STABILITY: The Stabilization of Atherosclerotic Plaque by Initiation of Darapladib Therapy Trial

• Sponsor: GlaxoSmithKline (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00799903
• Collaborator: (none)
• Enrollment: 15,828
• Locations: 651
• Arms: 2
• Duration (Months): 58.5
• Patients Per Site: 24.3
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

This study will test whether darapladib can safely lower the chances of having a cardiovascular event (such as a heart attack or stroke) in people with coronary heart disease.

Condition or Disease	Intervention/Treatment	Phase
Atherosclerosis	Drug: Darapladib; Drug: Placebo	Phase 3

Detailed Description

Subjects who qualify for the study will be randomized 1:1 to either darapladib or placebo administered in addition to standard therapy. Following the baseline visit, subjects will be expected to return for clinic visits at 1 month, 3 months, and every 6 months until the end of the study. Average time in the study for an individual subject is expected to be about 3 years.

Study Design

• Study Type: Interventional
• Actual Enrollment: 15828 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: LPL100601, A Clinical Outcomes Study of Darapladib Versus Placebo in Subjects With Chronic Coronary Heart Disease to Compare the Incidence of Major Adverse Cardiovascular Events (MACE)
• Study Start Date: Dec 1, 2008
• Actual Primary Completion Date: Oct 1, 2013
• Actual Study Completion Date: Oct 17, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Darapladib Single daily oral tablet	Drug: Darapladib; Lp-PLA2 inhibitor administered in addition to standard therapy
Placebo Comparator: Placebo Single daily oral tablet	Drug: Placebo; Placebo administered in addition to standard therapy

Outcome Measures

Primary Outcome Measures

1. Number of Participants With First Occurrence of Any Component of the Composite of Major Adverse Cardiovascular Events (Cardiovascular [CV] Death, Non-fatal Myocardial Infarction [MI] or Non-fatal Stroke) During the Time Period for Follow-up of CV Events [From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 4.25 years/average of 3.51 years)]

   CV death=death due to a CV cause, which included but was not limited to deaths resulting from stroke, arrhythmia, sudden death (witnessed/unwitnessed), MI, heart failure, pulmonary embolism, peripheral arterial disease, or complications of a CV procedure. Deaths not clearly attributable to non-CV causes are considered to be CV deaths. Acute MI=evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia. Prior MI diagnosed post-randomization (e.g., silent MI)=the development of new pathological Q waves with/without symptoms OR imaging evidence of a region of loss of viable myocardium that is thinned and fails to contract, in the absence of a non-ischemic cause (pre-event imaging data required for verification of new abnormality), OR pathological findings of a healed/healing MI. Stroke=presence of a new focal neurologic deficit thought to be of vascular origin, with signs/symptoms lasting >24 hours or results in death (in <24 hours).

Secondary Outcome Measures

1. Number of Participants With First Occurrence of Any Event in the Composite of Major Coronary Events (Coronary Heart Disease [CHD] Death, Non-fatal MI, or Urgent Coronary Revascularization [CR] for MI) During the Time Period for Follow-up (FU) of CV Events [From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 4.25 years/average of 3.51 years)]

   CHD death=occurrence of a fatal MI, death caused by documented cardiac arrest, death resulting from heart failure in a participant with known CHD, death from other forms of acute/chronic CHD, unwitnessed death of unknown origin, or sudden death. Acute MI=evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia. Prior MI diagnosed post-randomization (e.g.,silent MI)=the development of new pathological Q waves with/without symptoms OR imaging evidence of a region of loss of viable myocardium that is thinned and fails to contract, in the absence of a non-ischemic cause (pre-event imaging data required for verification of new abnormality), OR pathological findings of a healed/healing MI. Urgent CR for MI=ischemic discomfort at rest that prompted CR (percutaneous coronary intervention [PCI: any attempt at CR even if not successful] or coronary artery bypass graft) during the same hospitalization or resulted in hospital transfer for the purpose of CR.

2. Number of Participants With First Occurrence of Any Event in the Composite of Total Coronary Events (CHD Death, Non-fatal MI, Hospitalization for Unstable Angina, or Any Coronary Revascularization Procedure) During Time Period for FU of CV Events [From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 4.25 years/average of 3.51 years)]

   CHD death, acute MI, and prior MI are defined in the previous secondary endpoint (major coronary events). Hospitalization for unstable angina=one of the following, but not fulfilling the criteria for MI: ischemic discomfort at rest associated with electrocardiogram (ECG) changes leading to hospitalization; ischemic discomfort at rest regardless of ECG changes leading to hospitalization and revascularization during the same admission; ischemic discomfort at rest in hospital associated with ECG changes; ischemic discomfort at rest in hospital without ECG changes resulting in revascularization during the same admission. NOTE: The event was not considered to be unstable angina if, after invasive/non-invasive testing or other diagnostic testing, the discomfort is found not to be caused by myocardial ischemia.

3. Number of Participants With CV Death During the Time Period for Follow-up of CV Events [From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 4.25 years/average of 3.51 years)]

   CV death is defined as a death due to a CV cause, which included but was not limited to deaths resulting from stroke, arrhythmia, sudden death (witnessed/unwitnessed), MI, heart failure, pulmonary embolism, peripheral arterial disease, or complications of a CV procedure. Deaths not clearly attributable to non-CV causes are considered to be CV deaths.

4. Number of Participants With First Occurrence of MI (Fatal/Non-fatal) During the Time Period for Follow-up of CV Events [From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 4.25 years/average of 3.51 years)]

   Acute MI is defined as evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia. Prior MI diagnosed post-randomization (e.g., silent MI)=the development of new pathological Q waves with/without symptoms OR imaging evidence of a region of loss of viable myocardium that is thinned and fails to contract, in the absence of a non-ischemic cause (pre-event imaging data required for verification of new abnormality), OR pathological findings of a healed/healing MI.

5. Number of Participants With First Occurrence of Stroke (Fatal/Non-fatal) During the Time Period for Follow-up of CV Events [From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 4.25 years/average of 3.51 years)]

   Stroke is defined as the presence of a new focal neurologic deficit thought to be of vascular origin, with signs/symptoms lasting >24 hours or results in death (in <24 hours).

6. Number of Participants With First Occurrence of Any Component of the Composite of All-cause Mortality, Non-fatal MI, or Non-fatal Stroke During the Time Period for Follow-up of CV Events [From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 4.25 years/average of 3.51 years)]

   Acute MI is defined as evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia. Prior MI diagnosed post-randomization (e.g., silent MI)=the development of new pathological Q waves with/without symptoms OR imaging evidence of a region of loss of viable myocardium that is thinned and fails to contract, in the absence of a non-ischemic cause (pre-event imaging data required for verification of new abnormality), OR pathological findings of a healed/healing MI. Stroke=presence of a new focal neurologic deficit thought to be of vascular origin, with signs/symptoms lasting >24 hours or results in death (in <24 hours).

7. Number of Participants With All-cause Mortality During the Time Period for Vital Status [From randomization until death or study completion (up to 4.49 years/average of 3.65 years)]

   The number of participants with all-cause mortality was assessed.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Men or women at least 18 years old. Women must be post-menopausal or using a highly effective method for avoidance of pregnancy.

• Current treatment with statin therapy unless the study doctor determines statins are not appropriate for the subject.

• Chronic coronary heart disease

• At least one of the following:

• At least 60 years old

• Diabetes requiring treatment with medication

• Low HDL cholesterol ("good cholesterol")

• Currently smoke cigarettes or stopped smoking within the past 3 months

• Diagnosed mild or moderate reduction in kidney function

• Cerebrovascular disease (carotid artery disease or ischemic stroke more than 3 months prior to study entry) OR peripheral arterial disease.

Exclusion Criteria:

• Planned coronary revascularization (such as stent placement or heart bypass) or any other major surgical procedure.

• Liver disease

• Severe reduction in kidney function OR removal of a kidney OR kidney transplant

• Severe heart failure

• Blood pressure higher than normal despite lifestyle changes and treatment with medications

• Any life-threatening disease expected to result in death within the next 2 years (other than heart disease)

• Severe asthma that is poorly controlled with medication

• Pregnant (Note: A pregnancy test will be performed on all non-sterile women prior to study entry)

• Previous severe allergic response to food, drink, insect stings, etc.

• Drug or alcohol abuse within the past 6 months OR mental/psychological impairment that may prevent the subject from complying with study procedures or understanding the goal and potential risks of participating in the study.

• Certain medications that may interfere with the study medication (these will be identified by the study doctor)

• Participation in a study of an investigational medication within the past 30 days

