Effect of Albiglutide, When Added to Standard Blood Glucose Lowering Therapies, on Major Cardiovascular Events in Subjects With Type 2 Diabetes Mellitus
Study Details
Study Description
Brief Summary
Albiglutide is an analogue of glucagon-like peptide-1 (GLP-1), used to treat type 2 diabetes This study will test whether albiglutide affects the occurrence of major cardiovascular events such as heart attacks or strokes and other important medical outcomes in persons with type 2 diabetes, when used alone or added to other diabetes treatments.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 4 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Albiglutide Albiglutide once weekly by subcutaneous injection. Starting dose 30 mg may be increased to 50 mg if needed. Albiglutide will be administered in addition to standard therapy for diabetes and cardiovascular health. |
Biological: Albiglutide 30 mg
Once weekly subcutaneous injection. Starting dose 30 mg may be increased to 50 mg if needed.
Biological: Albiglutide 50 mg
Once weekly subcutaneous injection. Starting dose 30 mg may be increased to 50 mg if needed.
|
Placebo Comparator: Placebo Placebo once weekly by subcutaneous injection. Placebo will be administered in addition to standard therapy for diabetes and cardiovascular health. |
Biological: Albiglutide matching placebo
Once weekly subcutaneous injection. Matched to 30 mg and 50 mg albiglutide.
|
Outcome Measures
Primary Outcome Measures
- Time to First Occurrence of Major Adverse Cardiovascular Events (MACE) During Cardiovascular (CV) Follow-up Time Period [Median of 1.65 person years for CV follow-up time period]
Time to MACE defined as the time to first occurrence of Cardiovascular Endpoint Committee (CEC)-adjudicated MACE (CV death, myocardial infarction [MI] or stroke) was analyzed using a Cox Proportional Hazards regression model with treatment group as the only covariate. The incidence rate per 100 person years (100*number of participants with at least 1 event)/first event person-years) is presented along with 95% confidence interval. First event person-years=(cumulative total time to first event for participants who have the event+cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period. The analysis was performed on the Intent to Treat (ITT) Population which comprised of all randomized participants excluding participants who did not provide consent.
Secondary Outcome Measures
- Time to First Occurrence of MACE or Urgent Revascularization for Unstable Angina [Median of 1.65 person years for CV follow-up time period]
Time to first occurrence of CEC-adjudicated MACE (CV death, MI or stroke) or urgent revascularization for unstable angina was analyzed using a Cox Proportional Hazards regression model with treatment group as the only covariate. The incidence rate per 100 person years (100*number of participants with at least 1 event)/first event person-years) is presented along with 95% confidence interval. First event person-years=(cumulative total time to first event for participants who have the event+cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period.
- Time to Adjudicated CV Death [Median of 1.65 person years for the CV follow-up time period]
Time to adjudicated CV death was analyzed using a Cox Proportional Hazards regression model with treatment group as the only covariate. The incidence rate per 100 person years (100*number of participants with at least 1 event)/first event person-years) is presented along with 95% confidence interval. First event person-years=(cumulative total time to first event for participants who have the event+cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period.
- Time to First Occurrence of Adjudicated MI [Median of 1.65 person years for CV follow-up time period]
Time to first occurrence of adjudicated MI was analyzed using a Cox Proportional Hazards regression model with treatment group as the only covariate. The incidence rate per 100 person years (100*number of participants with at least 1 event)/first event person-years) is presented along with 95% confidence interval. First event person-years=(cumulative total time to first event for participants who have the event+cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period.
- Time to First Occurrence of Adjudicated Stroke [Median of 1.65 person years for CV follow-up time period]
Time to first occurrence of adjudicated stroke was analyzed using a Cox Proportional Hazards regression model with treatment group as the only covariate. The incidence rate per 100 person years (100*number of participants with at least 1 event)/first event person-years) is presented along with 95% confidence interval. First event person-years=(cumulative total time to first event for participants who have the event+cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period.
- Time to First Occurrence of Adjudicated CV Death or Hospitalization for Heart Failure (HF) [Median of 1.65 person years for CV follow-up time period]
Time to first occurrence of adjudicated CV death or hospitalization for HF was analyzed using a Cox Proportional Hazards regression model with treatment group as the only covariate. The incidence rate per 100 person years (100*number of participants with at least 1 event)/first event person-years) is presented along with 95% confidence interval. First event person-years=(cumulative total time to first event for participants who have the event+cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period.
- Time to Initiation of Insulin of More Than 3 Months Duration for Those Participants Not Treated With Insulin at Study Start [Up to 2.7 years]
Time to initiation of insulin of more than 3 months duration in participants not treated with insulin at study start was analyzed using a Cox Proportional Hazards regression model with treatment group as the only covariate. The incidence rate per 100 person years (100*number of participants with at least 1 event)/first event person-years) is presented along with 95% confidence interval. First event person-years=(cumulative total time to first event for participants who have the event+cumulative total of censored time for participants without the event)/365.25, based on the on-therapy and post-therapy AE time period. The analysis was performed on Non-Insulin Population which comprised of participants in the ITT Population who were not on insulin at Baseline.
- Time to Initiation of Prandial Insulin in Those Participants on Basal Insulin at Study Start [Up to 2.7 years]
Time to initiation of prandial insulin in those participants on basal insulin at study start was analyzed using a Cox Proportional Hazards regression model with treatment group as the only covariate. The incidence rate per 100 person years (100*number of participants with at least 1 event)/first event person-years) is presented along with 95% confidence interval. First event person-years=(cumulative total time to first event for participants who have the event+cumulative total of censored time for participants without the event)/365.25, based on the on-therapy and post-therapy AE time period. The analysis was performed on Basal Insulin Population which comprised of participants in the ITT Population who were on basal insulin but not on other insulin at Baseline (i.e., will not include a participant on a mixed insulin or on a prandial-only insulin).
- Percentage of Participants Achieving Composite Metabolic Endpoint [Months 8, 16, 24 and final assessment (up to 2.7 years)]
Percentage of participants achieving composite metabolic endpoint defined as the percentage of participants achieving glycemic control (glycated hemoglobin [HbA1c] <=7% ) with no severe hypoglycemic incidents and weight gain < 5%. Final Assessment is the latest post-Baseline assessment of both HbA1c and weight.
