdom	S60 2UD
1269	Research Site	Rugby		United Kingdom	CV22 5PX
1270	Research Site	Sandbach		United Kingdom	CW11 1EQ
1271	Research Site	Sheffield		United Kingdom	S5 7AU
1272	Research Site	St Austell		United Kingdom	PL26 7RL
1273	Research Site	St. Leonards-on-Sea		United Kingdom	TN37 7RD
1274	Research Site	Stevenage		United Kingdom	SG1 4AB
1275	Research Site	Stoke-on-Trent		United Kingdom	ST4 6DG
1276	Research Site	Swansea		United Kingdom	SA2 8PP
1277	Research Site	Telford		United Kingdom	TF1 6TF
1278	Research Site	Torquay		United Kingdom	TQ2 7AA
1279	Research Site	Welwyn Garden City		United Kingdom	AL7 4HQ
1280	Research Site	West Bromwich		United Kingdom	B71 4HJ
1281	Research Site	Whitby		United Kingdom	YO21 1SD
1282	Research Site	Wiltshire		United Kingdom	BA15 1DQ
1283	Research Site	Wirral		United Kingdom	CH49 5PE
1284	Research Site	Wolverhampton		United Kingdom	WV10 0QP
1285	Research Site	Worcester		United Kingdom	WR5 1DD
1286	Research Site	Wrexham		United Kingdom	LL13 7TD
1287	Research Site	York		United Kingdom	YO31 8HE

Sponsors and Collaborators

• Amgen

Investigators

• Study Director: MD, Amgen

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• AmgenTrials clinical trials website

Publications

• Fonarow GC, Keech AC, Pedersen TR, Giugliano RP, Sever PS, Lindgren P, van Hout B, Villa G, Qian Y, Somaratne R, Sabatine MS. Cost-effectiveness of Evolocumab Therapy for Reducing Cardiovascular Events in Patients With Atherosclerotic Cardiovascular Disease. JAMA Cardiol. 2017 Oct 1;2(10):1069-1078. doi: 10.1001/jamacardio.2017.2762. Erratum in: JAMA Cardiol. 2017 Oct 1;2(10):1170.
• Fonarow GC, van Hout B, Villa G, Arellano J, Lindgren P. Updated Cost-effectiveness Analysis of Evolocumab in Patients With Very High-risk Atherosclerotic Cardiovascular Disease. JAMA Cardiol. 2019 Jul 1;4(7):691-695. doi: 10.1001/jamacardio.2019.1647.
• Sabatine MS, Giugliano RP, Keech AC, Honarpour N, Wiviott SD, Murphy SA, Kuder JF, Wang H, Liu T, Wasserman SM, Sever PS, Pedersen TR; FOURIER Steering Committee and Investigators. Evolocumab and Clinical Outcomes in Patients with Cardiovascular Disease. N Engl J Med. 2017 May 4;376(18):1713-1722. doi: 10.1056/NEJMoa1615664. Epub 2017 Mar 17.
• Schludi B, Giugliano RP, Sabatine MS, Raal FJ, Teramoto T, Koren MJ, Stein EA, Wang H, Monsalvo ML. Time-averaged low-density lipoprotein cholesterol lowering with evolocumab: Pooled analysis of phase 2 trials. J Clin Lipidol. 2022 Jun 6. pii: S1933-2874(22)00174-X. doi: 10.1016/j.jacl.2022.05.069. [Epub ahead of print]

• Responsible Party: Amgen
• ClinicalTrials.gov Identifier: NCT01764633
• Other Study ID Numbers: 20110118; 2014/01/004324; 2012-001398-97
• First Posted: Jan 9, 2013
• Last Update Posted: Jul 22, 2022
• Last Verified: Jul 1, 2022

• Keywords provided by Amgen: High cholesterol; Treatment for high cholesterol; Lowering cholesterol; Lowering high cholesterol; Hypercholesterolemia
• Additional relevant MeSH terms: Dyslipidemias; Evolocumab

Study Results

Participant Flow

Recruitment Details	Participants were enrolled at 1242 clinical centers in 49 countries in the regions of Europe (62.9%), North America (16.6%), Asia Pacific (13.9%), and Latin America (6.6%) from 08 February 2013 to 05 June 2015.
Pre-assignment Detail	Eligible participants were randomized in a 1:1 ratio to receive either subcutaneous (SC) evolocumab or placebo. Randomization was stratified by the final screening low-density lipoprotein cholesterol (LDL-C) level (< 85 mg/dL vs ≥ 85 mg/dL) and by geographical region.

Arm/Group Title	Placebo	Evolocumab
Arm/Group Description	Participants received placebo subcutaneous injections either once every 2 weeks (Q2W) or once a month (QM) according to their own preference.	Participants received evolocumab subcutaneous injections either 140 mg Q2W or 420 mg QM according to their own preference.
Period Title: Overall Study
STARTED	13780	13784
Received Treatment	13756	13769
COMPLETED	13662	13691
NOT COMPLETED	118	93

Baseline Characteristics

Arm/Group Title	Placebo	Evolocumab	Total
Arm/Group Description	Participants received placebo subcutaneous injections either once every 2 weeks (Q2W) or once a month (QM) according to their own preference.	Participants received evolocumab subcutaneous injections either 140 mg Q2W or 420 mg QM according to their own preference.	Total of all reporting groups
Overall Participants	13780	13784	27564
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	62.5 (8.9)	62.5 (9.1)	62.5 (9.0)
Age, Customized (Count of Participants)
< 65 years	7687 55.8%	7623 55.3%	15310 55.5%
≥ 65 years	6093 44.2%	6161 44.7%	12254 44.5%
Sex: Female, Male (Count of Participants)
Female	3382 24.5%	3387 24.6%	6769 24.6%
Male	10398 75.5%	10397 75.4%	20795 75.4%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	1084 7.9%	1093 7.9%	2177 7.9%
Not Hispanic or Latino	12694 92.1%	12688 92%	25382 92.1%
Unknown or Not Reported	2 0%	3 0%	5 0%
Race/Ethnicity, Customized (Count of Participants)
American Indian or Alaska Native	80 0.6%	60 0.4%	140 0.5%
Asian	1349 9.8%	1374 10%	2723 9.9%
Black or African American	352 2.6%	317 2.3%	669 2.4%
Native Hawaiian or Other Pacific Islander	11 0.1%	15 0.1%	26 0.1%
White	11710 85%	11748 85.2%	23458 85.1%
Multiple	12 0.1%	19 0.1%	31 0.1%
Other	266 1.9%	251 1.8%	517 1.9%
Low-density Lipoprotein Cholesterol (Count of Participants)
< 85 mg/dL	4803 34.9%	4809 34.9%	9612 34.9%
≥ 85 mg/dL	8977 65.1%	8975 65.1%	17952 65.1%
Geographical Region (Count of Participants)
Europe	8669 62.9%	8667 62.9%	17336 62.9%
North America	2284 16.6%	2286 16.6%	4570 16.6%
Latin America	910 6.6%	913 6.6%	1823 6.6%
Asia Pacific	1917 13.9%	1918 13.9%	3835 13.9%

Outcome Measures

1. Primary Outcome

Title	Time to Cardiovascular Death, Myocardial Infarction, Hospitalization for Unstable Angina, Stroke, or Coronary Revascularization
Description	All deaths and potential endpoint events were adjudicated by an independent external Clinical Events Committee (CEC) led by the Thrombolysis in Myocardial Infarction (TIMI) Study Group, using standardized definitions based on the "Standardized Definitions for Cardiovascular and Stroke End Point Events in Clinical Trials and the Third Universal Definition of Myocardial Infarction". Time to cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization was defined as the time from randomization to the first occurrence of any component of the composite endpoint and was analyzed using Kaplan-Meier (KM) survival analysis. KM estimates of the percentage of participants with an event are reported. Participants with no event were censored based on last non-fatal potential endpoint collection date.
Time Frame	Events that occurred from randomization to the last confirmed survival status date; the median duration of follow-up was 26 months. KM estimates at 6, 12, 18, 24, 30 and 36 months are reported.

Outcome Measure Data

Analysis Population Description

All randomized participants; The number of participants entered at each time point represents the number of participants at risk.

Arm/Group Title	Placebo	Evolocumab
Arm/Group Description	Participants received placebo subcutaneous injections either once every 2 weeks (Q2W) or once a month (QM) according to their own preference.	Participants received evolocumab subcutaneous injections either 140 mg Q2W or 420 mg QM according to their own preference.
Measure Participants	13780	13784
KM estimate at 6 months	3.11 0%	2.74 0%
KM estimate at 12 months	6.01 0%	5.31 0%
KM estimate at 18 months	8.32 0.1%	7.25 0.1%
KM estimate at 24 months	10.66 0.1%	9.13 0.1%
KM estimate at 30 months	12.72 0.1%	10.91 0.1%
KM estimate at 36 months	14.64 0.1%	12.57 0.1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Evolocumab
	Comments	The primary endpoint was compared between treatment groups at a significance level of 0.05.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	< 0.0001
	Comments
	Method	Log Rank
	Comments	Two-sided log-rank test stratified by randomization stratification factors (final screening LDL-C level and region).
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.85
	Confidence Interval	(2-Sided) 95%; 0.79 to 0.92
	Parameter Dispersion	Type: Value:
	Estimation Comments	Based on a Cox model stratified by the randomization stratification factors.

2. Secondary Outcome

Title	Time to Cardiovascular Death, Myocardial Infarction, or Stroke
Description	All deaths and potential endpoint events were adjudicated by an independent external CEC led by the TIMI Study Group, using standardized definitions based on the "Standardized Definitions for Cardiovascular and Stroke End Point Events in Clinical Trials and the Third Universal Definition of Myocardial Infarction". Time to cardiovascular death, myocardial infarction, or stroke was defined as the time from randomization to the first occurrence of any component of the composite endpoint and was analyzed using Kaplan-Meier (KM) survival analysis. KM estimates of the percentage of participants with an event are reported. Participants with no event were censored based on last non-fatal potential endpoint collection date.
Time Frame	Events that occurred from randomization to the last confirmed survival status date; the median duration of follow-up was 26 months. KM estimates at 6, 12, 18, 24, 30 and 36 months are reported.

Outcome Measure Data

Analysis Population Description

All randomized participants; The number of participants entered at each time point represents the number of participants at risk.

Arm/Group Title	Placebo	Evolocumab
Arm/Group Description	Participants received placebo subcutaneous injections either once every 2 weeks (Q2W) or once a month (QM) according to their own preference.	Participants received evolocumab subcutaneous injections either 140 mg Q2W or 420 mg QM according to their own preference.
Measure Participants	13780	13784
KM estimate at 6 months	1.86 0%	1.65 0%
KM estimate at 12 months	3.68 0%	3.10 0%
KM estimate at 18 months	5.18 0%	4.29 0%
KM estimate at 24 months	6.83 0%	5.47 0%
KM estimate at 30 months	8.31 0.1%	6.66 0%
KM estimate at 36 months	9.93 0.1%	7.90 0.1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Evolocumab
	Comments	If the primary endpoint reached statistical significance at the 0.05 level, the key secondary endpoint (composite of cardiovascular death, myocardial infarction, and stroke) was tested at a significance level of 0.05.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	< 0.0001
	Comments
	Method	Log Rank
	Comments	Two-sided log-rank test stratified by randomization stratification factors (final screening LDL-C level and region).
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.80
	Confidence Interval	(2-Sided) 95%; 0.73 to 0.88
	Parameter Dispersion	Type: Value:
	Estimation Comments	Based on a Cox model stratified by the randomization stratification factors.

3. Secondary Outcome

Title	Time to Cardiovascular Death
Description	All deaths and potential endpoint events were adjudicated by an independent external CEC led by the TIMI Study Group, using standardized definitions based on the "Standardized Definitions for Cardiovascular and Stroke End Point Events in Clinical Trials and the Third Universal Definition of Myocardial Infarction". Cardiovascular death includes death resulting from an acute myocardial infarction (MI), sudden cardiac death, death due to heart failure (HF), death due to stroke, death due to cardiovascular (CV) procedures, death due to CV hemorrhage, and death due to other CV causes. Time to cardiovascular death was defined as the time from randomization to the date of cardiovascular death and was analyzed using Kaplan-Meier (KM) survival analysis. KM estimates of the percentage of participants with an event are reported. Participants with no event were censored based on the last confirmed survival status date.
Time Frame	Events that occurred from randomization to the last confirmed survival status date; the median duration of follow-up was 26 months. KM estimates at 6, 12, 18, 24, 30 and 36 months are reported.

Outcome Measure Data

Analysis Population Description

All randomized participants; The number of participants entered at each time point represents the number of participants at risk.

Arm/Group Title	Placebo	Evolocumab
Arm/Group Description	Participants received placebo subcutaneous injections either once every 2 weeks (Q2W) or once a month (QM) according to their own preference.	Participants received evolocumab subcutaneous injections either 140 mg Q2W or 420 mg QM according to their own preference.
Measure Participants	13780	13784
KM estimate at 6 months	0.40 0%	0.39 0%
KM estimate at 12 months	0.82 0%	0.79 0%
KM estimate at 18 months	1.19 0%	1.20 0%
KM estimate at 24 months	1.57 0%	1.64 0%
KM estimate at 30 months	1.99 0%	2.11 0%
KM estimate at 36 months	2.39 0%	2.49 0%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Evolocumab
	Comments	If the primary and key secondary endpoints reached a statistical significance level of 0.05, then the endpoint of cardiovascular death was tested at a significance level of 0.05.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.6188
	Comments
	Method	Log Rank
	Comments	Two-sided log-rank test stratified by randomization stratification factors (final screening LDL-C level and region).
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.05
	Confidence Interval	(2-Sided) 95%; 0.88 to 1.25
	Parameter Dispersion	Type: Value:
	Estimation Comments	Based on a Cox model stratified by the randomization stratification factors.

4. Secondary Outcome

Title	Time to All Cause Death
Description	Time to all-cause death was defined as the time from randomization to the date of death and was analyzed using Kaplan-Meier (KM) survival analysis. KM estimates of the percentage of participants with an event are reported. Participants with no event were censored based on the last confirmed survival status date.
Time Frame	Events that occurred from randomization to the last confirmed survival status date; the median duration of follow-up was 26 months. KM estimates at 6, 12, 18, 24, 30 and 36 months are reported.

Outcome Measure Data

Analysis Population Description

All randomized participants; The number of participants entered at each time point represents the number of participants at risk.

Arm/Group Title	Placebo	Evolocumab
Arm/Group Description	Participants received placebo subcutaneous injections either once every 2 weeks (Q2W) or once a month (QM) according to their own preference.	Participants received evolocumab subcutaneous injections either 140 mg Q2W or 420 mg QM according to their own preference.
Measure Participants	13780	13784
KM estimate at 6 months	0.62 0%	0.55 0%
KM estimate at 12 months	1.29 0%	1.26 0%
KM estimate at 18 months	1.96 0%	1.94 0%
KM estimate at 24 months	2.78 0%	2.81 0%
KM estimate at 30 months	3.48 0%	3.63 0%
KM estimate at 36 months	4.28 0%	4.75 0%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Evolocumab
	Comments	If the primary, key secondary, and endpoint cardiovascular death reached a statistical significance level of 0.05, then the endpoint of all-cause death was tested at a significance level of 0.04 and remaining secondary endpoints at an overall significant level of 0.01 by applying the Hochberg method.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.5368
	Comments
	Method	Log Rank
	Comments	Two-sided log-rank test stratified by randomization stratification factors (final screening LDL-C level and region).
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.04
	Confidence Interval	(2-Sided) 95%; 0.91 to 1.19
	Parameter Dispersion	Type: Value:
	Estimation Comments	Based on a Cox model stratified by the randomization stratification factors.

5. Secondary Outcome

Title	Time to First Myocardial Infarction
Description	All deaths and potential endpoint events were adjudicated by an independent external CEC led by the TIMI Study Group, using standardized definitions based on the "Standardized Definitions for Cardiovascular and Stroke End Point Events in Clinical Trials and the Third Universal Definition of Myocardial Infarction". The diagnosis of myocardial infarction required the combination of: Evidence of myocardial necrosis (either changes in cardiac biomarkers or post-mortem pathological findings); and Supporting information derived from the clinical presentation, electrocardiographic changes, or the results of myocardial or coronary artery Imaging. Time to first myocardial infarction was defined as the time from randomization to the date of the first MI and was analyzed using Kaplan-Meier survival analysis. KM estimates of the percentage of participants with an event are reported. Participants with no event were censored based on last non-fatal potential endpoint collection date.
Time Frame	Events that occurred from randomization to the last confirmed survival status date; the median duration of follow-up was 26 months. KM estimates at 6, 12, 18, 24, 30 and 36 months are reported.

Outcome Measure Data

Analysis Population Description

All randomized participants; The number of participants entered at each time point represents the number of participants at risk.

Arm/Group Title	Placebo	Evolocumab
Arm/Group Description	Participants received placebo subcutaneous injections either once every 2 weeks (Q2W) or once a month (QM) according to their own preference.	Participants received evolocumab subcutaneous injections either 140 mg Q2W or 420 mg QM according to their own preference.
Measure Participants	13780	13784
KM estimate at 6 months	1.14 0%	1.06 0%
KM estimate at 12 months	2.39 0%	1.90 0%
KM estimate at 18 months	3.33 0%	2.55 0%
KM estimate at 24 months	4.30 0%	3.21 0%
KM estimate at 30 months	5.25 0%	3.83 0%
KM estimate at 36 months	6.28 0%	4.41 0%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Evolocumab
	Comments	If the primary, key secondary, and endpoint of cardiovascular death reached a statistical significance level of 0.05, then the endpoint of all-cause death was tested at a significance level of 0.04 and remaining secondary endpoints were tested at an overall significance level of 0.01 by applying the Hochberg method.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	< 0.0001
	Comments
	Method	Log Rank
	Comments	Two-sided log-rank test stratified by randomization stratification factors (final screening LDL-C level and region).
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.73
	Confidence Interval	(2-Sided) 95%; 0.65 to 0.82
	Parameter Dispersion	Type: Value:
	Estimation Comments	Based on a Cox model stratified by the randomization stratification factors.

6. Secondary Outcome

Title	Time to First Stroke
Description	All deaths and potential endpoint events were adjudicated by an independent external CEC led by the TIMI Study Group, using standardized definitions based on the "Standardized Definitions for Cardiovascular and Stroke End Point Events in Clinical Trials and the Third Universal Definition of Myocardial Infarction". Stroke was defined as an acute episode of focal or global neurological dysfunction caused by brain, spinal cord, or retinal vascular injury as a result of hemorrhage or infarction. Time to first stroke was defined as the time from randomization to the date of the stroke and was analyzed using Kaplan-Meier (KM) survival analysis. KM estimates of the percentage of participants with an event are reported. Participants with no event were censored based on last non-fatal potential endpoint collection date.
Time Frame	Events that occurred from randomization to the last confirmed survival status date; the median duration of follow-up was 26 months. KM estimates at 6, 12, 18, 24, 30 and 36 months are reported.

Outcome Measure Data

Analysis Population Description

All randomized participants; The number of participants entered at each time point represents the number of participants at risk.