• Current participation in a study of an investigational device

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Birmingham	Alabama	United States	35235
2	GSK Investigational Site	Birmingham	Alabama	United States	35294-0007
3	GSK Investigational Site	Huntsville	Alabama	United States	35801
4	GSK Investigational Site	Anchorage	Alaska	United States	99508
5	GSK Investigational Site	Little Rock	Arkansas	United States	72204
6	GSK Investigational Site	Concord	California	United States	94520
7	GSK Investigational Site	Lomita	California	United States	90717
8	GSK Investigational Site	Los Angeles	California	United States	90024
9	GSK Investigational Site	Los Angeles	California	United States	90036
10	GSK Investigational Site	Madera	California	United States	93637
11	GSK Investigational Site	Oakland	California	United States	94611
12	GSK Investigational Site	Oakland	California	United States	94612
13	GSK Investigational Site	Poway	California	United States	92064
14	GSK Investigational Site	Sacramento	California	United States	95819
15	GSK Investigational Site	San Diego	California	United States	92161
16	GSK Investigational Site	San Ramon	California	United States	94582
17	GSK Investigational Site	Santa Ana	California	United States	92705
18	GSK Investigational Site	Spring Valley	California	United States	91978
19	GSK Investigational Site	Thousand Oaks	California	United States	91360
20	GSK Investigational Site	Colorado Springs	Colorado	United States	80920
21	GSK Investigational Site	Denver	Colorado	United States	80218
22	GSK Investigational Site	Golden	Colorado	United States	80401
23	GSK Investigational Site	Thornton	Colorado	United States	80229
24	GSK Investigational Site	Bridgeport	Connecticut	United States	06606
25	GSK Investigational Site	Bridgeport	Connecticut	United States	06610
26	GSK Investigational Site	Hartford	Connecticut	United States	06067
27	GSK Investigational Site	Newark	Delaware	United States	19718
28	GSK Investigational Site	Atlantis	Florida	United States	33462
29	GSK Investigational Site	Gainesville	Florida	United States	32610
30	GSK Investigational Site	Hollywood	Florida	United States	33023
31	GSK Investigational Site	Jacksonville Beach	Florida	United States	32250
32	GSK Investigational Site	Jacksonville	Florida	United States	32207
33	GSK Investigational Site	Jacksonville	Florida	United States	32216
34	GSK Investigational Site	Jacksonville	Florida	United States	32258
35	GSK Investigational Site	Miami	Florida	United States	33136
36	GSK Investigational Site	Miami	Florida	United States	33183
37	GSK Investigational Site	Ocala	Florida	United States	34471
38	GSK Investigational Site	Ponte Vedra Beach	Florida	United States	32081
39	GSK Investigational Site	Conyers	Georgia	United States	30094
40	GSK Investigational Site	Aurora	Illinois	United States	60504
41	GSK Investigational Site	Chicago	Illinois	United States	60654
42	GSK Investigational Site	Melrose Park	Illinois	United States	60160
43	GSK Investigational Site	Avon	Indiana	United States	46123
44	GSK Investigational Site	Franklin	Indiana	United States	46131
45	GSK Investigational Site	Greenfield	Indiana	United States	46140
46	GSK Investigational Site	Indianapolis	Indiana	United States	46256
47	GSK Investigational Site	Indianapolis	Indiana	United States	46260
48	GSK Investigational Site	Valparaiso	Indiana	United States	46383
49	GSK Investigational Site	Iowa City	Iowa	United States	52242
50	GSK Investigational Site	West Des Moines	Iowa	United States	50266
51	GSK Investigational Site	Crestview Hills	Kentucky	United States	41017
52	GSK Investigational Site	Louisville	Kentucky	United States	40206
53	GSK Investigational Site	Louisville	Kentucky	United States	40213
54	GSK Investigational Site	Lafayette	Louisiana	United States	70503
55	GSK Investigational Site	New Iberia	Louisiana	United States	70563
56	GSK Investigational Site	Slidell	Louisiana	United States	70458
57	GSK Investigational Site	Auburn	Maine	United States	04210
58	GSK Investigational Site	Bangor	Maine	United States	04401
59	GSK Investigational Site	Scarborough	Maine	United States	04074
60	GSK Investigational Site	Baltimore	Maryland	United States	21209
61	GSK Investigational Site	Oxon Hill	Maryland	United States	20745
62	GSK Investigational Site	Prince Frederick	Maryland	United States	20678
63	GSK Investigational Site	Boston	Massachusetts	United States	02111
64	GSK Investigational Site	Natick	Massachusetts	United States	01760
65	GSK Investigational Site	Springfield	Massachusetts	United States	01103
66	GSK Investigational Site	Cadillac	Michigan	United States	49601
67	GSK Investigational Site	Detroit	Michigan	United States	48202
68	GSK Investigational Site	Petoskey	Michigan	United States	49770
69	GSK Investigational Site	Saint Cloud	Minnesota	United States	56303
70	GSK Investigational Site	Saint Louis	Missouri	United States	63110
71	GSK Investigational Site	Grand Island	Nebraska	United States	68803
72	GSK Investigational Site	Las Vegas	Nevada	United States	89103
73	GSK Investigational Site	Las Vegas	Nevada	United States	89130
74	GSK Investigational Site	Browns Mills	New Jersey	United States	08015
75	GSK Investigational Site	Elizabeth	New Jersey	United States	07202
76	GSK Investigational Site	West Orange	New Jersey	United States	07052
77	GSK Investigational Site	Albuquerque	New Mexico	United States	87102
78	GSK Investigational Site	Buffalo	New York	United States	14215
79	GSK Investigational Site	New York	New York	United States	10001
80	GSK Investigational Site	New York	New York	United States	10016
81	GSK Investigational Site	New York	New York	United States	10021
82	GSK Investigational Site	Westfield	New York	United States	14787
83	GSK Investigational Site	Williamsville	New York	United States	14221
84	GSK Investigational Site	Charlotte	North Carolina	United States	28204
85	GSK Investigational Site	Durham	North Carolina	United States	27710
86	GSK Investigational Site	Gastonia	North Carolina	United States	28054
87	GSK Investigational Site	Matthews	North Carolina	United States	28105
88	GSK Investigational Site	Salisbury	North Carolina	United States	28144
89	GSK Investigational Site	Statesville	North Carolina	United States	28677
90	GSK Investigational Site	Wilmington	North Carolina	United States	28401
91	GSK Investigational Site	Grand Forks	North Dakota	United States	58201
92	GSK Investigational Site	Cincinnati	Ohio	United States	45227
93	GSK Investigational Site	Cincinnati	Ohio	United States	45246
94	GSK Investigational Site	Elyria	Ohio	United States	44035
95	GSK Investigational Site	Garfield Heights	Ohio	United States	44125
96	GSK Investigational Site	Kettering	Ohio	United States	45429
97	GSK Investigational Site	Middleburg Heights	Ohio	United States	44130
98	GSK Investigational Site	Sandusky	Ohio	United States	44870
99	GSK Investigational Site	Toledo	Ohio	United States	43614
100	GSK Investigational Site	Westlake	Ohio	United States	44145
101	GSK Investigational Site	Oklahoma City	Oklahoma	United States	73120
102	GSK Investigational Site	Portland	Oregon	United States	97219
103	GSK Investigational Site	Beaver	Pennsylvania	United States	15009
104	GSK Investigational Site	Danville	Pennsylvania	United States	17822-4201
105	GSK Investigational Site	Doylestown	Pennsylvania	United States	18901
106	GSK Investigational Site	Erie	Pennsylvania	United States	16502
107	GSK Investigational Site	Jersey Shore	Pennsylvania	United States	17740
108	GSK Investigational Site	Lewistown	Pennsylvania	United States	17044
109	GSK Investigational Site	Philadelphia	Pennsylvania	United States	19104
110	GSK Investigational Site	Philipsburg	Pennsylvania	United States	16866
111	GSK Investigational Site	Pittsburgh	Pennsylvania	United States	15212
112	GSK Investigational Site	Port Matilda	Pennsylvania	United States	16870
113	GSK Investigational Site	Sayre	Pennsylvania	United States	18840
114	GSK Investigational Site	Scranton	Pennsylvania	United States	18503
115	GSK Investigational Site	Scranton	Pennsylvania	United States	18505
116	GSK Investigational Site	Sellersville	Pennsylvania	United States	18960
117	GSK Investigational Site	Wilkes-Barre	Pennsylvania	United States	18702
118	GSK Investigational Site	York	Pennsylvania	United States	17403
119	GSK Investigational Site	Providence	Rhode Island	United States	02904
120	GSK Investigational Site	Charleston	South Carolina	United States	29401
121	GSK Investigational Site	Charleston	South Carolina	United States	29425-6240
122	GSK Investigational Site	Spartanburg	South Carolina	United States	29303
123	GSK Investigational Site	Rapid City	South Dakota	United States	57701
124	GSK Investigational Site	Sioux Falls	South Dakota	United States	57105
125	GSK Investigational Site	Bristol	Tennessee	United States	37620
126	GSK Investigational Site	Johnson City	Tennessee	United States	37601
127	GSK Investigational Site	Amarillo	Texas	United States	79106
128	GSK Investigational Site	Austin	Texas	United States	78705
129	GSK Investigational Site	Corpus Christi	Texas	United States	78404
130	GSK Investigational Site	Dallas	Texas	United States	75226
131	GSK Investigational Site	Dallas	Texas	United States	75231
132	GSK Investigational Site	Georgetown	Texas	United States	78626
133	GSK Investigational Site	Harker Heights	Texas	United States	76548
134	GSK Investigational Site	Houston	Texas	United States	77030
135	GSK Investigational Site	Houston	Texas	United States	77081
136	GSK Investigational Site	Plano	Texas	United States	75024
137	GSK Investigational Site	San Antonio	Texas	United States	78217
138	GSK Investigational Site	San Antonio	Texas	United States	78244
139	GSK Investigational Site	Victoria	Texas	United States	77901
140	GSK Investigational Site	Draper	Utah	United States	84020
141	GSK Investigational Site	Burke	Virginia	United States	22015
142	GSK Investigational Site	Norfolk	Virginia	United States	23502
143	GSK Investigational Site	Richmond	Virginia	United States	23294
144	GSK Investigational Site	Winchester	Virginia	United States	22601
145	GSK Investigational Site	Kirkland	Washington	United States	98034
146	GSK Investigational Site	Olympia	Washington	United States	98502
147	GSK Investigational Site	Renton	Washington	United States	98057
148	GSK Investigational Site	Seattle	Washington	United States	98104
149	GSK Investigational Site	Spokane	Washington	United States	99204
150	GSK Investigational Site	Spokane	Washington	United States	99207
151	GSK Investigational Site	Spokane	Washington	United States	99208
152	GSK Investigational Site	Tacoma	Washington	United States	98405
153	GSK Investigational Site	Walla Walla	Washington	United States	99362
154	GSK Investigational Site	Wenatchee	Washington	United States	98801
155	GSK Investigational Site	Wausau	Wisconsin	United States	54401
156	GSK Investigational Site	Adrogue	Buenos Aires	Argentina	B1846DSK
157	GSK Investigational Site	Bahia Blanca	Buenos Aires	Argentina	B8000FTD
158	GSK Investigational Site	Caba	Buenos Aires	Argentina	C1124AAJ
159	GSK Investigational Site	Ciudad Autonoma de Buenos Aires	Buenos Aires	Argentina	C1405BCH
160	GSK Investigational Site	Ciudad Autónoma de Buenos Aires	Buenos Aires	Argentina	C1125ABD
161	GSK Investigational Site	Ciudad Autónoma de Buenos Aires	Buenos Aires	Argentina	C1437JCP
162	GSK Investigational Site	Junin	Buenos Aires	Argentina
163	GSK Investigational Site	La Plata	Buenos Aires	Argentina	B1900AXI
164	GSK Investigational Site	Mar del Plata	Buenos Aires	Argentina	B7600FZN
165	GSK Investigational Site	Ramos Mejia	Buenos Aires	Argentina	B1704ETD
166	GSK Investigational Site	Cordoba	Córdova	Argentina	X5000EPU
167	GSK Investigational Site	Rosario	Santa Fe	Argentina	S2000CVD
168	GSK Investigational Site	Buenos Aires		Argentina	1425
169	GSK Investigational Site	Corrientes		Argentina	W3400AMZ
170	GSK Investigational Site	Corrientes		Argentina	W3400CLH
171	GSK Investigational Site	Mendoza		Argentina	M5500CCG
172	GSK Investigational Site	Santa Fe		Argentina	3000
173	GSK Investigational Site	Tucuman		Argentina	T4000ICL
174	GSK Investigational Site	Garran	Australian Capital Territory	Australia	2606
175	GSK Investigational Site	Coffs Harbour	New South Wales	Australia	2450
176	GSK Investigational Site	Concord	New South Wales	Australia	2139
177	GSK Investigational Site	Gosford	New South Wales	Australia	2250
178	GSK Investigational Site	Liverpool	New South Wales	Australia	2170
179	GSK Investigational Site	Auchenflower	Queensland	Australia	4066
180	GSK Investigational Site	Kippa Ring	Queensland	Australia	4021
181	GSK Investigational Site	Sherwood	Queensland	Australia	4075
182	GSK Investigational Site	Bedford Park	South Australia	Australia	5042
183	GSK Investigational Site	Ballarat	Victoria	Australia
184	GSK Investigational Site	Caulfield South	Victoria	Australia	3162
185	GSK Investigational Site	Frankston	Victoria	Australia	3199
186	GSK Investigational Site	Malvern	Victoria	Australia	3144
187	GSK Investigational Site	Fremantle	Western Australia	Australia	6160
188	GSK Investigational Site	Joondalup	Western Australia	Australia	6027
189	GSK Investigational Site	Nedlands	Western Australia	Australia	6009
190	GSK Investigational Site	Aalst		Belgium	9300
191	GSK Investigational Site	Antwerpen		Belgium	2020
192	GSK Investigational Site	Bonheiden		Belgium	2820
193	GSK Investigational Site	Bruxelles		Belgium	1200
194	GSK Investigational Site	Genk		Belgium	3600
195	GSK Investigational Site	Hasselt		Belgium	3500
196	GSK Investigational Site	La Louvière		Belgium	7100
197	GSK Investigational Site	Leuven		Belgium	3000
198	GSK Investigational Site	Liège		Belgium	4000
199	GSK Investigational Site	Roeselaere		Belgium	8800
200	GSK Investigational Site	Yvoir		Belgium	5530
201	GSK Investigational Site	Salvador	Bahía	Brazil	41810010
202	GSK Investigational Site	Goiânia	Goiás	Brazil	74605-050
203	GSK Investigational Site	Belo Horizonte	Minas Gerais	Brazil	30150-221.
204	GSK Investigational Site	Belo Horizonte	Minas Gerais	Brazil	30380090
205	GSK Investigational Site	Curitiba	Paraná	Brazil	80730150
206	GSK Investigational Site	Pelotas	Rio Grande Do Sul	Brazil	96015-290
207	GSK Investigational Site	Porto Alegre	Rio Grande Do Sul	Brazil	90610000
208	GSK Investigational Site	Porto Alegre	Rio Grande Do Sul	Brazil	90880-480
209	GSK Investigational Site	Natal	Rio Grande Du Norte	Brazil	59020-100
210	GSK Investigational Site	Campinas	São Paulo	Brazil	13059740
211	GSK Investigational Site	São José do Rio Preto	São Paulo	Brazil	15015210
212	GSK Investigational Site	São José do Rio Preto	São Paulo	Brazil	15090-000
213	GSK Investigational Site	Rio de Janeiro		Brazil	20551-030
214	GSK Investigational Site	São Paulo		Brazil	04012-909
215	GSK Investigational Site	São Paulo		Brazil	04012180
216	GSK Investigational Site	São Paulo		Brazil	05403-000
217	GSK Investigational Site	São Paulo		Brazil	05403000
218	GSK Investigational Site	Dimitrovgrad		Bulgaria	6400
219	GSK Investigational Site	Pleven		Bulgaria	5800
220	GSK Investigational Site	Plovdiv		Bulgaria	4003
221	GSK Investigational Site	Ruse		Bulgaria	7002
222	GSK Investigational Site	Sofia		Bulgaria	1000
223	GSK Investigational Site	Sofia		Bulgaria	1233
224	GSK Investigational Site	Sofia		Bulgaria	1431
225	GSK Investigational Site	Sofia		Bulgaria	1527
226	GSK Investigational Site	Sofia		Bulgaria	1606
227	GSK Investigational Site	Veliko Tarnovo		Bulgaria	5000
228	GSK Investigational Site	Edmonton	Alberta	Canada	T6G 2B7
229	GSK Investigational Site	Kelowna	British Columbia	Canada	V1Y 1E4
230	GSK Investigational Site	New Westminister	British Columbia	Canada	V3L 3W4
231	GSK Investigational Site	New Westminster	British Columbia	Canada	V3L 3W4
232	GSK Investigational Site	Surrey	British Columbia	Canada	V3V 1N1
233	GSK Investigational Site	Vancouver	British Columbia	Canada	V5Z 1M9
234	GSK Investigational Site	Victoria	British Columbia	Canada	V8R 4R2
235	GSK Investigational Site	Winnipeg	Manitoba	Canada	R2H 2A6
236	GSK Investigational Site	Bay Roberts	Newfoundland and Labrador	Canada	A0A 1G0
237	GSK Investigational Site	St. John's	Newfoundland and Labrador	Canada	A1B 3V6
238	GSK Investigational Site	Halifax	Nova Scotia	Canada	B3H 3A7
239	GSK Investigational Site	Truro	Nova Scotia	Canada	B2N 1L2
240	GSK Investigational Site	Ajax	Ontario	Canada	L1S 7K8
241	GSK Investigational Site	Brampton	Ontario	Canada	L6Z 4N5
242	GSK Investigational Site	Hamilton	Ontario	Canada	L8L 2X2
243	GSK Investigational Site	Kitchener	Ontario	Canada	N2M 5N6
244	GSK Investigational Site	Mississauga	Ontario	Canada	L5B 2P7
245	GSK Investigational Site	Oshawa	Ontario	Canada	L1J 2J9
246	GSK Investigational Site	Ottawa	Ontario	Canada	K1Y 4W7
247	GSK Investigational Site	Scarborough	Ontario	Canada	M1E 5E9
248	GSK Investigational Site	Thornhill	Ontario	Canada	L4J 8L7
249	GSK Investigational Site	Toronto	Ontario	Canada	M3H 5S4
250	GSK Investigational Site	Toronto	Ontario	Canada	M4G 3E8
251	GSK Investigational Site	Toronto	Ontario	Canada	M5C 2T2
252	GSK Investigational Site	Gatineau	Quebec	Canada	J8Y 6S8
253	GSK Investigational Site	Greenfield Park	Quebec	Canada	J4V 2H1
254	GSK Investigational Site	Levis	Quebec	Canada	G6V 4Z5
255	GSK Investigational Site	Montreal	Quebec	Canada	H1T 1C8
256	GSK Investigational Site	Montreal	Quebec	Canada	H1T 3Y7
257	GSK Investigational Site	Quebec City	Quebec	Canada	G1J 1Z6
258	GSK Investigational Site	Quebec City	Quebec	Canada	G1L 3L5
259	GSK Investigational Site	Saint Charles-Borromee	Quebec	Canada	J6E 6J2
260	GSK Investigational Site	Sherbrooke	Quebec	Canada	J1J 2E3
261	GSK Investigational Site	Trois Rivières	Quebec	Canada	G8T 7A1
262	GSK Investigational Site	Talcahuano	Región Del Biobio	Chile	427 0918
263	GSK Investigational Site	Santiago	Región Metro De Santiago	Chile	750 0922
264	GSK Investigational Site	Santiago	Región Metro De Santiago	Chile	7500503
265	GSK Investigational Site	Santiago	Región Metro De Santiago	Chile	7571831
266	GSK Investigational Site	Santiago	Región Metro De Santiago	Chile	833 0074
267	GSK Investigational Site	Santiago	Región Metro De Santiago	Chile	8360160
268	GSK Investigational Site	Santiago	Región Metro De Santiago	Chile	8380456
269	GSK Investigational Site	Viña del Mar	Valparaíso	Chile
270	GSK Investigational Site	Guangzhou	Guangdong	China	510080
271	GSK Investigational Site	Nanjing	Jiangsu	China	210029
272	GSK Investigational Site	Xian	Shaanxi	China	710061
273	GSK Investigational Site	Jinan	Shandong	China	250012
274	GSK Investigational Site	Hang Zhou	Zhejiang	China	310003
275	GSK Investigational Site	Beijing		China	100034
276	GSK Investigational Site	Beijing		China	100044
277	GSK Investigational Site	Beijing		China	100730
278	GSK Investigational Site	Beijing		China	100853
279	GSK Investigational Site	Guangzhou		China	510100
280	GSK Investigational Site	Haerbin		China	150001
281	GSK Investigational Site	Shanghai		China	200032
282	GSK Investigational Site	Shanghai		China	200040
283	GSK Investigational Site	Shanghai		China	200127
284	GSK Investigational Site	Shanghai		China	200233
285	GSK Investigational Site	Wuhan		China	430022
286	GSK Investigational Site	Caslav		Czechia	286 01
287	GSK Investigational Site	Chomutov		Czechia	430 02
288	GSK Investigational Site	Chrudim		Czechia	537 27
289	GSK Investigational Site	Jihlava		Czechia	586 33
290	GSK Investigational Site	Kladno		Czechia	272 80
291	GSK Investigational Site	Kolin		Czechia	280 00
292	GSK Investigational Site	Kromeriz		Czechia	767 55
293	GSK Investigational Site	Milevsko		Czechia	399 01
294	GSK Investigational Site	Pisek		Czechia	397 01
295	GSK Investigational Site	Praha 2		Czechia	128 08
296	GSK Investigational Site	Pribram		Czechia	261 26
297	GSK Investigational Site	Slany		Czechia
298	GSK Investigational Site	Svitavy		Czechia	568 25
299	GSK Investigational Site	Tabor		Czechia	390 03
300	GSK Investigational Site	Usti nad Orlici		Czechia	562 18
301	GSK Investigational Site	Aarhus		Denmark	DK-8000
302	GSK Investigational Site	Esbjerg		Denmark	6700
303	GSK Investigational Site	Koebenhavn OE		Denmark	2100
304	GSK Investigational Site	Silkeborg		Denmark	8600
305	GSK Investigational Site	Tallinn		Estonia	1162
306	GSK Investigational Site	Tallinn		Estonia	13419
307	GSK Investigational Site	Tartu		Estonia	51014
308	GSK Investigational Site	Aix en Provence cedex 1		France	13616
309	GSK Investigational Site	Avignon		France	84082
310	GSK Investigational Site	Besançon Cedex		France	25030
311	GSK Investigational Site	Bron Cedex		France	69677
312	GSK Investigational Site	Créteil		France	94010
313	GSK Investigational Site	Dijon		France	21079
314	GSK Investigational Site	Lille Cedex		France	59037
315	GSK Investigational Site	Marseille cedex 5		France	13385
316	GSK Investigational Site	Metz Cedex 03		France	57085
317	GSK Investigational Site	Nantes Cedex 1		France	44093
318	GSK Investigational Site	Narbonne Cedex		France	11108
319	GSK Investigational Site	Nimes		France	30000
320	GSK Investigational Site	Paris Cedex 13		France	75651
321	GSK Investigational Site	Paris Cedex 18		France	75877
322	GSK Investigational Site	Paris		France	75010
323	GSK Investigational Site	Paris		France	75015
324	GSK Investigational Site	Pessac cedex		France	33604
325	GSK Investigational Site	Roubaix		France	59056
326	GSK Investigational Site	Strasbourg cedex		France	67091
327	GSK Investigational Site	Toulouse Cedex 09		France	31059
328	GSK Investigational Site	Tourcoing		France	59208
329	GSK Investigational Site	Deggingen	Baden-Wuerttemberg	Germany	73326
330	GSK Investigational Site	Gueglingen	Baden-Wuerttemberg	Germany	74363
331	GSK Investigational Site	Heidelberg	Baden-Wuerttemberg	Germany	69120
332	GSK Investigational Site	Ulm	Baden-Wuerttemberg	Germany	89081
333	GSK Investigational Site	Aschaffenburg	Bayern	Germany	63739
334	GSK Investigational Site	Haag	Bayern	Germany	83527
335	GSK Investigational Site	Hoehenkirchen-Siegertsbrunn	Bayern	Germany	85635
336	GSK Investigational Site	Kuenzing	Bayern	Germany	94550
337	GSK Investigational Site	Muehldorf	Bayern	Germany	84453
338	GSK Investigational Site	Muenchen	Bayern	Germany	80336
339	GSK Investigational Site	Sulzbach-Rosenberg	Bayern	Germany	92237
340	GSK Investigational Site	Wallerfing	Bayern	Germany	94574
341	GSK Investigational Site	Bernau	Brandenburg	Germany	16321
342	GSK Investigational Site	Frankfurt/M.	Hessen	Germany	60594
343	GSK Investigational Site	Kelkheim	Hessen	Germany	65779
344	GSK Investigational Site	Hannover	Niedersachsen	Germany	30625
345	GSK Investigational Site	Weyhe-Leeste	Niedersachsen	Germany	28844
346	GSK Investigational Site	Bad Oeynhausen	Nordrhein-Westfalen	Germany	32545
347	GSK Investigational Site	Dorsten	Nordrhein-Westfalen	Germany	46282
348	GSK Investigational Site	Eschweiler	Nordrhein-Westfalen	Germany	52249
349	GSK Investigational Site	Essen	Nordrhein-Westfalen	Germany	45359
350	GSK Investigational Site	Goch	Nordrhein-Westfalen	Germany	47574
351	GSK Investigational Site	Herford	Nordrhein-Westfalen	Germany	32049
352	GSK Investigational Site	Lienen-Kattenvenne	Nordrhein-Westfalen	Germany	49536
353	GSK Investigational Site	Witten	Nordrhein-Westfalen	Germany	58455
354	GSK Investigational Site	Mainz	Rheinland-Pfalz	Germany	55116
355	GSK Investigational Site	Rhaunen	Rheinland-Pfalz	Germany	55624
356	GSK Investigational Site	Magdeburg	Sachsen-Anhalt	Germany	39112
357	GSK Investigational Site	Delitzsch	Sachsen	Germany	04509
358	GSK Investigational Site	Dresden	Sachsen	Germany	01307
359	GSK Investigational Site	Leipzg	Sachsen	Germany	04109
360	GSK Investigational Site	Leipzig	Sachsen	Germany	04315
361	GSK Investigational Site	Leipzig	Sachsen	Germany	04329
362	GSK Investigational Site	Schmiedeberg	Sachsen	Germany	01762
363	GSK Investigational Site	Berlin		Germany	10367
364	GSK Investigational Site	Berlin		Germany	10559
365	GSK Investigational Site	Berlin		Germany	10787
366	GSK Investigational Site	Berlin		Germany	12157
367	GSK Investigational Site	Berlin		Germany	13055
368	GSK Investigational Site	Berlin		Germany	13086
369	GSK Investigational Site	Berlin		Germany	13125
370	GSK Investigational Site	Berlin		Germany	13347
371	GSK Investigational Site	Berlin		Germany	13353
372	GSK Investigational Site	Berlin		Germany	13405
373	GSK Investigational Site	Hamburg		Germany	22041
374	GSK Investigational Site	Agia Varvara, Athens		Greece	123 51
375	GSK Investigational Site	Alexandroupolis		Greece	68100
376	GSK Investigational Site	Athens		Greece	11527
377	GSK Investigational Site	Athens		Greece	124 62
378	GSK Investigational Site	Athens		Greece	176 74
379	GSK Investigational Site	Chalkida		Greece	341 00
380	GSK Investigational Site	Ioannina		Greece	45500
381	GSK Investigational Site	Magoula, Elefsina		Greece	192 00
382	GSK Investigational Site	Patras		Greece	26 500
383	GSK Investigational Site	Thessaloniki		Greece	546 42
384	GSK Investigational Site	Voula / Athens		Greece	166 73
385	GSK Investigational Site	Hong Kong		Hong Kong
386	GSK Investigational Site	Shatin, New Territories		Hong Kong
387	GSK Investigational Site	Berettyóújfalu		Hungary
388	GSK Investigational Site	Budapest		Hungary	1032
389	GSK Investigational Site	Budapest		Hungary	1033
390	GSK Investigational Site	Budapest		Hungary	1096
391	GSK Investigational Site	Esztergom		Hungary
392	GSK Investigational Site	Gyula		Hungary	5700
393	GSK Investigational Site	Komárom		Hungary	2921
394	GSK Investigational Site	Mosonmagyaróvár		Hungary	9200
395	GSK Investigational Site	Szikszó		Hungary
396	GSK Investigational Site	Szolnok		Hungary	5004
397	GSK Investigational Site	Székesfehérvár		Hungary	8000
398	GSK Investigational Site	Sátoraljaújhely		Hungary	3980
399	GSK Investigational Site	Ahmedabad		India	380060
400	GSK Investigational Site	Bangalore		India	560 099
401	GSK Investigational Site	Bangalore		India	560034
402	GSK Investigational Site	Cochin		India	683572
403	GSK Investigational Site	Jaipur		India	302001
404	GSK Investigational Site	Jaipur		India	302017
405	GSK Investigational Site	Mysore		India	570020
406	GSK Investigational Site	New Delhi		India	110060
407	GSK Investigational Site	Patiala		India	147001
408	GSK Investigational Site	Pune		India	411004
409	GSK Investigational Site	Pune		India	411030
410	GSK Investigational Site	Saket,Delhi		India	110017
411	GSK Investigational Site	Vadodara		India	390015
412	GSK Investigational Site	Vijayawada		India	520008
413	GSK Investigational Site	Chieti	Abruzzo	Italy	66013
414	GSK Investigational Site	Napoli	Campania	Italy	80131
415	GSK Investigational Site	Carpi	Emilia-Romagna	Italy	41012
416	GSK Investigational Site	Cona (Ferrara)	Emilia-Romagna	Italy	44124
417	GSK Investigational Site	Parma	Emilia-Romagna	Italy	43100
418	GSK Investigational Site	Roma	Lazio	Italy	00135
419	GSK Investigational Site	Milano	Lombardia	Italy	20162
420	GSK Investigational Site	Ascoli Piceno	Marche	Italy	63100
421	GSK Investigational Site	Cuneo	Piemonte	Italy	12100
422	GSK Investigational Site	Novara	Piemonte	Italy	28100
423	GSK Investigational Site	Pisa	Toscana	Italy	56126
424	GSK Investigational Site	Treviso	Veneto	Italy	31100
425	GSK Investigational Site	Aichi		Japan	487-0013
426	GSK Investigational Site	Chiba		Japan	270-2251
427	GSK Investigational Site	Fukuoka		Japan	802-8555
428	GSK Investigational Site	Fukuoka		Japan	811-3195
429	GSK Investigational Site	Fukuoka		Japan	819-1104
430	GSK Investigational Site	Hokkaido		Japan	063-0005
431	GSK Investigational Site	Hokkaido		Japan	065-0033
432	GSK Investigational Site	Kagoshima		Japan	892-0853
433	GSK Investigational Site	Kanagawa		Japan	240-0116
434	GSK Investigational Site	Kanagawa		Japan	247-8533
435	GSK Investigational Site	Kyoto		Japan	611-0042
436	GSK Investigational Site	Nagano		Japan	386-8610
437	GSK Investigational Site	Nagasaki		Japan	856-8562
438	GSK Investigational Site	Nagasaki		Japan	859-3615
439	GSK Investigational Site	Oita		Japan	870-1133
440	GSK Investigational Site	Osaka		Japan	574-0074
441	GSK Investigational Site	Shiga		Japan	520-2192
442	GSK Investigational Site	Shizuoka		Japan	411-8611
443	GSK Investigational Site	Tokyo		Japan	141-0001
444	GSK Investigational Site	Cheongju		Korea, Republic of	361-711
445	GSK Investigational Site	Dae-Gu		Korea, Republic of	700-721
446	GSK Investigational Site	Gangnam-gu, Seoul		Korea, Republic of	135-710
447	GSK Investigational Site	Gwangju		Korea, Republic of	501-757
448	GSK Investigational Site	jeonju-si, Jeollabuk-Do		Korea, Republic of	561-712
449	GSK Investigational Site	Seo-gu Busan		Korea, Republic of	602-739
450	GSK Investigational Site	Seongnam-si Gyeonggi-do		Korea, Republic of	463-707
451	GSK Investigational Site	Seoul		Korea, Republic of	110-744
452	GSK Investigational Site	Seoul		Korea, Republic of	120-752
453	GSK Investigational Site	Seoul		Korea, Republic of	130-702
454	GSK Investigational Site	Seoul		Korea, Republic of	136-705
455	GSK Investigational Site	Seoul		Korea, Republic of	137-701
456	GSK Investigational Site	Seoul		Korea, Republic of	138-736
457	GSK Investigational Site	Seoul		Korea, Republic of	143-729
458	GSK Investigational Site	Uijeongbu-si Kyonggi-do		Korea, Republic of	480-717
459	GSK Investigational Site	Monterrey NL	Nuevo León	Mexico	64718
460	GSK Investigational Site	Durango		Mexico	34080
461	GSK Investigational Site	Mexico		Mexico	10700
462	GSK Investigational Site	México D.F,		Mexico	07760
463	GSK Investigational Site	Amsterdam		Netherlands	1105 AZ
464	GSK Investigational Site	Beverwijk		Netherlands	1942 LE
465	GSK Investigational Site	Den Haag		Netherlands	2597 AX
466	GSK Investigational Site	Doetinchem		Netherlands	7009 BL
467	GSK Investigational Site	Eindhoven		Netherlands	5623 EJ
468	GSK Investigational Site	Enschede		Netherlands	7513 ER
469	GSK Investigational Site	Goes		Netherlands	4462 RA
470	GSK Investigational Site	Harderwijk		Netherlands	3844 DG
471	GSK Investigational Site	Hoofddorp		Netherlands	2134 TM
472	GSK Investigational Site	Leeuwarden		Netherlands	8934 AD
473	GSK Investigational Site	Rotterdam		Netherlands	3079 DZ
474	GSK Investigational Site	Sittard-geleen		Netherlands	6162 BG
475	GSK Investigational Site	Sneek		Netherlands	8601 ZK
476	GSK Investigational Site	Tiel		Netherlands	4002 WP
477	GSK Investigational Site	Christchurch		New Zealand
478	GSK Investigational Site	Dunedin		New Zealand
479	GSK Investigational Site	Grafton, Auckland		New Zealand	1030
480	GSK Investigational Site	Hamilton		New Zealand	3204
481	GSK Investigational Site	Lower Hutt		New Zealand
482	GSK Investigational Site	Nelson		New Zealand
483	GSK Investigational Site	Otahuhu, Auckland		New Zealand	1640
484	GSK Investigational Site	Palmerston North		New Zealand	4410
485	GSK Investigational Site	Takapuna, Auckland		New Zealand	0622
486	GSK Investigational Site	Tauranga		New Zealand	3112
487	GSK Investigational Site	Timaru		New Zealand	7910
488	GSK Investigational Site	Whangarei		New Zealand
489	GSK Investigational Site	Bergen		Norway	5021
490	GSK Investigational Site	Moss		Norway	1501
491	GSK Investigational Site	Oslo		Norway	0160
492	GSK Investigational Site	Oslo		Norway	0407
493	GSK Investigational Site	Karachi		Pakistan	75510
494	GSK Investigational Site	Karachi		Pakistan	75950
495	GSK Investigational Site	Korangi / Karachi		Pakistan
496	GSK Investigational Site	Lahore		Pakistan	54000
497	GSK Investigational Site	Lahore		Pakistan
498	GSK Investigational Site	Multan		Pakistan	60000
499	GSK Investigational Site	Rawalpindi Cantt		Pakistan	46000
500	GSK Investigational Site	Jesus Maria	Lima	Peru	Lima 11
501	GSK Investigational Site	Callao		Peru	Callao 2
502	GSK Investigational Site	Lima		Peru	Lima 11
503	GSK Investigational Site	Ermita, Manila		Philippines	1000
504	GSK Investigational Site	Manila		Philippines	1000
505	GSK Investigational Site	Manila		Philippines	1100
506	GSK Investigational Site	Quezon City		Philippines	1109
507	GSK Investigational Site	Quezon City		Philippines	1113
508	GSK Investigational Site	Quezon City		Philippines
509	GSK Investigational Site	San Juan		Philippines	1502
510	GSK Investigational Site	Bydgoszcz		Poland	85-079
511	GSK Investigational Site	Bydgoszcz		Poland	85-435
512	GSK Investigational Site	Gdynia		Poland	81-423
513	GSK Investigational Site	Kowanowko		Poland
514	GSK Investigational Site	Krakow		Poland	31-202
515	GSK Investigational Site	Mielec		Poland	39-300
516	GSK Investigational Site	Ostrow Wielkopolski		Poland	63-400
517	GSK Investigational Site	Plonsk		Poland	09 - 100
518	GSK Investigational Site	Radom		Poland	26-617
519	GSK Investigational Site	Ruda Slaska		Poland	41-706
520	GSK Investigational Site	Siemianowice Slaskie		Poland	41-100
521	GSK Investigational Site	Skierniewice		Poland
522	GSK Investigational Site	Torun		Poland	87-100
523	GSK Investigational Site	Tychy		Poland	43-100
524	GSK Investigational Site	Warszawa		Poland	03-285
525	GSK Investigational Site	Warszawa		Poland	04-073
526	GSK Investigational Site	Wloclawek		Poland	87-800
527	GSK Investigational Site	Wroclaw		Poland	50-349
528	GSK Investigational Site	Bucharest		Romania	011461
529	GSK Investigational Site	Bucharest		Romania	011601
530	GSK Investigational Site	Bucharest		Romania	011794
531	GSK Investigational Site	Bucharest		Romania	022328
532	GSK Investigational Site	Bucharest		Romania	041915
533	GSK Investigational Site	Bucharest		Romania	042122
534	GSK Investigational Site	Bucharest		Romania	050098
535	GSK Investigational Site	Deva		Romania	330084
536	GSK Investigational Site	Galati		Romania	800087
537	GSK Investigational Site	Targu Mures		Romania	540136
538	GSK Investigational Site	Ekaterinburg		Russian Federation	620109
539	GSK Investigational Site	Ekaterinburg		Russian Federation	620144
540	GSK Investigational Site	Kemerovo		Russian Federation	650002
541	GSK Investigational Site	Kemerovo		Russian Federation	650055
542	GSK Investigational Site	Moscow		Russian Federation	111020
543	GSK Investigational Site	Moscow		Russian Federation	111539
544	GSK Investigational Site	Moscow		Russian Federation	117292
545	GSK Investigational Site	Moscow		Russian Federation	119620
546	GSK Investigational Site	Moscow		Russian Federation	121 552
547	GSK Investigational Site	Moscow		Russian Federation	121552
548	GSK Investigational Site	Novosibirsk		Russian Federation	630003
549	GSK Investigational Site	Novosibirsk		Russian Federation	630008
550	GSK Investigational Site	Novosibirsk		Russian Federation	630047
551	GSK Investigational Site	Ryazan		Russian Federation	390026
552	GSK Investigational Site	S.-Petresburg		Russian Federation	195067
553	GSK Investigational Site	St Pertersburg		Russian Federation	196247
554	GSK Investigational Site	St'Petersburg		Russian Federation	194156
555	GSK Investigational Site	St-Petersburg		Russian Federation	193312
556	GSK Investigational Site	St-Petersburg		Russian Federation	195067
557	GSK Investigational Site	St-Petersburg		Russian Federation	199106
558	GSK Investigational Site	Yekaterinburg		Russian Federation
559	GSK Investigational Site	Bratislava		Slovakia	813 69
560	GSK Investigational Site	Bratislava		Slovakia	833 05
561	GSK Investigational Site	Kosice		Slovakia	040 22
562	GSK Investigational Site	Nitra		Slovakia	949 01
563	GSK Investigational Site	Parktown	Gauteng	South Africa	2193
564	GSK Investigational Site	Bellville		South Africa	7531
565	GSK Investigational Site	Bloemfontein		South Africa	9301
566	GSK Investigational Site	Kempton Park		South Africa	1619
567	GSK Investigational Site	Kuils River		South Africa	7580
568	GSK Investigational Site	Moreletapark		South Africa	0181
569	GSK Investigational Site	Olivedale		South Africa	2188
570	GSK Investigational Site	Paarl		South Africa	7646
571	GSK Investigational Site	Parktown West		South Africa	2193
572	GSK Investigational Site	Parow		South Africa	7505
573	GSK Investigational Site	Pinelands		South Africa	7405
574	GSK Investigational Site	Somerset West		South Africa	7130
575	GSK Investigational Site	Soweto		South Africa	2013
576	GSK Investigational Site	Umhlanga		South Africa	4319
577	GSK Investigational Site	Alicante		Spain	03114
578	GSK Investigational Site	Granada		Spain	18012
579	GSK Investigational Site	Jerez de la Frontera		Spain	11407
580	GSK Investigational Site	Madrid		Spain	28029
581	GSK Investigational Site	Madrid		Spain	28031
582	GSK Investigational Site	Madrid		Spain	28034
583	GSK Investigational Site	Madrid		Spain	28040
584	GSK Investigational Site	Madrid		Spain	28041
585	GSK Investigational Site	Madrid		Spain	28046
586	GSK Investigational Site	Madrid		Spain
587	GSK Investigational Site	Malaga		Spain	29010
588	GSK Investigational Site	Marid		Spain	28040
589	GSK Investigational Site	Oviedo		Spain	33006
590	GSK Investigational Site	Pozuelo de Alarcón/Madrid		Spain	28223
591	GSK Investigational Site	San Juan (Alicante)		Spain	03550
592	GSK Investigational Site	San Sebastián de los Reyes/Madrid		Spain
593	GSK Investigational Site	San Sebastián		Spain	20014
594	GSK Investigational Site	Santander		Spain	39008
595	GSK Investigational Site	Sevilla		Spain	41071
596	GSK Investigational Site	Sta Coloma de Gramanet (Barcelona)		Spain	08923
597	GSK Investigational Site	Valdemoro/Madrid		Spain	28340
598	GSK Investigational Site	Eksjö		Sweden	SE-575 36
599	GSK Investigational Site	Göteborg		Sweden	SE-413 45
600	GSK Investigational Site	Göteborg		Sweden	SE-416 85
601	GSK Investigational Site	Linköping		Sweden	SE-581 85
602	GSK Investigational Site	Lund		Sweden	SE-222 21
603	GSK Investigational Site	Malmö		Sweden	SE-205 02
604	GSK Investigational Site	Stockholm		Sweden	SE-111 35
605	GSK Investigational Site	Stockholm		Sweden	SE-111 57
606	GSK Investigational Site	Stockholm		Sweden	SE-182 88
607	GSK Investigational Site	Umeå		Sweden	SE-901 85
608	GSK Investigational Site	Uppsala		Sweden	SE-751 85
609	GSK Investigational Site	Västervik		Sweden	SE-593 81
610	GSK Investigational Site	Västerås		Sweden	SE-721 89
611	GSK Investigational Site	Östersund		Sweden	SE-831 83
612	GSK Investigational Site	Changhua		Taiwan	500
613	GSK Investigational Site	Taichung		Taiwan	407
614	GSK Investigational Site	Tainan		Taiwan	704
615	GSK Investigational Site	Taipei City		Taiwan	104
616	GSK Investigational Site	Taipei		Taiwan	100
617	GSK Investigational Site	Taipei		Taiwan	112
618	GSK Investigational Site	Bangkok		Thailand	10330
619	GSK Investigational Site	Bangkok		Thailand	10400
620	GSK Investigational Site	Bangkok		Thailand	10700
621	GSK Investigational Site	Chiangmai		Thailand	50200
622	GSK Investigational Site	Donetsk		Ukraine	83045
623	GSK Investigational Site	Kharkiv		Ukraine	61002
624	GSK Investigational Site	Kharkiv		Ukraine	61018
625	GSK Investigational Site	Kharkiv		Ukraine	61037
626	GSK Investigational Site	Kharkiv		Ukraine	61176
627	GSK Investigational Site	Kyiv		Ukraine	02660
628	GSK Investigational Site	Kyiv		Ukraine	03680
629	GSK Investigational Site	Kyiv		Ukraine	04114
630	GSK Investigational Site	Lviv		Ukraine	79044
631	GSK Investigational Site	Odesa		Ukraine	65025
632	GSK Investigational Site	Odesa		Ukraine	65114
633	GSK Investigational Site	Vinnytsia		Ukraine	21029
634	GSK Investigational Site	Zaporizhzhia		Ukraine	69118
635	GSK Investigational Site	Cambridge	Cambridgeshire	United Kingdom	CB2 0QQ
636	GSK Investigational Site	Glasgow	Lanarkshire	United Kingdom	G11 6NT
637	GSK Investigational Site	Motherwell	Lanarkshire	United Kingdom	ML1 3JX
638	GSK Investigational Site	Chelsea	London	United Kingdom	SW3 6NP
639	GSK Investigational Site	Liverpool	Merseyside	United Kingdom
640	GSK Investigational Site	Harrow	Middlesex	United Kingdom	HA1 3UJ
641	GSK Investigational Site	Chertsey	Surrey	United Kingdom	KT16 0PZ
642	GSK Investigational Site	Chichester	Sussex West	United Kingdom	PO19 4SE
643	GSK Investigational Site	Barnet		United Kingdom	EN5 3DJ
644	GSK Investigational Site	Coatbridge		United Kingdom	ML5 3AP
645	GSK Investigational Site	Cottingham		United Kingdom	HU16 5JQ
646	GSK Investigational Site	Cumbernauld		United Kingdom	G67 1BJ
647	GSK Investigational Site	Hamilton		United Kingdom	ML3 8AA
648	GSK Investigational Site	Hertfordshire		United Kingdom
649	GSK Investigational Site	Liverpool		United Kingdom	L7 8XP
650	GSK Investigational Site	Newcastle-upon-Tyne		United Kingdom	NE7 7DN
651	GSK Investigational Site	Paisley		United Kingdom	PA2 9PN