- Time to First Occurrence of a Clinically Important Microvascular Event [Up to 2.7 years]
Clinically important microvascular events were defined as the following: need for renal transplant or dialysis, new diabetes-related blindness, and procedures (laser photocoagulation or anti-vascular endothelial growth factor treatment or vitrectomy for diabetic retinopathy/eye disease). Time to first occurrence of a clinically important microvascular event was analyzed using a Cox Proportional Hazards regression model with treatment group as the only covariate. The incidence rate per 100 person years (100*number of participants with at least 1 event)/first event person-years) is presented along with 95% confidence interval. First event person-years=(cumulative total time to first event for participants who have the event+cumulative total of censored time for participants without the event)/365.25, based on the on-therapy and post-therapy AE time period.
- Change From Baseline in HbA1c [Baseline and Months 8 and 16]
Change from Baseline in HbA1c was analyzed using mixed model repeated measures (MMRM) including observed case data (does not impute any missing data). Baseline is the last non-missing value assessed on or before treatment start date. Change from Baseline is the value at specified time point minus the Baseline value. Change from Baseline in HbA1c using Baseline data from Local or Central Laboratory, and post-Baseline Central Laboratory data is presented.
- Change From Baseline in Body Weight [Baseline and Months 8 and 16]
Change from Baseline in body weight was analyzed using mixed model repeated measures including observed case data (does not impute any missing data). Baseline is the last non-missing value assessed on or before treatment start date. Change from Baseline is the value at specified time point minus the Baseline value.
- Change From Baseline in Treatment Related Impact Measures-Diabetes (TRIM-D) Total Score [Baseline and Months 8 and 16]
The TRIM-D is a 28 item treatment satisfaction measure with 5 domains assessing Treatment Burden, Daily Life, Diabetes Management, Compliance and Psychological Health. The raw score ranges for each subscale were: treatment burden (6 to 30), daily life (5 to 25), diabetes management (5 to 25), compliance (4 to 20) and psychological health (8 to 40), higher scores indicating better health state. Total raw score was determined by summing the raw scores for each of the subscales and the total score (transformed) was determined as [(raw score minus lowest possible raw score)/possible raw score range] x100. The possible total (transformed) score range is 0-100, where higher scores indicated better health state. Baseline is the last non-missing value assessed on or before treatment start date. Change from Baseline is the value at specified time point minus the Baseline value.
- Change From Baseline in EuroQol- 5 Dimension (EQ-5D) Visual Analogue Scale (VAS) Score [Baseline and Months 8 and 16]
The EQ-5D is a standardized instrument used to evaluate generic health-related quality of life, comprising 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. It provides a simple descriptive profile and a single index value for health status. The EQ-5D self-reported questionnaire includes a visual analog scale (VAS), which records the respondent's self-rated health status on a graduated (0-100) scale, where 0 represents the worst imaginable health state and 100 represents the best imaginable health state. Baseline is the last non-missing value assessed on or before treatment start date. Change from Baseline is the value at specified time point minus the Baseline value.
- Time to Death [Median of 1.73 years for the Vital Status follow-up time period]
Time to death was analyzed using a Cox Proportional Hazards regression model with treatment group as the only covariate. The incidence rate per 100 person years (100*number of participants who died/endpoint person-years) is presented along with 95% confidence interval. Endpoint person-years=(cumulative total time to event for participants who have the event+cumulative total of censored time for participants without the event)/365.25, based on the Vital Status follow-up time period.
- Number of Participants With Non-fatal Serious Adverse Events (SAEs) [Up to 2.7 years]
SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; is a congenital anomaly/birth defect; other important medical events that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed before; is associated with liver injury and impaired liver function. Number of participants with on-therapy non-fatal SAEs are presented. Safety Population comprised of all randomized participants who received at least one dose of study treatment.
- Number of Participants With Adverse Events (AEs) Leading to Discontinuation of Investigational Product (AELD) [Up to 2.7 years]
The number of participants with on-therapy AEs leading to discontinuation of investigational product is reported.
- Number of Participants With AEs of Special Interest [Up to 2.7 years]
The protocol defined AEs of special interest included: development of thyroid cancer; hematologic malignancy; pancreatic cancer; pancreatitis (investigator reported and pancreatitis positively adjudicated by the Pancreatic Adjudication Committee [PAC]); investigational product injection site reactions; immunological reactions; severe hypoglycemic events; hepatic events; hepatic enzyme elevations (including gamma glutamyl transferase [GGT]); serious gastrointestinal (GI) events; appendicitis; atrial fibrillation/flutter; pneumonia; worsening renal function and diabetic retinopathy. The number of participants with on-therapy AEs of special interest is reported.
- Change in Estimated Glomerular Filtration Rate (eGFR) Calculated Using Modification of Diet in Renal Disease (MDRD) Formula [Baseline and Months 8 and 16]
Blood samples were collected for the measurement of serum creatinine. Serum creatinine values were used to calculate eGFR using the MDRD formula, eGFR=175 x (serum creatinine)^-1.154 x (Age)^-0.203 x (0.742 if female) x (1.212 if African American). Baseline is the last non-missing value assessed on or before treatment start date. Change from Baseline is the value at specified time point minus the Baseline value. Change from Baseline in eGFR using Baseline data from Local or Central Laboratory, and post-Baseline Central Laboratory data for the on-treatment time period is presented.
- Change From Baseline in Blood Pressure [Baseline and Months 8,16,24 and end of study (up to 2.7 years)]
Systolic blood pressure (SBP) and diastolic blood pressure (DBP) were taken with the participant in a semi-recumbent or seated position after at least a 5-minute rest period. Baseline is the last non-missing value assessed on or before treatment start date. Change from Baseline is the value at specified time point minus the Baseline value.
- Change From Baseline in Heart Rate [Baseline and Months 8, 16, 24 and end of study (up to 2.7 years)]
Heart rate was measured with the participant in a semi-recumbent or seated position after at least a 5-minute rest period. Baseline is the last non-missing value assessed on or before treatment start date. Change from Baseline is the value at specified time point minus the Baseline value.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Men or women at least 40 years old. Women must be post-menopausal or using a highly effective method for avoidance of pregnancy.