Arm/Group Title	Placebo	Evolocumab
Arm/Group Description	Participants received placebo subcutaneous injections either once every 2 weeks (Q2W) or once a month (QM) according to their own preference.	Participants received evolocumab subcutaneous injections either 140 mg Q2W or 420 mg QM according to their own preference.
Measure Participants	13780	13784
KM estimate at 6 months	0.50 0%	0.31 0%
KM estimate at 12 months	0.85 0%	0.70 0%
KM estimate at 18 months	1.30 0%	1.05 0%
KM estimate at 24 months	1.80 0%	1.36 0%
KM estimate at 30 months	2.15 0%	1.71 0%
KM estimate at 36 months	2.60 0%	2.18 0%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Evolocumab
	Comments	If the primary, key secondary, and endpoint of cardiovascular death reached a statistical significance level of 0.05, then the endpoint of all-cause death was tested at a significance level of 0.04 and remaining secondary endpoints were tested at an overall significance level of 0.01 by applying the Hochberg method.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0101
	Comments
	Method	Log Rank
	Comments	Two-sided log-rank test stratified by randomization stratification factors (final screening LDL-C level and region).
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.79
	Confidence Interval	(2-Sided) 95%; 0.66 to 0.95
	Parameter Dispersion	Type: Value:
	Estimation Comments	Based on a Cox model stratified by the randomization stratification factors.

7. Secondary Outcome

Title	Time to First Coronary Revascularization
Description	All deaths and potential endpoint events were adjudicated by an independent external CEC led by the TIMI Study Group, using standardized definitions based on the "Standardized Definitions for Cardiovascular and Stroke End Point Events in Clinical Trials and the Third Universal Definition of Myocardial Infarction". Time to first coronary revascularization was defined as the time from randomization to the date of the coronary revascularization and was analyzed using Kaplan-Meier (KM) survival analysis. KM estimates of the percentage of participants with an event are reported. Participants with no event were censored based on last non-fatal potential endpoint collection date.
Time Frame	Events that occurred from randomization to the last confirmed survival status date; the median duration of follow-up was 26 months. KM estimates at 6, 12, 18, 24, 30 and 36 months are reported.

Outcome Measure Data

Analysis Population Description

All randomized participants; the number of participants entered at each time point represents the number of participants at risk.

Arm/Group Title	Placebo	Evolocumab
Arm/Group Description	Participants received placebo subcutaneous injections either once every 2 weeks (Q2W) or once a month (QM) according to their own preference.	Participants received evolocumab subcutaneous injections either 140 mg Q2W or 420 mg QM according to their own preference.
Measure Participants	13780	13784
KM estimate at 6 months	1.87 0%	1.60 0%
KM estimate at 12 months	3.71 0%	3.13 0%
KM estimate at 18 months	5.20 0%	4.16 0%
KM estimate at 24 months	6.57 0%	5.22 0%
KM estimate at 30 months	7.91 0.1%	6.13 0%
KM estimate at 36 months	9.17 0.1%	7.01 0.1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Evolocumab
	Comments	If the primary, key secondary, and endpoint of cardiovascular death reached a statistical significance level of 0.05, then the endpoint of all-cause death was tested at a significance level of 0.04 and remaining secondary endpoints were tested at an overall significance level of 0.01 by applying the Hochberg method.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	< 0.0001
	Comments
	Method	Log Rank
	Comments	Two-sided log-rank test stratified by randomization stratification factors (final screening LDL-C level and region).
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.78
	Confidence Interval	(2-Sided) 95%; 0.71 to 0.86
	Parameter Dispersion	Type: Value:
	Estimation Comments	Based on a Cox model stratified by the randomization stratification factors.

8. Secondary Outcome

Title	Time to Cardiovascular Death or First Hospitalization for Worsening Heart Failure
Description	All events were adjudicated by an independent external CEC led by the TIMI Study Group, using standardized definitions. HF hospitalization was defined as an event that met all of the following criteria: Admitted to hospital with a primary diagnosis of HF In hospital for at least 24 hours Documented new or worsening symptoms due to HF, including at least 1 of the following: Dyspnea Decreased exercise tolerance Fatigue Other symptoms of worsened end-organ perfusion or volume overload Evidence of new or worsening HF consisting of at least 2 physical exam findings or 1 physical exam finding and at least 1 laboratory criterion Received new or increased treatment for HF. Time to CV death or first hospitalization for worsening HF was defined as the time from randomization to the first occurrence of any component of the endpoint analyzed using KM survival analysis. Participants with no event were censored based on last non-fatal potential endpoint collection date.
Time Frame	Events that occurred from randomization to the last confirmed survival status date; the median duration of follow-up was 26 months. KM estimates at 6, 12, 18, 24, 30 and 36 months are reported.

Outcome Measure Data

Analysis Population Description

All randomized participants; the number of participants entered at each time point represents the number of participants at risk.

Arm/Group Title	Placebo	Evolocumab
Arm/Group Description	Participants received placebo subcutaneous injections either once every 2 weeks (Q2W) or once a month (QM) according to their own preference.	Participants received evolocumab subcutaneous injections either 140 mg Q2W or 420 mg QM according to their own preference.
Measure Participants	13780	13784
KM estimate at 6 months	0.79 0%	0.64 0%
KM estimate at 12 months	1.35 0%	1.29 0%
KM estimate at 18 months	1.99 0%	1.99 0%
KM estimate at 24 months	2.70 0%	2.64 0%
KM estimate at 30 months	3.45 0%	3.31 0%
KM estimate at 36 months	4.03 0%	4.13 0%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Evolocumab
	Comments	If the primary, key secondary, and endpoint of cardiovascular death reached a statistical significance level of 0.05, then the endpoint of all-cause death was tested at a significance level of 0.04 and remaining secondary endpoints were tested at an overall significance level of 0.01 by applying the Hochberg method.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.8179
	Comments
	Method	Log Rank
	Comments	Two-sided log-rank test stratified by randomization stratification factors (final screening LDL-C level and region).
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.98
	Confidence Interval	(2-Sided) 95%; 0.86 to 1.13
	Parameter Dispersion	Type: Value:
	Estimation Comments	Based on a Cox model stratified by the randomization stratification factors.

9. Secondary Outcome

Title	Time to First Ischemic Fatal or Non-Fatal Stroke or Transient Ischemic Attack
Description	All deaths and potential endpoint events were adjudicated by an independent external CEC led by the TIMI Study Group, using standardized definitions. Ischemic stroke was defined as an acute episode of focal cerebral, spinal, or retinal dysfunction caused by infarction of central nervous system tissue. Transient ischemic attack (TIA) was defined as a transient episode of focal neurological dysfunction caused by brain, spinal cord, or retinal ischemia, without acute infarction. Time to first ischemic fatal or non-fatal stroke or TIA was defined as the time from randomization to the first occurrence of any component of the composite endpoint and was analyzed using KM analysis. KM estimates of the percentage of participants with an event are reported. Participants with no event were censored based on last non-fatal potential endpoint collection date.
Time Frame	Events that occurred from randomization to the last confirmed survival status date; the median duration of follow-up was 26 months. KM estimates at 6, 12, 18, 24, 30 and 36 months are reported.

Outcome Measure Data

Analysis Population Description

All randomized participants; the number of participants entered at each time point represents the number of participants at risk.

Arm/Group Title	Placebo	Evolocumab
Arm/Group Description	Participants received placebo subcutaneous injections either once every 2 weeks (Q2W) or once a month (QM) according to their own preference.	Participants received evolocumab subcutaneous injections either 140 mg Q2W or 420 mg QM according to their own preference.
Measure Participants	13780	13784
KM estimate at 6 months	0.61 0%	0.42 0%
KM estimate at 12 months	1.05 0%	0.83 0%
KM estimate at 18 months	1.52 0%	1.18 0%
KM estimate at 24 months	2.05 0%	1.46 0%
KM estimate at 30 months	2.40 0%	1.92 0%
KM estimate at 36 months	2.81 0%	2.48 0%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Evolocumab
	Comments	If the primary, key secondary, and endpoint of cardiovascular death reached a statistical significance level of 0.05, then the endpoint of all-cause death was tested at a significance level of 0.04 and remaining secondary endpoints were tested at an overall significance level of 0.01 by applying the Hochberg method.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0035
	Comments
	Method	Log Rank
	Comments	Two-sided log-rank test stratified by randomization stratification factors (final screening LDL-C level and region).
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.77
	Confidence Interval	(2-Sided) 95%; 0.65 to 0.92
	Parameter Dispersion	Type: Value:
	Estimation Comments	Based on a Cox model stratified by the randomization stratification factors.