Sponsors and Collaborators

• GlaxoSmithKline

Investigators

• Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Publications

None provided.

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT00799903
• Other Study ID Numbers: 100601
• First Posted: Dec 1, 2008
• Last Update Posted: Aug 10, 2017
• Last Verified: Mar 1, 2017

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by GlaxoSmithKline: heart disease; Lp-PLA2 inhibitor; cardiovascular disease; coronary heart disease; CV risk; Atherosclerosis
• Additional relevant MeSH terms: Heart Diseases; Atherosclerosis; Darapladib

Study Results

Participant Flow

Recruitment Details	The study consisted of a Screening Phase of up to 8 weeks duration, a Treatment Phase, an End-of-Treatment (EOT) visit, and a Follow-up visit scheduled for 35 +/- 7 days after last study drug intake. The median treatment duration was anticipated to be 2.75 years.
Pre-assignment Detail	During the Screening Phase of the study, participants presenting with chronic Coronary Heart Disease (CHD) were randomized within 8 weeks. In addition to chronic CHD, participants were required to have at least one additional predictor of cardiovascular risk specified in the protocol.

Arm/Group Title	Placebo	Darapladib
Arm/Group Description	Participants were randomized to receive matching placebo once daily.	Participants were randomized to receive darapladib 160 milligram (mg) enteric-coated tablets once daily.
Period Title: Overall Study
STARTED	7904	7924
COMPLETED	7631	7646
NOT COMPLETED	273	278

Baseline Characteristics

Arm/Group Title	Placebo	Darapladib	Total
Arm/Group Description	Participants were randomized to receive matching placebo once daily.	Participants were randomized to receive darapladib 160 milligram (mg) enteric-coated tablets once daily.	Total of all reporting groups
Overall Participants	7904	7924	15828
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	64.3 (9.39)	64.5 (9.31)	64.4 (9.35)
Sex: Female, Male (Count of Participants)
Female	1506 19.1%	1461 18.4%	2967 18.7%
Male	6398 80.9%	6463 81.6%	12861 81.3%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	108 1.4%	106 1.3%	214 1.4%
Asian	1366 17.3%	1351 17%	2717 17.2%
Native Hawaiian or Other Pacific Islander	11 0.1%	4 0.1%	15 0.1%
Black or African American	191 2.4%	175 2.2%	366 2.3%
White	6177 78.2%	6233 78.7%	12410 78.4%
More than one race	51 0.6%	55 0.7%	106 0.7%
Unknown or Not Reported	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With First Occurrence of Any Component of the Composite of Major Adverse Cardiovascular Events (Cardiovascular [CV] Death, Non-fatal Myocardial Infarction [MI] or Non-fatal Stroke) During the Time Period for Follow-up of CV Events
Description	CV death=death due to a CV cause, which included but was not limited to deaths resulting from stroke, arrhythmia, sudden death (witnessed/unwitnessed), MI, heart failure, pulmonary embolism, peripheral arterial disease, or complications of a CV procedure. Deaths not clearly attributable to non-CV causes are considered to be CV deaths. Acute MI=evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia. Prior MI diagnosed post-randomization (e.g., silent MI)=the development of new pathological Q waves with/without symptoms OR imaging evidence of a region of loss of viable myocardium that is thinned and fails to contract, in the absence of a non-ischemic cause (pre-event imaging data required for verification of new abnormality), OR pathological findings of a healed/healing MI. Stroke=presence of a new focal neurologic deficit thought to be of vascular origin, with signs/symptoms lasting >24 hours or results in death (in <24 hours).
Time Frame	From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 4.25 years/average of 3.51 years)

Outcome Measure Data

Analysis Population Description

All-randomized Intent-to-treat (ITT) population comprised of all randomized participants.

Arm/Group Title	Placebo	Darapladib
Arm/Group Description	Participants were randomized to receive matching placebo once daily.	Participants were randomized to receive darapladib 160 milligram (mg) enteric-coated tablets once daily.
Measure Participants	7904	7924
Count of Participants [Participants]	819 10.4%	769 9.7%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Darapladib
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.199
	Comments	Hazard ratio and p-value are estimated using a Cox proportional hazard regression model with treatment as the only covariate. A hazard ratio < 1 indicates a lower risk with this treatment compared to Placebo.
	Method	Regression, Cox
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.94
	Confidence Interval	(2-Sided) 95.1%; 0.85 to 1.03
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Number of Participants With First Occurrence of Any Event in the Composite of Major Coronary Events (Coronary Heart Disease [CHD] Death, Non-fatal MI, or Urgent Coronary Revascularization [CR] for MI) During the Time Period for Follow-up (FU) of CV Events
Description	CHD death=occurrence of a fatal MI, death caused by documented cardiac arrest, death resulting from heart failure in a participant with known CHD, death from other forms of acute/chronic CHD, unwitnessed death of unknown origin, or sudden death. Acute MI=evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia. Prior MI diagnosed post-randomization (e.g.,silent MI)=the development of new pathological Q waves with/without symptoms OR imaging evidence of a region of loss of viable myocardium that is thinned and fails to contract, in the absence of a non-ischemic cause (pre-event imaging data required for verification of new abnormality), OR pathological findings of a healed/healing MI. Urgent CR for MI=ischemic discomfort at rest that prompted CR (percutaneous coronary intervention [PCI: any attempt at CR even if not successful] or coronary artery bypass graft) during the same hospitalization or resulted in hospital transfer for the purpose of CR.
Time Frame	From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 4.25 years/average of 3.51 years)

Outcome Measure Data

Analysis Population Description

All Randomized (ITT) Population

Arm/Group Title	Placebo	Darapladib
Arm/Group Description	Participants were randomized to receive matching placebo once daily.	Participants were randomized to receive darapladib 160 milligram (mg) enteric-coated tablets once daily.
Measure Participants	7904	7924
Count of Participants [Participants]	814 10.3%	737 9.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Darapladib
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.045
	Comments	Hazard ratio and p-value are estimated using a Cox proportional hazard regression model with treatment as the only covariate. A hazard ratio < 1 indicates a lower risk with this treatment compared to Placebo.
	Method	Regression, Cox
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.90
	Confidence Interval	(2-Sided) 95%; 0.82 to 1.00
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	Number of Participants With First Occurrence of Any Event in the Composite of Total Coronary Events (CHD Death, Non-fatal MI, Hospitalization for Unstable Angina, or Any Coronary Revascularization Procedure) During Time Period for FU of CV Events
Description	CHD death, acute MI, and prior MI are defined in the previous secondary endpoint (major coronary events). Hospitalization for unstable angina=one of the following, but not fulfilling the criteria for MI: ischemic discomfort at rest associated with electrocardiogram (ECG) changes leading to hospitalization; ischemic discomfort at rest regardless of ECG changes leading to hospitalization and revascularization during the same admission; ischemic discomfort at rest in hospital associated with ECG changes; ischemic discomfort at rest in hospital without ECG changes resulting in revascularization during the same admission. NOTE: The event was not considered to be unstable angina if, after invasive/non-invasive testing or other diagnostic testing, the discomfort is found not to be caused by myocardial ischemia.
Time Frame	From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 4.25 years/average of 3.51 years)

Outcome Measure Data

Analysis Population Description

All Randomized (ITT) Population

Arm/Group Title	Placebo	Darapladib
Arm/Group Description	Participants were randomized to receive matching placebo once daily.	Participants were randomized to receive darapladib 160 milligram (mg) enteric-coated tablets once daily.
Measure Participants	7904	7924
Count of Participants [Participants]	1269 16.1%	1159 14.6%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Darapladib
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.019
	Comments	Hazard ratio and p-value are estimated using a Cox proportional hazard regression model with treatment as the only covariate. A hazard ratio < 1 indicates a lower risk with this treatment compared to Placebo.
	Method	Regression, Cox
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.91
	Confidence Interval	(2-Sided) 95%; 0.84 to 0.98
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Secondary Outcome

Title	Number of Participants With CV Death During the Time Period for Follow-up of CV Events
Description	CV death is defined as a death due to a CV cause, which included but was not limited to deaths resulting from stroke, arrhythmia, sudden death (witnessed/unwitnessed), MI, heart failure, pulmonary embolism, peripheral arterial disease, or complications of a CV procedure. Deaths not clearly attributable to non-CV causes are considered to be CV deaths.
Time Frame	From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 4.25 years/average of 3.51 years)

Outcome Measure Data

Analysis Population Description

All Randomized (ITT) Population

Arm/Group Title	Placebo	Darapladib
Arm/Group Description	Participants were randomized to receive matching placebo once daily.	Participants were randomized to receive darapladib 160 milligram (mg) enteric-coated tablets once daily.
Measure Participants	7904	7924
Count of Participants [Participants]	373 4.7%	359 4.5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Darapladib
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.594
	Comments	Hazard ratio and p-value are estimated using a Cox proportional hazard regression model with treatment as the only covariate. A hazard ratio < 1 indicates a lower risk with this treatment compared to Placebo.
	Method	Regression, Cox
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.96
	Confidence Interval	(2-Sided) 95%; 0.83 to 1.11
	Parameter Dispersion	Type: Value:
	Estimation Comments

5. Secondary Outcome

Title	Number of Participants With First Occurrence of MI (Fatal/Non-fatal) During the Time Period for Follow-up of CV Events
Description	Acute MI is defined as evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia. Prior MI diagnosed post-randomization (e.g., silent MI)=the development of new pathological Q waves with/without symptoms OR imaging evidence of a region of loss of viable myocardium that is thinned and fails to contract, in the absence of a non-ischemic cause (pre-event imaging data required for verification of new abnormality), OR pathological findings of a healed/healing MI.
Time Frame	From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 4.25 years/average of 3.51 years)

Outcome Measure Data

Analysis Population Description

All Randomized (ITT) Population

Arm/Group Title	Placebo	Darapladib
Arm/Group Description	Participants were randomized to receive matching placebo once daily.	Participants were randomized to receive darapladib 160 milligram (mg) enteric-coated tablets once daily.
Measure Participants	7904	7924
Count of Participants [Participants]	405 5.1%	361 4.6%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Darapladib
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.108
	Comments	Hazard ratio and p-value are estimated using a Cox proportional hazard regression model with treatment as the only covariate. A hazard ratio < 1 indicates a lower risk with this treatment compared to Placebo.
	Method	Regression, Cox
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.89
	Confidence Interval	(2-Sided) 95%; 0.77 to 1.03
	Parameter Dispersion	Type: Value:
	Estimation Comments

6. Secondary Outcome

Title	Number of Participants With First Occurrence of Stroke (Fatal/Non-fatal) During the Time Period for Follow-up of CV Events
Description	Stroke is defined as the presence of a new focal neurologic deficit thought to be of vascular origin, with signs/symptoms lasting >24 hours or results in death (in <24 hours).
Time Frame	From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 4.25 years/average of 3.51 years)

Outcome Measure Data

Analysis Population Description

All Randomized (ITT) Population

Arm/Group Title	Placebo	Darapladib
Arm/Group Description	Participants were randomized to receive matching placebo once daily.	Participants were randomized to receive darapladib 160 milligram (mg) enteric-coated tablets once daily.
Measure Participants	7904	7924
Count of Participants [Participants]	152 1.9%	154 1.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Darapladib
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.920
	Comments	Hazard ratio and p-value are estimated using a Cox proportional hazard regression model with treatment as the only covariate. A hazard ratio < 1 indicates a lower risk with this treatment compared to Placebo.
	Method	Regression, Cox
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.01
	Confidence Interval	(2-Sided) 95%; 0.81 to 1.27
	Parameter Dispersion	Type: Value:
	Estimation Comments

7. Secondary Outcome

Title	Number of Participants With First Occurrence of Any Component of the Composite of All-cause Mortality, Non-fatal MI, or Non-fatal Stroke During the Time Period for Follow-up of CV Events
Description	Acute MI is defined as evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia. Prior MI diagnosed post-randomization (e.g., silent MI)=the development of new pathological Q waves with/without symptoms OR imaging evidence of a region of loss of viable myocardium that is thinned and fails to contract, in the absence of a non-ischemic cause (pre-event imaging data required for verification of new abnormality), OR pathological findings of a healed/healing MI. Stroke=presence of a new focal neurologic deficit thought to be of vascular origin, with signs/symptoms lasting >24 hours or results in death (in <24 hours).
Time Frame	From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 4.25 years/average of 3.51 years)

Outcome Measure Data

Analysis Population Description

All Randomized (ITT) Population

Arm/Group Title	Placebo	Darapladib
Arm/Group Description	Participants were randomized to receive matching placebo once daily.	Participants were randomized to receive darapladib 160 milligram (mg) enteric-coated tablets once daily.
Measure Participants	7904	7924
Count of Participants [Participants]	962 12.2%	926 11.7%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Darapladib
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.397
	Comments	Hazard ratio and p-value are estimated using a Cox proportional hazard regression model with treatment as the only covariate. A hazard ratio < 1 indicates a lower risk with this treatment compared to Placebo.
	Method	Regression, Cox
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.96
	Confidence Interval	(2-Sided) 95%; 0.88 to 1.05
	Parameter Dispersion	Type: Value:
	Estimation Comments

8. Secondary Outcome

Title	Number of Participants With All-cause Mortality During the Time Period for Vital Status
Description	The number of participants with all-cause mortality was assessed.
Time Frame	From randomization until death or study completion (up to 4.49 years/average of 3.65 years)