-
Diagnosis of type 2 diabetes.
-
Established cardiovascular disease with at least one of the following: coronary artery disease, cerebrovascular disease, or peripheral arterial disease.
-
HbA1c >7.0% (53 mmol/mol) (based on the most recent documented laboratory measurement within 6 months).
-
Able and willing to provide informed consent.
Exclusion Criteria:
-
Severely reduced kidney function: eGFR <30 ml/min/1.73 m^2 (based on the last measured and documented laboratory measurement within 6 months) or renal replacement therapy.
-
Use of a GLP-1 receptor agonist at Screening.
-
Severe gastroparesis
-
History of pancreatitis or considered clinically at significant risk of developing pancreatitis during the course of the study.
-
Personal or family history of medullary carcinoma of the thyroid or subject with multiple endocrine neoplasia type 2 (MEN-2). Personal history of pancreatic neuroendocrine tumours.
-
Medical history which might limit the subject's ability to take trial treatments for the duration of the study or to otherwise complete the study.
-
Breastfeeding, pregnancy, or planning a pregnancy during the course of the study. Note: a pregnancy test will be performed on all women of child bearing potential prior to study entry.
-
Known allergy to any GLP-1 receptor agonist or excipients of albiglutide.
-
Use of another investigational product within 30 days or according to local regulations, or currently enrolled in a study of an investigational device.
-
Any other reason the investigator deems the subject to be unsuitable for the study.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | GSK Investigational Site | Birmingham | Alabama | United States | 35211 |
2 | GSK Investigational Site | Birmingham | Alabama | United States | 35235 |
3 | GSK Investigational Site | Mobile | Alabama | United States | 36608 |
4 | GSK Investigational Site | Chandler | Arizona | United States | 85284 |
5 | GSK Investigational Site | Glendale | Arizona | United States | 85308 |
6 | GSK Investigational Site | Goodyear | Arizona | United States | 85395 |
7 | GSK Investigational Site | Tempe | Arizona | United States | 85283 |
8 | GSK Investigational Site | Tucson | Arizona | United States | 85741 |
9 | GSK Investigational Site | Tucson | Arizona | United States | 85745 |
10 | GSK Investigational Site | Little Rock | Arkansas | United States | 72209 |
11 | GSK Investigational Site | Searcy | Arkansas | United States | 72143 |
12 | GSK Investigational Site | Chula Vista | California | United States | 91910 |
13 | GSK Investigational Site | Lancaster | California | United States | 93534 |
14 | GSK Investigational Site | Lomita | California | United States | 90717 |
15 | GSK Investigational Site | Long Beach | California | United States | 90807 |
16 | GSK Investigational Site | Long Beach | California | United States | 90822 |
17 | GSK Investigational Site | Los Angeles | California | United States | 90017 |
18 | GSK Investigational Site | Los Angeles | California | United States | 90073 |
19 | GSK Investigational Site | Moreno Valley | California | United States | 92555 |
20 | GSK Investigational Site | Northridge | California | United States | 91325 |
21 | GSK Investigational Site | Oakland | California | United States | 94607 |
22 | GSK Investigational Site | San Diego | California | United States | 92103 |
23 | GSK Investigational Site | San Diego | California | United States | 92117 |
24 | GSK Investigational Site | San Marino | California | United States | 91108 |
25 | GSK Investigational Site | San Ramon | California | United States | 94583 |
26 | GSK Investigational Site | Simi Valley | California | United States | 93065 |
27 | GSK Investigational Site | Stanford | California | United States | 94305 |
28 | GSK Investigational Site | Torrance | California | United States | 90502 |
29 | GSK Investigational Site | Denver | Colorado | United States | 80220 |
30 | GSK Investigational Site | Littleton | Colorado | United States | 80120 |
31 | GSK Investigational Site | Littleton | Colorado | United States | 80127 |
32 | GSK Investigational Site | New Haven | Connecticut | United States | 06511 |
33 | GSK Investigational Site | Belle Glade | Florida | United States | 33430 |
34 | GSK Investigational Site | Bradenton | Florida | United States | 34201 |
35 | GSK Investigational Site | Bradenton | Florida | United States | 34209 |
36 | GSK Investigational Site | Coral Gables | Florida | United States | 33134 |
37 | GSK Investigational Site | Coral Springs | Florida | United States | 33065 |
38 | GSK Investigational Site | Fleming Island | Florida | United States | 32003 |
39 | GSK Investigational Site | Inverness | Florida | United States | 34452 |
40 | GSK Investigational Site | Jacksonville | Florida | United States | 32216 |
41 | GSK Investigational Site | Lake Worth | Florida | United States | 33467 |
42 | GSK Investigational Site | Lakeland | Florida | United States | 33805 |
43 | GSK Investigational Site | Miami | Florida | United States | 33174 |
44 | GSK Investigational Site | Ocala | Florida | United States | 34471 |
45 | GSK Investigational Site | Ponte Vedra | Florida | United States | 32081 |
46 | GSK Investigational Site | Port Charlotte | Florida | United States | 33952 |
47 | GSK Investigational Site | Port Orange | Florida | United States | 32127 |
48 | GSK Investigational Site | Saint Petersburg | Florida | United States | 33713 |