Adverse Events

Time Frame	From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.
Adverse Event Reporting Description	Deaths by any cause were adjudicated efficacy endpoints in this study and were summarized as a secondary endpoint. Events that were negatively adjudicated (did not meet the definitions of an endpoint), were reclassified as an adverse event or serious adverse event Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Arm/Group Title	Placebo		Evolocumab
Arm/Group Description	Participants received placebo subcutaneous injections either once every 2 weeks (Q2W) or once a month (QM) according to their own preference.		Participants received evolocumab subcutaneous injections either 140 mg Q2W or 420 mg QM according to their own preference.
All Cause Mortality
	Placebo		Evolocumab
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Placebo		Evolocumab
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3404/13756 (24.7%)		3410/13769 (24.8%)
Blood and lymphatic system disorders
Anaemia	27/13756 (0.2%)		27/13769 (0.2%)
Anaemia of chronic disease	1/13756 (0%)		0/13769 (0%)
Autoimmune haemolytic anaemia	1/13756 (0%)		0/13769 (0%)
Coagulopathy	2/13756 (0%)		2/13769 (0%)
Febrile neutropenia	2/13756 (0%)		3/13769 (0%)
Haemorrhagic anaemia	5/13756 (0%)		2/13769 (0%)
Haemorrhagic disorder	1/13756 (0%)		0/13769 (0%)
Hypochromic anaemia	1/13756 (0%)		2/13769 (0%)
Immune thrombocytopenic purpura	1/13756 (0%)		2/13769 (0%)
Iron deficiency anaemia	6/13756 (0%)		9/13769 (0.1%)
Leukocytosis	4/13756 (0%)		2/13769 (0%)
Lymphadenitis	1/13756 (0%)		0/13769 (0%)
Lymphadenopathy	3/13756 (0%)		2/13769 (0%)
Lymphadenopathy mediastinal	2/13756 (0%)		0/13769 (0%)
Microcytic anaemia	1/13756 (0%)		0/13769 (0%)
Neutropenia	0/13756 (0%)		1/13769 (0%)
Normochromic normocytic anaemia	0/13756 (0%)		4/13769 (0%)
Pancytopenia	0/13756 (0%)		1/13769 (0%)
Pernicious anaemia	0/13756 (0%)		1/13769 (0%)
Polycythaemia	0/13756 (0%)		2/13769 (0%)
Spleen disorder	1/13756 (0%)		0/13769 (0%)
Thrombocytopenia	1/13756 (0%)		0/13769 (0%)
Cardiac disorders
Acute coronary syndrome	11/13756 (0.1%)		6/13769 (0%)
Acute left ventricular failure	2/13756 (0%)		0/13769 (0%)
Acute myocardial infarction	23/13756 (0.2%)		11/13769 (0.1%)
Angina pectoris	221/13756 (1.6%)		208/13769 (1.5%)
Angina unstable	278/13756 (2%)		233/13769 (1.7%)
Aortic valve disease	1/13756 (0%)		2/13769 (0%)
Aortic valve incompetence	2/13756 (0%)		2/13769 (0%)
Aortic valve stenosis	8/13756 (0.1%)		10/13769 (0.1%)
Arrhythmia	4/13756 (0%)		1/13769 (0%)
Arrhythmia supraventricular	1/13756 (0%)		3/13769 (0%)
Arteriosclerosis coronary artery	1/13756 (0%)		3/13769 (0%)
Arteritis coronary	1/13756 (0%)		0/13769 (0%)
Atrial fibrillation	132/13756 (1%)		119/13769 (0.9%)
Atrial flutter	17/13756 (0.1%)		25/13769 (0.2%)
Atrial tachycardia	2/13756 (0%)		2/13769 (0%)
Atrial thrombosis	0/13756 (0%)		1/13769 (0%)
Atrioventricular block	5/13756 (0%)		4/13769 (0%)
Atrioventricular block complete	13/13756 (0.1%)		16/13769 (0.1%)
Atrioventricular block first degree	3/13756 (0%)		1/13769 (0%)
Atrioventricular block second degree	7/13756 (0.1%)		7/13769 (0.1%)
Bifascicular block	1/13756 (0%)		0/13769 (0%)
Bradyarrhythmia	2/13756 (0%)		2/13769 (0%)
Bradycardia	13/13756 (0.1%)		10/13769 (0.1%)
Bundle branch block bilateral	1/13756 (0%)		0/13769 (0%)
Bundle branch block left	0/13756 (0%)		3/13769 (0%)
Bundle branch block right	0/13756 (0%)		1/13769 (0%)
Cardiac aneurysm	1/13756 (0%)		0/13769 (0%)
Cardiac arrest	5/13756 (0%)		3/13769 (0%)
Cardiac asthma	0/13756 (0%)		1/13769 (0%)
Cardiac disorder	1/13756 (0%)		0/13769 (0%)
Cardiac failure	66/13756 (0.5%)		66/13769 (0.5%)
Cardiac failure acute	10/13756 (0.1%)		13/13769 (0.1%)
Cardiac failure chronic	47/13756 (0.3%)		50/13769 (0.4%)
Cardiac failure congestive	37/13756 (0.3%)		46/13769 (0.3%)
Cardiac flutter	0/13756 (0%)		1/13769 (0%)
Cardiac tamponade	1/13756 (0%)		0/13769 (0%)
Cardiac ventricular thrombosis	1/13756 (0%)		0/13769 (0%)
Cardio-respiratory arrest	1/13756 (0%)		2/13769 (0%)
Cardiogenic shock	3/13756 (0%)		2/13769 (0%)
Cardiomyopathy	4/13756 (0%)		2/13769 (0%)
Cardiopulmonary failure	0/13756 (0%)		1/13769 (0%)
Cardiorenal syndrome	1/13756 (0%)		0/13769 (0%)
Cardiotoxicity	1/13756 (0%)		0/13769 (0%)
Cardiovascular disorder	0/13756 (0%)		1/13769 (0%)
Congestive cardiomyopathy	2/13756 (0%)		1/13769 (0%)
Coronary artery disease	46/13756 (0.3%)		32/13769 (0.2%)
Coronary artery occlusion	4/13756 (0%)		1/13769 (0%)
Coronary artery stenosis	4/13756 (0%)		5/13769 (0%)
Coronary artery thrombosis	0/13756 (0%)		1/13769 (0%)
Diastolic dysfunction	1/13756 (0%)		0/13769 (0%)
Dressler's syndrome	1/13756 (0%)		1/13769 (0%)
Extrasystoles	0/13756 (0%)		1/13769 (0%)
Heart alternation	1/13756 (0%)		0/13769 (0%)
Heart valve incompetence	1/13756 (0%)		0/13769 (0%)
Hypertensive cardiomyopathy	0/13756 (0%)		1/13769 (0%)
Hypertensive heart disease	1/13756 (0%)		1/13769 (0%)
Intracardiac thrombus	0/13756 (0%)		2/13769 (0%)
Ischaemic cardiomyopathy	6/13756 (0%)		7/13769 (0.1%)
Left ventricular dysfunction	7/13756 (0.1%)		1/13769 (0%)
Left ventricular failure	2/13756 (0%)		1/13769 (0%)
Microvascular coronary artery disease	1/13756 (0%)		1/13769 (0%)
Mitral valve incompetence	3/13756 (0%)		11/13769 (0.1%)
Mitral valve stenosis	0/13756 (0%)		1/13769 (0%)
Myocardial infarction	31/13756 (0.2%)		31/13769 (0.2%)
Myocardial ischaemia	21/13756 (0.2%)		26/13769 (0.2%)
Myocardial necrosis	0/13756 (0%)		1/13769 (0%)
Myocarditis	2/13756 (0%)		1/13769 (0%)
Palpitations	8/13756 (0.1%)		7/13769 (0.1%)
Pericardial effusion	2/13756 (0%)		3/13769 (0%)
Pericarditis	2/13756 (0%)		4/13769 (0%)
Prinzmetal angina	3/13756 (0%)		0/13769 (0%)
Pulseless electrical activity	0/13756 (0%)		1/13769 (0%)
Rhythm idioventricular	0/13756 (0%)		1/13769 (0%)
Silent myocardial infarction	2/13756 (0%)		1/13769 (0%)
Sinus arrest	1/13756 (0%)		1/13769 (0%)
Sinus bradycardia	4/13756 (0%)		4/13769 (0%)
Sinus node dysfunction	18/13756 (0.1%)		17/13769 (0.1%)
Sinus tachycardia	0/13756 (0%)		1/13769 (0%)
Stress cardiomyopathy	0/13756 (0%)		1/13769 (0%)
Supraventricular tachycardia	9/13756 (0.1%)		9/13769 (0.1%)
Tachycardia	4/13756 (0%)		3/13769 (0%)
Torsade de pointes	1/13756 (0%)		1/13769 (0%)
Ventricular arrhythmia	6/13756 (0%)		4/13769 (0%)
Ventricular extrasystoles	5/13756 (0%)		7/13769 (0.1%)
Ventricular fibrillation	8/13756 (0.1%)		12/13769 (0.1%)
Ventricular hypertrophy	0/13756 (0%)		1/13769 (0%)
Ventricular tachyarrhythmia	0/13756 (0%)		2/13769 (0%)
Ventricular tachycardia	27/13756 (0.2%)		23/13769 (0.2%)
Congenital, familial and genetic disorders
Adenomatous polyposis coli	1/13756 (0%)		2/13769 (0%)
Arteriovenous malformation	0/13756 (0%)		1/13769 (0%)
Atrial septal defect	2/13756 (0%)		0/13769 (0%)
Carbohydrate metabolism disorder	2/13756 (0%)		0/13769 (0%)
Corneal dystrophy	1/13756 (0%)		1/13769 (0%)
Exomphalos	0/13756 (0%)		1/13769 (0%)
Gastrointestinal arteriovenous malformation	1/13756 (0%)		0/13769 (0%)
Hereditary motor and sensory neuropathy	0/13756 (0%)		1/13769 (0%)
Hydrocele	1/13756 (0%)		2/13769 (0%)
Hypertrophic cardiomyopathy	0/13756 (0%)		1/13769 (0%)
Intracranial lipoma	1/13756 (0%)		0/13769 (0%)
Subependymal nodular heterotopia	1/13756 (0%)		0/13769 (0%)
Ear and labyrinth disorders
Acute vestibular syndrome	0/13756 (0%)		2/13769 (0%)
Deafness	1/13756 (0%)		1/13769 (0%)
Deafness neurosensory	1/13756 (0%)		1/13769 (0%)
Deafness unilateral	1/13756 (0%)		0/13769 (0%)
Hypoacusis	1/13756 (0%)		0/13769 (0%)
Inner ear inflammation	0/13756 (0%)		1/13769 (0%)
Meniere's disease	1/13756 (0%)		2/13769 (0%)
Otorrhoea	0/13756 (0%)		1/13769 (0%)
Sudden hearing loss	1/13756 (0%)		1/13769 (0%)
Tinnitus	0/13756 (0%)		1/13769 (0%)
Vertigo	13/13756 (0.1%)		9/13769 (0.1%)
Vertigo positional	1/13756 (0%)		7/13769 (0.1%)
Vestibular disorder	1/13756 (0%)		0/13769 (0%)
Vestibular ischaemia	0/13756 (0%)		1/13769 (0%)
Endocrine disorders
Adrenal insufficiency	1/13756 (0%)		1/13769 (0%)
Adrenal mass	0/13756 (0%)		1/13769 (0%)
Basedow's disease	1/13756 (0%)		0/13769 (0%)
Goitre	3/13756 (0%)		3/13769 (0%)
Hyperparathyroidism	1/13756 (0%)		0/13769 (0%)
Hyperparathyroidism primary	1/13756 (0%)		1/13769 (0%)
Hyperthyroidism	3/13756 (0%)		4/13769 (0%)
Hypoaldosteronism	1/13756 (0%)		0/13769 (0%)
Inappropriate antidiuretic hormone secretion	0/13756 (0%)		1/13769 (0%)
Thyroid mass	4/13756 (0%)		1/13769 (0%)
Eye disorders
Angle closure glaucoma	0/13756 (0%)		1/13769 (0%)
Blepharochalasis	1/13756 (0%)		0/13769 (0%)
Cataract	22/13756 (0.2%)		15/13769 (0.1%)
Cataract nuclear	1/13756 (0%)		0/13769 (0%)
Dacryoadenitis acquired	1/13756 (0%)		0/13769 (0%)
Diabetic retinopathy	0/13756 (0%)		2/13769 (0%)
Ectropion	1/13756 (0%)		0/13769 (0%)
Eyelid ptosis	2/13756 (0%)		1/13769 (0%)
Glaucoma	1/13756 (0%)		1/13769 (0%)
Iridocyclitis	1/13756 (0%)		1/13769 (0%)
Macular degeneration	1/13756 (0%)		1/13769 (0%)
Macular fibrosis	1/13756 (0%)		3/13769 (0%)
Ocular myasthenia	0/13756 (0%)		1/13769 (0%)
Ophthalmoplegia	0/13756 (0%)		1/13769 (0%)
Pterygium	0/13756 (0%)		1/13769 (0%)
Retinal artery occlusion	0/13756 (0%)		1/13769 (0%)
Retinal artery thrombosis	1/13756 (0%)		0/13769 (0%)
Retinal detachment	5/13756 (0%)		3/13769 (0%)
Retinal tear	0/13756 (0%)		1/13769 (0%)
Retinal vascular disorder	1/13756 (0%)		0/13769 (0%)
Retinal vein thrombosis	1/13756 (0%)		0/13769 (0%)
Strabismus	1/13756 (0%)		1/13769 (0%)
Uveitis	1/13756 (0%)		0/13769 (0%)
Visual acuity reduced	0/13756 (0%)		1/13769 (0%)
Visual impairment	1/13756 (0%)		0/13769 (0%)
Vitreous floaters	1/13756 (0%)		0/13769 (0%)
Vitreous haemorrhage	1/13756 (0%)		2/13769 (0%)
Gastrointestinal disorders
Abdominal adhesions	1/13756 (0%)		1/13769 (0%)
Abdominal discomfort	1/13756 (0%)		1/13769 (0%)
Abdominal distension	1/13756 (0%)		2/13769 (0%)
Abdominal hernia	8/13756 (0.1%)		11/13769 (0.1%)
Abdominal pain	19/13756 (0.1%)		12/13769 (0.1%)
Abdominal pain lower	2/13756 (0%)		2/13769 (0%)
Abdominal pain upper	13/13756 (0.1%)		12/13769 (0.1%)
Abdominal wall haematoma	0/13756 (0%)		2/13769 (0%)
Alcoholic pancreatitis	2/13756 (0%)		0/13769 (0%)
Anal fissure	1/13756 (0%)		2/13769 (0%)
Anal fistula	4/13756 (0%)		1/13769 (0%)
Anal incontinence	0/13756 (0%)		1/13769 (0%)
Anastomotic ulcer perforation	1/13756 (0%)		0/13769 (0%)
Ascites	3/13756 (0%)		1/13769 (0%)
Barrett's oesophagus	2/13756 (0%)		1/13769 (0%)
Chronic gastritis	1/13756 (0%)		3/13769 (0%)
Coeliac artery stenosis	3/13756 (0%)		0/13769 (0%)
Colitis	8/13756 (0.1%)		6/13769 (0%)
Colitis ischaemic	2/13756 (0%)		10/13769 (0.1%)
Colitis ulcerative	5/13756 (0%)		2/13769 (0%)
Colonic fistula	1/13756 (0%)		0/13769 (0%)
Constipation	9/13756 (0.1%)		9/13769 (0.1%)
Crohn's disease	1/13756 (0%)		2/13769 (0%)
Diarrhoea	4/13756 (0%)		9/13769 (0.1%)
Diverticulum	4/13756 (0%)		4/13769 (0%)
Diverticulum intestinal	3/13756 (0%)		3/13769 (0%)
Diverticulum intestinal haemorrhagic	4/13756 (0%)		1/13769 (0%)
Duodenal ulcer	5/13756 (0%)		5/13769 (0%)
Duodenal ulcer haemorrhage	5/13756 (0%)		5/13769 (0%)
Duodenitis	5/13756 (0%)		1/13769 (0%)
Dyspepsia	4/13756 (0%)		7/13769 (0.1%)
Dysphagia	4/13756 (0%)		1/13769 (0%)
Enteritis	2/13756 (0%)		0/13769 (0%)
Enterocolitis	1/13756 (0%)		0/13769 (0%)
Epiploic appendagitis	0/13756 (0%)		2/13769 (0%)
Erosive oesophagitis	1/13756 (0%)		1/13769 (0%)
Faecaloma	0/13756 (0%)		4/13769 (0%)
Food poisoning	1/13756 (0%)		4/13769 (0%)
Gastric cyst	1/13756 (0%)		0/13769 (0%)
Gastric disorder	1/13756 (0%)		0/13769 (0%)
Gastric haemorrhage	2/13756 (0%)		0/13769 (0%)
Gastric ulcer	8/13756 (0.1%)		9/13769 (0.1%)
Gastric ulcer haemorrhage	6/13756 (0%)		7/13769 (0.1%)
Gastric ulcer perforation	0/13756 (0%)		2/13769 (0%)
Gastritis	17/13756 (0.1%)		19/13769 (0.1%)
Gastritis alcoholic	0/13756 (0%)		1/13769 (0%)
Gastritis erosive	3/13756 (0%)		3/13769 (0%)
Gastritis haemorrhagic	3/13756 (0%)		0/13769 (0%)
Gastroduodenal haemorrhage	0/13756 (0%)		1/13769 (0%)
Gastroduodenitis	1/13756 (0%)		1/13769 (0%)
Gastrointestinal angiodysplasia	0/13756 (0%)		2/13769 (0%)
Gastrointestinal angiodysplasia haemorrhagic	1/13756 (0%)		0/13769 (0%)
Gastrointestinal haemorrhage	16/13756 (0.1%)		27/13769 (0.2%)
Gastrointestinal pain	0/13756 (0%)		1/13769 (0%)
Gastrointestinal polyp haemorrhage	2/13756 (0%)		0/13769 (0%)
Gastrointestinal ulcer	1/13756 (0%)		0/13769 (0%)
Gastrointestinal ulcer haemorrhage	0/13756 (0%)		1/13769 (0%)
Gastrooesophageal reflux disease	15/13756 (0.1%)		14/13769 (0.1%)
Haematemesis	2/13756 (0%)		4/13769 (0%)
Haematochezia	1/13756 (0%)		4/13769 (0%)
Haemorrhagic erosive gastritis	0/13756 (0%)		2/13769 (0%)
Haemorrhoidal haemorrhage	5/13756 (0%)		3/13769 (0%)
Haemorrhoids	10/13756 (0.1%)		6/13769 (0%)
Haemorrhoids thrombosed	0/13756 (0%)		1/13769 (0%)
Hernial eventration	0/13756 (0%)		2/13769 (0%)
Hiatus hernia	3/13756 (0%)		9/13769 (0.1%)
Ileus	7/13756 (0.1%)		6/13769 (0%)
Ileus paralytic	2/13756 (0%)		0/13769 (0%)
Impaired gastric emptying	1/13756 (0%)		3/13769 (0%)
Incarcerated inguinal hernia	1/13756 (0%)		1/13769 (0%)
Incarcerated umbilical hernia	0/13756 (0%)		1/13769 (0%)
Inflammatory bowel disease	1/13756 (0%)		0/13769 (0%)
Inguinal hernia	22/13756 (0.2%)		32/13769 (0.2%)
Intestinal dilatation	1/13756 (0%)		0/13769 (0%)
Intestinal fistula	0/13756 (0%)		1/13769 (0%)
Intestinal haemorrhage	0/13756 (0%)		1/13769 (0%)
Intestinal ischaemia	2/13756 (0%)		0/13769 (0%)
Intestinal obstruction	5/13756 (0%)		3/13769 (0%)
Intestinal polyp	2/13756 (0%)		1/13769 (0%)
Intestinal prolapse	0/13756 (0%)		1/13769 (0%)
Intra-abdominal fluid collection	1/13756 (0%)		0/13769 (0%)
Intra-abdominal haematoma	1/13756 (0%)		0/13769 (0%)
Intra-abdominal haemorrhage	1/13756 (0%)		0/13769 (0%)
Intussusception	0/13756 (0%)		1/13769 (0%)
Irritable bowel syndrome	1/13756 (0%)		0/13769 (0%)
Large intestinal haemorrhage	1/13756 (0%)		1/13769 (0%)
Large intestinal obstruction	3/13756 (0%)		1/13769 (0%)
Large intestinal ulcer	1/13756 (0%)		0/13769 (0%)
Large intestine perforation	0/13756 (0%)		1/13769 (0%)
Large intestine polyp	16/13756 (0.1%)		10/13769 (0.1%)
Leukoplakia oral	1/13756 (0%)		0/13769 (0%)
Lower gastrointestinal haemorrhage	3/13756 (0%)		2/13769 (0%)
Mallory-Weiss syndrome	2/13756 (0%)		0/13769 (0%)
Mechanical ileus	1/13756 (0%)		0/13769 (0%)
Melaena	2/13756 (0%)		1/13769 (0%)