Outcome Measure Data

Analysis Population Description

All Randomized (ITT) Population

Arm/Group Title	Placebo	Darapladib
Arm/Group Description	Participants were randomized to receive matching placebo once daily.	Participants were randomized to receive darapladib 160 milligram (mg) enteric-coated tablets once daily.
Measure Participants	7904	7924
Count of Participants [Participants]	577 7.3%	582 7.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Darapladib
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.870
	Comments	Hazard ratio and p-value are estimated using a Cox proportional hazard regression model with treatment as the only covariate. A hazard ratio < 1 indicates a lower risk with this treatment compared to Placebo.
	Method	Regression, Cox
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.01
	Confidence Interval	(2-Sided) 95%; 0.90 to 1.13
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Time Frame	Start=Randomization; Stop=Longer of 35 days after last dose of IP or follow-up (FU) visit. "SAEs assessed as related to IP, study participation, or a GSK concomitant medication" and cancer/GI polyps/neoplasms were recorded up to/including any FU contact.
Adverse Event Reporting Description	SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product. Post-randomization AEs have an onset date that is on or after the randomization date.
Arm/Group Title	Placebo		Darapladib
Arm/Group Description	Participants were randomized to receive matching placebo once daily.		Participants were randomized to receive darapladib 160 milligram (mg) enteric-coated tablets once daily.
All Cause Mortality
	Placebo		Darapladib
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	577/7904 (7.3%)		582/7924 (7.3%)
Serious Adverse Events
	Placebo		Darapladib
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3448/7890 (43.7%)		3369/7912 (42.6%)
Blood and lymphatic system disorders
Anaemia	52/7890 (0.7%)		42/7912 (0.5%)
Iron deficiency anaemia	8/7890 (0.1%)		6/7912 (0.1%)
Thrombocytopenia	7/7890 (0.1%)		5/7912 (0.1%)
Disseminated intravascular coagulation	3/7890 (0%)		3/7912 (0%)
Haemorrhagic anaemia	1/7890 (0%)		5/7912 (0.1%)
Coagulopathy	3/7890 (0%)		0/7912 (0%)
Febrile neutropenia	2/7890 (0%)		1/7912 (0%)
Hypochromic anaemia	3/7890 (0%)		0/7912 (0%)
Lymphadenopathy	1/7890 (0%)		1/7912 (0%)
Microcytic anaemia	2/7890 (0%)		0/7912 (0%)
Anaemia macrocytic	0/7890 (0%)		1/7912 (0%)
Anaemia megaloblastic	0/7890 (0%)		1/7912 (0%)
Anaemia of chronic disease	1/7890 (0%)		0/7912 (0%)
Bone marrow failure	0/7890 (0%)		1/7912 (0%)
Bone marrow ischaemia	1/7890 (0%)		0/7912 (0%)
Haemolytic anaemia	0/7890 (0%)		1/7912 (0%)
Hyperprothrombinaemia	1/7890 (0%)		0/7912 (0%)
Idiopathic thrombocytopenic purpura	0/7890 (0%)		1/7912 (0%)
Jaundice acholuric	1/7890 (0%)		0/7912 (0%)
Pancytopenia	0/7890 (0%)		1/7912 (0%)
Polycythaemia	1/7890 (0%)		0/7912 (0%)
Spontaneous haematoma	1/7890 (0%)		0/7912 (0%)
Cardiac disorders
Angina unstable	489/7890 (6.2%)		472/7912 (6%)
Acute myocardial infarction	359/7890 (4.6%)		303/7912 (3.8%)
Angina pectoris	271/7890 (3.4%)		248/7912 (3.1%)
Coronary artery disease	177/7890 (2.2%)		168/7912 (2.1%)
Cardiac failure	178/7890 (2.3%)		155/7912 (2%)
Cardiac failure congestive	135/7890 (1.7%)		125/7912 (1.6%)
Atrial fibrillation	135/7890 (1.7%)		123/7912 (1.6%)
Coronary artery stenosis	59/7890 (0.7%)		56/7912 (0.7%)
Myocardial infarction	54/7890 (0.7%)		56/7912 (0.7%)
Myocardial ischaemia	41/7890 (0.5%)		47/7912 (0.6%)
Ventricular tachycardia	42/7890 (0.5%)		37/7912 (0.5%)
Atrial flutter	27/7890 (0.3%)		27/7912 (0.3%)
Cardiac arrest	26/7890 (0.3%)		28/7912 (0.4%)
Bradycardia	19/7890 (0.2%)		24/7912 (0.3%)
Ventricular fibrillation	19/7890 (0.2%)		22/7912 (0.3%)
Sick sinus syndrome	24/7890 (0.3%)		15/7912 (0.2%)
Cardiac failure chronic	19/7890 (0.2%)		17/7912 (0.2%)
Coronary artery occlusion	17/7890 (0.2%)		19/7912 (0.2%)
Acute coronary syndrome	17/7890 (0.2%)		17/7912 (0.2%)
Cardio-respiratory arrest	15/7890 (0.2%)		15/7912 (0.2%)
Cardiogenic shock	11/7890 (0.1%)		16/7912 (0.2%)
Cardiac failure acute	16/7890 (0.2%)		10/7912 (0.1%)
Ischaemic cardiomyopathy	14/7890 (0.2%)		11/7912 (0.1%)
Supraventricular tachycardia	8/7890 (0.1%)		14/7912 (0.2%)
Left ventricular dysfunction	8/7890 (0.1%)		13/7912 (0.2%)
Arteriosclerosis coronary artery	15/7890 (0.2%)		5/7912 (0.1%)
Mitral valve incompetence	9/7890 (0.1%)		10/7912 (0.1%)
Left ventricular failure	6/7890 (0.1%)		12/7912 (0.2%)
Aortic valve stenosis	10/7890 (0.1%)		7/7912 (0.1%)
Atrioventricular block complete	12/7890 (0.2%)		5/7912 (0.1%)
Ventricular extrasystoles	9/7890 (0.1%)		8/7912 (0.1%)
Arrhythmia	8/7890 (0.1%)		7/7912 (0.1%)
Atrioventricular block second degree	7/7890 (0.1%)		8/7912 (0.1%)
Atrioventricular block	9/7890 (0.1%)		5/7912 (0.1%)
Palpitations	9/7890 (0.1%)		5/7912 (0.1%)
Cardiac discomfort	6/7890 (0.1%)		5/7912 (0.1%)
Pericardial effusion	6/7890 (0.1%)		5/7912 (0.1%)
Cardiovascular disorder	6/7890 (0.1%)		4/7912 (0.1%)
Cardiopulmonary failure	2/7890 (0%)		6/7912 (0.1%)
Cardiomyopathy	4/7890 (0.1%)		3/7912 (0%)
Tachycardia	4/7890 (0.1%)		3/7912 (0%)
Atrial tachycardia	1/7890 (0%)		5/7912 (0.1%)
Arrhythmia supraventricular	4/7890 (0.1%)		1/7912 (0%)
Cardiac disorder	3/7890 (0%)		2/7912 (0%)
Cardiovascular insufficiency	4/7890 (0.1%)		1/7912 (0%)
Congestive cardiomyopathy	4/7890 (0.1%)		1/7912 (0%)
Sinus bradycardia	1/7890 (0%)		4/7912 (0.1%)
Ventricular arrhythmia	1/7890 (0%)		4/7912 (0.1%)
Bundle branch block left	2/7890 (0%)		2/7912 (0%)
Cardiac asthma	1/7890 (0%)		3/7912 (0%)
Right ventricular failure	3/7890 (0%)		1/7912 (0%)
Acute left ventricular failure	3/7890 (0%)		0/7912 (0%)
Aortic valve incompetence	1/7890 (0%)		2/7912 (0%)
Arteriospasm coronary	2/7890 (0%)		1/7912 (0%)
Cardiac aneurysm	1/7890 (0%)		2/7912 (0%)
Cardiac tamponade	2/7890 (0%)		1/7912 (0%)
Coronary artery insufficiency	1/7890 (0%)		2/7912 (0%)
Myocardial fibrosis	2/7890 (0%)		1/7912 (0%)
Bradyarrhythmia	2/7890 (0%)		0/7912 (0%)
Diastolic dysfunction	1/7890 (0%)		1/7912 (0%)
Nodal arrhythmia	1/7890 (0%)		1/7912 (0%)
Pericarditis	1/7890 (0%)		1/7912 (0%)
Postinfarction angina	2/7890 (0%)		0/7912 (0%)
Prinzmetal angina	1/7890 (0%)		1/7912 (0%)
Pulseless electrical activity	2/7890 (0%)		0/7912 (0%)
Silent myocardial infarction	0/7890 (0%)		2/7912 (0%)
Sinus arrest	1/7890 (0%)		1/7912 (0%)
Sinus arrhythmia	0/7890 (0%)		2/7912 (0%)
Stress cardiomyopathy	1/7890 (0%)		1/7912 (0%)
Supraventricular extrasystoles	2/7890 (0%)		0/7912 (0%)
Tricuspid valve disease	0/7890 (0%)		2/7912 (0%)
Aortic valve disease	1/7890 (0%)		0/7912 (0%)
Aortic valve disease mixed	1/7890 (0%)		0/7912 (0%)
Atrial thrombosis	1/7890 (0%)		0/7912 (0%)
Atrioventricular block first degree	0/7890 (0%)		1/7912 (0%)
Atrioventricular dissociation	0/7890 (0%)		1/7912 (0%)
Bifascicular block	1/7890 (0%)		0/7912 (0%)
Bundle branch block right	1/7890 (0%)		0/7912 (0%)
Cardiac valve disease	1/7890 (0%)		0/7912 (0%)
Cardiovascular deconditioning	1/7890 (0%)		0/7912 (0%)
Chronic left ventricular failure	1/7890 (0%)		0/7912 (0%)
Chronotropic incompetence	1/7890 (0%)		0/7912 (0%)
Conduction disorder	1/7890 (0%)		0/7912 (0%)
Cor pulmonale chronic	1/7890 (0%)		0/7912 (0%)
Extrasystoles	1/7890 (0%)		0/7912 (0%)
Hypertensive cardiomyopathy	1/7890 (0%)		0/7912 (0%)
Hypertensive heart disease	1/7890 (0%)		0/7912 (0%)
Intracardiac thrombus	0/7890 (0%)		1/7912 (0%)
Left ventricular hypertrophy	0/7890 (0%)		1/7912 (0%)
Mitral valve disease	1/7890 (0%)		0/7912 (0%)
Mitral valve stenosis	1/7890 (0%)		0/7912 (0%)
Myocarditis	1/7890 (0%)		0/7912 (0%)
Pericardial haemorrhage	0/7890 (0%)		1/7912 (0%)
Pericarditis constrictive	0/7890 (0%)		1/7912 (0%)
Sinoatrial block	1/7890 (0%)		0/7912 (0%)
Sinus tachycardia	0/7890 (0%)		1/7912 (0%)
Supraventricular tachyarrhythmia	1/7890 (0%)		0/7912 (0%)
Systolic dysfunction	1/7890 (0%)		0/7912 (0%)
Torsade de pointes	1/7890 (0%)		0/7912 (0%)
Trifascicular block	0/7890 (0%)		1/7912 (0%)
Ventricular dyssynchrony	1/7890 (0%)		0/7912 (0%)
Ventricular tachyarrhythmia	1/7890 (0%)		0/7912 (0%)
Congenital, familial and genetic disorders
Hydrocele	5/7890 (0.1%)		6/7912 (0.1%)
Atrial septal defect	0/7890 (0%)		2/7912 (0%)
Hypertrophic cardiomyopathy	0/7890 (0%)		2/7912 (0%)
Arteriovenous malformation	0/7890 (0%)		1/7912 (0%)
Congenital coronary artery malformation	0/7890 (0%)		1/7912 (0%)
Spinal vessel congenital anomaly	0/7890 (0%)		1/7912 (0%)
Syringomyelia	1/7890 (0%)		0/7912 (0%)
Ear and labyrinth disorders
Vertigo	6/7890 (0.1%)		14/7912 (0.2%)
Vestibular disorder	4/7890 (0.1%)		2/7912 (0%)
Vertigo positional	3/7890 (0%)		1/7912 (0%)
Vertigo labyrinthine	1/7890 (0%)		2/7912 (0%)
Deafness	0/7890 (0%)		2/7912 (0%)
Sudden hearing loss	1/7890 (0%)		1/7912 (0%)
Otosclerosis	1/7890 (0%)		0/7912 (0%)
Ototoxicity	0/7890 (0%)		1/7912 (0%)
Tinnitus	0/7890 (0%)		1/7912 (0%)
Endocrine disorders
Hyperthyroidism	4/7890 (0.1%)		4/7912 (0.1%)
Goitre	2/7890 (0%)		3/7912 (0%)
Adrenal disorder	0/7890 (0%)		1/7912 (0%)
Adrenal insufficiency	0/7890 (0%)		1/7912 (0%)
Hyperparathyroidism	0/7890 (0%)		1/7912 (0%)
Hyperparathyroidism primary	0/7890 (0%)		1/7912 (0%)
Hypothyroidism	1/7890 (0%)		0/7912 (0%)
Thyroid cyst	1/7890 (0%)		0/7912 (0%)
Thyroid disorder	0/7890 (0%)		1/7912 (0%)
Toxic nodular goitre	1/7890 (0%)		0/7912 (0%)
Eye disorders
Cataract	16/7890 (0.2%)		16/7912 (0.2%)
Retinal detachment	3/7890 (0%)		3/7912 (0%)
Amaurosis fugax	3/7890 (0%)		1/7912 (0%)
Vitreous haemorrhage	2/7890 (0%)		2/7912 (0%)
Diabetic retinopathy	0/7890 (0%)		3/7912 (0%)
Diplopia	1/7890 (0%)		2/7912 (0%)
Glaucoma	1/7890 (0%)		2/7912 (0%)
Blindness	1/7890 (0%)		1/7912 (0%)
Ocular vascular disorder	1/7890 (0%)		1/7912 (0%)
Retinal artery occlusion	0/7890 (0%)		2/7912 (0%)
Retinal ischaemia	0/7890 (0%)		2/7912 (0%)
Retinal tear	2/7890 (0%)		0/7912 (0%)
Retinal vein occlusion	1/7890 (0%)		1/7912 (0%)
Vision blurred	1/7890 (0%)		1/7912 (0%)
Blindness unilateral	0/7890 (0%)		1/7912 (0%)
Conjunctivitis	0/7890 (0%)		1/7912 (0%)
Dacryostenosis acquired	0/7890 (0%)		1/7912 (0%)
Diabetic eye disease	1/7890 (0%)		0/7912 (0%)
Eye disorder	1/7890 (0%)		0/7912 (0%)
Eye haemorrhage	1/7890 (0%)		0/7912 (0%)
Eye pain	1/7890 (0%)		0/7912 (0%)
Eyelid ptosis	0/7890 (0%)		1/7912 (0%)
Ocular retrobulbar haemorrhag	1/7890 (0%)		0/7912 (0%)
Ophthalmoplegia	1/7890 (0%)		0/7912 (0%)
Optic ischaemic neuropathy	1/7890 (0%)		0/7912 (0%)
Pterygium	1/7890 (0%)		0/7912 (0%)
Retinal artery thrombosis	1/7890 (0%)		0/7912 (0%)
Retinal degeneration	0/7890 (0%)		1/7912 (0%)
Retinal haemorrhage	0/7890 (0%)		1/7912 (0%)
Retinal vascular thrombosis	1/7890 (0%)		0/7912 (0%)
Retinopathy	1/7890 (0%)		0/7912 (0%)
Ulcerative keratitis	0/7890 (0%)		1/7912 (0%)
Visual acuity reduced	1/7890 (0%)		0/7912 (0%)
Gastrointestinal disorders
Inguinal hernia	48/7890 (0.6%)		31/7912 (0.4%)
Gastrointestinal haemorrhage	26/7890 (0.3%)		30/7912 (0.4%)
Diarrhoea	21/7890 (0.3%)		23/7912 (0.3%)
Abdominal pain	25/7890 (0.3%)		12/7912 (0.2%)
Large intestine polyp	16/7890 (0.2%)		21/7912 (0.3%)
Upper gastrointestinal haemorrhage	16/7890 (0.2%)		18/7912 (0.2%)
Gastrooesophageal reflux disease	18/7890 (0.2%)		14/7912 (0.2%)
Gastritis	18/7890 (0.2%)		12/7912 (0.2%)
Pancreatitis	15/7890 (0.2%)		15/7912 (0.2%)
Gastric ulcer	7/7890 (0.1%)		17/7912 (0.2%)
Nausea	12/7890 (0.2%)		11/7912 (0.1%)
Rectal haemorrhage	9/7890 (0.1%)		13/7912 (0.2%)
Small intestinal obstruction	9/7890 (0.1%)		11/7912 (0.1%)
Colitis	12/7890 (0.2%)		7/7912 (0.1%)
Pancreatitis acute	12/7890 (0.2%)		7/7912 (0.1%)
Vomiting	12/7890 (0.2%)		7/7912 (0.1%)
Abdominal pain upper	7/7890 (0.1%)		11/7912 (0.1%)
Constipation	5/7890 (0.1%)		11/7912 (0.1%)
Intestinal obstruction	7/7890 (0.1%)		9/7912 (0.1%)
Lower gastrointestinal haemorrhage	10/7890 (0.1%)		4/7912 (0.1%)
Ileus	7/7890 (0.1%)		6/7912 (0.1%)
Umbilical hernia	7/7890 (0.1%)		6/7912 (0.1%)
Diverticulum intestinal	5/7890 (0.1%)		7/7912 (0.1%)
Duodenal ulcer haemorrhage	7/7890 (0.1%)		5/7912 (0.1%)
Abdominal hernia	5/7890 (0.1%)		6/7912 (0.1%)
Colitis ischaemic	5/7890 (0.1%)		6/7912 (0.1%)
Duodenal ulcer	6/7890 (0.1%)		5/7912 (0.1%)
Gastric ulcer haemorrhage	6/7890 (0.1%)		5/7912 (0.1%)
Haemorrhoids	8/7890 (0.1%)		2/7912 (0%)
Gastric haemorrhage	3/7890 (0%)		6/7912 (0.1%)
Gastritis erosive	7/7890 (0.1%)		2/7912 (0%)
Intestinal ischaemia	5/7890 (0.1%)		4/7912 (0.1%)
Ascites	5/7890 (0.1%)		3/7912 (0%)
Dyspepsia	4/7890 (0.1%)		4/7912 (0.1%)
Dysphagia	4/7890 (0.1%)		4/7912 (0.1%)
Melaena	3/7890 (0%)		5/7912 (0.1%)
Diverticulum	3/7890 (0%)		3/7912 (0%)
Oesophagitis	1/7890 (0%)		5/7912 (0.1%)
Pancreatitis chronic	4/7890 (0.1%)		2/7912 (0%)
Diverticulum intestinal haemorrhagic	4/7890 (0.1%)		1/7912 (0%)
Duodenitis	1/7890 (0%)		4/7912 (0.1%)
Gastritis haemorrhagic	3/7890 (0%)		2/7912 (0%)
Anal fistula	3/7890 (0%)		1/7912 (0%)
Enterovesical fistula	2/7890 (0%)		2/7912 (0%)
Haematemesis	2/7890 (0%)		2/7912 (0%)
Mallory-Weiss syndrome	4/7890 (0.1%)		0/7912 (0%)
Oesophageal ulcer	1/7890 (0%)		3/7912 (0%)
Peptic ulcer	1/7890 (0%)		3/7912 (0%)
Colitis ulcerative	1/7890 (0%)		2/7912 (0%)
Diverticulitis intestinal haemorrhagic	1/7890 (0%)		2/7912 (0%)
Gastric polyps	2/7890 (0%)		1/7912 (0%)
Haematochezia	1/7890 (0%)		2/7912 (0%)
Hiatus hernia	1/7890 (0%)		2/7912 (0%)
Inguinal hernia, obstructive	2/7890 (0%)		1/7912 (0%)
Intestinal haemorrhage	1/7890 (0%)		2/7912 (0%)
Intestinal perforation	1/7890 (0%)		2/7912 (0%)
Large intestine perforation	2/7890 (0%)		1/7912 (0%)
Peptic ulcer haemorrhage	2/7890 (0%)		1/7912 (0%)
Umbilical hernia, obstructive	2/7890 (0%)		1/7912 (0%)
Abdominal distension	0/7890 (0%)		2/7912 (0%)
Abdominal strangulated hernia	2/7890 (0%)		0/7912 (0%)
Abdominal wall haematoma	0/7890 (0%)		2/7912 (0%)
Crohn's disease	1/7890 (0%)		1/7912 (0%)
Diaphragmatic hernia	0/7890 (0%)		2/7912 (0%)
Diverticular perforation	0/7890 (0%)		2/7912 (0%)
Duodenal ulcer perforation	2/7890 (0%)		0/7912 (0%)
Enteritis	1/7890 (0%)		1/7912 (0%)
Enterocolitis	1/7890 (0%)		1/7912 (0%)
Erosive duodenitis	1/7890 (0%)		1/7912 (0%)
Faecal incontinence	1/7890 (0%)		1/7912 (0%)
Gastritis atrophic	1/7890 (0%)		1/7912 (0%)
Gastrointestinal necrosis	1/7890 (0%)		1/7912 (0%)
Gastrointestinal angidysplasia	2/7890 (0%)		0/7912 (0%)
Haemorrhoidal haemorrhage	0/7890 (0%)		2/7912 (0%)
Ileus paralytic	0/7890 (0%)		2/7912 (0%)
Large intestinal ulcer	0/7890 (0%)		2/7912 (0%)
Oesophageal varices haemorrhage	1/7890 (0%)		1/7912 (0%)
Proctitis	1/7890 (0%)		1/7912 (0%)
Rectal polyp	1/7890 (0%)		1/7912 (0%)
Rectal prolapse	2/7890 (0%)		0/7912 (0%)
Stomach mass	1/7890 (0%)		1/7912 (0%)
Volvulus	0/7890 (0%)		2/7912 (0%)
Abdominal adhesions	1/7890 (0%)		0/7912 (0%)
Abdominal hernia obstructive	1/7890 (0%)		0/7912 (0%)
Abdominal wall mass	1/7890 (0%)		0/7912 (0%)
Acute abdomen	1/7890 (0%)		0/7912 (0%)
Alcoholic pancreatitis	0/7890 (0%)		1/7912 (0%)
Anal fissure	0/7890 (0%)		1/7912 (0%)
Anorectal disorder	0/7890 (0%)		1/7912 (0%)
Appendix disorder	0/7890 (0%)		1/7912 (0%)
Buccal polyp	0/7890 (0%)		1/7912 (0%)
Colonic stenosis	1/7890 (0%)		0/7912 (0%)
Dental caries	1/7890 (0%)		0/7912 (0%)
Diabetic gastroparesis	0/7890 (0%)		1/7912 (0%)
Diarrhoea haemorrhagic	1/7890 (0%)		0/7912 (0%)
Dieulafoy's vascular malformation	0/7890 (0%)		1/7912 (0%)
Duodenal polyp	1/7890 (0%)		0/7912 (0%)
Duodenal vascular ectasia	1/7890 (0%)		0/7912 (0%)
Epigastric discomfort	0/7890 (0%)		1/7912 (0%)
Erosive oesophagitis	0/7890 (0%)		1/7912 (0%)
Faeces discoloured	0/7890 (0%)		1/7912 (0%)
Femoral hernia, obstructive	1/7890 (0%)		0/7912 (0%)
Frequent bowel movements	1/7890 (0%)		0/7912 (0%)
Gallstone ileus	0/7890 (0%)		1/7912 (0%)
Gastric dysplasia	0/7890 (0%)		1/7912 (0%)
Gastroduodenal ulcer	1/7890 (0%)		0/7912 (0%)
Gastroduodenitis	1/7890 (0%)		0/7912 (0%)
Gastrointestinal erosion	1/7890 (0%)		0/7912 (0%)
Gastrointestinal ischaemia	1/7890 (0%)		0/7912 (0%)
Gastrointestinal motility disorder	1/7890 (0%)		0/7912 (0%)
Gastrointestinal pain	1/7890 (0%)		0/7912 (0%)
Gastrointestinal ulcer haemorrhage	1/7890 (0%)		0/7912 (0%)
Gastrointestinal angiodysplasia haemorrhagic	1/7890 (0%)		0/7912 (0%)