49 | GSK Investigational Site | Vero Beach | Florida | United States | 32960 |
50 | GSK Investigational Site | Wellington | Florida | United States | 33449 |
51 | GSK Investigational Site | Atlanta | Georgia | United States | 30318 |
52 | GSK Investigational Site | Atlanta | Georgia | United States | 30342 |
53 | GSK Investigational Site | Conyers | Georgia | United States | 30094 |
54 | GSK Investigational Site | Cumming | Georgia | United States | 30041 |
55 | GSK Investigational Site | Decatur | Georgia | United States | 30033 |
56 | GSK Investigational Site | Dunwoody | Georgia | United States | 30338 |
57 | GSK Investigational Site | Snellville | Georgia | United States | 30078 |
58 | GSK Investigational Site | Tucker | Georgia | United States | 30084 |
59 | GSK Investigational Site | Aurora | Illinois | United States | 60504 |
60 | GSK Investigational Site | Champaign | Illinois | United States | 61820 |
61 | GSK Investigational Site | Gurnee | Illinois | United States | 60031 |
62 | GSK Investigational Site | Moline | Illinois | United States | 61265 |
63 | GSK Investigational Site | Avon | Indiana | United States | 46123 |
64 | GSK Investigational Site | Franklin | Indiana | United States | 46131 |
65 | GSK Investigational Site | Greenfield | Indiana | United States | 46140 |
66 | GSK Investigational Site | Muncie | Indiana | United States | 47304- |
67 | GSK Investigational Site | Munster | Indiana | United States | 46321 |
68 | GSK Investigational Site | West Des Moines | Iowa | United States | 50265 |
69 | GSK Investigational Site | Topeka | Kansas | United States | 66606 |
70 | GSK Investigational Site | Lexington | Kentucky | United States | 40503 |
71 | GSK Investigational Site | Louisville | Kentucky | United States | 40213 |
72 | GSK Investigational Site | New Orleans | Louisiana | United States | 70115 |
73 | GSK Investigational Site | Lewiston | Maine | United States | 04240 |
74 | GSK Investigational Site | Annapolis | Maryland | United States | 21401 |
75 | GSK Investigational Site | Saint Cloud | Minnesota | United States | 56303 |
76 | GSK Investigational Site | Saint Paul | Minnesota | United States | 55102 |
77 | GSK Investigational Site | Saint Louis | Missouri | United States | 63136 |
78 | GSK Investigational Site | Omaha | Nebraska | United States | 68124 |
79 | GSK Investigational Site | Las Vegas | Nevada | United States | 89086 |
80 | GSK Investigational Site | Camden | New Jersey | United States | 08103 |
81 | GSK Investigational Site | Haddon Heights | New Jersey | United States | 08035 |
82 | GSK Investigational Site | Albuquerque | New Mexico | United States | 87102 |
83 | GSK Investigational Site | Brooklyn | New York | United States | 11215 |
84 | GSK Investigational Site | North Massapequa | New York | United States | 11758 |
85 | GSK Investigational Site | Charlotte | North Carolina | United States | 28207 |
86 | GSK Investigational Site | Charlotte | North Carolina | United States | 28209 |
87 | GSK Investigational Site | Charlotte | North Carolina | United States | 28277 |
88 | GSK Investigational Site | Hickory | North Carolina | United States | 28601 |
89 | GSK Investigational Site | Rocky Mount | North Carolina | United States | 27804 |
90 | GSK Investigational Site | Salisbury | North Carolina | United States | 28144 |
91 | GSK Investigational Site | Statesville | North Carolina | United States | 28625 |
92 | GSK Investigational Site | Wilmington | North Carolina | United States | 28401 |
93 | GSK Investigational Site | Winston-Salem | North Carolina | United States | 27157 |
94 | GSK Investigational Site | Fargo | North Dakota | United States | 58103 |
95 | GSK Investigational Site | Cleveland | Ohio | United States | 44122 |
96 | GSK Investigational Site | Columbus | Ohio | United States | 43210 |
97 | GSK Investigational Site | Sandusky | Ohio | United States | 44870 |
98 | GSK Investigational Site | Springfield | Ohio | United States | 45504 |
99 | GSK Investigational Site | Toledo | Ohio | United States | 43614 |
100 | GSK Investigational Site | Camp Hill | Pennsylvania | United States | 17011 |
101 | GSK Investigational Site | Feasterville | Pennsylvania | United States | 19053 |
102 | GSK Investigational Site | Harleysville | Pennsylvania | United States | 19438 |
103 | GSK Investigational Site | Jersey Shore | Pennsylvania | United States | 17740 |
104 | GSK Investigational Site | Lansdale | Pennsylvania | United States | 19446 |
105 | GSK Investigational Site | Newport | Pennsylvania | United States | 17074 |
106 | GSK Investigational Site | Penndel | Pennsylvania | United States | 19047 |
107 | GSK Investigational Site | Pittsburgh | Pennsylvania | United States | 15212 |
108 | GSK Investigational Site | Pittsburgh | Pennsylvania | United States | 15240 |
109 | GSK Investigational Site | Sellersville | Pennsylvania | United States | 18960 |
110 | GSK Investigational Site | Pawtucket | Rhode Island | United States | 02860 |
111 | GSK Investigational Site | Anderson | South Carolina | United States | 29621 |
112 | GSK Investigational Site | Columbia | South Carolina | United States | 29223 |
113 | GSK Investigational Site | Myrtle Beach | South Carolina | United States | 29572 |
114 | GSK Investigational Site | Rapid City | South Dakota | United States | 57701 |
115 | GSK Investigational Site | Rapid City | South Dakota | United States | 57702 |