Mesenteric arterial occlusion	1/13756 (0%)		0/13769 (0%)
Mesenteric artery stenosis	1/13756 (0%)		1/13769 (0%)
Mesenteric artery thrombosis	1/13756 (0%)		0/13769 (0%)
Mesenteric vein thrombosis	1/13756 (0%)		0/13769 (0%)
Nausea	4/13756 (0%)		5/13769 (0%)
Odynophagia	1/13756 (0%)		0/13769 (0%)
Oesophageal achalasia	1/13756 (0%)		1/13769 (0%)
Oesophageal food impaction	1/13756 (0%)		0/13769 (0%)
Oesophageal obstruction	0/13756 (0%)		1/13769 (0%)
Oesophageal spasm	3/13756 (0%)		2/13769 (0%)
Oesophageal stenosis	2/13756 (0%)		0/13769 (0%)
Oesophageal ulcer	1/13756 (0%)		2/13769 (0%)
Oesophageal varices haemorrhage	1/13756 (0%)		0/13769 (0%)
Oesophagitis	4/13756 (0%)		1/13769 (0%)
Oesophagitis ulcerative	1/13756 (0%)		0/13769 (0%)
Palatal swelling	1/13756 (0%)		0/13769 (0%)
Pancreatic cyst	2/13756 (0%)		0/13769 (0%)
Pancreatic disorder	1/13756 (0%)		0/13769 (0%)
Pancreatic necrosis	1/13756 (0%)		0/13769 (0%)
Pancreatic phlegmon	1/13756 (0%)		0/13769 (0%)
Pancreatic pseudocyst	0/13756 (0%)		1/13769 (0%)
Pancreatitis	16/13756 (0.1%)		10/13769 (0.1%)
Pancreatitis acute	22/13756 (0.2%)		14/13769 (0.1%)
Pancreatitis chronic	0/13756 (0%)		1/13769 (0%)
Pancreatitis necrotising	1/13756 (0%)		3/13769 (0%)
Pancreatolithiasis	1/13756 (0%)		1/13769 (0%)
Peptic ulcer	2/13756 (0%)		1/13769 (0%)
Peptic ulcer haemorrhage	2/13756 (0%)		1/13769 (0%)
Periodontal disease	0/13756 (0%)		1/13769 (0%)
Peritoneal haematoma	0/13756 (0%)		1/13769 (0%)
Proctitis	2/13756 (0%)		0/13769 (0%)
Rectal haemorrhage	9/13756 (0.1%)		6/13769 (0%)
Rectal polyp	2/13756 (0%)		0/13769 (0%)
Reflux gastritis	0/13756 (0%)		1/13769 (0%)
Retching	1/13756 (0%)		0/13769 (0%)
Retroperitoneal fibrosis	1/13756 (0%)		0/13769 (0%)
Retroperitoneal haematoma	1/13756 (0%)		1/13769 (0%)
Retroperitoneal haemorrhage	1/13756 (0%)		0/13769 (0%)
Salivary gland enlargement	0/13756 (0%)		2/13769 (0%)
Small intestinal haemorrhage	0/13756 (0%)		1/13769 (0%)
Small intestinal obstruction	6/13756 (0%)		4/13769 (0%)
Small intestine ulcer	1/13756 (0%)		0/13769 (0%)
Strangulated umbilical hernia	1/13756 (0%)		1/13769 (0%)
Stress ulcer	1/13756 (0%)		0/13769 (0%)
Thrombosis mesenteric vessel	0/13756 (0%)		1/13769 (0%)
Tongue cyst	0/13756 (0%)		1/13769 (0%)
Tongue oedema	1/13756 (0%)		1/13769 (0%)
Tooth disorder	1/13756 (0%)		0/13769 (0%)
Tooth impacted	0/13756 (0%)		1/13769 (0%)
Umbilical hernia	14/13756 (0.1%)		10/13769 (0.1%)
Upper gastrointestinal haemorrhage	9/13756 (0.1%)		13/13769 (0.1%)
Varices oesophageal	1/13756 (0%)		1/13769 (0%)
Volvulus	1/13756 (0%)		0/13769 (0%)
Vomiting	10/13756 (0.1%)		4/13769 (0%)
General disorders
Asthenia	6/13756 (0%)		8/13769 (0.1%)
Breakthrough pain	1/13756 (0%)		0/13769 (0%)
Catheter site extravasation	1/13756 (0%)		0/13769 (0%)
Chest discomfort	5/13756 (0%)		4/13769 (0%)
Chest pain	49/13756 (0.4%)		42/13769 (0.3%)
Complication associated with device	0/13756 (0%)		2/13769 (0%)
Cyst rupture	0/13756 (0%)		1/13769 (0%)
Drug intolerance	0/13756 (0%)		1/13769 (0%)
Drug withdrawal syndrome	0/13756 (0%)		1/13769 (0%)
Exercise tolerance decreased	0/13756 (0%)		2/13769 (0%)
Fat necrosis	0/13756 (0%)		1/13769 (0%)
Fatigue	4/13756 (0%)		2/13769 (0%)
Gait disturbance	0/13756 (0%)		5/13769 (0%)
General physical health deterioration	0/13756 (0%)		1/13769 (0%)
Generalised oedema	1/13756 (0%)		0/13769 (0%)
Hernia	1/13756 (0%)		2/13769 (0%)
Impaired healing	5/13756 (0%)		4/13769 (0%)
Implant site inflammation	0/13756 (0%)		1/13769 (0%)
Incarcerated hernia	0/13756 (0%)		2/13769 (0%)
Inflammation	2/13756 (0%)		0/13769 (0%)
Malaise	1/13756 (0%)		3/13769 (0%)
Mass	0/13756 (0%)		1/13769 (0%)
Medical device discomfort	1/13756 (0%)		1/13769 (0%)
Mucosal inflammation	1/13756 (0%)		0/13769 (0%)
Multiple organ dysfunction syndrome	0/13756 (0%)		4/13769 (0%)
Non-cardiac chest pain	133/13756 (1%)		109/13769 (0.8%)
Oedema peripheral	1/13756 (0%)		4/13769 (0%)
Pacemaker generated arrhythmia	1/13756 (0%)		0/13769 (0%)
Pain	0/13756 (0%)		1/13769 (0%)
Peripheral swelling	1/13756 (0%)		0/13769 (0%)
Pyrexia	9/13756 (0.1%)		5/13769 (0%)
Sensation of foreign body	1/13756 (0%)		0/13769 (0%)
Soft tissue inflammation	0/13756 (0%)		1/13769 (0%)
Strangulated hernia	0/13756 (0%)		1/13769 (0%)
Sudden cardiac death	1/13756 (0%)		0/13769 (0%)
Surgical failure	2/13756 (0%)		0/13769 (0%)
Systemic inflammatory response syndrome	3/13756 (0%)		1/13769 (0%)
Vascular stent occlusion	1/13756 (0%)		1/13769 (0%)
Vascular stent restenosis	1/13756 (0%)		2/13769 (0%)
Vascular stent stenosis	3/13756 (0%)		2/13769 (0%)
Vascular stent thrombosis	1/13756 (0%)		0/13769 (0%)
Hepatobiliary disorders
Acute hepatic failure	1/13756 (0%)		1/13769 (0%)
Ampulla of Vater stenosis	1/13756 (0%)		0/13769 (0%)
Autoimmune hepatitis	0/13756 (0%)		2/13769 (0%)
Bile duct obstruction	1/13756 (0%)		1/13769 (0%)
Bile duct stenosis	1/13756 (0%)		1/13769 (0%)
Bile duct stone	5/13756 (0%)		6/13769 (0%)
Biliary colic	5/13756 (0%)		4/13769 (0%)
Biliary cyst	1/13756 (0%)		0/13769 (0%)
Cholangitis	2/13756 (0%)		5/13769 (0%)
Cholangitis acute	6/13756 (0%)		0/13769 (0%)
Cholecystitis	7/13756 (0.1%)		14/13769 (0.1%)
Cholecystitis acute	31/13756 (0.2%)		40/13769 (0.3%)
Cholecystitis chronic	5/13756 (0%)		5/13769 (0%)
Cholecystocholangitis	1/13756 (0%)		0/13769 (0%)
Cholelithiasis	23/13756 (0.2%)		27/13769 (0.2%)
Cholelithiasis migration	1/13756 (0%)		0/13769 (0%)
Cholelithiasis obstructive	0/13756 (0%)		1/13769 (0%)
Cholestasis	1/13756 (0%)		0/13769 (0%)
Cirrhosis alcoholic	0/13756 (0%)		1/13769 (0%)
Drug-induced liver injury	0/13756 (0%)		3/13769 (0%)
Gallbladder perforation	0/13756 (0%)		1/13769 (0%)
Gallbladder polyp	0/13756 (0%)		1/13769 (0%)
Hepatic cirrhosis	2/13756 (0%)		1/13769 (0%)
Hepatic cyst	0/13756 (0%)		1/13769 (0%)
Hepatic failure	0/13756 (0%)		2/13769 (0%)
Hepatic fibrosis	1/13756 (0%)		0/13769 (0%)
Hepatic function abnormal	0/13756 (0%)		1/13769 (0%)
Hepatic pain	0/13756 (0%)		1/13769 (0%)
Hepatic steatosis	2/13756 (0%)		0/13769 (0%)
Hepatitis acute	1/13756 (0%)		0/13769 (0%)
Hepatitis alcoholic	1/13756 (0%)		1/13769 (0%)
Hepatitis toxic	0/13756 (0%)		1/13769 (0%)
Hepatorenal syndrome	0/13756 (0%)		1/13769 (0%)
Hepatotoxicity	1/13756 (0%)		1/13769 (0%)
Hypertransaminasaemia	0/13756 (0%)		1/13769 (0%)
Jaundice	0/13756 (0%)		1/13769 (0%)
Liver disorder	1/13756 (0%)		0/13769 (0%)
Porcelain gallbladder	1/13756 (0%)		0/13769 (0%)
Portal vein thrombosis	1/13756 (0%)		1/13769 (0%)
Subacute hepatic failure	0/13756 (0%)		1/13769 (0%)
Immune system disorders
Allergy to arthropod sting	0/13756 (0%)		2/13769 (0%)
Anaphylactic reaction	3/13756 (0%)		2/13769 (0%)
Anaphylactic shock	0/13756 (0%)		2/13769 (0%)
Drug hypersensitivity	0/13756 (0%)		1/13769 (0%)
Food allergy	1/13756 (0%)		0/13769 (0%)
Hypersensitivity	3/13756 (0%)		1/13769 (0%)
Mite allergy	0/13756 (0%)		1/13769 (0%)
Sarcoidosis	1/13756 (0%)		0/13769 (0%)
Transplant rejection	0/13756 (0%)		1/13769 (0%)
Infections and infestations
Abdominal abscess	1/13756 (0%)		0/13769 (0%)
Abdominal sepsis	0/13756 (0%)		2/13769 (0%)
Abdominal wall abscess	0/13756 (0%)		1/13769 (0%)
Abscess	1/13756 (0%)		0/13769 (0%)
Abscess bacterial	1/13756 (0%)		1/13769 (0%)
Abscess limb	4/13756 (0%)		10/13769 (0.1%)
Abscess of eyelid	0/13756 (0%)		1/13769 (0%)
Abscess of salivary gland	0/13756 (0%)		1/13769 (0%)
Abscess soft tissue	0/13756 (0%)		1/13769 (0%)
Acute sinusitis	1/13756 (0%)		0/13769 (0%)
Amoebic dysentery	0/13756 (0%)		1/13769 (0%)
Anal abscess	5/13756 (0%)		2/13769 (0%)
Anal fistula infection	1/13756 (0%)		0/13769 (0%)
Appendiceal abscess	2/13756 (0%)		0/13769 (0%)
Appendicitis	14/13756 (0.1%)		20/13769 (0.1%)
Appendicitis perforated	5/13756 (0%)		2/13769 (0%)
Arteritis infective	1/13756 (0%)		0/13769 (0%)
Arthritis bacterial	2/13756 (0%)		0/13769 (0%)
Atypical pneumonia	2/13756 (0%)		0/13769 (0%)
Bacteraemia	1/13756 (0%)		1/13769 (0%)
Bacterial pericarditis	0/13756 (0%)		1/13769 (0%)
Bacterial prostatitis	1/13756 (0%)		0/13769 (0%)
Bacterial pyelonephritis	0/13756 (0%)		1/13769 (0%)
Bacterial sepsis	0/13756 (0%)		1/13769 (0%)
Bacteroides bacteraemia	1/13756 (0%)		0/13769 (0%)
Beta haemolytic streptococcal infection	1/13756 (0%)		0/13769 (0%)
Bone abscess	0/13756 (0%)		1/13769 (0%)
Breast abscess	0/13756 (0%)		2/13769 (0%)
Bronchitis	30/13756 (0.2%)		17/13769 (0.1%)
Bronchitis bacterial	2/13756 (0%)		2/13769 (0%)
Burkholderia cepacia complex infection	1/13756 (0%)		0/13769 (0%)
Burkholderia pseudomallei infection	0/13756 (0%)		1/13769 (0%)
Bursitis infective	0/13756 (0%)		2/13769 (0%)
Campylobacter gastroenteritis	1/13756 (0%)		2/13769 (0%)
Carbuncle	2/13756 (0%)		0/13769 (0%)
Catheter site infection	0/13756 (0%)		1/13769 (0%)
Cellulitis	28/13756 (0.2%)		39/13769 (0.3%)
Cellulitis gangrenous	1/13756 (0%)		0/13769 (0%)
Cervicitis	0/13756 (0%)		1/13769 (0%)
Cholecystitis infective	2/13756 (0%)		2/13769 (0%)
Chronic hepatitis B	1/13756 (0%)		0/13769 (0%)
Chronic sinusitis	0/13756 (0%)		1/13769 (0%)
Clostridium difficile colitis	2/13756 (0%)		6/13769 (0%)
Clostridium difficile infection	2/13756 (0%)		3/13769 (0%)
Colonic abscess	0/13756 (0%)		1/13769 (0%)
Creutzfeldt-Jakob disease	1/13756 (0%)		0/13769 (0%)
Cystitis	5/13756 (0%)		3/13769 (0%)
Cystitis escherichia	1/13756 (0%)		1/13769 (0%)
Dengue fever	4/13756 (0%)		1/13769 (0%)
Device related infection	3/13756 (0%)		1/13769 (0%)
Device related sepsis	1/13756 (0%)		2/13769 (0%)
Diabetic foot infection	6/13756 (0%)		2/13769 (0%)
Diabetic gangrene	1/13756 (0%)		1/13769 (0%)
Diarrhoea infectious	0/13756 (0%)		1/13769 (0%)
Diverticulitis	26/13756 (0.2%)		16/13769 (0.1%)
Diverticulitis intestinal haemorrhagic	0/13756 (0%)		1/13769 (0%)
Eczema infected	1/13756 (0%)		0/13769 (0%)
Embolic pneumonia	0/13756 (0%)		1/13769 (0%)
Empyema	3/13756 (0%)		0/13769 (0%)
Encephalitis viral	1/13756 (0%)		0/13769 (0%)
Endocarditis	1/13756 (0%)		1/13769 (0%)
Endocarditis bacterial	1/13756 (0%)		0/13769 (0%)
Endocarditis haemophilus	1/13756 (0%)		0/13769 (0%)
Endophthalmitis	0/13756 (0%)		1/13769 (0%)
Enteritis infectious	1/13756 (0%)		0/13769 (0%)
Enterobacter bacteraemia	0/13756 (0%)		1/13769 (0%)
Enterococcal bacteraemia	2/13756 (0%)		1/13769 (0%)
Enterococcal sepsis	0/13756 (0%)		1/13769 (0%)
Epididymitis	3/13756 (0%)		1/13769 (0%)
Epiglottitis	2/13756 (0%)		0/13769 (0%)
Erysipelas	19/13756 (0.1%)		16/13769 (0.1%)
Erysipeloid	0/13756 (0%)		1/13769 (0%)
Escherichia bacteraemia	2/13756 (0%)		0/13769 (0%)
Escherichia sepsis	3/13756 (0%)		4/13769 (0%)
Escherichia urinary tract infection	0/13756 (0%)		2/13769 (0%)
Febrile infection	0/13756 (0%)		1/13769 (0%)
Fungal peritonitis	0/13756 (0%)		1/13769 (0%)
Furuncle	1/13756 (0%)		0/13769 (0%)
Gallbladder empyema	1/13756 (0%)		0/13769 (0%)
Gangrene	12/13756 (0.1%)		6/13769 (0%)
Gastritis viral	0/13756 (0%)		1/13769 (0%)
Gastroenteritis	14/13756 (0.1%)		19/13769 (0.1%)
Gastroenteritis adenovirus	0/13756 (0%)		1/13769 (0%)
Gastroenteritis bacterial	0/13756 (0%)		2/13769 (0%)
Gastroenteritis clostridial	0/13756 (0%)		1/13769 (0%)
Gastroenteritis rotavirus	1/13756 (0%)		1/13769 (0%)
Gastroenteritis salmonella	2/13756 (0%)		2/13769 (0%)
Gastroenteritis viral	3/13756 (0%)		3/13769 (0%)
Gastrointestinal infection	2/13756 (0%)		1/13769 (0%)
Gingival abscess	1/13756 (0%)		0/13769 (0%)
Graft infection	2/13756 (0%)		1/13769 (0%)
Groin abscess	0/13756 (0%)		1/13769 (0%)
H1N1 influenza	1/13756 (0%)		0/13769 (0%)
Haematoma infection	1/13756 (0%)		0/13769 (0%)
Helicobacter infection	1/13756 (0%)		0/13769 (0%)
Hepatitis A	1/13756 (0%)		0/13769 (0%)
Hepatitis B	2/13756 (0%)		1/13769 (0%)
Hepatitis C	0/13756 (0%)		3/13769 (0%)
Hepatitis E	1/13756 (0%)		3/13769 (0%)
Herpes zoster	3/13756 (0%)		5/13769 (0%)
Implant site infection	0/13756 (0%)		1/13769 (0%)
Incision site infection	0/13756 (0%)		1/13769 (0%)
Infected bite	1/13756 (0%)		1/13769 (0%)
Infected cyst	3/13756 (0%)		0/13769 (0%)
Infected skin ulcer	2/13756 (0%)		2/13769 (0%)
Infection	0/13756 (0%)		1/13769 (0%)
Infection in an immunocompromised host	1/13756 (0%)		0/13769 (0%)
Infectious colitis	1/13756 (0%)		0/13769 (0%)
Infectious pleural effusion	2/13756 (0%)		1/13769 (0%)
Infective exacerbation of chronic obstructive airways disease	5/13756 (0%)		3/13769 (0%)
Infective tenosynovitis	0/13756 (0%)		1/13769 (0%)
Influenza	6/13756 (0%)		9/13769 (0.1%)
Intervertebral discitis	0/13756 (0%)		1/13769 (0%)
Kidney infection	1/13756 (0%)		1/13769 (0%)
Laryngitis	2/13756 (0%)		1/13769 (0%)
Liver abscess	0/13756 (0%)		2/13769 (0%)
Localised infection	6/13756 (0%)		6/13769 (0%)
Lower respiratory tract infection	15/13756 (0.1%)		14/13769 (0.1%)
Lower respiratory tract infection viral	0/13756 (0%)		2/13769 (0%)
Lung abscess	1/13756 (0%)		0/13769 (0%)
Lung infection	3/13756 (0%)		5/13769 (0%)
Mastoiditis	1/13756 (0%)		1/13769 (0%)
Mediastinitis	0/13756 (0%)		1/13769 (0%)
Medical device site infection	1/13756 (0%)		0/13769 (0%)
Meningitis	1/13756 (0%)		0/13769 (0%)
Meningitis bacterial	0/13756 (0%)		1/13769 (0%)
Meningitis pneumococcal	1/13756 (0%)		0/13769 (0%)
Muscle abscess	0/13756 (0%)		1/13769 (0%)
Nasopharyngitis	0/13756 (0%)		1/13769 (0%)
Necrotising fasciitis	1/13756 (0%)		2/13769 (0%)
Neurosyphilis	0/13756 (0%)		1/13769 (0%)
Neutropenic infection	1/13756 (0%)		0/13769 (0%)
Nosocomial infection	1/13756 (0%)		0/13769 (0%)
Ophthalmic herpes zoster	1/13756 (0%)		1/13769 (0%)
Oral fungal infection	1/13756 (0%)		0/13769 (0%)
Orchitis	2/13756 (0%)		2/13769 (0%)
Osteomyelitis	7/13756 (0.1%)		16/13769 (0.1%)
Osteomyelitis acute	1/13756 (0%)		1/13769 (0%)
Osteomyelitis chronic	2/13756 (0%)		0/13769 (0%)
Otitis externa	0/13756 (0%)		1/13769 (0%)
Otitis externa bacterial	0/13756 (0%)		1/13769 (0%)
Otitis media	0/13756 (0%)		2/13769 (0%)
Pancreas infection	0/13756 (0%)		1/13769 (0%)
Paronychia	0/13756 (0%)		1/13769 (0%)
Parotitis	1/13756 (0%)		0/13769 (0%)
Pelvic abscess	2/13756 (0%)		0/13769 (0%)
Perineal abscess	1/13756 (0%)		0/13769 (0%)
Periodontitis	2/13756 (0%)		1/13769 (0%)
Perirectal abscess	0/13756 (0%)		1/13769 (0%)
Peritonitis	2/13756 (0%)		4/13769 (0%)
Peritonitis bacterial	2/13756 (0%)		1/13769 (0%)
Pharyngeal abscess	1/13756 (0%)		0/13769 (0%)
Pharyngitis	0/13756 (0%)		1/13769 (0%)
Pharyngitis streptococcal	1/13756 (0%)		0/13769 (0%)
Pneumococcal sepsis	0/13756 (0%)		1/13769 (0%)