Gastrooesophagitis	1/7890 (0%)		0/7912 (0%)
Haemorrhagic erosive gastritis	1/7890 (0%)		0/7912 (0%)
Hypoaesthesia oral	1/7890 (0%)		0/7912 (0%)
Ileal ulcer	1/7890 (0%)		0/7912 (0%)
Ileitis	1/7890 (0%)		1/7912 (0%)
Internal hernia	1/7890 (0%)		0/7912 (0%)
Intestinal infarction	0/7890 (0%)		1/7912 (0%)
Intestinal polyp	1/7890 (0%)		0/7912 (0%)
Large intestinal ulcer	0/7890 (0%)		1/7912 (0%)
Lip haematoma	1/7890 (0%)		0/7912 (0%)
Lumbar hernia	0/7890 (0%)		1/7912 (0%)
Mesenteric artery stenosis	0/7890 (0%)		1/7912 (0%)
Mesenteric occlusion	0/7890 (0%)		1/7912 (0%)
Mesenteric panniculitis	0/7890 (0%)		1/7912 (0%)
Mouth cyst	0/7890 (0%)		1/7912 (0%)
Oedema mouth	0/7890 (0%)		1/7912 (0%)
Oedematous pancreatitis	0/7890 (0%)		1/7912 (0%)
Oesophageal dysplasia	0/7890 (0%)		1/7912 (0%)
Oesophageal perforation	1/7890 (0%)		0/7912 (0%)
Oesophageal ulcer haemorrhage	1/7890 (0%)		0/7912 (0%)
Oesophageal varices haemorrhage	1/7890 (0%)		0/7912 (0%)
Oral pain	1/7890 (0%)		0/7912 (0%)
Pancreatic calcification	0/7890 (0%)		1/7912 (0%)
Pancreatic disorder	1/7890 (0%)		0/7912 (0%)
Pancreatitis haemorrhagic	0/7890 (0%)		1/7912 (0%)
Pancreatitis necrotising	0/7890 (0%)		1/7912 (0%)
Papilla of	1/7890 (0%)		0/7912 (0%)
Paraesthesia oral	1/7890 (0%)		0/7912 (0%)
Peptic ulcer perforation	0/7890 (0%)		1/7912 (0%)
Pneumatosis intestinalis	1/7890 (0%)		0/7912 (0%)
Poor dental condition	0/7890 (0%)		1/7912 (0%)
Proctalgia	1/7890 (0%)		0/7912 (0%)
Proctitis ulcerative	1/7890 (0%)		0/7912 (0%)
Reflux gastritis	0/7890 (0%)		1/7912 (0%)
Retroperitoneal haematoma	0/7890 (0%)		1/7912 (0%)
Retroperitoneal haemorrhage	0/7890 (0%)		1/7912 (0%)
Small intestinal perforation	1/7890 (0%)		0/7912 (0%)
Spigelian hernia	1/7890 (0%)		0/7912 (0%)
Subileus	0/7890 (0%)		1/7912 (0%)
Tooth disorder	0/7890 (0%)		1/7912 (0%)
Toothache	1/7890 (0%)		0/7912 (0%)
General disorders
Non-cardiac chest pain	196/7890 (2.5%)		191/7912 (2.4%)
Death	73/7890 (0.9%)		56/7912 (0.7%)
Sudden death	56/7890 (0.7%)		57/7912 (0.7%)
Sudden cardiac death	22/7890 (0.3%)		24/7912 (0.3%)
Chest pain	18/7890 (0.2%)		11/7912 (0.1%)
Asthenia	15/7890 (0.2%)		11/7912 (0.1%)
Pyrexia	12/7890 (0.2%)		12/7912 (0.2%)
Device occlusion	11/7890 (0.1%)		12/7912 (0.2%)
Fatigue	9/7890 (0.1%)		8/7912 (0.1%)
Chest discomfort	7/7890 (0.1%)		9/7912 (0.1%)
Oedema peripheral	6/7890 (0.1%)		8/7912 (0.1%)
Multi-organ failure	6/7890 (0.1%)		6/7912 (0.1%)
Device malfunction	5/7890 (0.1%)		4/7912 (0.1%)
Hernia	5/7890 (0.1%)		3/7912 (0%)
Malaise	2/7890 (0%)		3/7912 (0%)
Medical device complication	4/7890 (0.1%)		1/7912 (0%)
Device dislocation	1/7890 (0%)		3/7912 (0%)
Adverse drug reaction	2/7890 (0%)		1/7912 (0%)
Gait disturbance	0/7890 (0%)		3/7912 (0%)
Thrombosis in device	1/7890 (0%)		2/7912 (0%)
General physical health deterioration	2/7890 (0%)		0/7912 (0%)
Ill-defined disorder	1/7890 (0%)		1/7912 (0%)
Medical device pain	2/7890 (0%)		0/7912 (0%)
Pain	1/7890 (0%)		1/7912 (0%)
Spinal pain	1/7890 (0%)		1/7912 (0%)
Ulcer haemorrhage	2/7890 (0%)		0/7912 (0%)
Axillary pain	1/7890 (0%)		0/7912 (0%)
Cardiac complication associated with device	0/7890 (0%)		1/7912 (0%)
Chills	1/7890 (0%)		0/7912 (0%)
Device battery issue	1/7890 (0%)		0/7912 (0%)
Device lead damage	0/7890 (0%)		1/7912 (0%)
Device lead issue	1/7890 (0%)		0/7912 (0%)
Device power source issue	1/7890 (0%)		0/7912 (0%)
Drowning	1/7890 (0%)		0/7912 (0%)
Drug intolerance	1/7890 (0%)		0/7912 (0%)
Exercise tolerance decreased	0/7890 (0%)		1/7912 (0%)
Face oedema	1/7890 (0%)		0/7912 (0%)
Fat necrosis	1/7890 (0%)		0/7912 (0%)
Generalised oedema	0/7890 (0%)		1/7912 (0%)
Hypothermia	1/7890 (0%)		0/7912 (0%)
Impaired healing	0/7890 (0%)		1/7912 (0%)
Implant site thrombosis	0/7890 (0%)		1/7912 (0%)
Inflammation	0/7890 (0%)		1/7912 (0%)
Influenza like illness	1/7890 (0%)		0/7912 (0%)
Ischaemic ulcer	1/7890 (0%)		0/7912 (0%)
Lipogranuloma	1/7890 (0%)		0/7912 (0%)
Medical device site reaction	1/7890 (0%)		0/7912 (0%)
Multi-organ disorder	1/7890 (0%)		0/7912 (0%)
Nodule	0/7890 (0%)		1/7912 (0%)
Polyp	0/7890 (0%)		1/7912 (0%)
Puncture site haemorrhage	0/7890 (0%)		1/7912 (0%)
Stent embolisation	1/7890 (0%)		0/7912 (0%)
Systemic inflammatory response syndrome	1/7890 (0%)		0/7912 (0%)
Vestibulitis	0/7890 (0%)		1/7912 (0%)
Hepatobiliary disorders
Cholelithiasis	28/7890 (0.4%)		30/7912 (0.4%)
Cholecystitis acute	24/7890 (0.3%)		19/7912 (0.2%)
Cholecystitis chronic	7/7890 (0.1%)		5/7912 (0.1%)
Bile duct stone	3/7890 (0%)		6/7912 (0.1%)
Hepatic function abnormal	2/7890 (0%)		5/7912 (0.1%)
Cholangitis	3/7890 (0%)		3/7912 (0%)
Jaundice cholestatic	3/7890 (0%)		3/7912 (0%)
Biliary colic	1/7890 (0%)		3/7912 (0%)
Hepatic steatosis	3/7890 (0%)		1/7912 (0%)
Hepatic cirrhosis	0/7890 (0%)		3/7912 (0%)
Hepatic failure	1/7890 (0%)		2/7912 (0%)
Acute hepatic failure	1/7890 (0%)		1/7912 (0%)
Cholangitis acute	2/7890 (0%)		0/7912 (0%)
Cholelithiasis obstructive	2/7890 (0%)		0/7912 (0%)
Cholestasish	1/7890 (0%)		1/7912 (0%)
Gallbladder disorder	1/7890 (0%)		1/7912 (0%)
Hepatitis	0/7890 (0%)		2/7912 (0%)
Hepatitis alcoholic	2/7890 (0%)		0/7912 (0%)
Hepatocellular injury	2/7890 (0%)		0/7912 (0%)
Hepatotoxicity	2/7890 (0%)		0/7912 (0%)
Ischaemic hepatitis	2/7890 (0%)		0/7912 (0%)
Jaundice	1/7890 (0%)		1/7912 (0%)
Portal hypertension	2/7890 (0%)		0/7912 (0%)
Alcoholic liver disease	1/7890 (0%)		0/7912 (0%)
Bile duct obstruction	1/7890 (0%)		0/7912 (0%)
Bile duct stenosis	1/7890 (0%)		0/7912 (0%)
Biliary fistula	1/7890 (0%)		0/7912 (0%)
Drug-induced liver injury	1/7890 (0%)		0/7912 (0%)
Gallbladder pain	1/7890 (0%)		0/7912 (0%)
Gallbladder perforation	1/7890 (0%)		0/7912 (0%)
Hepatic cyst	1/7890 (0%)		0/7912 (0%)
Hepatic haemorrhage	0/7890 (0%)		1/7912 (0%)
Hepatic mass	0/7890 (0%)		1/7912 (0%)
Hepatitis acute	1/7890 (0%)		0/7912 (0%)
Hepatitis toxic	0/7890 (0%)		1/7912 (0%)
Hepatorenal failure	0/7890 (0%)		1/7912 (0%)
Hydrocholecystis	0/7890 (0%)		1/7912 (0%)
Hyperbilirubinaemia	0/7890 (0%)		1/7912 (0%)
Liver injury	0/7890 (0%)		3/7912 (0%)
Pneumobilia	0/7890 (0%)		1/7912 (0%)
Immune system disorders
Anaphylactic reaction	1/7890 (0%)		4/7912 (0.1%)
Allergy to arthropod sting	3/7890 (0%)		1/7912 (0%)
Hypersensitivity	2/7890 (0%)		2/7912 (0%)
Allergy to arthropod bite	1/7890 (0%)		1/7912 (0%)
Allergic oedema	0/7890 (0%)		1/7912 (0%)
Food allergy	0/7890 (0%)		1/7912 (0%)
Infections and infestations
Pneumonia	160/7890 (2%)		139/7912 (1.8%)
Cellulitis	46/7890 (0.6%)		38/7912 (0.5%)
Urinary tract infection	36/7890 (0.5%)		43/7912 (0.5%)
Gastroenteritis	29/7890 (0.4%)		31/7912 (0.4%)
Sepsis	23/7890 (0.3%)		35/7912 (0.4%)
Bronchitis	18/7890 (0.2%)		24/7912 (0.3%)
Appendicitis	19/7890 (0.2%)		15/7912 (0.2%)
Septic shock	25/7890 (0.3%)		9/7912 (0.1%)
Urosepsis	15/7890 (0.2%)		14/7912 (0.2%)
Diverticulitis	11/7890 (0.1%)		15/7912 (0.2%)
Lobar pneumonia	17/7890 (0.2%)		9/7912 (0.1%)
Erysipelas	14/7890 (0.2%)		8/7912 (0.1%)
Bronchopneumonia	7/7890 (0.1%)		12/7912 (0.2%)
Localised infection	9/7890 (0.1%)		9/7912 (0.1%)
Lower respiratory tract infection	10/7890 (0.1%)		8/7912 (0.1%)
Pyelonephritis	6/7890 (0.1%)		12/7912 (0.2%)
Osteomyelitis	7/7890 (0.1%)		10/7912 (0.1%)
Respiratory tract infection	7/7890 (0.1%)		8/7912 (0.1%)
Device related infection	8/7890 (0.1%)		6/7912 (0.1%)
Influenza	7/7890 (0.1%)		7/7912 (0.1%)
Lung infection	8/7890 (0.1%)		5/7912 (0.1%)
Staphylococcal infection	6/7890 (0.1%)		6/7912 (0.1%)
Gastroenteritis viral	5/7890 (0.1%)		5/7912 (0.1%)
Herpes zoster	5/7890 (0.1%)		5/7912 (0.1%)
Peritonitis	7/7890 (0.1%)		3/7912 (0%)
Wound infection	6/7890 (0.1%)		3/7912 (0%)
Infection	4/7890 (0.1%)		4/7912 (0.1%)
Postoperative wound infection	3/7890 (0%)		5/7912 (0.1%)
Gangrene	4/7890 (0.1%)		3/7912 (0%)
Post procedural infection	1/7890 (0%)		6/7912 (0.1%)
Upper respiratory tract infection	3/7890 (0%)		4/7912 (0.1%)
Appendicitis perforated	3/7890 (0%)		3/7912 (0%)
Bacteraemia	1/7890 (0%)		5/7912 (0.1%)
Infective exacerbation of chronic obstructive airways disease	3/7890 (0%)		3/7912 (0%)
Viral infection	2/7890 (0%)		4/7912 (0.1%)
Abscess	5/7890 (0.1%)		0/7912 (0%)
Arthritis infective	2/7890 (0%)		3/7912 (0%)
Cholecystitis infective	1/7890 (0%)		4/7912 (0.1%)
Clostridium difficile infection	3/7890 (0%)		2/7912 (0%)
Pulmonary tuberculosis	3/7890 (0%)		2/7912 (0%)
Pyelonephritis acute	1/7890 (0%)		4/7912 (0.1%)
Anal abscess	1/7890 (0%)		3/7912 (0%)
Arthritis bacterial	1/7890 (0%)		3/7912 (0%)
Clostridium difficile colitis	2/7890 (0%)		2/7912 (0%)
Cystitis	2/7890 (0%)		2/7912 (0%)
Diabetic gangrene	2/7890 (0%)		2/7912 (0%)
Endocarditis	0/7890 (0%)		4/7912 (0.1%)
Enterocolitis infectious	1/7890 (0%)		3/7912 (0%)
Escherichia bacteraemia	3/7890 (0%)		1/7912 (0%)
Escherichia sepsis	0/7890 (0%)		4/7912 (0.1%)
Orchitis	2/7890 (0%)		2/7912 (0%)
Pneumonia bacterial	0/7890 (0%)		4/7912 (0.1%)
Postoperative abscess	0/7890 (0%)		4/7912 (0.1%)
Skin infection	2/7890 (0%)		2/7912 (0%)
Abdominal wall abscess	0/7890 (0%)		3/7912 (0%)
Abscess limb	2/7890 (0%)		1/7912 (0%)
Dengue fever	1/7890 (0%)		2/7912 (0%)
Diabetic foot infection	2/7890 (0%)		1/7912 (0%)
Enterococcal sepsis	2/7890 (0%)		1/7912 (0%)
H1N1 influenza	2/7890 (0%)		1/7912 (0%)
Haematoma infection	2/7890 (0%)		1/7912 (0%)
Intervertebral discitis	2/7890 (0%)		1/7912 (0%)
Pneumonia klebsiella	1/7890 (0%)		2/7912 (0%)
Salmonellosis	1/7890 (0%)		2/7912 (0%)
Sepsis syndrome	1/7890 (0%)		2/7912 (0%)
Soft tissue infection	0/7890 (0%)		3/7912 (0%)
Staphylococcal bacteraemia	1/7890 (0%)		2/7912 (0%)
Streptococcal bacteraemia	1/7890 (0%)		2/7912 (0%)
Acute hepatitis B	1/7890 (0%)		1/7912 (0%)
Arteriosclerotic gangrene	1/7890 (0%)		1/7912 (0%)
Bacterial pyelonephritis	2/7890 (0%)		0/7912 (0%)
Campylobacter gastroenteritis	1/7890 (0%)		1/7912 (0%)
Chronic sinusitis	2/7890 (0%)		0/7912 (0%)
Device related sepsis	1/7890 (0%)		1/7912 (0%)
Dysentery	1/7890 (0%)		1/7912 (0%)
Ear infection	1/7890 (0%)		1/7912 (0%)
Escherichia urinary tract infection	0/7890 (0%)		2/7912 (0%)
Extradural abscess	1/7890 (0%)		1/7912 (0%)
Gastritis viral	1/7890 (0%)		1/7912 (0%)
Gastroenteritis salmonella	1/7890 (0%)		1/7912 (0%)
Giardiasis	2/7890 (0%)		0/7912 (0%)
Hepatitis B	2/7890 (0%)		0/7912 (0%)
Implant site infection	2/7890 (0%)		0/7912 (0%)
Infected skin ulcer	1/7890 (0%)		1/7912 (0%)
Infectious pleural effusion	1/7890 (0%)		1/7912 (0%)
Klebsiella bacteraemia	1/7890 (0%)		1/7912 (0%)
Klebsiella sepsis	1/7890 (0%)		1/7912 (0%)
Liver abscess	1/7890 (0%)		1/7912 (0%)
Lyme disease	2/7890 (0%)		0/7912 (0%)
Nasopharyngitis	1/7890 (0%)		1/7912 (0%)
Osteomyelitis chronic	0/7890 (0%)		2/7912 (0%)
Peritonsillar abscess	2/7890 (0%)		0/7912 (0%)
Pharyngitis	0/7890 (0%)		2/7912 (0%)
Pneumonia streptococcal	2/7890 (0%)		0/7912 (0%)
Pseudomonal bacteraemia	0/7890 (0%)		2/7912 (0%)
Pyelonephritis chronic	2/7890 (0%)		0/7912 (0%)
Retroperitoneal abscess	2/7890 (0%)		0/7912 (0%)
Scrotal abscess	1/7890 (0%)		1/7912 (0%)
Streptococcal infection	2/7890 (0%)		0/7912 (0%)
Streptococcal sepsis	1/7890 (0%)		1/7912 (0%)
Subcutaneous abscess	1/7890 (0%)		1/7912 (0%)
Urinary tract infection bacterial	0/7890 (0%)		2/7912 (0%)
Abdominal abscess	0/7890 (0%)		1/7912 (0%)
Abdominal infection	0/7890 (0%)		1/7912 (0%)
Abdominal sepsis	0/7890 (0%)		1/7912 (0%)
Abdominal wall infection	1/7890 (0%)		0/7912 (0%)
Abscess jaw	1/7890 (0%)		0/7912 (0%)
Acute pulmonary histoplasmosis	0/7890 (0%)		1/7912 (0%)
Amoebiasis	1/7890 (0%)		0/7912 (0%)
Appendiceal abscess	1/7890 (0%)		0/7912 (0%)
Bacterial sepsis	0/7890 (0%)		1/7912 (0%)
Biliary sepsis	1/7890 (0%)		0/7912 (0%)
Bone abscess	1/7890 (0%)		0/7912 (0%)
Borrelia infection	1/7890 (0%)		0/7912 (0%)
Bronchitis bacterial	1/7890 (0%)		0/7912 (0%)
Bursitis infective	1/7890 (0%)		0/7912 (0%)
Carbuncle	1/7890 (0%)		0/7912 (0%)
Catheter site infection	1/7890 (0%)		0/7912 (0%)
Cellulitis gangrenous	1/7890 (0%)		0/7912 (0%)
Cellulitis staphylococcal	1/7890 (0%)		0/7912 (0%)
Cholangitis suppurative	0/7890 (0%)		1/7912 (0%)
Diarrhoea infectious	1/7890 (0%)		0/7912 (0%)
Disseminated tuberculosis	1/7890 (0%)		0/7912 (0%)
Echinococciasis	1/7890 (0%)		0/7912 (0%)
Empyema	1/7890 (0%)		0/7912 (0%)
Endocarditis bacterial	1/7890 (0%)		0/7912 (0%)
Endocarditis enterococcal	0/7890 (0%)		1/7912 (0%)
Endocarditis staphylococcal	1/7890 (0%)		0/7912 (0%)
Endometritis	0/7890 (0%)		1/7912 (0%)
Endophthalmitis	1/7890 (0%)		0/7912 (0%)
Enteritis infectious	1/7890 (0%)		0/7912 (0%)
Enterobacter infection	1/7890 (0%)		0/7912 (0%)
Enterococcal bacteraemia	1/7890 (0%)		0/7912 (0%)
Enterococcal infection	1/7890 (0%)		0/7912 (0%)
Epiglottitis	0/7890 (0%)		1/7912 (0%)
Escherichia infection	1/7890 (0%)		0/7912 (0%)
External ear cellulitis	1/7890 (0%)		0/7912 (0%)
Febrile infection	0/7890 (0%)		1/7912 (0%)
Fungal oesophagitis	0/7890 (0%)		1/7912 (0%)
Gallbladder empyema	1/7890 (0%)		0/7912 (0%)
Gastroenteritis rotavirus	0/7890 (0%)		1/7912 (0%)
Gastrointestinal viral infection	0/7890 (0%)		1/7912 (0%)
Genital infection fungal	1/7890 (0%)		0/7912 (0%)
Graft infection	1/7890 (0%)		0/7912 (0%)
Groin abscess	1/7890 (0%)		0/7912 (0%)
HIV infection	1/7890 (0%)		0/7912 (0%)
Helicobacter gastritis	0/7890 (0%)		1/7912 (0%)
Helicobacter infection	1/7890 (0%)		0/7912 (0%)
Hepatitis A	1/7890 (0%)		0/7912 (0%)
Hepatitis C	0/7890 (0%)		1/7912 (0%)
Hepatitis E	1/7890 (0%)		0/7912 (0%)
Hepatitis viral	1/7890 (0%)		0/7912 (0%)
Herpes zoster ophthalmic	1/7890 (0%)		0/7912 (0%)
Histoplasmosis	0/7890 (0%)		1/7912 (0%)
Infected bites	0/7890 (0%)		1/7912 (0%)
Infective myositis	0/7890 (0%)		1/7912 (0%)
Intertrigo candida	0/7890 (0%)		1/7912 (0%)
Keratitis herpetic	1/7890 (0%)		0/7912 (0%)
Kidney infection	1/7890 (0%)		0/7912 (0%)
Laryngitis	0/7890 (0%)		1/7912 (0%)
Leptospirosis	0/7890 (0%)		1/7912 (0%)
Lung abscess	1/7890 (0%)		0/7912 (0%)
Lymphangitis	1/7890 (0%)		0/7912 (0%)
Mastoiditis	0/7890 (0%)		1/7912 (0%)
Mediastinitis	1/7890 (0%)		0/7912 (0%)
Meningitis	0/7890 (0%)		1/7912 (0%)
Meningitis bacterial	1/7890 (0%)		0/7912 (0%)
Meningitis cryptococcal	1/7890 (0%)		0/7912 (0%)
Mycoplasma infection	1/7890 (0%)		0/7912 (0%)
Mycotoxicosis	1/7890 (0%)		0/7912 (0%)
Necrotising fasciitis	1/7890 (0%)		0/7912 (0%)
Oesophageal candidiasis	1/7890 (0%)		0/7912 (0%)
Oral candidiasis	0/7890 (0%)		1/7912 (0%)
Otitis media	0/7890 (0%)		1/7912 (0%)
Otitis media chronic	0/7890 (0%)		1/7912 (0%)
Paronychia	1/7890 (0%)		0/7912 (0%)
Parotitis	1/7890 (0%)		0/7912 (0%)
Perineal abscess	1/7890 (0%)		0/7912 (0%)
Periorbital cellulitis	1/7890 (0%)		0/7912 (0%)
Peritoneal abscess	1/7890 (0%)		0/7912 (0%)
Peritonsillitis	1/7890 (0%)		0/7912 (0%)
Plasmodium vivax infection	0/7890 (0%)		1/7912 (0%)
Pneumococcal sepsis	1/7890 (0%)		0/7912 (0%)
Pneumonia chlamydial	1/7890 (0%)		0/7912 (0%)
Pneumonia necrotising	0/7890 (0%)		1/7912 (0%)
Pneumonia viral	1/7890 (0%)		0/7912 (0%)
Prostatic abscess	1/7890 (0%)		0/7912 (0%)
Pseudomembranous colitis	1/7890 (0%)		0/7912 (0%)
Pseudomonas infection	0/7890 (0%)		1/7912 (0%)
Psoas abscess	0/7890 (0%)		1/7912 (0%)
Pulmonary sepsis	1/7890 (0%)		0/7912 (0%)
Pyopneumothorax	1/7890 (0%)		0/7912 (0%)
Respiratory tract infection viral	0/7890 (0%)		1/7912 (0%)
Retroperitoneal infection	1/7890 (0%)		0/7912 (0%)
Salmonella sepsis	1/7890 (0%)		0/7912 (0%)
Scrub typhus	1/7890 (0%)		0/7912 (0%)
Septic embolus	0/7890 (0%)		1/7912 (0%)
Sialoadenitis	1/7890 (0%)		0/7912 (0%)
Sinobronchitis	1/7890 (0%)		0/7912 (0%)
Sinusitis	0/7890 (0%)		1/7912 (0%)
Staphylococcal osteomyelitis	1/7890 (0%)		0/7912 (0%)
Staphylococcal sepsis	0/7890 (0%)		1/7912 (0%)
Subacute endocarditis	0/7890 (0%)		1/7912 (0%)
Superinfection	1/7890 (0%)		0/7912 (0%)
Suspected transmission of an infectious agent via product	1/7890 (0%)		0/7912 (0%)
Tinea pedis	0/7890 (0%)		1/7912 (0%)
Tongue abscess	1/7890 (0%)		0/7912 (0%)
Tonsillitis	1/7890 (0%)		0/7912 (0%)
Tooth abscess	1/7890 (0%)		0/7912 (0%)
Tracheitis	1/7890 (0%)		0/7912 (0%)
Tracheobronchitis	0/7890 (0%)		1/7912 (0%)
Tracheobronchitis viral	0/7890 (0%)		1/7912 (0%)
Tuberculosis	0/7890 (0%)		1/7912 (0%)
Urethritis	1/7890 (0%)		0/7912 (0%)
Urinary tract infection pseudomonal	1/7890 (0%)		0/7912 (0%)
Vaginal abscess	1/7890 (0%)		0/7912 (0%)