116 | GSK Investigational Site | Bristol | Tennessee | United States | 37620 |
117 | GSK Investigational Site | Kingsport | Tennessee | United States | 37660 |
118 | GSK Investigational Site | Memphis | Tennessee | United States | 38104 |
119 | GSK Investigational Site | Memphis | Tennessee | United States | 38119 |
120 | GSK Investigational Site | Nashville | Tennessee | United States | 37203 |
121 | GSK Investigational Site | Nashville | Tennessee | United States | 37212 |
122 | GSK Investigational Site | Arlington | Texas | United States | 76014 |
123 | GSK Investigational Site | Austin | Texas | United States | 78731 |
124 | GSK Investigational Site | Bellaire | Texas | United States | 77401 |
125 | GSK Investigational Site | Dallas | Texas | United States | 75216 |
126 | GSK Investigational Site | Dallas | Texas | United States | 75231 |
127 | GSK Investigational Site | Dallas | Texas | United States | 75234 |
128 | GSK Investigational Site | Dallas | Texas | United States | |
129 | GSK Investigational Site | El Paso | Texas | United States | 79925 |
130 | GSK Investigational Site | Georgetown | Texas | United States | 78626 |
131 | GSK Investigational Site | Houston | Texas | United States | 77070 |
132 | GSK Investigational Site | Huntsville | Texas | United States | 77340 |
133 | GSK Investigational Site | Kingwood | Texas | United States | 77339 |
134 | GSK Investigational Site | Plano | Texas | United States | 75093 |
135 | GSK Investigational Site | San Antonio | Texas | United States | 78229 |
136 | GSK Investigational Site | San Antonio | Texas | United States | 78258 |
137 | GSK Investigational Site | Schertz | Texas | United States | 78154 |
138 | GSK Investigational Site | Suite 101 | Texas | United States | 76132 |
139 | GSK Investigational Site | Tyler | Texas | United States | 75708 |
140 | GSK Investigational Site | Layton | Utah | United States | 84401 |
141 | GSK Investigational Site | Manassas | Virginia | United States | 20109 |
142 | GSK Investigational Site | Federal Way | Washington | United States | 98003 |
143 | GSK Investigational Site | Spokane | Washington | United States | 99208 |
144 | GSK Investigational Site | Tacoma | Washington | United States | 98405 |
145 | GSK Investigational Site | Wenatchee | Washington | United States | 98801 |
146 | GSK Investigational Site | Madison | Wisconsin | United States | 53713 |
147 | GSK Investigational Site | Adrogue | Buenos Aires | Argentina | B1846DSK |
148 | GSK Investigational Site | Bahia Blanca | Buenos Aires | Argentina | B8000FTD |
149 | GSK Investigational Site | Ciudad Autonoma de Buenos Aires | Buenos Aires | Argentina | 1205 |
150 | GSK Investigational Site | Ciudad Autonoma de Buenos Aires | Buenos Aires | Argentina | C1179AAB |
151 | GSK Investigational Site | Ciudad autónoma de Buenos Aires | Buenos Aires | Argentina | C141AH |
152 | GSK Investigational Site | Mar del Plata | Buenos Aires | Argentina | B7600FZN |
153 | GSK Investigational Site | Mar del Plata | Buenos Aires | Argentina | |
154 | GSK Investigational Site | Pergamino | Buenos Aires | Argentina | B2700CPM |
155 | GSK Investigational Site | Córdoba | Córdova | Argentina | 5000 |
156 | GSK Investigational Site | Godoy Cruz | Mendoza | Argentina | M5501ARP |
157 | GSK Investigational Site | San Rafael | Mendoza | Argentina | 5600 |
158 | GSK Investigational Site | Rosario | Santa Fe | Argentina | 2000 |
159 | GSK Investigational Site | Rosario | Santa Fe | Argentina | S2000C |
160 | GSK Investigational Site | Berazategui | Argentina | 1886 | |
161 | GSK Investigational Site | Buenos Aires | Argentina | 1093 | |
162 | GSK Investigational Site | Buenos Aires | Argentina | 1407 | |
163 | GSK Investigational Site | Buenos Aires | Argentina | C1061ABD | |
164 | GSK Investigational Site | Buenos Aires | Argentina | C1180A | |
165 | GSK Investigational Site | Buenos Aires | Argentina | C1425AGC | |
166 | GSK Investigational Site | Buenos Aires | Argentina | ||
167 | GSK Investigational Site | Ciudad Autonoma de Buenos Aires | Argentina | C1056ABJ | |
168 | GSK Investigational Site | Ciudad Autonoma de Buenos Aires | Argentina | C1406BOA | |
169 | GSK Investigational Site | Ciudad Autonoma de Buenos Aires | Argentina | C1428D | |
170 | GSK Investigational Site | Ciudad Autónoma de Buenos Aires | Argentina | C1128A | |
171 | GSK Investigational Site | Ciudad Autónoma de Buenos Aires | Argentina | C1426A | |
172 | GSK Investigational Site | Cordoba | Argentina | 5016 | |
173 | GSK Investigational Site | La Plata | Argentina | B1902C | |
174 | GSK Investigational Site | Mendoza | Argentina | 5500 | |
175 | GSK Investigational Site | Mendoza | Argentina | M5500CCE | |
176 | GSK Investigational Site | Mendoza | Argentina | M5500C | |
177 | GSK Investigational Site | Santa Fe | Argentina | 3000 | |
178 | GSK Investigational Site | Bonheiden | Belgium | 2820 | |
179 | GSK Investigational Site | Brussels | Belgium | 1090 | |
180 | GSK Investigational Site | Bruxelles | Belgium | 1070 | |
181 | GSK Investigational Site | Edegem | Belgium | 2650 | |
182 | GSK Investigational Site | Leuven | Belgium | 3000 | |
183 | GSK Investigational Site | Liège | Belgium | 4000 | |
184 | GSK Investigational Site | Roeselare | Belgium | 8800 | |
185 | GSK Investigational Site | Byala | Bulgaria | 7100 | |
186 | GSK Investigational Site | Gabrovo | Bulgaria | 5300 | |
187 | GSK Investigational Site | Montana | Bulgaria | ||