Pneumonia	152/13756 (1.1%)		147/13769 (1.1%)
Pneumonia adenoviral	0/13756 (0%)		1/13769 (0%)
Pneumonia bacterial	11/13756 (0.1%)		18/13769 (0.1%)
Pneumonia influenzal	1/13756 (0%)		1/13769 (0%)
Pneumonia legionella	1/13756 (0%)		1/13769 (0%)
Pneumonia pneumococcal	1/13756 (0%)		0/13769 (0%)
Pneumonia staphylococcal	2/13756 (0%)		0/13769 (0%)
Pneumonia viral	0/13756 (0%)		1/13769 (0%)
Post procedural infection	3/13756 (0%)		4/13769 (0%)
Post procedural pneumonia	1/13756 (0%)		0/13769 (0%)
Post procedural sepsis	1/13756 (0%)		1/13769 (0%)
Postoperative abscess	4/13756 (0%)		0/13769 (0%)
Postoperative wound infection	8/13756 (0.1%)		3/13769 (0%)
Prostate infection	0/13756 (0%)		1/13769 (0%)
Prostatic abscess	1/13756 (0%)		1/13769 (0%)
Pseudomembranous colitis	1/13756 (0%)		1/13769 (0%)
Psoas abscess	0/13756 (0%)		1/13769 (0%)
Pulmonary sepsis	1/13756 (0%)		0/13769 (0%)
Pulmonary tuberculosis	3/13756 (0%)		0/13769 (0%)
Pyelonephritis	4/13756 (0%)		10/13769 (0.1%)
Pyelonephritis acute	6/13756 (0%)		6/13769 (0%)
Pyelonephritis chronic	0/13756 (0%)		1/13769 (0%)
Pyonephrosis	1/13756 (0%)		1/13769 (0%)
Rectal abscess	1/13756 (0%)		1/13769 (0%)
Respiratory tract infection	8/13756 (0.1%)		8/13769 (0.1%)
Respiratory tract infection bacterial	0/13756 (0%)		1/13769 (0%)
Rhinitis	0/13756 (0%)		1/13769 (0%)
Rhinovirus infection	0/13756 (0%)		1/13769 (0%)
Salmonellosis	0/13756 (0%)		1/13769 (0%)
Salpingitis	0/13756 (0%)		1/13769 (0%)
Scrotal abscess	1/13756 (0%)		1/13769 (0%)
Scrotal infection	1/13756 (0%)		0/13769 (0%)
Sepsis	31/13756 (0.2%)		21/13769 (0.2%)
Septic shock	9/13756 (0.1%)		6/13769 (0%)
Sinusitis	1/13756 (0%)		1/13769 (0%)
Skin bacterial infection	0/13756 (0%)		1/13769 (0%)
Skin infection	2/13756 (0%)		1/13769 (0%)
Soft tissue infection	1/13756 (0%)		0/13769 (0%)
Spermatic cord funiculitis	0/13756 (0%)		1/13769 (0%)
Splenic abscess	1/13756 (0%)		0/13769 (0%)
Staphylococcal abscess	1/13756 (0%)		0/13769 (0%)
Staphylococcal bacteraemia	3/13756 (0%)		1/13769 (0%)
Staphylococcal infection	2/13756 (0%)		0/13769 (0%)
Staphylococcal sepsis	2/13756 (0%)		1/13769 (0%)
Streptococcal sepsis	1/13756 (0%)		2/13769 (0%)
Subcutaneous abscess	1/13756 (0%)		2/13769 (0%)
Testicular abscess	0/13756 (0%)		1/13769 (0%)
Tick-borne viral encephalitis	1/13756 (0%)		0/13769 (0%)
Tonsillitis	1/13756 (0%)		0/13769 (0%)
Tooth abscess	1/13756 (0%)		3/13769 (0%)
Tracheitis	0/13756 (0%)		2/13769 (0%)
Tracheobronchitis	3/13756 (0%)		0/13769 (0%)
Tuberculosis	0/13756 (0%)		1/13769 (0%)
Upper respiratory tract infection	6/13756 (0%)		6/13769 (0%)
Upper respiratory tract infection bacterial	3/13756 (0%)		0/13769 (0%)
Ureteritis	0/13756 (0%)		1/13769 (0%)
Urinary tract infection	37/13756 (0.3%)		41/13769 (0.3%)
Urinary tract infection bacterial	7/13756 (0.1%)		7/13769 (0.1%)
Urosepsis	15/13756 (0.1%)		12/13769 (0.1%)
Vestibular neuronitis	1/13756 (0%)		2/13769 (0%)
Viral infection	3/13756 (0%)		4/13769 (0%)
Viral myocarditis	1/13756 (0%)		0/13769 (0%)
Viral pericarditis	0/13756 (0%)		2/13769 (0%)
Viral upper respiratory tract infection	1/13756 (0%)		0/13769 (0%)
Vulval abscess	1/13756 (0%)		2/13769 (0%)
Wound abscess	0/13756 (0%)		1/13769 (0%)
Wound infection	11/13756 (0.1%)		6/13769 (0%)
Wound infection bacterial	1/13756 (0%)		0/13769 (0%)
Wound infection staphylococcal	0/13756 (0%)		1/13769 (0%)
Wound sepsis	2/13756 (0%)		0/13769 (0%)
Injury, poisoning and procedural complications
Abdominal injury	0/13756 (0%)		1/13769 (0%)
Accidental overdose	2/13756 (0%)		3/13769 (0%)
Acetabulum fracture	2/13756 (0%)		0/13769 (0%)
Alcohol poisoning	3/13756 (0%)		3/13769 (0%)
Anaemia postoperative	0/13756 (0%)		1/13769 (0%)
Anastomotic fistula	0/13756 (0%)		1/13769 (0%)
Anastomotic leak	1/13756 (0%)		0/13769 (0%)
Anastomotic stenosis	1/13756 (0%)		0/13769 (0%)
Animal bite	0/13756 (0%)		2/13769 (0%)
Animal scratch	0/13756 (0%)		1/13769 (0%)
Ankle fracture	12/13756 (0.1%)		8/13769 (0.1%)
Aortic injury	0/13756 (0%)		1/13769 (0%)
Arterial bypass occlusion	1/13756 (0%)		1/13769 (0%)
Arterial bypass thrombosis	0/13756 (0%)		1/13769 (0%)
Arterial injury	1/13756 (0%)		0/13769 (0%)
Arterial restenosis	1/13756 (0%)		0/13769 (0%)
Arteriovenous fistula site complication	0/13756 (0%)		1/13769 (0%)
Arthropod bite	1/13756 (0%)		1/13769 (0%)
Avulsion fracture	1/13756 (0%)		0/13769 (0%)
Back injury	0/13756 (0%)		2/13769 (0%)
Carbon monoxide poisoning	1/13756 (0%)		0/13769 (0%)
Carotid artery restenosis	0/13756 (0%)		1/13769 (0%)
Cartilage injury	1/13756 (0%)		0/13769 (0%)
Cervical vertebral fracture	1/13756 (0%)		4/13769 (0%)
Chemical burn of gastrointestinal tract	1/13756 (0%)		0/13769 (0%)
Chemical poisoning	0/13756 (0%)		1/13769 (0%)
Chest injury	1/13756 (0%)		0/13769 (0%)
Clavicle fracture	1/13756 (0%)		3/13769 (0%)
Comminuted fracture	0/13756 (0%)		1/13769 (0%)
Concussion	3/13756 (0%)		5/13769 (0%)
Contusion	3/13756 (0%)		6/13769 (0%)
Coronary artery restenosis	0/13756 (0%)		2/13769 (0%)
Cranial nerve injury	0/13756 (0%)		1/13769 (0%)
Craniocerebral injury	3/13756 (0%)		6/13769 (0%)
Diffuse axonal injury	0/13756 (0%)		1/13769 (0%)
Dislocation of sternum	0/13756 (0%)		1/13769 (0%)
Dislocation of vertebra	0/13756 (0%)		1/13769 (0%)
Endotracheal intubation complication	0/13756 (0%)		1/13769 (0%)
Extradural haematoma	1/13756 (0%)		0/13769 (0%)
Eye contusion	1/13756 (0%)		0/13769 (0%)
Eye injury	2/13756 (0%)		1/13769 (0%)
Eye operation complication	0/13756 (0%)		1/13769 (0%)
Face injury	1/13756 (0%)		0/13769 (0%)
Facial bones fracture	4/13756 (0%)		3/13769 (0%)
Fall	13/13756 (0.1%)		17/13769 (0.1%)
Femoral neck fracture	7/13756 (0.1%)		4/13769 (0%)
Femur fracture	9/13756 (0.1%)		20/13769 (0.1%)
Fibula fracture	0/13756 (0%)		1/13769 (0%)
Foot fracture	4/13756 (0%)		5/13769 (0%)
Forearm fracture	3/13756 (0%)		4/13769 (0%)
Foreign body aspiration	1/13756 (0%)		0/13769 (0%)
Fracture	2/13756 (0%)		1/13769 (0%)
Fracture displacement	0/13756 (0%)		1/13769 (0%)
Fractured ischium	0/13756 (0%)		1/13769 (0%)
Fractured sacrum	1/13756 (0%)		0/13769 (0%)
Graft complication	1/13756 (0%)		0/13769 (0%)
Graft thrombosis	1/13756 (0%)		0/13769 (0%)
Hand fracture	3/13756 (0%)		0/13769 (0%)
Head injury	8/13756 (0.1%)		6/13769 (0%)
Heat exhaustion	1/13756 (0%)		0/13769 (0%)
Heat stroke	0/13756 (0%)		1/13769 (0%)
Hip fracture	11/13756 (0.1%)		11/13769 (0.1%)
Humerus fracture	8/13756 (0.1%)		6/13769 (0%)
Ilium fracture	0/13756 (0%)		2/13769 (0%)
Incisional hernia	4/13756 (0%)		5/13769 (0%)
Incomplete spinal fusion	0/13756 (0%)		1/13769 (0%)
Inflammation of wound	1/13756 (0%)		0/13769 (0%)
Injury	2/13756 (0%)		5/13769 (0%)
Intentional overdose	5/13756 (0%)		1/13769 (0%)
Jaw fracture	1/13756 (0%)		0/13769 (0%)
Joint dislocation	5/13756 (0%)		4/13769 (0%)
Joint dislocation postoperative	0/13756 (0%)		2/13769 (0%)
Joint injury	1/13756 (0%)		2/13769 (0%)
Kidney contusion	1/13756 (0%)		0/13769 (0%)
Laceration	4/13756 (0%)		4/13769 (0%)
Ligament rupture	2/13756 (0%)		3/13769 (0%)
Limb crushing injury	1/13756 (0%)		1/13769 (0%)
Limb fracture	1/13756 (0%)		0/13769 (0%)
Limb injury	3/13756 (0%)		2/13769 (0%)
Limb traumatic amputation	1/13756 (0%)		4/13769 (0%)
Lower limb fracture	3/13756 (0%)		3/13769 (0%)
Lumbar vertebral fracture	4/13756 (0%)		7/13769 (0.1%)
Medication error	1/13756 (0%)		0/13769 (0%)
Meniscus injury	4/13756 (0%)		8/13769 (0.1%)
Metal poisoning	1/13756 (0%)		0/13769 (0%)
Multiple fractures	1/13756 (0%)		1/13769 (0%)
Multiple injuries	2/13756 (0%)		0/13769 (0%)
Muscle contusion	1/13756 (0%)		0/13769 (0%)
Muscle rupture	1/13756 (0%)		0/13769 (0%)
Neck injury	0/13756 (0%)		1/13769 (0%)
Open globe injury	0/13756 (0%)		1/13769 (0%)
Overdose	2/13756 (0%)		2/13769 (0%)
Patella fracture	3/13756 (0%)		4/13769 (0%)
Pelvic fracture	2/13756 (0%)		1/13769 (0%)
Peripheral arterial reocclusion	0/13756 (0%)		2/13769 (0%)
Peripheral artery restenosis	2/13756 (0%)		2/13769 (0%)
Perirenal haematoma	0/13756 (0%)		1/13769 (0%)
Peroneal nerve palsy postoperative	0/13756 (0%)		1/13769 (0%)
Pneumoconiosis	0/13756 (0%)		1/13769 (0%)
Pneumonitis chemical	0/13756 (0%)		1/13769 (0%)
Pneumothorax traumatic	1/13756 (0%)		1/13769 (0%)
Poisoning	1/13756 (0%)		0/13769 (0%)
Post concussion syndrome	0/13756 (0%)		1/13769 (0%)
Post laminectomy syndrome	1/13756 (0%)		0/13769 (0%)
Post procedural complication	1/13756 (0%)		2/13769 (0%)
Post procedural constipation	1/13756 (0%)		0/13769 (0%)
Post procedural haematoma	3/13756 (0%)		3/13769 (0%)
Post procedural haematuria	0/13756 (0%)		1/13769 (0%)
Post procedural haemorrhage	7/13756 (0.1%)		6/13769 (0%)
Post procedural myocardial infarction	2/13756 (0%)		0/13769 (0%)
Post procedural swelling	1/13756 (0%)		1/13769 (0%)
Post-traumatic neck syndrome	1/13756 (0%)		0/13769 (0%)
Post-traumatic pain	0/13756 (0%)		1/13769 (0%)
Postoperative respiratory failure	1/13756 (0%)		1/13769 (0%)
Postoperative thoracic procedure complication	2/13756 (0%)		0/13769 (0%)
Postoperative wound complication	1/13756 (0%)		0/13769 (0%)
Procedural complication	1/13756 (0%)		0/13769 (0%)
Procedural haemorrhage	1/13756 (0%)		1/13769 (0%)
Procedural hypotension	1/13756 (0%)		0/13769 (0%)
Procedural pain	1/13756 (0%)		2/13769 (0%)
Procedural pneumothorax	3/13756 (0%)		0/13769 (0%)
Pubis fracture	2/13756 (0%)		2/13769 (0%)
Radial head dislocation	1/13756 (0%)		0/13769 (0%)
Radiation mucositis	0/13756 (0%)		1/13769 (0%)
Radiation oesophagitis	1/13756 (0%)		0/13769 (0%)
Radius fracture	4/13756 (0%)		1/13769 (0%)
Rib fracture	11/13756 (0.1%)		7/13769 (0.1%)
Road traffic accident	6/13756 (0%)		4/13769 (0%)
Sacroiliac fracture	0/13756 (0%)		1/13769 (0%)
Scapula fracture	1/13756 (0%)		1/13769 (0%)
Seroma	3/13756 (0%)		0/13769 (0%)
Skeletal injury	0/13756 (0%)		1/13769 (0%)
Skin abrasion	1/13756 (0%)		1/13769 (0%)
Skull fracture	0/13756 (0%)		3/13769 (0%)
Skull fractured base	1/13756 (0%)		0/13769 (0%)
Snake bite	0/13756 (0%)		2/13769 (0%)
Spinal column injury	1/13756 (0%)		1/13769 (0%)
Spinal compression fracture	4/13756 (0%)		5/13769 (0%)
Spinal cord injury	1/13756 (0%)		0/13769 (0%)
Spinal cord injury lumbar	0/13756 (0%)		1/13769 (0%)
Spinal fracture	3/13756 (0%)		2/13769 (0%)
Splenic injury	1/13756 (0%)		0/13769 (0%)
Stab wound	2/13756 (0%)		1/13769 (0%)
Sternal fracture	0/13756 (0%)		2/13769 (0%)
Subarachnoid haemorrhage	3/13756 (0%)		3/13769 (0%)
Subcutaneous haematoma	0/13756 (0%)		1/13769 (0%)
Subdural haematoma	11/13756 (0.1%)		6/13769 (0%)
Subdural haemorrhage	2/13756 (0%)		3/13769 (0%)
Tendon injury	0/13756 (0%)		2/13769 (0%)
Tendon rupture	8/13756 (0.1%)		6/13769 (0%)
Thermal burn	2/13756 (0%)		2/13769 (0%)
Thoracic vertebral fracture	3/13756 (0%)		3/13769 (0%)
Tibia fracture	2/13756 (0%)		7/13769 (0.1%)
Toxicity to various agents	4/13756 (0%)		0/13769 (0%)
Transplant failure	1/13756 (0%)		0/13769 (0%)
Traumatic arthritis	0/13756 (0%)		1/13769 (0%)
Traumatic fracture	1/13756 (0%)		0/13769 (0%)
Traumatic haematoma	0/13756 (0%)		2/13769 (0%)
Traumatic haemothorax	3/13756 (0%)		0/13769 (0%)
Traumatic intracranial haemorrhage	0/13756 (0%)		1/13769 (0%)
Traumatic shock	0/13756 (0%)		1/13769 (0%)
Traumatic ulcer	0/13756 (0%)		1/13769 (0%)
Ulna fracture	0/13756 (0%)		1/13769 (0%)
Ulnar nerve injury	1/13756 (0%)		0/13769 (0%)
Upper limb fracture	2/13756 (0%)		5/13769 (0%)
Urethral stricture postoperative	0/13756 (0%)		1/13769 (0%)
Vascular bypass dysfunction	2/13756 (0%)		1/13769 (0%)
Vascular graft complication	1/13756 (0%)		0/13769 (0%)
Vascular graft occlusion	5/13756 (0%)		2/13769 (0%)
Vascular graft thrombosis	0/13756 (0%)		3/13769 (0%)
Vascular procedure complication	1/13756 (0%)		0/13769 (0%)
Vascular pseudoaneurysm	3/13756 (0%)		2/13769 (0%)
Wound	3/13756 (0%)		2/13769 (0%)
Wound dehiscence	1/13756 (0%)		4/13769 (0%)
Wound evisceration	0/13756 (0%)		1/13769 (0%)
Wound haemorrhage	1/13756 (0%)		0/13769 (0%)
Wound necrosis	1/13756 (0%)		1/13769 (0%)
Wound secretion	0/13756 (0%)		1/13769 (0%)
Wrist fracture	1/13756 (0%)		3/13769 (0%)
Investigations
Alanine aminotransferase increased	15/13756 (0.1%)		11/13769 (0.1%)
Arteriogram coronary	3/13756 (0%)		5/13769 (0%)
Arteriogram coronary abnormal	2/13756 (0%)		1/13769 (0%)
Arteriogram coronary normal	0/13756 (0%)		1/13769 (0%)
Aspartate aminotransferase increased	11/13756 (0.1%)		6/13769 (0%)
Blood alkaline phosphatase increased	1/13756 (0%)		0/13769 (0%)
Blood bilirubin increased	1/13756 (0%)		0/13769 (0%)
Blood creatine phosphokinase increased	6/13756 (0%)		7/13769 (0.1%)
Blood creatinine increased	1/13756 (0%)		2/13769 (0%)
Blood glucose decreased	1/13756 (0%)		0/13769 (0%)
Blood glucose fluctuation	1/13756 (0%)		0/13769 (0%)
Blood glucose increased	1/13756 (0%)		2/13769 (0%)
Blood potassium increased	1/13756 (0%)		0/13769 (0%)
Blood pressure increased	0/13756 (0%)		1/13769 (0%)
Cardiac stress test abnormal	0/13756 (0%)		1/13769 (0%)
Ejection fraction decreased	2/13756 (0%)		4/13769 (0%)
Electrocardiogram QT prolonged	0/13756 (0%)		1/13769 (0%)
Electrocardiogram ST segment depression	0/13756 (0%)		2/13769 (0%)
Electrocardiogram abnormal	1/13756 (0%)		1/13769 (0%)
Exercise electrocardiogram abnormal	0/13756 (0%)		1/13769 (0%)
False positive investigation result	0/13756 (0%)		1/13769 (0%)
Haemoglobin decreased	0/13756 (0%)		1/13769 (0%)
Heart rate increased	1/13756 (0%)		0/13769 (0%)
Heart rate irregular	1/13756 (0%)		0/13769 (0%)
Hepatic enzyme increased	8/13756 (0.1%)		24/13769 (0.2%)
Hepatitis A antibody positive	0/13756 (0%)		1/13769 (0%)
Hepatitis A virus test positive	0/13756 (0%)		1/13769 (0%)
Hepatitis B antibody positive	1/13756 (0%)		0/13769 (0%)
Hepatitis C virus test positive	0/13756 (0%)		1/13769 (0%)
Influenza A virus test positive	0/13756 (0%)		1/13769 (0%)
Influenza B virus test positive	0/13756 (0%)		1/13769 (0%)
International normalised ratio abnormal	0/13756 (0%)		1/13769 (0%)
International normalised ratio increased	4/13756 (0%)		1/13769 (0%)
Investigation	0/13756 (0%)		1/13769 (0%)
Lipase increased	1/13756 (0%)		0/13769 (0%)
Liver function test abnormal	4/13756 (0%)		7/13769 (0.1%)
Liver function test increased	7/13756 (0.1%)		0/13769 (0%)
Medical observation	0/13756 (0%)		1/13769 (0%)
Myocardial necrosis marker increased	1/13756 (0%)		2/13769 (0%)
Oxygen saturation decreased	1/13756 (0%)		0/13769 (0%)
Precancerous cells present	1/13756 (0%)		0/13769 (0%)