Varicella	1/7890 (0%)		0/7912 (0%)
Vestibular neuronitis	1/7890 (0%)		0/7912 (0%)
Viral tracheitis	1/7890 (0%)		0/7912 (0%)
Viral upper respiratory tract infection	1/7890 (0%)		0/7912 (0%)
Wound infection staphylococcal	0/7890 (0%)		1/7912 (0%)
Wound sepsis	1/7890 (0%)		0/7912 (0%)
Injury, poisoning and procedural complications
Coronary artery restenosis	28/7890 (0.4%)		19/7912 (0.2%)
Fall	17/7890 (0.2%)		11/7912 (0.1%)
Femur fracture	11/7890 (0.1%)		12/7912 (0.2%)
Hip fracture	10/7890 (0.1%)		13/7912 (0.2%)
Subdural haematoma	8/7890 (0.1%)		15/7912 (0.2%)
Femoral neck fracture	12/7890 (0.2%)		6/7912 (0.1%)
Head injury	11/7890 (0.1%)		7/7912 (0.1%)
Tendon rupture	8/7890 (0.1%)		8/7912 (0.1%)
Rib fracture	9/7890 (0.1%)		6/7912 (0.1%)
Laceration	9/7890 (0.1%)		4/7912 (0.1%)
Ankle fracture	7/7890 (0.1%)		4/7912 (0.1%)
Contusion	6/7890 (0.1%)		5/7912 (0.1%)
Radius fracture	5/7890 (0.1%)		6/7912 (0.1%)
Humerus fracture	5/7890 (0.1%)		5/7912 (0.1%)
Post procedural complication	5/7890 (0.1%)		5/7912 (0.1%)
Post procedural haemorrhage	4/7890 (0.1%)		6/7912 (0.1%)
Spinal compression fracture	5/7890 (0.1%)		5/7912 (0.1%)
Tibia fracture	5/7890 (0.1%)		5/7912 (0.1%)
Toxicity to various agents	6/7890 (0.1%)		4/7912 (0.1%)
Joint dislocation	5/7890 (0.1%)		4/7912 (0.1%)
Meniscus injury	8/7890 (0.1%)		1/7912 (0%)
Road traffic accident	6/7890 (0.1%)		3/7912 (0%)
Vascular graft occlusion	8/7890 (0.1%)		1/7912 (0%)
Multiple injuries	5/7890 (0.1%)		3/7912 (0%)
Vascular graft complication	6/7890 (0.1%)		2/7912 (0%)
Vascular pseudoaneurysm	5/7890 (0.1%)		3/7912 (0%)
Arterial restenosis	4/7890 (0.1%)		3/7912 (0%)
Joint injury	3/7890 (0%)		4/7912 (0.1%)
Lower limb fracture	4/7890 (0.1%)		3/7912 (0%)
Pelvic fracture	5/7890 (0.1%)		2/7912 (0%)
Concussion	4/7890 (0.1%)		2/7912 (0%)
Fibula fracture	4/7890 (0.1%)		2/7912 (0%)
Incisional hernia	4/7890 (0.1%)		2/7912 (0%)
Lumbar vertebral fracture	2/7890 (0%)		4/7912 (0.1%)
Overdose	5/7890 (0.1%)		1/7912 (0%)
Patella fracture	4/7890 (0.1%)		2/7912 (0%)
Thoracic vertebral fracture	2/7890 (0%)		4/7912 (0.1%)
Wound	2/7890 (0%)		4/7912 (0.1%)
Alcohol poisoning	4/7890 (0.1%)		1/7912 (0%)
Craniocerebral injury	3/7890 (0%)		2/7912 (0%)
Graft thrombosis	2/7890 (0%)		2/7912 (0%)
Limb injury	3/7890 (0%)		2/7912 (0%)
Post procedural myocardial infarction	3/7890 (0%)		2/7912 (0%)
Subdural haemorrhage	2/7890 (0%)		3/7912 (0%)
Accidental overdose	2/7890 (0%)		2/7912 (0%)
Foot fracture	4/7890 (0.1%)		0/7912 (0%)
Injury	3/7890 (0%)		1/7912 (0%)
Limb traumatic amputation	1/7890 (0%)		3/7912 (0%)
Procedural pain	3/7890 (0%)		1/7912 (0%)
Thermal burn	4/7890 (0.1%)		0/7912 (0%)
Wound dehiscence	2/7890 (0%)		2/7912 (0%)
Acetabulum fracture	3/7890 (0%)		0/7912 (0%)
Arterial injury	2/7890 (0%)		1/7912 (0%)
Burns second degree	2/7890 (0%)		1/7912 (0%)
Excoriation	3/7890 (0%)		0/7912 (0%)
Gun shot wound	2/7890 (0%)		1/7912 (0%)
Incisional hernia, Obstruction	3/7890 (0%)		0/7912 (0%)
Ligament rupture	2/7890 (0%)		1/7912 (0%)
Multiple fractures	1/7890 (0%)		2/7912 (0%)
Postoperative respiratory failure	1/7890 (0%)		2/7912 (0%)
Procedural haemorrhage	2/7890 (0%)		1/7912 (0%)
Bone contusion	2/7890 (0%)		0/7912 (0%)
Brain contusion	0/7890 (0%)		2/7912 (0%)
Clavicle fracture	1/7890 (0%)		1/7912 (0%)
Comminuted fracture	1/7890 (0%)		1/7912 (0%)
Ligament injury	1/7890 (0%)		1/7912 (0%)
Ligament sprain	1/7890 (0%)		1/7912 (0%)
Liver contusion	2/7890 (0%)		0/7912 (0%)
Muscle strain	1/7890 (0%)		1/7912 (0%)
Postoperative hernia	1/7890 (0%)		1/7912 (0%)
Procedural complication	2/7890 (0%)		0/7912 (0%)
Procedural hypotension	0/7890 (0%)		2/7912 (0%)
Pubis fracture	1/7890 (0%)		1/7912 (0%)
Skull fracture	0/7890 (0%)		2/7912 (0%)
Suture related complication	1/7890 (0%)		1/7912 (0%)
Transplant failure	2/7890 (0%)		0/7912 (0%)
Traumatic renal injury	1/7890 (0%)		1/7912 (0%)
Upper limb fracture	1/7890 (0%)		1/7912 (0%)
Vascular bypass dysfunction	2/7890 (0%)		0/7912 (0%)
Wound necrosis	0/7890 (0%)		2/7912 (0%)
Accident at home	1/7890 (0%)		0/7912 (0%)
Anaemia postoperative	1/7890 (0%)		0/7912 (0%)
Animal bite	1/7890 (0%)		0/7912 (0%)
Arteriovenous fistula thrombosis	0/7890 (0%)		1/7912 (0%)
Arthropod sting	0/7890 (0%)		1/7912 (0%)
Back injury	0/7890 (0%)		1/7912 (0%)
Burns first degree	1/7890 (0%)		0/7912 (0%)
Cardiac function disturbance postoperative	0/7890 (0%)		1/7912 (0%)
Cardiac procedure complication	1/7890 (0%)		0/7912 (0%)
Carotid artery restenosis	1/7890 (0%)		0/7912 (0%)
Chest injury	0/7890 (0%)		1/7912 (0%)
Eschar	1/7890 (0%)		0/7912 (0%)
Extradural haematoma	0/7890 (0%)		1/7912 (0%)
Eye injury	0/7890 (0%)		1/7912 (0%)
Eye penetration	0/7890 (0%)		1/7912 (0%)
Face injury	1/7890 (0%)		0/7912 (0%)
Forearm fracture	0/7890 (0%)		1/7912 (0%)
Foreign body	0/7890 (0%)		1/7912 (0%)
Fracture	0/7890 (0%)		1/7912 (0%)
Fractured sacrum	1/7890 (0%)		0/7912 (0%)
Gastrointestinal disorder postoperative	0/7890 (0%)		1/7912 (0%)
Gastrointestinal stoma complication	1/7890 (0%)		0/7912 (0%)
Hand fracture	1/7890 (0%)		0/7912 (0%)
Heart injury	1/7890 (0%)		0/7912 (0%)
Incision site haemorrhage	1/7890 (0%)		0/7912 (0%)
Inflammation of wound	0/7890 (0%)		1/7912 (0%)
Internal injury	0/7890 (0%)		1/7912 (0%)
Intervertebral disc injury	1/7890 (0%)		0/7912 (0%)
Jaw fracture	0/7890 (0%)		1/7912 (0%)
Kidney contusion	0/7890 (0%)		1/7912 (0%)
Limb crushing injury	1/7890 (0%)		0/7912 (0%)
Mental status changes postoperative	1/7890 (0%)		0/7912 (0%)
Muscle rupture	0/7890 (0%)		1/7912 (0%)
Periprosthetic fracture	1/7890 (0%)		0/7912 (0%)
Perirenal haematoma	1/7890 (0%)		0/7912 (0%)
Poisoning	1/7890 (0%)		0/7912 (0%)
Post laminectomy syndrome	1/7890 (0%)		0/7912 (0%)
Post procedural fistula	0/7890 (0%)		1/7912 (0%)
Post procedural haematoma	0/7890 (0%)		1/7912 (0%)
Post procedural stroke	1/7890 (0%)		0/7912 (0%)
Post procedural swelling	1/7890 (0%)		0/7912 (0%)
Postoperative ileus	1/7890 (0%)		0/7912 (0%)
Postoperative thoracic procedure complication	0/7890 (0%)		1/7912 (0%)
Postoperative thrombosis	1/7890 (0%)		0/7912 (0%)
Procedural headache	0/7890 (0%)		1/7912 (0%)
Procedural nausea	1/7890 (0%)		0/7912 (0%)
Procedural vomiting	1/7890 (0%)		0/7912 (0%)
Pulmonary contusion	1/7890 (0%)		0/7912 (0%)
Renal haematoma	0/7890 (0%)		1/7912 (0%)
Shunt stenosis	1/7890 (0%)		0/7912 (0%)
Skull fractured base	1/7890 (0%)		0/7912 (0%)
Soft tissue injury	1/7890 (0%)		0/7912 (0%)
Spinal column injury	0/7890 (0%)		1/7912 (0%)
Spinal fracture	1/7890 (0%)		0/7912 (0%)
Splenic rupture	1/7890 (0%)		0/7912 (0%)
Splinter	0/7890 (0%)		1/7912 (0%)
Subcutaneous haematoma	1/7890 (0%)		0/7912 (0%)
Synovial rupture	0/7890 (0%)		1/7912 (0%)
Tendon injury	1/7890 (0%)		0/7912 (0%)
Testicular injury	0/7890 (0%)		1/7912 (0%)
Transfusion reaction	1/7890 (0%)		0/7912 (0%)
Traumatic haematoma	0/7890 (0%)		1/7912 (0%)
Traumatic intracranial haemorrhage	1/7890 (0%)		0/7912 (0%)
Ulna fracture	0/7890 (0%)		1/7912 (0%)
Urinary bladder rupture	1/7890 (0%)		0/7912 (0%)
Vascular graft thrombosis	1/7890 (0%)		0/7912 (0%)
Vascular procedure complication	1/7890 (0%)		0/7912 (0%)
Venomous sting	0/7890 (0%)		1/7912 (0%)
Wound evisceration	0/7890 (0%)		1/7912 (0%)
Wound haematoma	0/7890 (0%)		1/7912 (0%)
Wrist fracture	0/7890 (0%)		1/7912 (0%)
Investigations
Alanine aminotransferase increased	11/7890 (0.1%)		4/7912 (0.1%)
Hepatic enzyme increased	5/7890 (0.1%)		8/7912 (0.1%)
International normalised ratio increased	5/7890 (0.1%)		3/7912 (0%)
Weight decreased	5/7890 (0.1%)		3/7912 (0%)
Aspartate aminotransferase increased	6/7890 (0.1%)		1/7912 (0%)
Liver function test abnormal	2/7890 (0%)		5/7912 (0.1%)
Blood bilirubin increased	2/7890 (0%)		4/7912 (0.1%)
Troponin increased	3/7890 (0%)		3/7912 (0%)
Blood creatinine increased	4/7890 (0.1%)		1/7912 (0%)
Blood glucose increased	3/7890 (0%)		2/7912 (0%)
Haemoglobin decreased	1/7890 (0%)		4/7912 (0.1%)
Blood pressure increased	1/7890 (0%)		3/7912 (0%)
Ejection fraction decreased	4/7890 (0.1%)		0/7912 (0%)
Electrocardiogram ST segment depression	3/7890 (0%)		0/7912 (0%)
Prostatic specific antigen increased	1/7890 (0%)		2/7912 (0%)
Blood potassium decreased	2/7890 (0%)		0/7912 (0%)
Blood pressure decreased	0/7890 (0%)		2/7912 (0%)
Cardiac stress test abnormal	0/7890 (0%)		2/7912 (0%)
Heart rate decreased	1/7890 (0%)		1/7912 (0%)
Heart rate irregular	2/7890 (0%)		0/7912 (0%)
Intraocular pressure increased	1/7890 (0%)		1/7912 (0%)
Troponin I increased	1/7890 (0%)		1/7912 (0%)
Activated partial thromboplastin time prolonged	0/7890 (0%)		1/7912 (0%)
Alanine aminotransferase abnormal	0/7890 (0%)		1/7912 (0%)
Aspartate aminotransferase abnormal	0/7890 (0%)		1/7912 (0%)
Bile output abnormal	1/7890 (0%)		0/7912 (0%)
Bilirubin conjugated increased	0/7890 (0%)		1/7912 (0%)
Blood alkaline phosphatase increased	0/7890 (0%)		1/7912 (0%)
Blood creatine phosphokinase increased	1/7890 (0%)		0/7912 (0%)
Blood glucose decreased	0/7890 (0%)		1/7912 (0%)
Blood urea increased	1/7890 (0%)		0/7912 (0%)
Blood urine present	1/7890 (0%)		0/7912 (0%)
C-reactive protein increased	1/7890 (0%)		0/7912 (0%)
Cardiac murmur	1/7890 (0%)		0/7912 (0%)
Carotid bruit	1/7890 (0%)		0/7912 (0%)
ECG signs of myocardial ischaemia	0/7890 (0%)		1/7912 (0%)
Gamma-glutamyltransferase increased	1/7890 (0%)		0/7912 (0%)
Heart rate increased	0/7890 (0%)		1/7912 (0%)
Hepatic enzyme abnormal	0/7890 (0%)		1/7912 (0%)
Occult blood positive	0/7890 (0%)		1/7912 (0%)
Oxygen saturation decreased	0/7890 (0%)		1/7912 (0%)
Red blood cell sedimentation rate increased	0/7890 (0%)		1/7912 (0%)
Scan myocardial perfusion abnormal	0/7890 (0%)		1/7912 (0%)
Streptococcus test positive	0/7890 (0%)		1/7912 (0%)
Stroke volume decreased	0/7890 (0%)		1/7912 (0%)
Transaminases increased	0/7890 (0%)		1/7912 (0%)
White blood cell count increased	0/7890 (0%)		1/7912 (0%)
Metabolism and nutrition disorders
Type 2 diabetes mellitus	37/7890 (0.5%)		27/7912 (0.3%)
Dehydration	24/7890 (0.3%)		33/7912 (0.4%)
Hypoglycaemia	26/7890 (0.3%)		24/7912 (0.3%)
Diabetes mellitus inadequate control	8/7890 (0.1%)		26/7912 (0.3%)
Hyperkalaemia	9/7890 (0.1%)		11/7912 (0.1%)
Hyponatraemia	8/7890 (0.1%)		10/7912 (0.1%)
Gout	5/7890 (0.1%)		5/7912 (0.1%)
Hyperglycaemia	5/7890 (0.1%)		4/7912 (0.1%)
Hypokalaemia	7/7890 (0.1%)		2/7912 (0%)
Diabetic ketoacidosis	5/7890 (0.1%)		3/7912 (0%)
Hypovolaemia	4/7890 (0.1%)		2/7912 (0%)
Obesity	2/7890 (0%)		4/7912 (0.1%)
Electrolyte imbalance	1/7890 (0%)		3/7912 (0%)
Fluid overload	2/7890 (0%)		2/7912 (0%)
Malnutrition	1/7890 (0%)		3/7912 (0%)
Metabolic acidosis	2/7890 (0%)		2/7912 (0%)
Type 1 diabetes mellitus	2/7890 (0%)		2/7912 (0%)
Cachexia	1/7890 (0%)		1/7912 (0%)
Diabetes mellitus	0/7890 (0%)		2/7912 (0%)
Failure to thrive	1/7890 (0%)		1/7912 (0%)
Hypertriglyceridaemia	1/7890 (0%)		1/7912 (0%)
Hypoalbuminaemia	0/7890 (0%)		2/7912 (0%)
Hypocalcaemia	0/7890 (0%)		2/7912 (0%)
Hypomagnesaemia	1/7890 (0%)		1/7912 (0%)
Ketoacidosis	1/7890 (0%)		1/7912 (0%)
Acidosis	1/7890 (0%)		0/7912 (0%)
Decreased appetite	1/7890 (0%)		0/7912 (0%)
Diabetic complication	0/7890 (0%)		1/7912 (0%)
Fluid retention	0/7890 (0%)		1/7912 (0%)
Fructose intolerance	0/7890 (0%)		1/7912 (0%)
Hypercalcaemia	0/7890 (0%)		1/7912 (0%)
Hyperlipidaemia	0/7890 (0%)		1/7912 (0%)
Hyperosmolar state	1/7890 (0%)		0/7912 (0%)
Hypophosphataemia	1/7890 (0%)		0/7912 (0%)
Insulin-requiring type 2 diabetes mellitus	1/7890 (0%)		0/7912 (0%)
Metabolic syndrome	0/7890 (0%)		1/7912 (0%)
Vitamin B12 deficiency	1/7890 (0%)		0/7912 (0%)
Vitamin D deficiency	1/7890 (0%)		0/7912 (0%)
Musculoskeletal and connective tissue disorders
Osteoarthritis	78/7890 (1%)		73/7912 (0.9%)
Back pain	27/7890 (0.3%)		20/7912 (0.3%)
Intervertebral disc protrusion	24/7890 (0.3%)		16/7912 (0.2%)
Arthralgia	19/7890 (0.2%)		13/7912 (0.2%)
Spinal column stenosis	16/7890 (0.2%)		13/7912 (0.2%)
Lumbar spinal stenosis	9/7890 (0.1%)		13/7912 (0.2%)
Arthritis	7/7890 (0.1%)		13/7912 (0.2%)
Musculoskeletal chest pain	9/7890 (0.1%)		11/7912 (0.1%)
Spinal osteoarthritis	12/7890 (0.2%)		5/7912 (0.1%)
Rotator cuff syndrome	9/7890 (0.1%)		7/7912 (0.1%)
Myalgia	6/7890 (0.1%)		9/7912 (0.1%)
Musculoskeletal pain	6/7890 (0.1%)		8/7912 (0.1%)
Rhabdomyolysis	4/7890 (0.1%)		7/7912 (0.1%)
Cervical spinal stenosis	9/7890 (0.1%)		1/7912 (0%)
Muscular weakness	6/7890 (0.1%)		3/7912 (0%)
Spondylolisthesis	3/7890 (0%)		5/7912 (0.1%)
Polymyalgia rheumatica	4/7890 (0.1%)		3/7912 (0%)
Gouty arthritis	3/7890 (0%)		3/7912 (0%)
Osteonecrosis	5/7890 (0.1%)		1/7912 (0%)
Intervertebral disc disorder	3/7890 (0%)		2/7912 (0%)
Intervertebral disc degeneration	2/7890 (0%)		3/7912 (0%)
Pain in extremity	2/7890 (0%)		3/7912 (0%)
Rheumatoid arthritis	2/7890 (0%)		3/7912 (0%)
Neck pain	0/7890 (0%)		4/7912 (0.1%)
Periarthritis	1/7890 (0%)		3/7912 (0%)
Arthritis reactive	1/7890 (0%)		2/7912 (0%)
Bursitis	1/7890 (0%)		2/7912 (0%)
Flank pain	1/7890 (0%)		2/7912 (0%)
Muscle haemorrhage	2/7890 (0%)		1/7912 (0%)
Articular calcification	1/7890 (0%)		1/7912 (0%)
Foot deformity	2/7890 (0%)		0/7912 (0%)
Intervertebral disc displacement	0/7890 (0%)		2/7912 (0%)
Osteitis	2/7890 (0%)		0/7912 (0%)
Polyarthritis	2/7890 (0%)		0/7912 (0%)
Scoliosis	2/7890 (0%)		0/7912 (0%)
Spondylitis	2/7890 (0%)		0/7912 (0%)
Tendon disorder	0/7890 (0%)		2/7912 (0%)
Arthropathy	0/7890 (0%)		1/7912 (0%)
Back disorder	0/7890 (0%)		1/7912 (0%)
Bone erosion	0/7890 (0%)		1/7912 (0%)
Bone fistula	0/7890 (0%)		1/7912 (0%)
Bone lesion	0/7890 (0%)		1/7912 (0%)
Bone pain	0/7890 (0%)		1/7912 (0%)
Chondromalacia	0/7890 (0%)		1/7912 (0%)
Chondropathy	0/7890 (0%)		1/7912 (0%)
Costochondritis	1/7890 (0%)		0/7912 (0%)
Dupuytren's contracture	0/7890 (0%)		1/7912 (0%)
Exostosis	1/7890 (0%)		0/7912 (0%)
Fistula	1/7890 (0%)		0/7912 (0%)
Haemarthrosis	1/7890 (0%)		0/7912 (0%)
Inclusion body myositis	0/7890 (0%)		1/7912 (0%)
Inguinal mass	0/7890 (0%)		1/7912 (0%)
Joint effusion	0/7890 (0%)		1/7912 (0%)
Joint swelling	0/7890 (0%)		1/7912 (0%)
Limb discomfort	0/7890 (0%)		1/7912 (0%)
Metatarsalgia	1/7890 (0%)		0/7912 (0%)
Monarthritis	0/7890 (0%)		1/7912 (0%)
Muscle spasms	0/7890 (0%)		1/7912 (0%)
Musculoskeletal discomfort	1/7890 (0%)		0/7912 (0%)
Myofascial pain syndrome	0/7890 (0%)		1/7912 (0%)
Myositis	0/7890 (0%)		1/7912 (0%)
Osteochondrosis	1/7890 (0%)		0/7912 (0%)
Osteoporosis	1/7890 (0%)		0/7912 (0%)
Osteoporotic fracture	1/7890 (0%)		0/7912 (0%)
Pathological fracture	1/7890 (0%)		0/7912 (0%)
Spinal deformity	0/7890 (0%)		1/7912 (0%)
Spondylolysis	1/7890 (0%)		0/7912 (0%)
Synovitis	1/7890 (0%)		0/7912 (0%)
Tendonitis	0/7890 (0%)		1/7912 (0%)
Tenosynovitis	0/7890 (0%)		1/7912 (0%)
Tenosynovitis stenosans	1/7890 (0%)		0/7912 (0%)
Vertebral foraminal stenosis	1/7890 (0%)		0/7912 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer	64/7890 (0.8%)		67/7912 (0.8%)
Lung neoplasm malignant	37/7890 (0.5%)		33/7912 (0.4%)
Colon cancer	32/7890 (0.4%)		21/7912 (0.3%)
Bladder cancer	19/7890 (0.2%)		21/7912 (0.3%)
Pancreatic carcinoma	8/7890 (0.1%)		17/7912 (0.2%)
Gastric cancer	10/7890 (0.1%)		10/7912 (0.1%)
Breast cancer	7/7890 (0.1%)		9/7912 (0.1%)
Adenocarcinoma of colon	4/7890 (0.1%)		10/7912 (0.1%)
Metastases to liver	9/7890 (0.1%)		5/7912 (0.1%)
Renal cancer	6/7890 (0.1%)		8/7912 (0.1%)
Hepatic cancer	6/7890 (0.1%)		7/7912 (0.1%)
Lung cancer metastatic	7/7890 (0.1%)		6/7912 (0.1%)
Malignant melanoma	3/7890 (0%)		9/7912 (0.1%)
Rectal cancer	10/7890 (0.1%)		2/7912 (0%)
Basal Cell Carcinoma	8/7890 (0.1%)		3/7912 (0%)
Metastases to bone	6/7890 (0.1%)		5/7912 (0.1%)
Metastases to lymph node	7/7890 (0.1%)		4/7912 (0.1%)
Metastases to lung	7/7890 (0.1%)		3/7912 (0%)
Small Cell Lung Cancer	5/7890 (0.1%)		5/7912 (0.1%)
Transitional cell carcinoma	4/7890 (0.1%)		6/7912 (0.1%)
Colon adenoma	5/7890 (0.1%)		4/7912 (0.1%)
Laryngeal cancer	1/7890 (0%)		8/7912 (0.1%)
Lung adenocarcinoma	3/7890 (0%)		6/7912 (0.1%)
Non-Small cell lung cancer	5/7890 (0.1%)		4/7912 (0.1%)
Oesophageal Carcinoma	5/7890 (0.1%)		4/7912 (0.1%)
Renal Cell Carcinoma	5/7890 (0.1%)		4/7912 (0.1%)
Chronic lymphocytic leukaemia	5/7890 (0.1%)		3/7912 (0%)
Prostate cancer metastatic	4/7890 (0.1%)		4/7912 (0.1%)