188 | GSK Investigational Site | Sevlievo | Bulgaria | 5400 | |
189 | GSK Investigational Site | Sofia | Bulgaria | 1202 | |
190 | GSK Investigational Site | Sofia | Bulgaria | 1407 | |
191 | GSK Investigational Site | Sofia | Bulgaria | 1632 | |
192 | GSK Investigational Site | Stara Zagora | Bulgaria | 6000 | |
193 | GSK Investigational Site | Kelowna | British Columbia | Canada | V1Y 1V6 |
194 | GSK Investigational Site | Surrey | British Columbia | Canada | V3V 0C6 |
195 | GSK Investigational Site | Victoria | British Columbia | Canada | V8R 4R2 |
196 | GSK Investigational Site | Victoria | British Columbia | Canada | V8V 4A |
197 | GSK Investigational Site | Winnipeg | Manitoba | Canada | 3P |
198 | GSK Investigational Site | Moncton | New Brunswick | Canada | E1G 1A7 |
199 | GSK Investigational Site | St. John's | Newfoundland and Labrador | Canada | A1B 3V6 |
200 | GSK Investigational Site | Halifax | Nova Scotia | Canada | B3H 1V7 |
201 | GSK Investigational Site | Truro | Nova Scotia | Canada | B2N 1L2 |
202 | GSK Investigational Site | Brampton | Ontario | Canada | L6Z 4N5 |
203 | GSK Investigational Site | Burlington | Ontario | Canada | L7M 4Y |
204 | GSK Investigational Site | Cambridge | Ontario | Canada | N1R 7R1 |
205 | GSK Investigational Site | Cornwall | Ontario | Canada | K6H4M4 |
206 | GSK Investigational Site | Corunna | Ontario | Canada | N0N 1G |
207 | GSK Investigational Site | Hamilton | Ontario | Canada | L8L 2X2 |
208 | GSK Investigational Site | London | Ontario | Canada | N5W 6A |
209 | GSK Investigational Site | London | Ontario | Canada | N6A 4V2 |
210 | GSK Investigational Site | Sarnia | Ontario | Canada | N7T 4X |
211 | GSK Investigational Site | Smiths Falls | Ontario | Canada | K7A 4W8 |
212 | GSK Investigational Site | Sudbury | Ontario | Canada | P3A 5H |
213 | GSK Investigational Site | Toronto | Ontario | Canada | M9V 4B |
214 | GSK Investigational Site | Brossard | Quebec | Canada | J4Z 2K |
215 | GSK Investigational Site | Chicoutimi | Quebec | Canada | G7H 7K9 |
216 | GSK Investigational Site | Greenfield Park | Quebec | Canada | J4V 2G |
217 | GSK Investigational Site | Greenfield Park | Quebec | Canada | J4V 2H1 |
218 | GSK Investigational Site | Laval | Quebec | Canada | H7T 2P5 |
219 | GSK Investigational Site | Levis | Quebec | Canada | G6V 4Z5 |
220 | GSK Investigational Site | Montreal | Quebec | Canada | H4N 2W |
221 | GSK Investigational Site | Sherbrooke | Quebec | Canada | J1J 2E3 |
222 | GSK Investigational Site | St-Charles-Borromée | Quebec | Canada | J6E 6J2 |
223 | GSK Investigational Site | St-Lambert | Quebec | Canada | J4P 2J |
224 | GSK Investigational Site | Trois-Rivieres | Quebec | Canada | G8T 7A1 |
225 | GSK Investigational Site | Beroun | Czechia | 266 01 | |
226 | GSK Investigational Site | Krnov | Czechia | 794 01 | |
227 | GSK Investigational Site | Olomouc | Czechia | 772 00 | |
228 | GSK Investigational Site | Ostrava | Czechia | 702 00 | |
229 | GSK Investigational Site | Praha 10 | Czechia | 100 00 | |
230 | GSK Investigational Site | Praha 1 | Czechia | 116 94 | |
231 | GSK Investigational Site | Praha 2 | Czechia | 128 08 | |
232 | GSK Investigational Site | Praha 4 | Czechia | 149 00 | |
233 | GSK Investigational Site | Praha 5 | Czechia | 150 00 | |
234 | GSK Investigational Site | Pribram 1 | Czechia | 261 01 | |
235 | GSK Investigational Site | Uherske Hradiste | Czechia | 686 01 | |
236 | GSK Investigational Site | Usti nad Labem | Czechia | 401 13 | |
237 | GSK Investigational Site | Zlin | Czechia | 760 01 | |
238 | GSK Investigational Site | Copenhagen | Denmark | 2100 | |
239 | GSK Investigational Site | Esbjerg | Denmark | 6700 | |
240 | GSK Investigational Site | Frederikssund | Denmark | DK-3600 | |
241 | GSK Investigational Site | Hellerup | Denmark | 2900 | |
242 | GSK Investigational Site | Herlev | Denmark | DK-273 | |
243 | GSK Investigational Site | Holbæk | Denmark | DK-430 | |
244 | GSK Investigational Site | Hvidovre | Denmark | 2650 | |
245 | GSK Investigational Site | København NV | Denmark | 2400 | |
246 | GSK Investigational Site | København S | Denmark | DK-230 | |
247 | GSK Investigational Site | Roskilde | Denmark | DK-400 | |
248 | GSK Investigational Site | Amiens Cedex 1 | France | 80054 | |
249 | GSK Investigational Site | Broglie | France | 27270 | |
250 | GSK Investigational Site | Corbeil-Essonnes | France | 91106 | |
251 | GSK Investigational Site | La Rochelle Cedex 1 | France | 17019 | |
252 | GSK Investigational Site | Nantes cedex 2 | France | 44277 | |
253 | GSK Investigational Site | Narbonne | France | 11100 | |
254 | GSK Investigational Site | Paris | France | 75010 | |
255 | GSK Investigational Site | Pau Cedex | France | 64046 | |
256 | GSK Investigational Site | Pierre-Bénite | France | 69310 | |
257 | GSK Investigational Site | Strasbourg cedex | France | 67091 | |
258 | GSK Investigational Site | Vandœuvre-lès-Nancy | France | 54511 | |
259 | GSK Investigational Site | Deggingen | Baden-Wuerttemberg | Germany | 73326 |
260 | GSK Investigational Site | Freiburg | Baden-Wuerttemberg | Germany | 79106 |
261 | GSK Investigational Site | Gueglingen | Baden-Wuerttemberg | Germany | 74363 |
262 | GSK Investigational Site | Karlsruhe | Baden-Wuerttemberg | Germany | 76199 |
263 | GSK Investigational Site | Ludwigsburg | Baden-Wuerttemberg | Germany | 71640 |
264 | GSK Investigational Site | Stuttgart | Baden-Wuerttemberg | Germany | 70199 |