Stress echocardiogram	0/13756 (0%)		1/13769 (0%)
Thyroid function test abnormal	0/13756 (0%)		1/13769 (0%)
Transaminases increased	5/13756 (0%)		6/13769 (0%)
Troponin I increased	2/13756 (0%)		1/13769 (0%)
Troponin T increased	0/13756 (0%)		1/13769 (0%)
Troponin increased	2/13756 (0%)		3/13769 (0%)
Weight decreased	2/13756 (0%)		0/13769 (0%)
Weight increased	0/13756 (0%)		1/13769 (0%)
Metabolism and nutrition disorders
Abnormal loss of weight	0/13756 (0%)		1/13769 (0%)
Cachexia	1/13756 (0%)		0/13769 (0%)
Decreased appetite	1/13756 (0%)		1/13769 (0%)
Dehydration	18/13756 (0.1%)		16/13769 (0.1%)
Diabetes mellitus	56/13756 (0.4%)		61/13769 (0.4%)
Diabetes mellitus inadequate control	11/13756 (0.1%)		6/13769 (0%)
Diabetic ketoacidosis	8/13756 (0.1%)		10/13769 (0.1%)
Diabetic metabolic decompensation	3/13756 (0%)		2/13769 (0%)
Electrolyte imbalance	1/13756 (0%)		3/13769 (0%)
Fluid retention	1/13756 (0%)		0/13769 (0%)
Glucose tolerance impaired	1/13756 (0%)		0/13769 (0%)
Gout	5/13756 (0%)		6/13769 (0%)
Hyperammonaemia	1/13756 (0%)		0/13769 (0%)
Hypercalcaemia	2/13756 (0%)		0/13769 (0%)
Hyperglycaemia	8/13756 (0.1%)		8/13769 (0.1%)
Hyperinsulinaemic hypoglycaemia	0/13756 (0%)		1/13769 (0%)
Hyperkalaemia	7/13756 (0.1%)		10/13769 (0.1%)
Hypernatraemia	1/13756 (0%)		0/13769 (0%)
Hyperosmolar hyperglycaemic state	0/13756 (0%)		1/13769 (0%)
Hypocalcaemia	1/13756 (0%)		1/13769 (0%)
Hypoglycaemia	11/13756 (0.1%)		17/13769 (0.1%)
Hypoglycaemia unawareness	1/13756 (0%)		0/13769 (0%)
Hypokalaemia	7/13756 (0.1%)		6/13769 (0%)
Hypomagnesaemia	1/13756 (0%)		0/13769 (0%)
Hyponatraemia	5/13756 (0%)		5/13769 (0%)
Hypovitaminosis	0/13756 (0%)		1/13769 (0%)
Hypovolaemia	1/13756 (0%)		2/13769 (0%)
Ketoacidosis	1/13756 (0%)		0/13769 (0%)
Malnutrition	2/13756 (0%)		0/13769 (0%)
Metabolic acidosis	1/13756 (0%)		2/13769 (0%)
Obesity	6/13756 (0%)		3/13769 (0%)
Type 1 diabetes mellitus	1/13756 (0%)		0/13769 (0%)
Type 2 diabetes mellitus	4/13756 (0%)		12/13769 (0.1%)
Vitamin B12 deficiency	0/13756 (0%)		1/13769 (0%)
Musculoskeletal and connective tissue disorders
Arthralgia	18/13756 (0.1%)		16/13769 (0.1%)
Arthritis	13/13756 (0.1%)		11/13769 (0.1%)
Arthropathy	3/13756 (0%)		4/13769 (0%)
Back pain	30/13756 (0.2%)		30/13769 (0.2%)
Bone deformity	1/13756 (0%)		0/13769 (0%)
Bone pain	1/13756 (0%)		0/13769 (0%)
Bursitis	2/13756 (0%)		3/13769 (0%)
Cervical spinal stenosis	0/13756 (0%)		3/13769 (0%)
Chondrocalcinosis pyrophosphate	0/13756 (0%)		1/13769 (0%)
Chondropathy	0/13756 (0%)		2/13769 (0%)
Costochondritis	3/13756 (0%)		1/13769 (0%)
Diabetic amyotrophy	1/13756 (0%)		0/13769 (0%)
Dupuytren's contracture	0/13756 (0%)		1/13769 (0%)
Enthesopathy	1/13756 (0%)		0/13769 (0%)
Exostosis	2/13756 (0%)		1/13769 (0%)
Exostosis of jaw	1/13756 (0%)		0/13769 (0%)
Facet joint syndrome	0/13756 (0%)		1/13769 (0%)
Femoroacetabular impingement	1/13756 (0%)		0/13769 (0%)
Fibromyalgia	1/13756 (0%)		0/13769 (0%)
Flank pain	2/13756 (0%)		0/13769 (0%)
Foot deformity	5/13756 (0%)		7/13769 (0.1%)
Fracture nonunion	1/13756 (0%)		0/13769 (0%)
Gouty arthritis	2/13756 (0%)		2/13769 (0%)
Groin pain	1/13756 (0%)		0/13769 (0%)
Intervertebral disc degeneration	3/13756 (0%)		8/13769 (0.1%)
Intervertebral disc disorder	2/13756 (0%)		4/13769 (0%)
Intervertebral disc displacement	1/13756 (0%)		1/13769 (0%)
Intervertebral disc protrusion	24/13756 (0.2%)		22/13769 (0.2%)
Jaw cyst	0/13756 (0%)		1/13769 (0%)
Joint adhesion	1/13756 (0%)		0/13769 (0%)
Joint effusion	2/13756 (0%)		1/13769 (0%)
Joint instability	1/13756 (0%)		1/13769 (0%)
Joint range of motion decreased	1/13756 (0%)		1/13769 (0%)
Joint swelling	2/13756 (0%)		0/13769 (0%)
Limb discomfort	0/13756 (0%)		1/13769 (0%)
Lumbar spinal stenosis	17/13756 (0.1%)		21/13769 (0.2%)
Mobility decreased	0/13756 (0%)		1/13769 (0%)
Monarthritis	1/13756 (0%)		0/13769 (0%)
Muscle spasms	0/13756 (0%)		1/13769 (0%)
Muscular weakness	1/13756 (0%)		2/13769 (0%)
Musculoskeletal chest pain	37/13756 (0.3%)		49/13769 (0.4%)
Musculoskeletal pain	5/13756 (0%)		5/13769 (0%)
Musculoskeletal stiffness	1/13756 (0%)		0/13769 (0%)
Myalgia	2/13756 (0%)		8/13769 (0.1%)
Myalgia intercostal	1/13756 (0%)		2/13769 (0%)
Myofascitis	1/13756 (0%)		0/13769 (0%)
Myopathy	0/13756 (0%)		2/13769 (0%)
Myositis	0/13756 (0%)		1/13769 (0%)
Neck pain	1/13756 (0%)		4/13769 (0%)
Neuropathic arthropathy	0/13756 (0%)		1/13769 (0%)
Nodal osteoarthritis	1/13756 (0%)		0/13769 (0%)
Osteitis	0/13756 (0%)		1/13769 (0%)
Osteoarthritis	100/13756 (0.7%)		91/13769 (0.7%)
Osteochondritis	1/13756 (0%)		0/13769 (0%)
Osteochondrosis	2/13756 (0%)		2/13769 (0%)
Osteolysis	1/13756 (0%)		0/13769 (0%)
Osteonecrosis	5/13756 (0%)		4/13769 (0%)
Osteoporosis	1/13756 (0%)		0/13769 (0%)
Osteoporotic fracture	0/13756 (0%)		2/13769 (0%)
Pain in extremity	4/13756 (0%)		8/13769 (0.1%)
Pain in jaw	0/13756 (0%)		1/13769 (0%)
Patellofemoral pain syndrome	1/13756 (0%)		0/13769 (0%)
Pathological fracture	0/13756 (0%)		1/13769 (0%)
Periarthritis	2/13756 (0%)		2/13769 (0%)
Polyarthritis	1/13756 (0%)		1/13769 (0%)
Polymyalgia rheumatica	2/13756 (0%)		2/13769 (0%)
Polymyositis	0/13756 (0%)		1/13769 (0%)
Pseudarthrosis	1/13756 (0%)		0/13769 (0%)
Psoriatic arthropathy	1/13756 (0%)		0/13769 (0%)
Rhabdomyolysis	7/13756 (0.1%)		4/13769 (0%)
Rheumatoid arthritis	2/13756 (0%)		3/13769 (0%)
Rotator cuff syndrome	9/13756 (0.1%)		8/13769 (0.1%)
Seronegative arthritis	1/13756 (0%)		0/13769 (0%)
Spinal column stenosis	5/13756 (0%)		6/13769 (0%)
Spinal instability	0/13756 (0%)		1/13769 (0%)
Spinal osteoarthritis	12/13756 (0.1%)		9/13769 (0.1%)
Spinal pain	5/13756 (0%)		8/13769 (0.1%)
Spondylitis	1/13756 (0%)		0/13769 (0%)
Spondyloarthropathy	1/13756 (0%)		0/13769 (0%)
Spondylolisthesis	2/13756 (0%)		3/13769 (0%)
Spondylolysis	1/13756 (0%)		0/13769 (0%)
Sympathetic posterior cervical syndrome	0/13756 (0%)		1/13769 (0%)
Symphysiolysis	0/13756 (0%)		1/13769 (0%)
Synovial cyst	5/13756 (0%)		1/13769 (0%)
Synovitis	1/13756 (0%)		0/13769 (0%)
Temporomandibular joint syndrome	0/13756 (0%)		1/13769 (0%)
Tendon necrosis	1/13756 (0%)		0/13769 (0%)
Tendonitis	2/13756 (0%)		1/13769 (0%)
Trigger finger	2/13756 (0%)		0/13769 (0%)
Vertebral foraminal stenosis	2/13756 (0%)		1/13769 (0%)
Vertebral osteophyte	1/13756 (0%)		0/13769 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute leukaemia	0/13756 (0%)		1/13769 (0%)
Acute myeloid leukaemia	1/13756 (0%)		0/13769 (0%)
Adenocarcinoma gastric	4/13756 (0%)		4/13769 (0%)
Adenocarcinoma of appendix	1/13756 (0%)		0/13769 (0%)
Adenocarcinoma of colon	12/13756 (0.1%)		17/13769 (0.1%)
Adenocarcinoma pancreas	0/13756 (0%)		2/13769 (0%)
Adrenal adenoma	1/13756 (0%)		1/13769 (0%)
Adrenal gland cancer	1/13756 (0%)		0/13769 (0%)
Adrenal neoplasm	1/13756 (0%)		0/13769 (0%)
Anal cancer stage III	1/13756 (0%)		0/13769 (0%)
Anal neoplasm	0/13756 (0%)		1/13769 (0%)
Anogenital warts	0/13756 (0%)		1/13769 (0%)
B-cell lymphoma	0/13756 (0%)		1/13769 (0%)
B-cell lymphoma stage I	0/13756 (0%)		1/13769 (0%)
B-cell prolymphocytic leukaemia	0/13756 (0%)		1/13769 (0%)
Basal cell carcinoma	11/13756 (0.1%)		4/13769 (0%)
Basosquamous carcinoma	0/13756 (0%)		1/13769 (0%)
Benign gastric neoplasm	0/13756 (0%)		1/13769 (0%)
Benign gastrointestinal neoplasm	1/13756 (0%)		0/13769 (0%)
Benign lung neoplasm	1/13756 (0%)		1/13769 (0%)
Benign neoplasm of adrenal gland	1/13756 (0%)		0/13769 (0%)
Benign neoplasm of bladder	1/13756 (0%)		0/13769 (0%)
Benign neoplasm of prostate	1/13756 (0%)		0/13769 (0%)
Benign neoplasm of spinal cord	1/13756 (0%)		0/13769 (0%)
Benign pancreatic neoplasm	0/13756 (0%)		1/13769 (0%)
Benign renal neoplasm	0/13756 (0%)		2/13769 (0%)
Bile duct cancer	0/13756 (0%)		1/13769 (0%)
Biliary adenoma	0/13756 (0%)		1/13769 (0%)
Bladder adenocarcinoma stage III	1/13756 (0%)		0/13769 (0%)
Bladder adenocarcinoma stage unspecified	4/13756 (0%)		1/13769 (0%)
Bladder cancer	8/13756 (0.1%)		12/13769 (0.1%)
Bladder cancer recurrent	1/13756 (0%)		1/13769 (0%)
Bladder cancer stage 0, with cancer in situ	1/13756 (0%)		2/13769 (0%)
Bladder cancer stage I, with cancer in situ	3/13756 (0%)		1/13769 (0%)
Bladder cancer stage III	0/13756 (0%)		1/13769 (0%)
Bladder neoplasm	2/13756 (0%)		3/13769 (0%)
Bladder papilloma	1/13756 (0%)		1/13769 (0%)
Bladder transitional cell carcinoma	6/13756 (0%)		9/13769 (0.1%)
Bladder transitional cell carcinoma recurrent	0/13756 (0%)		1/13769 (0%)
Bladder transitional cell carcinoma stage I	0/13756 (0%)		2/13769 (0%)
Bladder transitional cell carcinoma stage II	1/13756 (0%)		0/13769 (0%)
Bladder transitional cell carcinoma stage III	1/13756 (0%)		1/13769 (0%)
Bladder transitional cell carcinoma stage IV	1/13756 (0%)		0/13769 (0%)
Bowen's disease	1/13756 (0%)		0/13769 (0%)
Brain cancer metastatic	1/13756 (0%)		0/13769 (0%)
Brain neoplasm malignant	1/13756 (0%)		0/13769 (0%)
Breast cancer	6/13756 (0%)		6/13769 (0%)
Breast cancer female	1/13756 (0%)		0/13769 (0%)
Breast cancer in situ	0/13756 (0%)		1/13769 (0%)
Breast cancer recurrent	0/13756 (0%)		1/13769 (0%)
Bronchial carcinoma	1/13756 (0%)		4/13769 (0%)
Bronchial neoplasm	1/13756 (0%)		0/13769 (0%)
Burkitt's lymphoma	1/13756 (0%)		0/13769 (0%)
Carcinoid tumour pulmonary	0/13756 (0%)		1/13769 (0%)
Cervix carcinoma	0/13756 (0%)		1/13769 (0%)
Cholangiocarcinoma	2/13756 (0%)		1/13769 (0%)
Cholesteatoma	1/13756 (0%)		1/13769 (0%)
Choroid melanoma	1/13756 (0%)		0/13769 (0%)
Chronic lymphocytic leukaemia	3/13756 (0%)		2/13769 (0%)
Chronic myeloid leukaemia	1/13756 (0%)		0/13769 (0%)
Clear cell renal cell carcinoma	0/13756 (0%)		3/13769 (0%)
Colon adenoma	5/13756 (0%)		4/13769 (0%)
Colon cancer	5/13756 (0%)		11/13769 (0.1%)
Colon cancer metastatic	2/13756 (0%)		1/13769 (0%)
Colon cancer stage I	0/13756 (0%)		1/13769 (0%)
Colon cancer stage III	0/13756 (0%)		1/13769 (0%)
Colon neoplasm	1/13756 (0%)		0/13769 (0%)
Colorectal adenocarcinoma	0/13756 (0%)		1/13769 (0%)
Colorectal cancer	0/13756 (0%)		2/13769 (0%)
Colorectal cancer metastatic	2/13756 (0%)		0/13769 (0%)
Dermatofibrosarcoma protuberans	0/13756 (0%)		1/13769 (0%)
Diffuse large B-cell lymphoma	3/13756 (0%)		1/13769 (0%)
Ductal adenocarcinoma of pancreas	1/13756 (0%)		0/13769 (0%)
Endometrial adenocarcinoma	0/13756 (0%)		2/13769 (0%)
Endometrial adenoma	0/13756 (0%)		1/13769 (0%)
Fallopian tube cancer	0/13756 (0%)		1/13769 (0%)
Fibroma	0/13756 (0%)		1/13769 (0%)
Follicular thyroid cancer	0/13756 (0%)		1/13769 (0%)
Gallbladder neoplasm	1/13756 (0%)		0/13769 (0%)
Gastric adenoma	1/13756 (0%)		0/13769 (0%)
Gastric cancer	4/13756 (0%)		5/13769 (0%)
Gastric cancer stage 0	1/13756 (0%)		0/13769 (0%)
Gastric cancer stage IV	0/13756 (0%)		1/13769 (0%)
Gastrointestinal carcinoma	1/13756 (0%)		0/13769 (0%)
Gastrointestinal neoplasm	1/13756 (0%)		0/13769 (0%)
Gastrointestinal stromal tumour	1/13756 (0%)		0/13769 (0%)
Glioblastoma	4/13756 (0%)		1/13769 (0%)
Glioblastoma multiforme	0/13756 (0%)		2/13769 (0%)
Haemangiopericytoma	1/13756 (0%)		2/13769 (0%)
Hepatic cancer	0/13756 (0%)		1/13769 (0%)
Hepatic neoplasm	2/13756 (0%)		0/13769 (0%)
Hepatocellular carcinoma	3/13756 (0%)		0/13769 (0%)
Hodgkin's disease	2/13756 (0%)		2/13769 (0%)
Intraductal papillary mucinous neoplasm	1/13756 (0%)		0/13769 (0%)
Intraductal papillary-mucinous carcinoma of pancreas	1/13756 (0%)		0/13769 (0%)
Intraductal proliferative breast lesion	1/13756 (0%)		1/13769 (0%)
Invasive breast carcinoma	0/13756 (0%)		1/13769 (0%)
Invasive ductal breast carcinoma	6/13756 (0%)		2/13769 (0%)
Large cell lung cancer stage III	0/13756 (0%)		1/13769 (0%)
Laryngeal cancer	3/13756 (0%)		6/13769 (0%)
Laryngeal cancer metastatic	0/13756 (0%)		1/13769 (0%)
Laryngeal cancer stage 0	1/13756 (0%)		0/13769 (0%)
Laryngeal cancer stage IV	0/13756 (0%)		1/13769 (0%)
Laryngeal squamous cell carcinoma	0/13756 (0%)		1/13769 (0%)
Lip and/or oral cavity cancer	1/13756 (0%)		1/13769 (0%)
Lip and/or oral cavity cancer stage III	0/13756 (0%)		1/13769 (0%)
Lip squamous cell carcinoma	1/13756 (0%)		0/13769 (0%)
Lipoma	1/13756 (0%)		1/13769 (0%)
Liposarcoma	0/13756 (0%)		1/13769 (0%)
Lung adenocarcinoma	4/13756 (0%)		13/13769 (0.1%)
Lung adenocarcinoma metastatic	3/13756 (0%)		1/13769 (0%)
Lung adenocarcinoma stage I	2/13756 (0%)		4/13769 (0%)
Lung adenocarcinoma stage III	1/13756 (0%)		1/13769 (0%)
Lung adenocarcinoma stage IV	2/13756 (0%)		2/13769 (0%)
Lung cancer metastatic	3/13756 (0%)		3/13769 (0%)
Lung carcinoma cell type unspecified stage I	1/13756 (0%)		1/13769 (0%)
Lung carcinoma cell type unspecified stage II	0/13756 (0%)		2/13769 (0%)
Lung carcinoma cell type unspecified stage III	1/13756 (0%)		0/13769 (0%)
Lung carcinoma cell type unspecified stage IV	1/13756 (0%)		1/13769 (0%)
Lung neoplasm	4/13756 (0%)		1/13769 (0%)
Lung neoplasm malignant	15/13756 (0.1%)		19/13769 (0.1%)
Lung squamous cell carcinoma metastatic	1/13756 (0%)		1/13769 (0%)
Lung squamous cell carcinoma stage I	1/13756 (0%)		0/13769 (0%)
Lung squamous cell carcinoma stage III	2/13756 (0%)		1/13769 (0%)
Lymphoma	1/13756 (0%)		0/13769 (0%)
Lymphoproliferative disorder	1/13756 (0%)		0/13769 (0%)
Malignant anorectal neoplasm	1/13756 (0%)		0/13769 (0%)
Malignant ascites	0/13756 (0%)		1/13769 (0%)
Malignant melanoma	5/13756 (0%)		5/13769 (0%)
Malignant melanoma in situ	1/13756 (0%)		0/13769 (0%)
Malignant melanoma of sites other than skin	0/13756 (0%)		1/13769 (0%)
Malignant mesenteric neoplasm	0/13756 (0%)		1/13769 (0%)
Malignant neoplasm of pleura	1/13756 (0%)		0/13769 (0%)
Malignant neoplasm of renal pelvis	0/13756 (0%)		1/13769 (0%)
Malignant peritoneal neoplasm	1/13756 (0%)		1/13769 (0%)
Malignant urinary tract neoplasm	1/13756 (0%)		0/13769 (0%)
Meningioma	0/13756 (0%)		1/13769 (0%)
Meningioma benign	1/13756 (0%)		2/13769 (0%)
Mesothelioma	2/13756 (0%)		1/13769 (0%)
Mesothelioma malignant	1/13756 (0%)		0/13769 (0%)
Metastases to adrenals	0/13756 (0%)		1/13769 (0%)
Metastases to bone	3/13756 (0%)		4/13769 (0%)
Metastases to central nervous system	2/13756 (0%)		0/13769 (0%)
Metastases to liver	3/13756 (0%)		4/13769 (0%)
Metastases to lung	2/13756 (0%)		1/13769 (0%)
Metastases to lymph nodes	0/13756 (0%)		1/13769 (0%)
Metastases to pleura	0/13756 (0%)		2/13769 (0%)
Metastases to spine	0/13756 (0%)		2/13769 (0%)
Metastasis	1/13756 (0%)		0/13769 (0%)
Metastatic bronchial carcinoma	1/13756 (0%)		1/13769 (0%)