Squamous cell carcinoma	4/7890 (0.1%)		4/7912 (0.1%)
Bladder neoplasm	2/7890 (0%)		5/7912 (0.1%)
Cholangiocarcinoma	3/7890 (0%)		4/7912 (0.1%)
Plasma cell myeloma	4/7890 (0.1%)		3/7912 (0%)
Prostatic adenoma	4/7890 (0.1%)		3/7912 (0%)
Acute myeloid leukaemia	0/7890 (0%)		6/7912 (0.1%)
Myelodysplastic syndrome	3/7890 (0%)		3/7912 (0%)
Rectal adenocarcinoma	4/7890 (0.1%)		2/7912 (0%)
Adenocarcinoma	1/7890 (0%)		4/7912 (0.1%)
Adenocarcinoma gastric	2/7890 (0%)		3/7912 (0%)
Adenocarcinoma pancreas	3/7890 (0%)		2/7912 (0%)
Bladder transitional cell carcinoma	2/7890 (0%)		3/7912 (0%)
Bronchial carcinoma	4/7890 (0.1%)		1/7912 (0%)
Hepatic cancer metastatic	3/7890 (0%)		2/7912 (0%)
Lymphoma	4/7890 (0.1%)		1/7912 (0%)
Meningioma benign	3/7890 (0%)		2/7912 (0%)
Metastases to central nervous system	3/7890 (0%)		2/7912 (0%)
Metastatic lymphoma	1/7890 (0%)		4/7912 (0.1%)
B-cell lymphoma	2/7890 (0%)		2/7912 (0%)
Benign neoplasm of bladder	2/7890 (0%)		2/7912 (0%)
Benign salivary gland neoplasm	4/7890 (0.1%)		0/7912 (0%)
Bile duct cancer	1/7890 (0%)		0/7912 (0%)
Bladder cancer recurrent	3/7890 (0%)		1/7912 (0%)
Hepatocellular carcinoma	1/7890 (0%)		3/7912 (0%)
Lung neoplasm	2/7890 (0%)		2/7912 (0%)
Meningioma	2/7890 (0%)		2/7912 (0%)
Metastases to spine	4/7890 (0.1%)		0/7912 (0%)
Metastatic malignant melanoma	0/7890 (0%)		4/7912 (0.1%)
Metastatic neoplasm	2/7890 (0%)		2/7912 (0%)
Adenoma benign	2/7890 (0%)		1/7912 (0%)
Brain neoplasm	2/7890 (0%)		1/7912 (0%)
Chronic myeloid leukaemia	3/7890 (0%)		0/7912 (0%)
Endometrial cancer	1/7890 (0%)		2/7912 (0%)
Lipoma	1/7890 (0%)		2/7912 (0%)
Malignant neoplasm of unknown primary site	2/7890 (0%)		1/7912 (0%)
Metastases to adrenals	3/7890 (0%)		0/7912 (0%)
Non-Hodgkin's lymphoma	2/7890 (0%)		1/7912 (0%)
Non-small cell lung cancer metastatic	1/7890 (0%)		2/7912 (0%)
Oesophageal adenocarcinoma	0/7890 (0%)		3/7912 (0%)
Penile cancer	3/7890 (0%)		0/7912 (0%)
Renal neoplasm	1/7890 (0%)		2/7912 (0%)
Squamous cell carcinoma of lung	2/7890 (0%)		1/7912 (0%)
Benign breast neoplasm	1/7890 (0%)		1/7912 (0%)
Benign neoplasm of thyroid gland	1/7890 (0%)		1/7912 (0%)
Bile duct adenocarcinoma	2/7890 (0%)		0/7912 (0%)
Bone cancer	1/7890 (0%)		1/7912 (0%)
Bone cancer metastatic	1/7890 (0%)		1/7912 (0%)
Brain neoplasm benign	1/7890 (0%)		1/7912 (0%)
Cancer pain	1/7890 (0%)		1/7912 (0%)
Carcinoid tumour of the duodenum	0/7890 (0%)		2/7912 (0%)
Cervix carcinoma	0/7890 (0%)		2/7912 (0%)
Cholesteatoma	2/7890 (0%)		0/7912 (0%)
Colorectal cancer	0/7890 (0%)		2/7912 (0%)
Endometrial adenocarcinoma	0/7890 (0%)		2/7912 (0%)
Gallbladder cancer	2/7890 (0%)		0/7912 (0%)
Gastric adenoma	0/7890 (0%)		2/7912 (0%)
Glioma	1/7890 (0%)		1/7912 (0%)
Hypopharyngeal cancer	0/7890 (0%)		2/7912 (0%)
Laryngeal squamous cell carcinoma	2/7890 (0%)		0/7912 (0%)
Lymphocytic lymphoma	2/7890 (0%)		0/7912 (0%)
Malignant peritoneal neoplasm	0/7890 (0%)		2/7912 (0%)
Metastases to abdominal cavity	0/7890 (0%)		2/7912 (0%)
Metastatic carcinoma of the bladder	2/7890 (0%)		0/7912 (0%)
Neoplasm malignant	2/7890 (0%)		0/7912 (0%)
Neoplasm prostate	2/7890 (0%)		0/7912 (0%)
Pancreatic carcinoma metastatic	1/7890 (0%)		1/7912 (0%)
Papilloma	0/7890 (0%)		2/7912 (0%)
Renal cancer metastatic	1/7890 (0%)		1/7912 (0%)
Throat cancer	0/7890 (0%)		2/7912 (0%)
Tonsil cancer	2/7890 (0%)		0/7912 (0%)
Ureteric cancer	1/7890 (0%)		1/7912 (0%)
Uterine leiomyoma	1/7890 (0%)		1/7912 (0%)
Acoustic neuroma	0/7890 (0%)		1/7912 (0%)
Acute lymphocytic leukaemia	1/7890 (0%)		0/7912 (0%)
Adenoid cystic carcinoma	1/7890 (0%)		0/7912 (0%)
Adrenocortical carcinoma	1/7890 (0%)		0/7912 (0%)
Ameloblastoma	1/7890 (0%)		0/7912 (0%)
Anaplastic astrocytoma	1/7890 (0%)		0/7912 (0%)
Angiosarcoma	0/7890 (0%)		1/7912 (0%)
Benign anorectal neoplasm	1/7890 (0%)		0/7912 (0%)
Benign hepatic neoplasm	1/7890 (0%)		0/7912 (0%)
Benign lung neoplasm	1/7890 (0%)		0/7912 (0%)
Benign ovarian tumour	0/7890 (0%)		1/7912 (0%)
Bladder papilloma	0/7890 (0%)		1/7912 (0%)
Bowen's disease	0/7890 (0%)		1/7912 (0%)
Brain cancer metastatic	0/7890 (0%)		1/7912 (0%)
Brain neoplasm malignant	1/7890 (0%)		0/7912 (0%)
Breast cancer metastatic	1/7890 (0%)		0/7912 (0%)
Breast cancer stage I	1/7890 (0%)		0/7912 (0%)
Breast neoplasm	1/7890 (0%)		0/7912 (0%)
Carcinoid tumour of the gastrointestinal tract	1/7890 (0%)		0/7912 (0%)
Cardiac myxoma	1/7890 (0%)		0/7912 (0%)
Chondrosarcoma	1/7890 (0%)		0/7912 (0%)
Chronic leukaemia	0/7890 (0%)		1/7912 (0%)
Chronic lymphocytic leukaemia stage 0	0/7890 (0%)		1/7912 (0%)
Clear cell renal cell carcinoma	1/7890 (0%)		0/7912 (0%)
Colon cancer metastatic	0/7890 (0%)		1/7912 (0%)
Colon cancer stage 0	0/7890 (0%)		1/7912 (0%)
Colon cancer stage II	0/7890 (0%)		1/7912 (0%)
Colorectal adenocarcinoma	0/7890 (0%)		1/7912 (0%)
Diffuse large B-cell lymphoma	0/7890 (0%)		1/7912 (0%)
Endometrial cancer metastatic	1/7890 (0%)		0/7912 (0%)
Gastric cancer recurrent	1/7890 (0%)		0/7912 (0%)
Gastrointestinal carcinoma	1/7890 (0%)		0/7912 (0%)
Gastrointestinal stromal cancer	1/7890 (0%)		0/7912 (0%)
Gastrointestinal tract adenoma	1/7890 (0%)		0/7912 (0%)
Glioblastoma	0/7890 (0%)		1/7912 (0%)
Glottis carcinoma	1/7890 (0%)		0/7912 (0%)
Haemangioma	0/7890 (0%)		1/7912 (0%)
Hepatic neoplasm	1/7890 (0%)		1/7912 (0%)
Hypopharyngeal cancer recurrent	0/7890 (0%)		1/7912 (0%)
Intraductal papillary-mucinous carcinoma of pancreas	0/7890 (0%)		1/7912 (0%)
Invasive ductal breast carcinoma	1/7890 (0%)		0/7912 (0%)
Invasive lobular breast carcinoma	0/7890 (0%)		1/7912 (0%)
Large intestine benign neoplasm	1/7890 (0%)		0/7912 (0%)
Laryngeal cancer recurrent	0/7890 (0%)		1/7912 (0%)
Leiomyosarcoma	0/7890 (0%)		1/7912 (0%)
Lentigo maligna	1/7890 (0%)		0/7912 (0%)
Leukaemia	1/7890 (0%)		0/7912 (0%)
Lip and/or oral cavity cancer	1/7890 (0%)		0/7912 (0%)
Lip neoplasm malignant stage unspecified	1/7890 (0%)		0/7912 (0%)
Lung adenocarcinoma stage II	0/7890 (0%)		1/7912 (0%)
Lung adenocarcinoma stage IV	1/7890 (0%)		0/7912 (0%)
Lung adenocarcinoma metastatic	0/7890 (0%)		1/7912 (0%)
Lung carcinoma cell type unspecified recurrent	1/7890 (0%)		0/7912 (0%)
Lung carcinoma cell type unspecified stage III	0/7890 (0%)		1/7912 (0%)
Lung squamous cell carcinoma stage III	0/7890 (0%)		1/7912 (0%)
Lymphangiosis carcinomatosa	0/7890 (0%)		1/7912 (0%)
Malignant melanoma in situ	0/7890 (0%)		1/7912 (0%)
Malignant neoplasm of ampulla of Vater	0/7890 (0%)		1/7912 (0%)
Malignant palate neoplasm	1/7890 (0%)		0/7912 (0%)
Mantle cell lymphoma	1/7890 (0%)		0/7912 (0%)
Mediastinum neoplasm	1/7890 (0%)		0/7912 (0%)
Mesothelioma	0/7890 (0%)		1/7912 (0%)
Metastases to biliary tract	1/7890 (0%)		0/7912 (0%)
Metastases to peritoneum	0/7890 (0%)		1/7912 (0%)
Metastases to pleura	1/7890 (0%)		0/7912 (0%)
Metastases to the mediastinum	1/7890 (0%)		0/7912 (0%)
Metastatic bronchial carcinoma	1/7890 (0%)		0/7912 (0%)
Metastatic salivary gland cancer	1/7890 (0%)		0/7912 (0%)
Metastatic squamous cell carcinoma	0/7890 (0%)		1/7912 (0%)
Morton's neuroma	1/7890 (0%)		0/7912 (0%)
Neurilemmoma benign	0/7890 (0%)		1/7912 (0%)
Neuroendocrine carcinoma	1/7890 (0%)		0/7912 (0%)
Optic nerve neoplasm	1/7890 (0%)		0/7912 (0%)
Ovarian cancer	1/7890 (0%)		0/7912 (0%)
Papillary thyroid cancer	0/7890 (0%)		1/7912 (0%)
Parathyroid tumour benign	0/7890 (0%)		1/7912 (0%)
Peritoneal carcinoma metastatic	1/7890 (0%)		0/7912 (0%)
Phaeochromocytoma malignant	1/7890 (0%)		0/7912 (0%)
Pituitary tumour benign	1/7890 (0%)		0/7912 (0%)
Pleural mesothelioma	1/7890 (0%)		0/7912 (0%)
Polycythaemia vera	1/7890 (0%)		0/7912 (0%)
Prostate cancer recurrent	1/7890 (0%)		0/7912 (0%)
Rectosigmoid cancer	0/7890 (0%)		1/7912 (0%)
Salivary gland adenoma	0/7890 (0%)		1/7912 (0%)
Salivary gland neoplasm	1/7890 (0%)		0/7912 (0%)
Sarcoma	0/7890 (0%)		1/7912 (0%)
Signet-ring cell carcinoma	1/7890 (0%)		0/7912 (0%)
Skin cancer	0/7890 (0%)		1/7912 (0%)
Small cell lung cancer metastatic	0/7890 (0%)		1/7912 (0%)
Small intestine adenocarcinoma	1/7890 (0%)		0/7912 (0%)
Soft tissue cancer	0/7890 (0%)		1/7912 (0%)
Squamous cell carcinoma of the oral cavity	0/7890 (0%)		1/7912 (0%)
Squamous cell carcinoma of the tongue	0/7890 (0%)		1/7912 (0%)
Testicular malignant teratoma	0/7890 (0%)		1/7912 (0%)
Thymoma	0/7890 (0%)		1/7912 (0%)
Thyroid adenoma	1/7890 (0%)		0/7912 (0%)
Transitional cell cancer of the renal pelvis and ureter	0/7890 (0%)		1/7912 (0%)
Tumour haemorrhage	0/7890 (0%)		1/7912 (0%)
Tumour invasion	0/7890 (0%)		1/7912 (0%)
Ureteral neoplasm	1/7890 (0%)		0/7912 (0%)
Urinary bladder adenoma	0/7890 (0%)		1/7912 (0%)
Urinary tract neoplasm	1/7890 (0%)		0/7912 (0%)
Uterine cancer	1/7890 (0%)		0/7912 (0%)
Nervous system disorders
Ischaemic stroke	97/7890 (1.2%)		94/7912 (1.2%)
Transient ischaemic attack	87/7890 (1.1%)		67/7912 (0.8%)
Syncope	79/7890 (1%)		72/7912 (0.9%)
Carotid artery stenosis	47/7890 (0.6%)		48/7912 (0.6%)
Cerebrovascular accident	28/7890 (0.4%)		33/7912 (0.4%)
Dizziness	18/7890 (0.2%)		18/7912 (0.2%)
Haemorrhagic stroke	19/7890 (0.2%)		15/7912 (0.2%)
Ischaemic cerebral infarction	20/7890 (0.3%)		13/7912 (0.2%)
Presyncope	16/7890 (0.2%)		16/7912 (0.2%)
Cerebral infarction	7/7890 (0.1%)		15/7912 (0.2%)
Convulsion	8/7890 (0.1%)		5/7912 (0.1%)
Epilepsy	5/7890 (0.1%)		7/7912 (0.1%)
Headache	7/7890 (0.1%)		5/7912 (0.1%)
Sciatica	6/7890 (0.1%)		6/7912 (0.1%)
Subarachnoid haemorrhage	7/7890 (0.1%)		3/7912 (0%)
Brain stem infarction	4/7890 (0.1%)		5/7912 (0.1%)
Embolic stroke	4/7890 (0.1%)		5/7912 (0.1%)
Loss of consciousness	4/7890 (0.1%)		5/7912 (0.1%)
Carotid artery occlusion	7/7890 (0.1%)		1/7912 (0%)
Cervicobrachial syndrome	4/7890 (0.1%)		4/7912 (0.1%)
Dementia	4/7890 (0.1%)		4/7912 (0.1%)
Diabetic neuropathy	4/7890 (0.1%)		4/7912 (0.1%)
Lacunar infarction	6/7890 (0.1%)		2/7912 (0%)
Cerebral haemorrhage	2/7890 (0%)		5/7912 (0.1%)
Carpal tunnel syndrome	4/7890 (0.1%)		2/7912 (0%)
Haemorrhage intracranial	3/7890 (0%)		3/7912 (0%)
Vertebrobasilar insufficiency	4/7890 (0.1%)		2/7912 (0%)
Aphasia	1/7890 (0%)		4/7912 (0.1%)
Carotid artery disease	4/7890 (0.1%)		1/7912 (0%)
Embolic cerebral infarction	3/7890 (0%)		2/7912 (0%)
Hemiparesis	4/7890 (0.1%)		1/7912 (0%)
Tremor	0/7890 (0%)		5/7912 (0.1%)
Ataxia	3/7890 (0%)		1/7912 (0%)
Carotid arteriosclerosis	1/7890 (0%)		3/7912 (0%)
Encephalopathy	2/7890 (0%)		2/7912 (0%)
Metabolic encephalopathy	1/7890 (0%)		3/7912 (0%)
Neuralgia	2/7890 (0%)		2/7912 (0%)
VIIth nerve paralysis	3/7890 (0%)		1/7912 (0%)
Altered state of consciousness	0/7890 (0%)		3/7912 (0%)
Cerebral ischaemia	2/7890 (0%)		1/7912 (0%)
Cognitive disorder	1/7890 (0%)		2/7912 (0%)
Dysarthria	2/7890 (0%)		1/7912 (0%)
Hypoglycaemic coma	2/7890 (0%)		1/7912 (0%)
Intercostal neuralgia	0/7890 (0%)		3/7912 (0%)
Paraesthesia	1/7890 (0%)		2/7912 (0%)
Polyneuropathy	2/7890 (0%)		1/7912 (0%)
Thalamic infarction	1/7890 (0%)		2/7912 (0%)
Vascular dementia	2/7890 (0%)		1/7912 (0%)
Amyotrophic lateral sclerosis	0/7890 (0%)		2/7912 (0%)
Balance disorder	0/7890 (0%)		2/7912 (0%)
Brain oedema	1/7890 (0%)		1/7912 (0%)
Brain stem haemorrhage	1/7890 (0%)		1/7912 (0%)
Cerebellar haemorrhage	1/7890 (0%)		1/7912 (0%)
Cerebral arteriosclerosis	1/7890 (0%)		1/7912 (0%)
Cerebral haematoma	1/7890 (0%)		1/7912 (0%)
Cerebrovascular disorder	2/7890 (0%)		0/7912 (0%)
Cervical myelopathy	1/7890 (0%)		1/7912 (0%)
Coma	1/7890 (0%)		1/7912 (0%)
Dementia Alzheimer's type	1/7890 (0%)		1/7912 (0%)
Depressed level of consciousness	1/7890 (0%)		1/7912 (0%)
Grand mal convulsion	0/7890 (0%)		2/7912 (0%)
Hydrocephalus	1/7890 (0%)		1/7912 (0%)
Hypoaesthesia	1/7890 (0%)		1/7912 (0%)
Hypoxic-ischaemic encephalopathy	0/7890 (0%)		2/7912 (0%)
Intracranial aneurysm	0/7890 (0%)		2/7912 (0%)
Migraine	1/7890 (0%)		1/7912 (0%)
Mononeuritis	1/7890 (0%)		1/7912 (0%)
Nerve compression	2/7890 (0%)		0/7912 (0%)
Nervous system disorder	1/7890 (0%)		1/7912 (0%)
Normal pressure hydrocephalus	1/7890 (0%)		1/7912 (0%)
Paraplegia	0/7890 (0%)		2/7912 (0%)
Post herpetic neuralgia	1/7890 (0%)		1/7912 (0%)
Pseudoradicular syndrome	0/7890 (0%)		2/7912 (0%)
Radiculopathy	2/7890 (0%)		0/7912 (0%)
Reversible ischaemic neurological deficit	2/7890 (0%)		0/7912 (0%)
Senile dementia	1/7890 (0%)		1/7912 (0%)
Somnolence	2/7890 (0%)		0/7912 (0%)
Spondylitic myelopathy	2/7890 (0%)		0/7912 (0%)
Thrombotic cerebral infarction	2/7890 (0%)		0/7912 (0%)
Transient global amnesia	2/7890 (0%)		0/7912 (0%)
Vertebral artery stenosis	1/7890 (0%)		1/7912 (0%)
Alcoholic seizure	1/7890 (0%)		0/7912 (0%)
Basal ganglia infarction	1/7890 (0%)		0/7912 (0%)
Brain injury	0/7890 (0%)		1/7912 (0%)
Brain midline shift	0/7890 (0%)		1/7912 (0%)
Brain stem ischaemia	1/7890 (0%)		0/7912 (0%)
Brain stem stroke	0/7890 (0%)		1/7912 (0%)
Cauda equina syndrome	1/7890 (0%)		0/7912 (0%)
Central nervous system lesion	1/7890 (0%)		0/7912 (0%)
Cerebellar infarction	0/7890 (0%)		1/7912 (0%)
Cerebral artery embolism	1/7890 (0%)		0/7912 (0%)
Cerebral artery occlusion	0/7890 (0%)		1/7912 (0%)
Cerebral artery stenosis	1/7890 (0%)		0/7912 (0%)
Cerebral circulatory failure	1/7890 (0%)		0/7912 (0%)
Complex partial seizures	0/7890 (0%)		1/7912 (0%)
Complex regional pain syndrome	1/7890 (0%)		0/7912 (0%)
Critical illness polyneuropathy	1/7890 (0%)		0/7912 (0%)
Dementia with Lewy bodies	1/7890 (0%)		0/7912 (0%)
Diabetic hyperosmolar coma	0/7890 (0%)		1/7912 (0%)
Diabetic mononeuropathy	1/7890 (0%)		0/7912 (0%)
Disturbance in attention	1/7890 (0%)		0/7912 (0%)
Dizziness exertional	0/7890 (0%)		1/7912 (0%)
Dizziness postural	0/7890 (0%)		1/7912 (0%)
Dysaesthesia	0/7890 (0%)		1/7912 (0%)
Dyslalia	0/7890 (0%)		1/7912 (0%)
Dystonia	0/7890 (0%)		1/7912 (0%)
Encephalitis	1/7890 (0%)		0/7912 (0%)
Encephalomalacia	1/7890 (0%)		0/7912 (0%)
Facial paresis	0/7890 (0%)		1/7912 (0%)
Guillain-Barre syndrome	0/7890 (0%)		1/7912 (0%)
Haemorrhagic cerebral infarction	0/7890 (0%)		1/7912 (0%)
Haemorrhagic transformation stroke	1/7890 (0%)		0/7912 (0%)
Hemianopia	0/7890 (0%)		1/7912 (0%)
Hemiplegic migraine	1/7890 (0%)		0/7912 (0%)
Hypertensive encephalopathy	0/7890 (0%)		1/7912 (0%)
Hypoglycaemic unconsciousness	1/7890 (0%)		0/7912 (0%)
Hypotonia	1/7890 (0%)		0/7912 (0%)
Intraventricular haemorrhage	1/7890 (0%)		0/7912 (0%)
Ischaemic neuropathy	1/7890 (0%)		0/7912 (0%)
Lethargy	1/7890 (0%)		0/7912 (0%)
Memory impairment	1/7890 (0%)		0/7912 (0%)
Meningoradiculitis	0/7890 (0%)		1/7912 (0%)
Monoparesis	0/7890 (0%)		1/7912 (0%)
Movement disorder	0/7890 (0%)		1/7912 (0%)
Nerve root compression	0/7890 (0%)		1/7912 (0%)
Neuritis	0/7890 (0%)		1/7912 (0%)
Neuritis cranial	0/7890 (0%)		1/7912 (0%)
Neurological symptom	1/7890 (0%)		0/7912 (0%)
Neuropathy peripheral	0/7890 (0%)		1/7912 (0%)
Orthostatic intolerance	1/7890 (0%)		0/7912 (0%)
Paresis	1/7890 (0%)		0/7912 (0%)
Parkinson's disease	0/7890 (0%)		1/7912 (0%)
Partial seizures with secondary generalisation	1/7890 (0%)		0/7912 (0%)
Peripheral nerve paresis	1/7890 (0%)		0/7912 (0%)
Polyneuropathy chronic	0/7890 (0%)		1/7912 (0%)
Radicular syndrome	1/7890 (0%)		0/7912 (0%)
Radiculitis lumbosacral	0/7890 (0%)		1/7912 (0%)
Restless legs syndrome	1/7890 (0%)		0/7912 (0%)
Retrograde amnesia	1/7890 (0%)		0/7912 (0%)
Ruptured cerebral aneurysm	0/7890 (0%)		1/7912 (0%)
Sensory disturbance	0/7890 (0%)		1/7912 (0%)
Sensory loss	0/7890 (0%)		1/7912 (0%)
Simple partial seizures	1/7890 (0%)		0/7912 (0%)
Spinal claudication	0/7890 (0%)		1/7912 (0%)
Spinal cord compression	1/7890 (0%)		0/7912 (0%)
Spinal cord disorder	1/7890 (0%)		0/7912 (0%)
Spinal haematoma	1/7890 (0%)		0/7912 (0%)
Status epilepticus	1/7890 (0%)		0/7912 (0%)
Stupor	0/7890 (0%)		1/7912 (0%)
Thrombotic stroke	1/7890 (0%)		0/7912 (0%)
Trigeminal neuralgia	1/7890 (0%)		0/7912 (0%)
VIth nerve paralysis	0/7890 (0%)		1/7912 (0%)
Vascular encephalopathy	1/7890 (0%)		0/7912 (0%)
Vascular parkinsonism	1/7890 (0%)		0/7912 (0%)
Vertigo CNS origin	1/7890 (0%)		0/7912 (0%)
Vocal cord paralysis	1/7890 (0%)		0/7912 (0%)
White matter lesion	0/7890 (0%)		1/7912 (0%)
Psychiatric disorders
Confusional state	12/7890 (0.2%)		8/7912 (0.1%)
Depression	7/7890 (0.1%)		8/7912 (0.1%)
Delirium	4/7890 (0.1%)		7/7912 (0.1%)
Mental status changes	6/7890 (0.1%)		2/7912 (0%)