265 | GSK Investigational Site | Stuttgart | Baden-Wuerttemberg | Germany | 70378 |
266 | GSK Investigational Site | Villingen-Schwenningen | Baden-Wuerttemberg | Germany | 78048 |
267 | GSK Investigational Site | Wangen | Baden-Wuerttemberg | Germany | 88239 |
268 | GSK Investigational Site | Aschaffenburg | Bayern | Germany | 63739 |
269 | GSK Investigational Site | Dachau | Bayern | Germany | 85221 |
270 | GSK Investigational Site | Haag | Bayern | Germany | 83527 |
271 | GSK Investigational Site | Kuenzing | Bayern | Germany | 94550 |
272 | GSK Investigational Site | Rednitzhembach | Bayern | Germany | 91126 |
273 | GSK Investigational Site | Wallerfing | Bayern | Germany | 94574 |
274 | GSK Investigational Site | Elsterwerda | Brandenburg | Germany | 04910 |
275 | GSK Investigational Site | Falkensee | Brandenburg | Germany | 14612 |
276 | GSK Investigational Site | Potsdam | Brandenburg | Germany | 14469 |
277 | GSK Investigational Site | Floersheim | Hessen | Germany | 65439 |
278 | GSK Investigational Site | Gelnhausen | Hessen | Germany | 63571 |
279 | GSK Investigational Site | Hildesheim | Niedersachsen | Germany | 31139 |
280 | GSK Investigational Site | Stuhr | Niedersachsen | Germany | 28816 |
281 | GSK Investigational Site | Wardenburg | Niedersachsen | Germany | 26203 |
282 | GSK Investigational Site | Bad Oeynhausen | Nordrhein-Westfalen | Germany | 32545 |
283 | GSK Investigational Site | Bochum | Nordrhein-Westfalen | Germany | 44791 |
284 | GSK Investigational Site | Bochum | Nordrhein-Westfalen | Germany | 44869 |
285 | GSK Investigational Site | Essen | Nordrhein-Westfalen | Germany | 45136 |
286 | GSK Investigational Site | Essen | Nordrhein-Westfalen | Germany | 45329 |
287 | GSK Investigational Site | Essen | Nordrhein-Westfalen | Germany | 45359 |
288 | GSK Investigational Site | Kleve | Nordrhein-Westfalen | Germany | 47533 |
289 | GSK Investigational Site | Koeln | Nordrhein-Westfalen | Germany | 51069 |
290 | GSK Investigational Site | Muenster | Nordrhein-Westfalen | Germany | 48145 |
291 | GSK Investigational Site | Witten | Nordrhein-Westfalen | Germany | 58455 |
292 | GSK Investigational Site | Bad Kreuznach | Rheinland-Pfalz | Germany | 55545 |
293 | GSK Investigational Site | Ludwigshafen am Rhein | Rheinland-Pfalz | Germany | 67059 |
294 | GSK Investigational Site | Mainz | Rheinland-Pfalz | Germany | 55116 |
295 | GSK Investigational Site | Sankt Ingbert | Saarland | Germany | 66386 |
296 | GSK Investigational Site | Hohenmoelsen | Sachsen-Anhalt | Germany | 06679 |
297 | GSK Investigational Site | Jerichow | Sachsen-Anhalt | Germany | 39319 |
298 | GSK Investigational Site | Magdeburg | Sachsen-Anhalt | Germany | 39112 |
299 | GSK Investigational Site | Chemnitz | Sachsen | Germany | 09113 |
300 | GSK Investigational Site | Delitzsch | Sachsen | Germany | 04509 |
301 | GSK Investigational Site | Dresden | Sachsen | Germany | 01069 |
302 | GSK Investigational Site | Dresden | Sachsen | Germany | 01219 |
303 | GSK Investigational Site | Dresden | Sachsen | Germany | 01279 |
304 | GSK Investigational Site | Dresden | Sachsen | Germany | 01307 |
305 | GSK Investigational Site | Leipzg | Sachsen | Germany | 04109 |
306 | GSK Investigational Site | Leipzig | Sachsen | Germany | 04109 |
307 | GSK Investigational Site | Leipzig | Sachsen | Germany | 04249 |
308 | GSK Investigational Site | Oschatz | Sachsen | Germany | 04758 |
309 | GSK Investigational Site | Pirna | Sachsen | Germany | 01796 |
310 | GSK Investigational Site | Riesa | Sachsen | Germany | 01587 |
311 | GSK Investigational Site | Schkeuditz | Sachsen | Germany | 04435 |
312 | GSK Investigational Site | Berlin | Germany | 10117 | |
313 | GSK Investigational Site | Berlin | Germany | 10409 | |
314 | GSK Investigational Site | Berlin | Germany | 10789 | |
315 | GSK Investigational Site | Berlin | Germany | 12157 | |
316 | GSK Investigational Site | Berlin | Germany | 13405 | |
317 | GSK Investigational Site | Dortmund | Germany | 44137 | |
318 | GSK Investigational Site | Hamburg | Germany | 20099 | |
319 | GSK Investigational Site | Hamburg | Germany | 21073 | |
320 | GSK Investigational Site | Hamburg | Germany | 22041 | |
321 | GSK Investigational Site | Mannheim | Germany | 68163 | |
322 | GSK Investigational Site | Muenchen | Germany | 80809 | |
323 | GSK Investigational Site | Alexandroupolis | Greece | 68 100 | |
324 | GSK Investigational Site | Athens, | Greece | 11 527 | |
325 | GSK Investigational Site | Athens | Greece | 11521 | |
326 | GSK Investigational Site | Athens | Greece | 11528 | |
327 | GSK Investigational Site | Haidari, Athens | Greece | 12462 | |
328 | GSK Investigational Site | Heraklion, Crete | Greece | 71409 | |
329 | GSK Investigational Site | Ioannina | Greece | 45500 | |
330 | GSK Investigational Site | Lamia | Greece | 35100 | |
331 | GSK Investigational Site | Nikaia Piraeus | Greece | 184 54 | |
332 | GSK Investigational Site | Pireas | Greece | 18536 | |
333 | GSK Investigational Site | Thessaloniki | Greece | 546 36 | |
334 | GSK Investigational Site | Thessaloniki | Greece | 546 42 | |
335 | GSK Investigational Site | Thessaloniki | Greece | 54642 | |
336 | GSK Investigational Site | Thessaloniki | Greece | 564 29 | |
337 | GSK Investigational Site | Thessaloniki | Greece | 570 01 | |
338 | GSK Investigational Site | Thessaloniki | Greece | 570 10 | |
339 | GSK Investigational Site | Hong Kong | Hong Kong | ||