Metastatic malignant melanoma	1/13756 (0%)		1/13769 (0%)
Metastatic squamous cell carcinoma	2/13756 (0%)		0/13769 (0%)
Myelodysplastic syndrome	1/13756 (0%)		1/13769 (0%)
Myelofibrosis	1/13756 (0%)		0/13769 (0%)
Neoplasm	0/13756 (0%)		1/13769 (0%)
Neoplasm malignant	0/13756 (0%)		1/13769 (0%)
Neoplasm progression	1/13756 (0%)		0/13769 (0%)
Neoplasm prostate	1/13756 (0%)		0/13769 (0%)
Neuroendocrine carcinoma	0/13756 (0%)		1/13769 (0%)
Neuroendocrine carcinoma metastatic	0/13756 (0%)		1/13769 (0%)
Neuroendocrine tumour	1/13756 (0%)		1/13769 (0%)
Non-Hodgkin's lymphoma	1/13756 (0%)		2/13769 (0%)
Non-small cell lung cancer	4/13756 (0%)		3/13769 (0%)
Non-small cell lung cancer metastatic	2/13756 (0%)		0/13769 (0%)
Oesophageal adenocarcinoma	3/13756 (0%)		2/13769 (0%)
Oesophageal adenocarcinoma metastatic	0/13756 (0%)		1/13769 (0%)
Oesophageal carcinoma	1/13756 (0%)		1/13769 (0%)
Oesophageal squamous cell carcinoma	3/13756 (0%)		0/13769 (0%)
Oral cavity cancer metastatic	1/13756 (0%)		0/13769 (0%)
Oral neoplasm	1/13756 (0%)		1/13769 (0%)
Oral papilloma	1/13756 (0%)		0/13769 (0%)
Oropharyngeal cancer	1/13756 (0%)		0/13769 (0%)
Oropharyngeal squamous cell carcinoma	1/13756 (0%)		0/13769 (0%)
Ovarian adenoma	0/13756 (0%)		1/13769 (0%)
Ovarian cancer	1/13756 (0%)		0/13769 (0%)
Ovarian cancer stage II	0/13756 (0%)		1/13769 (0%)
Ovarian epithelial cancer	0/13756 (0%)		1/13769 (0%)
Pancreatic carcinoma	6/13756 (0%)		5/13769 (0%)
Pancreatic carcinoma metastatic	0/13756 (0%)		1/13769 (0%)
Papillary cystadenoma lymphomatosum	2/13756 (0%)		1/13769 (0%)
Papillary thyroid cancer	1/13756 (0%)		2/13769 (0%)
Parathyroid tumour benign	1/13756 (0%)		0/13769 (0%)
Penile cancer	1/13756 (0%)		0/13769 (0%)
Phaeochromocytoma	0/13756 (0%)		1/13769 (0%)
Pharyngeal cancer	1/13756 (0%)		0/13769 (0%)
Pharyngeal cancer stage IV	0/13756 (0%)		1/13769 (0%)
Pharyngeal neoplasm benign	1/13756 (0%)		0/13769 (0%)
Plasma cell myeloma	2/13756 (0%)		4/13769 (0%)
Plasmacytoma	0/13756 (0%)		1/13769 (0%)
Pleural mesothelioma malignant	0/13756 (0%)		1/13769 (0%)
Polycythaemia vera	0/13756 (0%)		1/13769 (0%)
Prostate cancer	40/13756 (0.3%)		41/13769 (0.3%)
Prostate cancer metastatic	2/13756 (0%)		4/13769 (0%)
Prostate cancer stage I	2/13756 (0%)		0/13769 (0%)
Prostate cancer stage II	1/13756 (0%)		2/13769 (0%)
Prostate cancer stage IV	0/13756 (0%)		2/13769 (0%)
Prostatic adenoma	1/13756 (0%)		6/13769 (0%)
Rectal adenocarcinoma	7/13756 (0.1%)		2/13769 (0%)
Rectal cancer	3/13756 (0%)		2/13769 (0%)
Rectal cancer stage III	0/13756 (0%)		2/13769 (0%)
Rectal cancer stage IV	0/13756 (0%)		1/13769 (0%)
Renal adenoma	0/13756 (0%)		1/13769 (0%)
Renal cancer	1/13756 (0%)		9/13769 (0.1%)
Renal cancer metastatic	1/13756 (0%)		0/13769 (0%)
Renal cancer stage I	1/13756 (0%)		0/13769 (0%)
Renal cell carcinoma	4/13756 (0%)		4/13769 (0%)
Renal cell carcinoma stage I	0/13756 (0%)		2/13769 (0%)
Renal cell carcinoma stage II	1/13756 (0%)		0/13769 (0%)
Renal cell carcinoma stage III	1/13756 (0%)		0/13769 (0%)
Renal neoplasm	1/13756 (0%)		2/13769 (0%)
Renal oncocytoma	1/13756 (0%)		0/13769 (0%)
Retroperitoneal neoplasm	0/13756 (0%)		1/13769 (0%)
Salivary gland adenoma	1/13756 (0%)		0/13769 (0%)
Sarcoma	1/13756 (0%)		1/13769 (0%)
Sarcoma metastatic	1/13756 (0%)		0/13769 (0%)
Schwannoma	1/13756 (0%)		0/13769 (0%)
Skin cancer	3/13756 (0%)		2/13769 (0%)
Small cell lung cancer	0/13756 (0%)		5/13769 (0%)
Small cell lung cancer limited stage	1/13756 (0%)		1/13769 (0%)
Small cell lung cancer metastatic	2/13756 (0%)		2/13769 (0%)
Small intestine carcinoma	1/13756 (0%)		0/13769 (0%)
Soft tissue sarcoma	0/13756 (0%)		1/13769 (0%)
Spindle cell sarcoma	1/13756 (0%)		0/13769 (0%)
Squamous cell carcinoma	4/13756 (0%)		0/13769 (0%)
Squamous cell carcinoma of head and neck	1/13756 (0%)		0/13769 (0%)
Squamous cell carcinoma of lung	3/13756 (0%)		3/13769 (0%)
Squamous cell carcinoma of skin	2/13756 (0%)		5/13769 (0%)
Squamous cell carcinoma of the oral cavity	4/13756 (0%)		0/13769 (0%)
Squamous cell carcinoma of the tongue	1/13756 (0%)		0/13769 (0%)
Squamous cell carcinoma of the vulva	1/13756 (0%)		0/13769 (0%)
Thyroid cancer	0/13756 (0%)		1/13769 (0%)
Thyroid cancer metastatic	1/13756 (0%)		0/13769 (0%)
Tongue neoplasm malignant stage unspecified	1/13756 (0%)		0/13769 (0%)
Tonsil cancer	1/13756 (0%)		0/13769 (0%)
Transitional cell cancer of the renal pelvis and ureter	0/13756 (0%)		1/13769 (0%)
Transitional cell carcinoma	2/13756 (0%)		3/13769 (0%)
Tumour haemorrhage	1/13756 (0%)		0/13769 (0%)
Undifferentiated sarcoma	0/13756 (0%)		1/13769 (0%)
Ureteral neoplasm	1/13756 (0%)		0/13769 (0%)
Uterine cancer	0/13756 (0%)		1/13769 (0%)
Uterine leiomyoma	0/13756 (0%)		1/13769 (0%)
Vocal cord neoplasm	0/13756 (0%)		2/13769 (0%)
Vulval cancer recurrent	1/13756 (0%)		0/13769 (0%)
Nervous system disorders
Altered state of consciousness	4/13756 (0%)		2/13769 (0%)
Amnesia	0/13756 (0%)		2/13769 (0%)
Amputation stump pain	0/13756 (0%)		1/13769 (0%)
Amyotrophic lateral sclerosis	0/13756 (0%)		1/13769 (0%)
Aphasia	2/13756 (0%)		0/13769 (0%)
Apraxia	1/13756 (0%)		0/13769 (0%)
Arachnoid cyst	1/13756 (0%)		0/13769 (0%)
Ataxia	1/13756 (0%)		1/13769 (0%)
Balance disorder	1/13756 (0%)		1/13769 (0%)
Basal ganglia infarction	0/13756 (0%)		1/13769 (0%)
Basilar artery aneurysm	0/13756 (0%)		1/13769 (0%)
Basilar artery stenosis	1/13756 (0%)		0/13769 (0%)
Carotid arteriosclerosis	6/13756 (0%)		5/13769 (0%)
Carotid artery disease	2/13756 (0%)		3/13769 (0%)
Carotid artery occlusion	7/13756 (0.1%)		3/13769 (0%)
Carotid artery stenosis	39/13756 (0.3%)		37/13769 (0.3%)
Carpal tunnel syndrome	3/13756 (0%)		6/13769 (0%)
Cauda equina syndrome	0/13756 (0%)		1/13769 (0%)
Cerebellar ataxia	0/13756 (0%)		1/13769 (0%)
Cerebellar infarction	0/13756 (0%)		1/13769 (0%)
Cerebral arteriosclerosis	1/13756 (0%)		0/13769 (0%)
Cerebral artery occlusion	1/13756 (0%)		1/13769 (0%)
Cerebral artery stenosis	0/13756 (0%)		1/13769 (0%)
Cerebral atrophy	0/13756 (0%)		1/13769 (0%)
Cerebral haematoma	1/13756 (0%)		0/13769 (0%)
Cerebral haemorrhage	0/13756 (0%)		1/13769 (0%)
Cerebral infarction	3/13756 (0%)		5/13769 (0%)
Cerebral ischaemia	6/13756 (0%)		1/13769 (0%)
Cerebral thrombosis	0/13756 (0%)		1/13769 (0%)
Cerebral vasoconstriction	0/13756 (0%)		1/13769 (0%)
Cerebrovascular accident	21/13756 (0.2%)		25/13769 (0.2%)
Cerebrovascular disorder	0/13756 (0%)		1/13769 (0%)
Cerebrovascular insufficiency	1/13756 (0%)		2/13769 (0%)
Cervical cord compression	0/13756 (0%)		1/13769 (0%)
Cervical myelopathy	1/13756 (0%)		2/13769 (0%)
Cervical radiculopathy	1/13756 (0%)		1/13769 (0%)
Cervicobrachial syndrome	1/13756 (0%)		3/13769 (0%)
Cervicogenic headache	0/13756 (0%)		1/13769 (0%)
Complex partial seizures	1/13756 (0%)		0/13769 (0%)
Dementia Alzheimer's type	1/13756 (0%)		0/13769 (0%)
Demyelinating polyneuropathy	0/13756 (0%)		1/13769 (0%)
Diabetic neuropathy	6/13756 (0%)		4/13769 (0%)
Dizziness	19/13756 (0.1%)		15/13769 (0.1%)
Dizziness postural	1/13756 (0%)		1/13769 (0%)
Dysarthria	0/13756 (0%)		2/13769 (0%)
Dystonia	1/13756 (0%)		0/13769 (0%)
Encephalitis autoimmune	1/13756 (0%)		0/13769 (0%)
Encephalopathy	2/13756 (0%)		2/13769 (0%)
Epilepsy	7/13756 (0.1%)		5/13769 (0%)
Facial paralysis	4/13756 (0%)		0/13769 (0%)
Generalised tonic-clonic seizure	2/13756 (0%)		2/13769 (0%)
Guillain-Barre syndrome	3/13756 (0%)		1/13769 (0%)
Haemorrhage intracranial	2/13756 (0%)		0/13769 (0%)
Headache	17/13756 (0.1%)		9/13769 (0.1%)
Hemiparesis	1/13756 (0%)		4/13769 (0%)
Hemiplegic migraine	0/13756 (0%)		1/13769 (0%)
Hepatic encephalopathy	1/13756 (0%)		0/13769 (0%)
Hydrocephalus	0/13756 (0%)		1/13769 (0%)
Hypertensive encephalopathy	2/13756 (0%)		0/13769 (0%)
Hypertonia	1/13756 (0%)		0/13769 (0%)
Hypoaesthesia	3/13756 (0%)		3/13769 (0%)
Hypoglycaemic coma	3/13756 (0%)		0/13769 (0%)
Hypoglycaemic encephalopathy	1/13756 (0%)		0/13769 (0%)
Hypoglycaemic unconsciousness	1/13756 (0%)		0/13769 (0%)
IIIrd nerve paralysis	1/13756 (0%)		0/13769 (0%)
Intracranial aneurysm	6/13756 (0%)		3/13769 (0%)
Intracranial mass	0/13756 (0%)		1/13769 (0%)
Ischaemic cerebral infarction	0/13756 (0%)		2/13769 (0%)
Ischaemic stroke	5/13756 (0%)		6/13769 (0%)
Lacunar infarction	2/13756 (0%)		2/13769 (0%)
Lacunar stroke	3/13756 (0%)		0/13769 (0%)
Lethargy	0/13756 (0%)		1/13769 (0%)
Loss of consciousness	7/13756 (0.1%)		2/13769 (0%)
Lumbar radiculopathy	1/13756 (0%)		3/13769 (0%)
Lumbosacral radiculopathy	2/13756 (0%)		0/13769 (0%)
Meralgia paraesthetica	1/13756 (0%)		0/13769 (0%)
Metabolic encephalopathy	1/13756 (0%)		1/13769 (0%)
Migraine	3/13756 (0%)		3/13769 (0%)
Migraine with aura	0/13756 (0%)		1/13769 (0%)
Monoparesis	1/13756 (0%)		0/13769 (0%)
Motor neurone disease	1/13756 (0%)		0/13769 (0%)
Myelopathy	2/13756 (0%)		1/13769 (0%)
Nerve compression	1/13756 (0%)		1/13769 (0%)
Nervous system disorder	1/13756 (0%)		1/13769 (0%)
Neuralgia	3/13756 (0%)		2/13769 (0%)
Neuritis	1/13756 (0%)		0/13769 (0%)
Neuroglycopenia	0/13756 (0%)		1/13769 (0%)
Neuromuscular pain	1/13756 (0%)		0/13769 (0%)
Neuropathy peripheral	3/13756 (0%)		5/13769 (0%)
Paraesthesia	4/13756 (0%)		3/13769 (0%)
Paraparesis	0/13756 (0%)		1/13769 (0%)
Paresis	0/13756 (0%)		1/13769 (0%)
Parkinson's disease	1/13756 (0%)		0/13769 (0%)
Parkinsonism	2/13756 (0%)		1/13769 (0%)
Partial seizures	1/13756 (0%)		0/13769 (0%)
Peripheral motor neuropathy	0/13756 (0%)		1/13769 (0%)
Peripheral sensory neuropathy	1/13756 (0%)		0/13769 (0%)
Peroneal nerve palsy	1/13756 (0%)		1/13769 (0%)
Petit mal epilepsy	1/13756 (0%)		1/13769 (0%)
Polyneuropathy	2/13756 (0%)		0/13769 (0%)
Polyneuropathy idiopathic progressive	1/13756 (0%)		0/13769 (0%)
Postictal state	1/13756 (0%)		0/13769 (0%)
Presyncope	4/13756 (0%)		9/13769 (0.1%)
Pseudoradicular syndrome	1/13756 (0%)		0/13769 (0%)
Psychomotor hyperactivity	1/13756 (0%)		0/13769 (0%)
Quadriplegia	0/13756 (0%)		1/13769 (0%)
Radicular syndrome	0/13756 (0%)		1/13769 (0%)
Radiculopathy	2/13756 (0%)		6/13769 (0%)
Retrograde amnesia	1/13756 (0%)		0/13769 (0%)
Sciatica	10/13756 (0.1%)		14/13769 (0.1%)
Sedation	0/13756 (0%)		1/13769 (0%)
Seizure	13/13756 (0.1%)		8/13769 (0.1%)
Speech disorder	0/13756 (0%)		1/13769 (0%)
Spinal claudication	1/13756 (0%)		0/13769 (0%)
Spinal cord compression	1/13756 (0%)		1/13769 (0%)
Status epilepticus	2/13756 (0%)		0/13769 (0%)
Stroke in evolution	2/13756 (0%)		1/13769 (0%)
Subdural effusion	0/13756 (0%)		1/13769 (0%)
Syncope	56/13756 (0.4%)		63/13769 (0.5%)
Tarsal tunnel syndrome	1/13756 (0%)		0/13769 (0%)
Tension headache	0/13756 (0%)		3/13769 (0%)
Thoracic outlet syndrome	1/13756 (0%)		0/13769 (0%)
Toxic encephalopathy	0/13756 (0%)		1/13769 (0%)
Transient global amnesia	1/13756 (0%)		1/13769 (0%)
Transient ischaemic attack	36/13756 (0.3%)		42/13769 (0.3%)
Unresponsive to stimuli	0/13756 (0%)		1/13769 (0%)
Vascular encephalopathy	2/13756 (0%)		3/13769 (0%)
Vertebral artery occlusion	0/13756 (0%)		2/13769 (0%)
Vertebrobasilar insufficiency	5/13756 (0%)		4/13769 (0%)
Vertigo CNS origin	0/13756 (0%)		2/13769 (0%)
Visual field defect	1/13756 (0%)		0/13769 (0%)
Vocal cord paralysis	0/13756 (0%)		1/13769 (0%)
Product Issues
Device battery issue	1/13756 (0%)		0/13769 (0%)
Device breakage	1/13756 (0%)		1/13769 (0%)
Device dislocation	2/13756 (0%)		1/13769 (0%)
Device failure	3/13756 (0%)		0/13769 (0%)
Device ineffective	0/13756 (0%)		1/13769 (0%)
Device leakage	0/13756 (0%)		1/13769 (0%)
Device loosening	1/13756 (0%)		1/13769 (0%)
Device malfunction	5/13756 (0%)		5/13769 (0%)
Device occlusion	3/13756 (0%)		1/13769 (0%)
Lead dislodgement	1/13756 (0%)		0/13769 (0%)
Thrombosis in device	1/13756 (0%)		0/13769 (0%)
Psychiatric disorders
Acute psychosis	1/13756 (0%)		0/13769 (0%)
Affective disorder	0/13756 (0%)		1/13769 (0%)
Alcohol abuse	4/13756 (0%)		2/13769 (0%)
Alcohol withdrawal syndrome	1/13756 (0%)		3/13769 (0%)
Alcoholism	0/13756 (0%)		1/13769 (0%)
Anxiety	7/13756 (0.1%)		4/13769 (0%)
Anxiety disorder	4/13756 (0%)		0/13769 (0%)
Anxiety disorder due to a general medical condition	1/13756 (0%)		0/13769 (0%)
Burnout syndrome	1/13756 (0%)		0/13769 (0%)
Confusional state	3/13756 (0%)		4/13769 (0%)
Conversion disorder	1/13756 (0%)		3/13769 (0%)
Delirium	3/13756 (0%)		1/13769 (0%)
Delirium tremens	0/13756 (0%)		1/13769 (0%)
Depressed mood	2/13756 (0%)		0/13769 (0%)
Depression	20/13756 (0.1%)		15/13769 (0.1%)
Depression suicidal	1/13756 (0%)		0/13769 (0%)
Drug abuse	1/13756 (0%)		0/13769 (0%)
Drug dependence	1/13756 (0%)		1/13769 (0%)
Hallucination	2/13756 (0%)		0/13769 (0%)
Hallucination, visual	1/13756 (0%)		1/13769 (0%)
Major depression	4/13756 (0%)		1/13769 (0%)
Mania	1/13756 (0%)		2/13769 (0%)
Mental disorder	0/13756 (0%)		1/13769 (0%)
Mental status changes	4/13756 (0%)		6/13769 (0%)
Mood disorder due to a general medical condition	1/13756 (0%)		1/13769 (0%)
Neurosis	0/13756 (0%)		1/13769 (0%)
Panic attack	1/13756 (0%)		3/13769 (0%)
Personality disorder	0/13756 (0%)		1/13769 (0%)
Psychiatric decompensation	0/13756 (0%)		1/13769 (0%)
Psychogenic seizure	0/13756 (0%)		1/13769 (0%)
Psychotic disorder	3/13756 (0%)		1/13769 (0%)
Somatic symptom disorder	1/13756 (0%)		2/13769 (0%)
Suicidal ideation	3/13756 (0%)		3/13769 (0%)
Suicide attempt	6/13756 (0%)		6/13769 (0%)
Renal and urinary disorders
Acute kidney injury	64/13756 (0.5%)		64/13769 (0.5%)
Acute prerenal failure	2/13756 (0%)		0/13769 (0%)
Azotaemia	1/13756 (0%)		0/13769 (0%)
Bladder dilatation	1/13756 (0%)		0/13769 (0%)
Bladder diverticulum	1/13756 (0%)		2/13769 (0%)
Bladder neck obstruction	1/13756 (0%)		1/13769 (0%)
Bladder obstruction	0/13756 (0%)		1/13769 (0%)
Bladder outlet obstruction	1/13756 (0%)		0/13769 (0%)
Bladder spasm	1/13756 (0%)		0/13769 (0%)
Bladder tamponade	0/13756 (0%)		1/13769 (0%)
Calculus bladder	2/13756 (0%)		1/13769 (0%)
Calculus urethral	0/13756 (0%)		3/13769 (0%)
Calculus urinary	6/13756 (0%)		3/13769 (0%)
Chronic kidney disease	15/13756 (0.1%)		17/13769 (0.1%)
Cystitis haemorrhagic	1/13756 (0%)		0/13769 (0%)
Diabetic nephropathy	1/13756 (0%)		2/13769 (0%)
Dysuria	0/13756 (0%)		1/13769 (0%)
End stage renal disease	4/13756 (0%)		2/13769 (0%)
Glomerulonephritis chronic	1/13756 (0%)		0/13769 (0%)
Glomerulonephritis membranous	0/13756 (0%)		1/13769 (0%)
Haematuria	12/13756 (0.1%)		17/13769 (0.1%)