Anxiety	4/7890 (0.1%)		2/7912 (0%)
Suicide attempt	1/7890 (0%)		5/7912 (0.1%)
Alcohol withdrawal syndrome	2/7890 (0%)		3/7912 (0%)
Completed suicide	3/7890 (0%)		2/7912 (0%)
Alcohol abuse	2/7890 (0%)		2/7912 (0%)
Anxiety disorder	2/7890 (0%)		2/7912 (0%)
Insomnia	1/7890 (0%)		2/7912 (0%)
Major depression	2/7890 (0%)		1/7912 (0%)
Suicidal ideation	2/7890 (0%)		1/7912 (0%)
Conversion disorder	1/7890 (0%)		1/7912 (0%)
Hallucination	0/7890 (0%)		2/7912 (0%)
Psychotic disorder	1/7890 (0%)		1/7912 (0%)
Suicidal behaviour	1/7890 (0%)		1/7912 (0%)
Aggression	1/7890 (0%)		0/7912 (0%)
Agitation	1/7890 (0%)		0/7912 (0%)
Alcoholism	1/7890 (0%)		0/7912 (0%)
Depression suicidal	1/7890 (0%)		0/7912 (0%)
Disorientation	0/7890 (0%)		1/7912 (0%)
Dysthymic disorder	1/7890 (0%)		0/7912 (0%)
Emotional distress	0/7890 (0%)		1/7912 (0%)
Hallucination, auditory	0/7890 (0%)		1/7912 (0%)
Impulse-control disorder	1/7890 (0%)		0/7912 (0%)
Mania	0/7890 (0%)		1/7912 (0%)
Mental disorder	0/7890 (0%)		1/7912 (0%)
Panic attack	1/7890 (0%)		0/7912 (0%)
Psychogenic seizure	1/7890 (0%)		0/7912 (0%)
Sleep disorder	0/7890 (0%)		1/7912 (0%)
Somatoform disorder cardiovascular	0/7890 (0%)		1/7912 (0%)
Renal and urinary disorders
Renal failure acute	61/7890 (0.8%)		83/7912 (1%)
Renal failure	17/7890 (0.2%)		31/7912 (0.4%)
Haematuria	15/7890 (0.2%)		12/7912 (0.2%)
Urinary retention	19/7890 (0.2%)		7/7912 (0.1%)
Renal failure chronic	13/7890 (0.2%)		10/7912 (0.1%)
Nephrolithiasis	10/7890 (0.1%)		11/7912 (0.1%)
Renal impairment	8/7890 (0.1%)		9/7912 (0.1%)
Calculus ureteric	9/7890 (0.1%)		6/7912 (0.1%)
Renal colic	8/7890 (0.1%)		6/7912 (0.1%)
Urethral stenosis	5/7890 (0.1%)		5/7912 (0.1%)
Renal artery stenosis	4/7890 (0.1%)		5/7912 (0.1%)
Hydronephrosis	7/7890 (0.1%)		0/7912 (0%)
Acute prerenal failure	3/7890 (0%)		3/7912 (0%)
Calculus urinary	5/7890 (0.1%)		1/7912 (0%)
Renal cyst	3/7890 (0%)		2/7912 (0%)
Renal tubular necrosis	2/7890 (0%)		2/7912 (0%)
Calculus bladder	2/7890 (0%)		1/7912 (0%)
Diabetic nephropathy	1/7890 (0%)		2/7912 (0%)
Nephrotic syndrome	0/7890 (0%)		3/7912 (0%)
Cystitis noninfective	2/7890 (0%)		0/7912 (0%)
Micturition disorder	2/7890 (0%)		0/7912 (0%)
Renal infarct	1/7890 (0%)		1/7912 (0%)
Tubulointerstitial nephritis	0/7890 (0%)		2/7912 (0%)
Ureteric obstruction	2/7890 (0%)		0/7912 (0%)
Ureteric stenosis	1/7890 (0%)		1/7912 (0%)
Urinary bladder polyp	1/7890 (0%)		1/7912 (0%)
Urinary incontinence	0/7890 (0%)		2/7912 (0%)
Urinary tract obstruction	1/7890 (0%)		1/7912 (0%)
Bladder dilatation	1/7890 (0%)		0/7912 (0%)
Bladder discomfort	0/7890 (0%)		1/7912 (0%)
Bladder dysfunction	0/7890 (0%)		1/7912 (0%)
Bladder hypertrophy	0/7890 (0%)		1/7912 (0%)
Cystitis glandularis	0/7890 (0%)		1/7912 (0%)
Cystitis haemorrhagic	1/7890 (0%)		0/7912 (0%)
Cystitis ulcerative	0/7890 (0%)		1/7912 (0%)
Dysuria	1/7890 (0%)		0/7912 (0%)
Glomerulonephritis	0/7890 (0%)		1/7912 (0%)
Glomerulonephritis Chronic	0/7890 (0%)		1/7912 (0%)
Incontinence	1/7890 (0%)		0/7912 (0%)
Lower urinary tract symptoms	1/7890 (0%)		0/7912 (0%)
Nephritic syndrome	1/7890 (0%)		0/7912 (0%)
Neurogenic bladder	1/7890 (0%)		0/7912 (0%)
Pollakiuria	1/7890 (0%)		0/7912 (0%)
Renal artery dissection	0/7890 (0%)		1/7912 (0%)
Renal artery arteriosclerosis	1/7890 (0%)		0/7912 (0%)
Renal cyst haemorrhage	0/7890 (0%)		1/7912 (0%)
Renal haemorrhage	0/7890 (0%)		1/7912 (0%)
Renal mass	1/7890 (0%)		0/7912 (0%)
Renal painr	0/7890 (0%)		1/7912 (0%)
Stress urinary incontinence	0/7890 (0%)		1/7912 (0%)
Urethral disorder	1/7890 (0%)		0/7912 (0%)
Urinary bladder haemorrhage	1/7890 (0%)		0/7912 (0%)
Reproductive system and breast disorders
Benign prostatic hyperplasia	28/7890 (0.4%)		31/7912 (0.4%)
Prostatitis	4/7890 (0.1%)		9/7912 (0.1%)
Prostatomegaly	8/7890 (0.1%)		2/7912 (0%)
Ovarian cyst	2/7890 (0%)		3/7912 (0%)
Uterine polyp	2/7890 (0%)		3/7912 (0%)
Acquired phimosis	2/7890 (0%)		2/7912 (0%)
Uterine prolapse	2/7890 (0%)		2/7912 (0%)
Epididymitis	1/7890 (0%)		2/7912 (0%)
Endometrial hyperplasia	1/7890 (0%)		1/7912 (0%)
Epididymal cyst	2/7890 (0%)		0/7912 (0%)
Scrotal oedema	2/7890 (0%)		0/7912 (0%)
Acquired hydrocele	1/7890 (0%)		0/7912 (0%)
Breast enlargement	1/7890 (0%)		0/7912 (0%)
Cervical dysplasia	1/7890 (0%)		0/7912 (0%)
Genital pain	1/7890 (0%)		0/7912 (0%)
Gynaecomastia	0/7890 (0%)		1/7912 (0%)
Ovarian mass	0/7890 (0%)		1/7912 (0%)
Pelvic fluid collection	1/7890 (0%)		0/7912 (0%)
Penile swelling	0/7890 (0%)		1/7912 (0%)
Peyronie's disease	1/7890 (0%)		0/7912 (0%)
Prostatic disorder	0/7890 (0%)		1/7912 (0%)
Prostatic obstruction	1/7890 (0%)		0/7912 (0%)
Prostatism	1/7890 (0%)		0/7912 (0%)
Scrotal swelling	0/7890 (0%)		1/7912 (0%)
Uterovaginal prolapse	0/7890 (0%)		1/7912 (0%)
Vaginal polyp	0/7890 (0%)		1/7912 (0%)
Vaginal prolapse	1/7890 (0%)		0/7912 (0%)
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease	52/7890 (0.7%)		50/7912 (0.6%)
Dyspnoea	39/7890 (0.5%)		52/7912 (0.7%)
Pulmonary embolism	26/7890 (0.3%)		35/7912 (0.4%)
Respiratory failure	24/7890 (0.3%)		18/7912 (0.2%)
Pleural effusion	20/7890 (0.3%)		12/7912 (0.2%)
Pulmonary oedema	15/7890 (0.2%)		17/7912 (0.2%)
Acute respiratory failure	18/7890 (0.2%)		10/7912 (0.1%)
Acute pulmonary oedema	14/7890 (0.2%)		12/7912 (0.2%)
Dyspnoea exertional	7/7890 (0.1%)		10/7912 (0.1%)
Epistaxis	6/7890 (0.1%)		10/7912 (0.1%)
Asthma	8/7890 (0.1%)		6/7912 (0.1%)
Haemoptysis	6/7890 (0.1%)		7/7912 (0.1%)
Pneumothorax	6/7890 (0.1%)		6/7912 (0.1%)
Sleep apnoea syndrome	6/7890 (0.1%)		4/7912 (0.1%)
Hypoxia	5/7890 (0.1%)		2/7912 (0%)
Pneumonia aspiration	4/7890 (0.1%)		3/7912 (0%)
Bronchitis chronic	4/7890 (0.1%)		2/7912 (0%)
Lung disorder	2/7890 (0%)		4/7912 (0.1%)
Atelectasis	1/7890 (0%)		4/7912 (0.1%)
Bronchiectasis	2/7890 (0%)		3/7912 (0%)
Cough	2/7890 (0%)		3/7912 (0%)
Interstitial lung disease	2/7890 (0%)		3/7912 (0%)
Lung infiltration	3/7890 (0%)		2/7912 (0%)
Pleuritic pain	1/7890 (0%)		4/7912 (0.1%)
Bronchospasm	0/7890 (0%)		4/7912 (0.1%)
Chronic respiratory failure	2/7890 (0%)		2/7912 (0%)
Pulmonary fibrosis	2/7890 (0%)		2/7912 (0%)
Pulmonary mass	0/7890 (0%)		4/7912 (0.1%)
Respiratory distress	2/7890 (0%)		2/7912 (0%)
Haemothorax	2/7890 (0%)		1/7912 (0%)
Obstructive airways disorder	3/7890 (0%)		0/7912 (0%)
Pulmonary congestion	2/7890 (0%)		1/7912 (0%)
Aspiration	2/7890 (0%)		0/7912 (0%)
Bronchial hyperreactivity	0/7890 (0%)		2/7912 (0%)
Bronchopulmonary disease	1/7890 (0%)		1/7912 (0%)
Hydropneumothorax	2/7890 (0%)		0/7912 (0%)
Idiopathic pulmonary fibrosis	1/7890 (0%)		1/7912 (0%)
Nasal septum deviation	0/7890 (0%)		2/7912 (0%)
Pulmonary hypertension	0/7890 (0%)		2/7912 (0%)
Respiratory arrest	1/7890 (0%)		1/7912 (0%)
Acute lung injury	0/7890 (0%)		1/7912 (0%)
Acute respiratory distress syndrome	0/7890 (0%)		1/7912 (0%)
Apnoea	1/7890 (0%)		0/7912 (0%)
Asphyxia	1/7890 (0%)		0/7912 (0%)
Bronchopleural fistula	1/7890 (0%)		0/7912 (0%)
Diaphragmatic disorder	1/7890 (0%)		0/7912 (0%)
Diaphragmatic paralysis	1/7890 (0%)		0/7912 (0%)
Dysphonia	0/7890 (0%)		1/7912 (0%)
Emphysema	1/7890 (0%)		0/7912 (0%)
Hydrothorax	1/7890 (0%)		0/7912 (0%)
Increased upper airway secretion	0/7890 (0%)		1/7912 (0%)
Laryngeal cyst	1/7890 (0%)		0/7912 (0%)
Laryngeal oedema	1/7890 (0%)		0/7912 (0%)
Laryngospasm	1/7890 (0%)		0/7912 (0%)
Lung consolidation	0/7890 (0%)		1/7912 (0%)
Lung cyst	1/7890 (0%)		0/7912 (0%)
Mediastinal haematoma	1/7890 (0%)		0/7912 (0%)
Mediastinal haemorrhage	1/7890 (0%)		0/7912 (0%)
Nasal mucosal hypertrophy	1/7890 (0%)		0/7912 (0%)
Nasal polyps	0/7890 (0%)		1/7912 (0%)
Nasal turbinate hypertrophy	0/7890 (0%)		1/7912 (0%)
Organising pneumonia	1/7890 (0%)		0/7912 (0%)
Oropharyngeal pain	0/7890 (0%)		1/7912 (0%)
Orthopnoea	1/7890 (0%)		0/7912 (0%)
Painful respiration	0/7890 (0%)		1/7912 (0%)
Pharyngeal oedema	0/7890 (0%)		1/7912 (0%)
Pneumonitis	1/7890 (0%)		0/7912 (0%)
Productive cough	1/7890 (0%)		0/7912 (0%)
Pulmonary arterial hypertension	0/7890 (0%)		1/7912 (0%)
Pulmonary haemorrhage	0/7890 (0%)		1/7912 (0%)
Respiratory disorder	0/7890 (0%)		1/7912 (0%)
Restrictive pulmonary disease	0/7890 (0%)		1/7912 (0%)
Snoring	1/7890 (0%)		0/7912 (0%)
Status asthmaticus	0/7890 (0%)		1/7912 (0%)
Vocal cord thickening	0/7890 (0%)		1/7912 (0%)
Wheezing	0/7890 (0%)		1/7912 (0%)
Nasal cyst	0/7890 (0%)		1/7912 (0%)
Skin and subcutaneous tissue disorders
Diabetic foot	14/7890 (0.2%)		5/7912 (0.1%)
Skin ulcer	8/7890 (0.1%)		5/7912 (0.1%)
Angioedema	2/7890 (0%)		3/7912 (0%)
Hyperhidrosis	4/7890 (0.1%)		1/7912 (0%)
Decubitus ulcer	1/7890 (0%)		3/7912 (0%)
Pruritus	0/7890 (0%)		3/7912 (0%)
Psoriasis	1/7890 (0%)		1/7912 (0%)
Rash	2/7890 (0%)		0/7912 (0%)
Actinic keratosis	1/7890 (0%)		0/7912 (0%)
Blister	1/7890 (0%)		0/7912 (0%)
Cold sweat	1/7890 (0%)		0/7912 (0%)
Dermatitis allergic	0/7890 (0%)		1/7912 (0%)
Drug eruption	0/7890 (0%)		1/7912 (0%)
Ecchymosis	1/7890 (0%)		0/7912 (0%)
Eczema	1/7890 (0%)		0/7912 (0%)
Eczema asteatotic	1/7890 (0%)		0/7912 (0%)
Erythema multiforme	0/7890 (0%)		1/7912 (0%)
Erythema nodosum	1/7890 (0%)		0/7912 (0%)
Keloid scar	0/7890 (0%)		1/7912 (0%)
Leukocytoclastic vasculitis	1/7890 (0%)		0/7912 (0%)
Neuropathic ulcer	0/7890 (0%)		1/7912 (0%)
Pemphigoid	1/7890 (0%)		0/7912 (0%)
Pyoderma gangrenosum	0/7890 (0%)		1/7912 (0%)
Rash generalised	0/7890 (0%)		1/7912 (0%)
Skin disorder	1/7890 (0%)		0/7912 (0%)
Skin necrosis	1/7890 (0%)		0/7912 (0%)
Stasis dermatitis	1/7890 (0%)		0/7912 (0%)
Swelling face	1/7890 (0%)		0/7912 (0%)
Urticaria	0/7890 (0%)		1/7912 (0%)
Social circumstances
Disability	0/7890 (0%)		1/7912 (0%)
Surgical and medical procedures
Coronary revascularisation	1/7890 (0%)		0/7912 (0%)
Vascular disorders
Peripheral arterial occlusive disease	55/7890 (0.7%)		46/7912 (0.6%)
Hypotension	39/7890 (0.5%)		27/7912 (0.3%)
Hypertension	32/7890 (0.4%)		29/7912 (0.4%)
Aortic aneurysm	24/7890 (0.3%)		35/7912 (0.4%)
Peripheral vascular disorder	27/7890 (0.3%)		24/7912 (0.3%)
Intermittent claudication	28/7890 (0.4%)		21/7912 (0.3%)
Peripheral artery stenosis	21/7890 (0.3%)		23/7912 (0.3%)
Peripheral ischaemia	20/7890 (0.3%)		19/7912 (0.2%)
Aortic stenosis	15/7890 (0.2%)		16/7912 (0.2%)
Hypertensive crisis	16/7890 (0.2%)		15/7912 (0.2%)
Haematoma	13/7890 (0.2%)		5/7912 (0.1%)
Femoral artery occlusion	12/7890 (0.2%)		5/7912 (0.1%)
Circulatory collapse	10/7890 (0.1%)		6/7912 (0.1%)
Orthostatic hypotension	8/7890 (0.1%)		7/7912 (0.1%)
Arteriosclerosis	6/7890 (0.1%)		7/7912 (0.1%)
Thrombosis	3/7890 (0%)		7/7912 (0.1%)
Hypovolaemic shock	2/7890 (0%)		6/7912 (0.1%)
Peripheral artery aneurysm	2/7890 (0%)		6/7912 (0.1%)
Peripheral artery thrombosis	5/7890 (0.1%)		3/7912 (0%)
Varicose vein	3/7890 (0%)		5/7912 (0.1%)
Iliac artery occlusion	7/7890 (0.1%)		0/7912 (0%)
Arterial stenosis	2/7890 (0%)		4/7912 (0.1%)
Aortic dissection	4/7890 (0.1%)		1/7912 (0%)
Extremity necrosis	1/7890 (0%)		4/7912 (0.1%)
Haemorrhage	3/7890 (0%)		2/7912 (0%)
Subclavian artery stenosis	4/7890 (0.1%)		1/7912 (0%)
Venous thrombosis	1/7890 (0%)		4/7912 (0.1%)
Aortic aneurysm rupture	1/7890 (0%)		3/7912 (0%)
Arterial occlusive disease	1/7890 (0%)		3/7912 (0%)
Diabetic vascular disorder	1/7890 (0%)		3/7912 (0%)
Thrombophlebitis	2/7890 (0%)		2/7912 (0%)
Ischaemia	2/7890 (0%)		1/7912 (0%)
Peripheral embolism	1/7890 (0%)		2/7912 (0%)
Shock	1/7890 (0%)		2/7912 (0%)
Shock haemorrhagic	1/7890 (0%)		2/7912 (0%)
Venous insufficiency	2/7890 (0%)		1/7912 (0%)
Accelerated hypertension	0/7890 (0%)		2/7912 (0%)
Aortic thrombosis	0/7890 (0%)		2/7912 (0%)
Arterial disorder	1/7890 (0%)		1/7912 (0%)
Arteriovenous fistula	1/7890 (0%)		1/7912 (0%)
Embolism	1/7890 (0%)		1/7912 (0%)
Hypertensive emergency	1/7890 (0%)		1/7912 (0%)
Phlebitis	2/7890 (0%)		0/7912 (0%)
Subclavian artery occlusion	2/7890 (0%)		0/7912 (0%)
Venous stenosis	2/7890 (0%)		0/7912 (0%)
Venous thrombosis limb	1/7890 (0%)		1/7912 (0%)
Aneurysm	1/7890 (0%)		0/7912 (0%)
Aneurysm ruptured	1/7890 (0%)		0/7912 (0%)
Angiopathy	1/7890 (0%)		0/7912 (0%)
Aortic arteriosclerosis	0/7890 (0%)		1/7912 (0%)
Aortic calcification	1/7890 (0%)		0/7912 (0%)
Aortic dilatation	1/7890 (0%)		0/7912 (0%)
Arterial insufficiency	1/7890 (0%)		0/7912 (0%)
Arterial rupture	1/7890 (0%)		0/7912 (0%)
Artery dissection	1/7890 (0%)		0/7912 (0%)
Bleeding varicose vein	1/7890 (0%)		0/7912 (0%)
Blood pressure fluctuation	0/7890 (0%)		1/7912 (0%)
Embolism venous	1/7890 (0%)		0/7912 (0%)
Extravasation blood	1/7890 (0%)		0/7912 (0%)
Femoral artery aneurysm	1/7890 (0%)		0/7912 (0%)
Haematocoele	0/7890 (0%)		1/7912 (0%)
Hypoperfusion	0/7890 (0%)		1/7912 (0%)
Iliac artery rupture	0/7890 (0%)		1/7912 (0%)
Infarction	0/7890 (0%)		1/7912 (0%)
Intra-abdominal haematoma	1/7890 (0%)		0/7912 (0%)
Ischaemic limb pain	1/7890 (0%)		0/7912 (0%)
Lymphocele	1/7890 (0%)		0/7912 (0%)
Orthostatic hypertension	0/7890 (0%)		1/7912 (0%)
Pelvic venous thrombosis	1/7890 (0%)		0/7912 (0%)
Phlebitis superficial	0/7890 (0%)		1/7912 (0%)
Poor peripheral circulation	0/7890 (0%)		1/7912 (0%)
Raynaud's phenomenon	1/7890 (0%)		0/7912 (0%)
Renovascular hypertension	0/7890 (0%)		1/7912 (0%)
Subclavian artery aneurysm	1/7890 (0%)		0/7912 (0%)
Subclavian steal syndrome	1/7890 (0%)		0/7912 (0%)
Temporal arteritis	1/7890 (0%)		0/7912 (0%)
Thromboangiitis obliterans	0/7890 (0%)		1/7912 (0%)
Varicose ulceration	0/7890 (0%)		1/7912 (0%)
Varicose vein ruptured	0/7890 (0%)		1/7912 (0%)
Vascular insufficiency	0/7890 (0%)		1/7912 (0%)
Deep vein thrombosis	17/7890 (0.2%)		10/7912 (0.1%)
Other (Not Including Serious) Adverse Events
	Placebo		Darapladib
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4885/7890 (61.9%)		5171/7912 (65.4%)
Blood and lymphatic system disorders
Anaemia	208/7890 (2.6%)		191/7912 (2.4%)
Cardiac disorders
Angina pectoris	528/7890 (6.7%)		457/7912 (5.8%)
Atrial fibrillation	245/7890 (3.1%)		257/7912 (3.2%)
Eye disorders
Cataract	198/7890 (2.5%)		203/7912 (2.6%)
Gastrointestinal disorders
Abdominal pain	188/7890 (2.4%)		163/7912 (2.1%)
Abdominal pain upper	152/7890 (1.9%)		180/7912 (2.3%)
Abnormal faeces	63/7890 (0.8%)		728/7912 (9.2%)
Constipation	255/7890 (3.2%)		247/7912 (3.1%)
Diarrhoea	479/7890 (6.1%)		949/7912 (12%)
Dyspepsia	182/7890 (2.3%)		177/7912 (2.2%)
Flatulence	92/7890 (1.2%)		189/7912 (2.4%)
Gastritis	192/7890 (2.4%)		159/7912 (2%)
Gastrooesophageal reflux disease	160/7890 (2%)		144/7912 (1.8%)
Large intestine polyp	265/7890 (3.4%)		259/7912 (3.3%)
Nausea	222/7890 (2.8%)		228/7912 (2.9%)
General disorders
Fatigue	357/7890 (4.5%)		354/7912 (4.5%)
Non-cardiac chest pain	376/7890 (4.8%)		366/7912 (4.6%)
Oedema peripheral	419/7890 (5.3%)		431/7912 (5.4%)
Infections and infestations
Bronchitis	416/7890 (5.3%)		389/7912 (4.9%)
Influenza	253/7890 (3.2%)		223/7912 (2.8%)
Nasopharyngitis	588/7890 (7.5%)		548/7912 (6.9%)
Sinusitis	189/7890 (2.4%)		157/7912 (2%)
Upper respiratory tract infection	425/7890 (5.4%)		367/7912 (4.6%)
Urinary tract infection	296/7890 (3.8%)		260/7912 (3.3%)
Investigations
Blood glucose increased	181/7890 (2.3%)		171/7912 (2.2%)
Blood pressure increased	197/7890 (2.5%)		173/7912 (2.2%)
Metabolism and nutrition disorders
Type 2 diabetes mellitus	608/7890 (7.7%)		566/7912 (7.2%)
Musculoskeletal and connective tissue disorders
Arthralgia	401/7890 (5.1%)		385/7912 (4.9%)
Back pain	466/7890 (5.9%)		421/7912 (5.3%)
Muscle spasms	168/7890 (2.1%)		164/7912 (2.1%)
Musculoskeletal pain	219/7890 (2.8%)		180/7912 (2.3%)
Myalgia	244/7890 (3.1%)		207/7912 (2.6%)
Osteoarthritis	176/7890 (2.2%)		167/7912 (2.1%)
Pain in extremity	354/7890 (4.5%)		315/7912 (4%)
Nervous system disorders
Dizziness	491/7890 (6.2%)		456/7912 (5.8%)
Headache	357/7890 (4.5%)		296/7912 (3.7%)
Psychiatric disorders
Insomnia	164/7890 (2.1%)		126/7912 (1.6%)
Renal and urinary disorders
Urine odour abnormal	81/7890 (1%)		473/7912 (6%)
Respiratory, thoracic and mediastinal disorders
Cough	404/7890 (5.1%)		401/7912 (5.1%)
Dyspnoea	346/7890 (4.4%)		324/7912 (4.1%)
Skin and subcutaneous tissue disorders
Skin odour abnormal	34/7890 (0.4%)		383/7912 (4.8%)
Vascular disorders
Hypertension	660/7890 (8.4%)		643/7912 (8.1%)
Hypotension	181/7890 (2.3%)		184/7912 (2.3%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.