Haemorrhage urinary tract	1/13756 (0%)		0/13769 (0%)
Hydronephrosis	4/13756 (0%)		3/13769 (0%)
Nephrolithiasis	29/13756 (0.2%)		16/13769 (0.1%)
Nephropathy toxic	1/13756 (0%)		2/13769 (0%)
Nephrotic syndrome	2/13756 (0%)		2/13769 (0%)
Neurogenic bladder	0/13756 (0%)		1/13769 (0%)
Nocturia	1/13756 (0%)		0/13769 (0%)
Obstructive uropathy	1/13756 (0%)		0/13769 (0%)
Prerenal failure	0/13756 (0%)		2/13769 (0%)
Pyelocaliectasis	1/13756 (0%)		0/13769 (0%)
Renal artery stenosis	6/13756 (0%)		1/13769 (0%)
Renal colic	4/13756 (0%)		3/13769 (0%)
Renal cyst	0/13756 (0%)		2/13769 (0%)
Renal cyst haemorrhage	0/13756 (0%)		1/13769 (0%)
Renal failure	4/13756 (0%)		5/13769 (0%)
Renal impairment	4/13756 (0%)		4/13769 (0%)
Renal infarct	0/13756 (0%)		2/13769 (0%)
Renal mass	2/13756 (0%)		0/13769 (0%)
Renal pain	0/13756 (0%)		1/13769 (0%)
Stress urinary incontinence	0/13756 (0%)		3/13769 (0%)
Tubulointerstitial nephritis	2/13756 (0%)		0/13769 (0%)
Ureteric rupture	0/13756 (0%)		1/13769 (0%)
Ureteric stenosis	0/13756 (0%)		1/13769 (0%)
Ureterolithiasis	5/13756 (0%)		9/13769 (0.1%)
Urethral stenosis	4/13756 (0%)		5/13769 (0%)
Urinary incontinence	6/13756 (0%)		1/13769 (0%)
Urinary retention	4/13756 (0%)		14/13769 (0.1%)
Urinary tract obstruction	3/13756 (0%)		3/13769 (0%)
Urinoma	1/13756 (0%)		0/13769 (0%)
Reproductive system and breast disorders
Adnexa uteri mass	0/13756 (0%)		1/13769 (0%)
Benign prostatic hyperplasia	26/13756 (0.2%)		30/13769 (0.2%)
Breast dysplasia	0/13756 (0%)		1/13769 (0%)
Breast enlargement	1/13756 (0%)		0/13769 (0%)
Breast pain	1/13756 (0%)		0/13769 (0%)
Cervical dysplasia	1/13756 (0%)		0/13769 (0%)
Cervical polyp	0/13756 (0%)		1/13769 (0%)
Cervix disorder	1/13756 (0%)		0/13769 (0%)
Cystocele	0/13756 (0%)		1/13769 (0%)
Endometrial hyperplasia	0/13756 (0%)		2/13769 (0%)
Endometrial thickening	0/13756 (0%)		1/13769 (0%)
Genital haemorrhage	0/13756 (0%)		1/13769 (0%)
Male genital tract fistula	0/13756 (0%)		1/13769 (0%)
Menorrhagia	3/13756 (0%)		1/13769 (0%)
Metrorrhagia	1/13756 (0%)		0/13769 (0%)
Ovarian cyst	1/13756 (0%)		1/13769 (0%)
Pelvic pain	1/13756 (0%)		0/13769 (0%)
Postmenopausal haemorrhage	1/13756 (0%)		0/13769 (0%)
Priapism	1/13756 (0%)		0/13769 (0%)
Prostatitis	5/13756 (0%)		1/13769 (0%)
Prostatomegaly	1/13756 (0%)		1/13769 (0%)
Reproductive tract disorder	0/13756 (0%)		1/13769 (0%)
Scrotal cyst	1/13756 (0%)		0/13769 (0%)
Scrotal oedema	0/13756 (0%)		1/13769 (0%)
Spermatic cord inflammation	1/13756 (0%)		0/13769 (0%)
Uterine atony	0/13756 (0%)		1/13769 (0%)
Uterine enlargement	1/13756 (0%)		1/13769 (0%)
Uterine haemorrhage	2/13756 (0%)		0/13769 (0%)
Uterine polyp	2/13756 (0%)		2/13769 (0%)
Uterine prolapse	0/13756 (0%)		3/13769 (0%)
Vaginal haemorrhage	0/13756 (0%)		3/13769 (0%)
Vaginal prolapse	0/13756 (0%)		1/13769 (0%)
Vulval disorder	1/13756 (0%)		0/13769 (0%)
Vulvar dysplasia	1/13756 (0%)		0/13769 (0%)
Vulvovaginal pruritus	1/13756 (0%)		0/13769 (0%)
Respiratory, thoracic and mediastinal disorders
Acquired diaphragmatic eventration	1/13756 (0%)		0/13769 (0%)
Acute pulmonary oedema	3/13756 (0%)		2/13769 (0%)
Acute respiratory distress syndrome	0/13756 (0%)		2/13769 (0%)
Acute respiratory failure	13/13756 (0.1%)		11/13769 (0.1%)
Apnoea	0/13756 (0%)		1/13769 (0%)
Asthma	11/13756 (0.1%)		8/13769 (0.1%)
Asthma-chronic obstructive pulmonary disease overlap syndrome	0/13756 (0%)		1/13769 (0%)
Atelectasis	1/13756 (0%)		1/13769 (0%)
Bronchial fistula	1/13756 (0%)		0/13769 (0%)
Bronchiectasis	0/13756 (0%)		2/13769 (0%)
Bronchitis chronic	4/13756 (0%)		2/13769 (0%)
Bronchospasm	1/13756 (0%)		1/13769 (0%)
Chronic obstructive pulmonary disease	64/13756 (0.5%)		64/13769 (0.5%)
Chronic respiratory failure	0/13756 (0%)		1/13769 (0%)
Combined pulmonary fibrosis and emphysema	0/13756 (0%)		1/13769 (0%)
Cough	3/13756 (0%)		1/13769 (0%)
Diaphragmatic paralysis	1/13756 (0%)		1/13769 (0%)
Dysphonia	0/13756 (0%)		1/13769 (0%)
Dyspnoea	18/13756 (0.1%)		28/13769 (0.2%)
Dyspnoea at rest	0/13756 (0%)		1/13769 (0%)
Dyspnoea exertional	11/13756 (0.1%)		6/13769 (0%)
Emphysema	2/13756 (0%)		1/13769 (0%)
Epiglottic cyst	1/13756 (0%)		0/13769 (0%)
Epistaxis	8/13756 (0.1%)		10/13769 (0.1%)
Haemoptysis	4/13756 (0%)		7/13769 (0.1%)
Haemothorax	2/13756 (0%)		1/13769 (0%)
Hiccups	1/13756 (0%)		0/13769 (0%)
Hyperventilation	1/13756 (0%)		0/13769 (0%)
Hypoxia	1/13756 (0%)		2/13769 (0%)
Idiopathic pulmonary fibrosis	2/13756 (0%)		0/13769 (0%)
Interstitial lung disease	3/13756 (0%)		2/13769 (0%)
Laryngeal oedema	1/13756 (0%)		0/13769 (0%)
Lung disorder	1/13756 (0%)		2/13769 (0%)
Nasal cyst	1/13756 (0%)		0/13769 (0%)
Nasal obstruction	0/13756 (0%)		1/13769 (0%)
Nasal polyps	0/13756 (0%)		4/13769 (0%)
Nasal septum deviation	1/13756 (0%)		1/13769 (0%)
Nasal turbinate hypertrophy	1/13756 (0%)		0/13769 (0%)
Nocturnal dyspnoea	0/13756 (0%)		1/13769 (0%)
Oropharyngeal pain	1/13756 (0%)		1/13769 (0%)
Orthopnoea	0/13756 (0%)		1/13769 (0%)
Pharyngeal cyst	1/13756 (0%)		0/13769 (0%)
Pickwickian syndrome	0/13756 (0%)		1/13769 (0%)
Pleural adhesion	0/13756 (0%)		1/13769 (0%)
Pleural disorder	0/13756 (0%)		1/13769 (0%)
Pleural effusion	11/13756 (0.1%)		5/13769 (0%)
Pleurisy	4/13756 (0%)		3/13769 (0%)
Pleuritic pain	2/13756 (0%)		0/13769 (0%)
Pneumonia aspiration	7/13756 (0.1%)		8/13769 (0.1%)
Pneumonitis	1/13756 (0%)		5/13769 (0%)
Pneumothorax	10/13756 (0.1%)		5/13769 (0%)
Productive cough	0/13756 (0%)		2/13769 (0%)
Pulmonary alveolar haemorrhage	0/13756 (0%)		1/13769 (0%)
Pulmonary arterial hypertension	0/13756 (0%)		1/13769 (0%)
Pulmonary congestion	0/13756 (0%)		1/13769 (0%)
Pulmonary embolism	28/13756 (0.2%)		20/13769 (0.1%)
Pulmonary fibrosis	2/13756 (0%)		3/13769 (0%)
Pulmonary hypertension	1/13756 (0%)		3/13769 (0%)
Pulmonary mass	3/13756 (0%)		0/13769 (0%)
Pulmonary oedema	2/13756 (0%)		1/13769 (0%)
Pulmonary pain	0/13756 (0%)		1/13769 (0%)
Respiratory disorder	1/13756 (0%)		1/13769 (0%)
Respiratory distress	0/13756 (0%)		1/13769 (0%)
Respiratory failure	8/13756 (0.1%)		16/13769 (0.1%)
Sleep apnoea syndrome	13/13756 (0.1%)		6/13769 (0%)
Stridor	1/13756 (0%)		0/13769 (0%)
Upper respiratory tract inflammation	1/13756 (0%)		0/13769 (0%)
Vocal cord leukoplakia	2/13756 (0%)		0/13769 (0%)
Skin and subcutaneous tissue disorders
Angioedema	2/13756 (0%)		3/13769 (0%)
Decubitus ulcer	0/13756 (0%)		1/13769 (0%)
Dermal cyst	1/13756 (0%)		1/13769 (0%)
Dermatitis	1/13756 (0%)		0/13769 (0%)
Dermatitis allergic	2/13756 (0%)		0/13769 (0%)
Dermatitis contact	0/13756 (0%)		1/13769 (0%)
Dermatitis exfoliative	0/13756 (0%)		1/13769 (0%)
Dermatomyositis	1/13756 (0%)		0/13769 (0%)
Diabetic foot	7/13756 (0.1%)		6/13769 (0%)
Drug eruption	0/13756 (0%)		2/13769 (0%)
Dry skin	0/13756 (0%)		1/13769 (0%)
Eczema	2/13756 (0%)		3/13769 (0%)
Eczema nummular	0/13756 (0%)		1/13769 (0%)
Excessive granulation tissue	1/13756 (0%)		0/13769 (0%)
Excessive skin	1/13756 (0%)		0/13769 (0%)
Henoch-Schonlein purpura	0/13756 (0%)		1/13769 (0%)
Hyperhidrosis	0/13756 (0%)		1/13769 (0%)
Ingrowing nail	1/13756 (0%)		0/13769 (0%)
Lichen myxoedematosus	1/13756 (0%)		0/13769 (0%)
Lichen planus	1/13756 (0%)		0/13769 (0%)
Papulopustular rosacea	0/13756 (0%)		1/13769 (0%)
Pemphigoid	0/13756 (0%)		1/13769 (0%)
Pruritus	1/13756 (0%)		0/13769 (0%)
Pruritus generalised	0/13756 (0%)		1/13769 (0%)
Psoriasis	1/13756 (0%)		4/13769 (0%)
Rash	0/13756 (0%)		3/13769 (0%)
Scar pain	0/13756 (0%)		1/13769 (0%)
Skin exfoliation	0/13756 (0%)		1/13769 (0%)
Skin ulcer	6/13756 (0%)		5/13769 (0%)
Stasis dermatitis	1/13756 (0%)		0/13769 (0%)
Subcutaneous emphysema	1/13756 (0%)		1/13769 (0%)
Swelling face	1/13756 (0%)		0/13769 (0%)
Urticaria	0/13756 (0%)		3/13769 (0%)
Social circumstances
Abstains from alcohol	1/13756 (0%)		0/13769 (0%)
Disability	1/13756 (0%)		0/13769 (0%)
Social stay hospitalisation	0/13756 (0%)		1/13769 (0%)
Substance abuser	1/13756 (0%)		0/13769 (0%)
Surgical and medical procedures
Abscess drainage	1/13756 (0%)		1/13769 (0%)
Aortic valve replacement	1/13756 (0%)		0/13769 (0%)
Arrhythmia prophylaxis	0/13756 (0%)		1/13769 (0%)
Arterial catheterisation	1/13756 (0%)		0/13769 (0%)
Arteriovenous fistula operation	1/13756 (0%)		1/13769 (0%)
Asthma prophylaxis	1/13756 (0%)		0/13769 (0%)
Cardiac ablation	0/13756 (0%)		1/13769 (0%)
Cardiac pacemaker insertion	1/13756 (0%)		1/13769 (0%)
Cardiac rehabilitation therapy	1/13756 (0%)		0/13769 (0%)
Cardiac resynchronisation therapy	0/13756 (0%)		2/13769 (0%)
Coronary arterial stent insertion	1/13756 (0%)		0/13769 (0%)
Coronary artery bypass	1/13756 (0%)		0/13769 (0%)
Coronary revascularisation	2/13756 (0%)		1/13769 (0%)
Elective procedure	1/13756 (0%)		0/13769 (0%)
Enterostomy	0/13756 (0%)		1/13769 (0%)
Finger amputation	0/13756 (0%)		1/13769 (0%)
Fracture treatment	1/13756 (0%)		0/13769 (0%)
Gastric banding reversal	1/13756 (0%)		0/13769 (0%)
Haemostasis	1/13756 (0%)		0/13769 (0%)
Hospitalisation	0/13756 (0%)		1/13769 (0%)
Implantable defibrillator insertion	2/13756 (0%)		0/13769 (0%)
Incisional hernia repair	0/13756 (0%)		1/13769 (0%)
Inguinal hernia repair	0/13756 (0%)		3/13769 (0%)
Knee arthroplasty	0/13756 (0%)		3/13769 (0%)
Large intestinal polypectomy	0/13756 (0%)		1/13769 (0%)
Large intestine anastomosis	1/13756 (0%)		0/13769 (0%)
Leg amputation	2/13756 (0%)		0/13769 (0%)
Open reduction of fracture	0/13756 (0%)		1/13769 (0%)
Percutaneous coronary intervention	1/13756 (0%)		3/13769 (0%)
Peripheral artery bypass	2/13756 (0%)		0/13769 (0%)
Plastic surgery to the face	1/13756 (0%)		0/13769 (0%)
Preoperative care	1/13756 (0%)		0/13769 (0%)
Proctectomy	1/13756 (0%)		0/13769 (0%)
Rehabilitation therapy	0/13756 (0%)		2/13769 (0%)
Spinal anaesthesia	0/13756 (0%)		1/13769 (0%)
Stent placement	0/13756 (0%)		1/13769 (0%)
Therapy cessation	1/13756 (0%)		0/13769 (0%)
Toe amputation	0/13756 (0%)		1/13769 (0%)
Transcatheter aortic valve implantation	1/13756 (0%)		0/13769 (0%)
Transurethral prostatectomy	1/13756 (0%)		0/13769 (0%)
Umbilical hernia repair	0/13756 (0%)		1/13769 (0%)
Urethral operation	1/13756 (0%)		0/13769 (0%)
Vascular disorders
Accelerated hypertension	2/13756 (0%)		3/13769 (0%)
Aneurysm	4/13756 (0%)		0/13769 (0%)
Angiopathy	1/13756 (0%)		0/13769 (0%)
Angiosclerosis	0/13756 (0%)		1/13769 (0%)
Aortic aneurysm	27/13756 (0.2%)		27/13769 (0.2%)
Aortic aneurysm rupture	1/13756 (0%)		1/13769 (0%)
Aortic occlusion	0/13756 (0%)		1/13769 (0%)
Aortic stenosis	8/13756 (0.1%)		7/13769 (0.1%)
Aortic thrombosis	1/13756 (0%)		1/13769 (0%)
Arterial occlusive disease	5/13756 (0%)		1/13769 (0%)
Arterial thrombosis	1/13756 (0%)		0/13769 (0%)
Arteriosclerosis	4/13756 (0%)		2/13769 (0%)
Arteriovenous fistula	1/13756 (0%)		0/13769 (0%)
Blood pressure fluctuation	1/13756 (0%)		1/13769 (0%)
Circulatory collapse	6/13756 (0%)		5/13769 (0%)
Cryoglobulinaemia	1/13756 (0%)		0/13769 (0%)
Deep vein thrombosis	14/13756 (0.1%)		7/13769 (0.1%)
Diabetic vascular disorder	0/13756 (0%)		1/13769 (0%)
Dry gangrene	0/13756 (0%)		4/13769 (0%)
Embolism	1/13756 (0%)		0/13769 (0%)
Embolism arterial	2/13756 (0%)		0/13769 (0%)
Embolism venous	1/13756 (0%)		0/13769 (0%)
Extremity necrosis	4/13756 (0%)		2/13769 (0%)
Granulomatosis with polyangiitis	1/13756 (0%)		0/13769 (0%)
Haematoma	5/13756 (0%)		2/13769 (0%)
Haemorrhage	0/13756 (0%)		1/13769 (0%)
Hypertension	41/13756 (0.3%)		56/13769 (0.4%)
Hypertensive crisis	12/13756 (0.1%)		15/13769 (0.1%)
Hypertensive emergency	0/13756 (0%)		1/13769 (0%)
Hypotension	13/13756 (0.1%)		9/13769 (0.1%)
Hypovolaemic shock	2/13756 (0%)		1/13769 (0%)
Iliac artery occlusion	3/13756 (0%)		5/13769 (0%)
Intermittent claudication	22/13756 (0.2%)		31/13769 (0.2%)
Internal haemorrhage	1/13756 (0%)		0/13769 (0%)
Leriche syndrome	2/13756 (0%)		1/13769 (0%)
Lymphocele	1/13756 (0%)		1/13769 (0%)
Lymphoedema	1/13756 (0%)		0/13769 (0%)
Malignant hypertension	2/13756 (0%)		1/13769 (0%)
Neurogenic shock	1/13756 (0%)		0/13769 (0%)
Orthostatic hypotension	7/13756 (0.1%)		9/13769 (0.1%)
Pelvic venous thrombosis	1/13756 (0%)		0/13769 (0%)
Peripheral arterial occlusive disease	82/13756 (0.6%)		94/13769 (0.7%)
Peripheral artery aneurysm	7/13756 (0.1%)		5/13769 (0%)
Peripheral artery dissection	1/13756 (0%)		0/13769 (0%)
Peripheral artery occlusion	16/13756 (0.1%)		20/13769 (0.1%)
Peripheral artery stenosis	33/13756 (0.2%)		27/13769 (0.2%)
Peripheral artery thrombosis	5/13756 (0%)		5/13769 (0%)
Peripheral circulatory failure	1/13756 (0%)		0/13769 (0%)
Peripheral embolism	3/13756 (0%)		1/13769 (0%)
Peripheral ischaemia	39/13756 (0.3%)		35/13769 (0.3%)
Peripheral vascular disorder	9/13756 (0.1%)		16/13769 (0.1%)
Peripheral venous disease	2/13756 (0%)		2/13769 (0%)
Poor peripheral circulation	1/13756 (0%)		0/13769 (0%)
Renovascular hypertension	1/13756 (0%)		0/13769 (0%)
Shock	0/13756 (0%)		1/13769 (0%)
Shock haemorrhagic	2/13756 (0%)		1/13769 (0%)
Subclavian artery embolism	1/13756 (0%)		0/13769 (0%)
Subclavian artery occlusion	0/13756 (0%)		1/13769 (0%)
Subclavian artery stenosis	5/13756 (0%)		4/13769 (0%)
Subclavian steal syndrome	1/13756 (0%)		1/13769 (0%)
Superior vena cava syndrome	0/13756 (0%)		1/13769 (0%)
Takayasu's arteritis	0/13756 (0%)		1/13769 (0%)
Temporal arteritis	1/13756 (0%)		1/13769 (0%)
Thromboangiitis obliterans	1/13756 (0%)		0/13769 (0%)
Thrombophlebitis	1/13756 (0%)		0/13769 (0%)
Thrombophlebitis superficial	1/13756 (0%)		1/13769 (0%)
Thrombosis	2/13756 (0%)		2/13769 (0%)
Varicose ulceration	1/13756 (0%)		0/13769 (0%)
Varicose vein	4/13756 (0%)		3/13769 (0%)
Vascular insufficiency	0/13756 (0%)		1/13769 (0%)
Vascular occlusion	0/13756 (0%)		1/13769 (0%)
Vascular stenosis	0/13756 (0%)		2/13769 (0%)
Vasodilatation	0/13756 (0%)		1/13769 (0%)
Vena cava thrombosis	0/13756 (0%)		1/13769 (0%)
Venous thrombosis	1/13756 (0%)		0/13769 (0%)
Venous thrombosis limb	2/13756 (0%)		1/13769 (0%)
Other (Not Including Serious) Adverse Events
	Placebo		Evolocumab
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3438/13756 (25%)		3500/13769 (25.4%)
Infections and infestations
Nasopharyngitis	1021/13756 (7.4%)		1067/13769 (7.7%)
Upper respiratory tract infection	649/13756 (4.7%)		692/13769 (5%)
Metabolism and nutrition disorders
Diabetes mellitus	1096/13756 (8%)		1156/13769 (8.4%)
Vascular disorders
Hypertension	1157/13756 (8.4%)		1069/13769 (7.8%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.