340 | GSK Investigational Site | Shatin | Hong Kong | ||
341 | GSK Investigational Site | Baja | Hungary | 6500 | |
342 | GSK Investigational Site | Budapest | Hungary | 1036 | |
343 | GSK Investigational Site | Budapest | Hungary | 1135 | |
344 | GSK Investigational Site | Debrecen | Hungary | 4026 | |
345 | GSK Investigational Site | Debrecen | Hungary | 4031 | |
346 | GSK Investigational Site | Eger | Hungary | 3300 | |
347 | GSK Investigational Site | Gödöllő | Hungary | 2100 | |
348 | GSK Investigational Site | Hatvan | Hungary | 3000 | |
349 | GSK Investigational Site | Komarom | Hungary | 2900 | |
350 | GSK Investigational Site | Miskolc | Hungary | 3529 | |
351 | GSK Investigational Site | Sátoraljaújhely | Hungary | 3980 | |
352 | GSK Investigational Site | Chieti | Abruzzo | Italy | 66100 |
353 | GSK Investigational Site | Catanzaro | Calabria | Italy | 88100 |
354 | GSK Investigational Site | Napoli | Campania | Italy | 80131 |
355 | GSK Investigational Site | Napoli | Campania | Italy | 80138 |
356 | GSK Investigational Site | Bologna | Emilia-Romagna | Italy | 40138 |
357 | GSK Investigational Site | Parma | Emilia-Romagna | Italy | 43100 |
358 | GSK Investigational Site | Ravenna | Emilia-Romagna | Italy | 48121 |
359 | GSK Investigational Site | Roma | Lazio | Italy | 00133 |
360 | GSK Investigational Site | Roma | Lazio | Italy | 00168 |
361 | GSK Investigational Site | Roma | Lazio | Italy | 00186 |
362 | GSK Investigational Site | Arenzano (GE) | Liguria | Italy | 16011 |
363 | GSK Investigational Site | Bergamo | Lombardia | Italy | 24127 |
364 | GSK Investigational Site | Milano | Lombardia | Italy | 20122 |
365 | GSK Investigational Site | Milano | Lombardia | Italy | 20132 |
366 | GSK Investigational Site | Milano | Lombardia | Italy | 20142 |
367 | GSK Investigational Site | Vigevano (PV) | Lombardia | Italy | 27029 |
368 | GSK Investigational Site | Ancona | Marche | Italy | 60131 |
369 | GSK Investigational Site | Ascoli Piceno | Marche | Italy | 63100 |
370 | GSK Investigational Site | Bari | Puglia | Italy | 70124 |
371 | GSK Investigational Site | San Giovanni Rotondo (FG) | Puglia | Italy | 71013 |
372 | GSK Investigational Site | Olbia (OT) | Sardegna | Italy | 07026 |
373 | GSK Investigational Site | Siena | Toscana | Italy | 53100 |
374 | GSK Investigational Site | S.Andrea Delle Fratte - S. Sisto (PG) | Umbria | Italy | 06132 |
375 | GSK Investigational Site | Padova | Veneto | Italy | 35128 |
376 | GSK Investigational Site | Daegu | Korea, Republic of | 42415 | |
377 | GSK Investigational Site | Daegu | Korea, Republic of | 700-71 | |
378 | GSK Investigational Site | Gyeonggi-do | Korea, Republic of | 463-70 | |
379 | GSK Investigational Site | Gyeonggido | Korea, Republic of | 420-717 | |
380 | GSK Investigational Site | Kangwondo | Korea, Republic of | 220-701 | |
381 | GSK Investigational Site | Pusan | Korea, Republic of | 602-73 | |
382 | GSK Investigational Site | Seoul | Korea, Republic of | 110-744 | |
383 | GSK Investigational Site | Seoul | Korea, Republic of | 120-752 | |
384 | GSK Investigational Site | Seoul | Korea, Republic of | 134-72 | |
385 | GSK Investigational Site | Seoul | Korea, Republic of | 135-71 | |
386 | GSK Investigational Site | Seoul | Korea, Republic of | 135-72 | |
387 | GSK Investigational Site | Seoul | Korea, Republic of | 137-70 | |
388 | GSK Investigational Site | Seoul | Korea, Republic of | 150-95 | |
389 | GSK Investigational Site | Seoul | Korea, Republic of | 152-703 | |
390 | GSK Investigational Site | Seoul | Korea, Republic of | 411-70 | |
391 | GSK Investigational Site | Suwon, Kyonggi-do | Korea, Republic of | 443-72 | |
392 | GSK Investigational Site | Suwon | Korea, Republic of | 442-723 | |
393 | GSK Investigational Site | Aguascalientes, Ags | Aguascalientes | Mexico | 20127 |
394 | GSK Investigational Site | Guadalajara | Jalisco | Mexico | 44150 |
395 | GSK Investigational Site | Guadalajara | Jalisco | Mexico | 44600 |
396 | GSK Investigational Site | Guadalajara | Jalisco | Mexico | 45116 |
397 | GSK Investigational Site | Tlaquepaque | Jalisco | Mexico | 45510 |
398 | GSK Investigational Site | Monterrey NL | Nuevo León | Mexico | 64718 |
399 | GSK Investigational Site | Monterrey | Nuevo León | Mexico | 64460 |
400 | GSK Investigational Site | Queretaro | Querétaro | Mexico | 76000 |
401 | GSK Investigational Site | Mazatlán | Sinaloa | Mexico | 82126 |
402 | GSK Investigational Site | Mazatlán | Sinaloa | Mexico | |
403 | GSK Investigational Site | Mérida | Yucatán | Mexico | 97129 |
404 | GSK Investigational Site | Aguascalientes | Mexico | 20230 | |
405 | GSK Investigational Site | Mexico, D.F. | Mexico | 11650 | |
406 | GSK Investigational Site | Alkmaar | Netherlands | 1815 JD | |
407 | GSK Investigational Site | Amsterdam | Netherlands | 1061 A | |
408 | GSK Investigational Site | Eindhoven | Netherlands | 5631 BM | |
409 | GSK Investigational Site | Gouda | Netherlands | 2803 H | |
410 | GSK Investigational Site | Hardenberg | Netherlands | 7772 SE | |
411 | GSK Investigational Site | Heerlen | Netherlands | 6419 PC | |
412 | GSK Investigational Site | Hoogeveen | Netherlands | 7909 A | |
413 | GSK Investigational Site | Meppel | Netherlands | 7943 K | |
414 | GSK Investigational Site | Rotterdam | Netherlands | 3051 G | |
415 | GSK Investigational Site | Sneek | Netherlands | 8601 Z | |
416 | GSK Investigational Site | Hoenefoss | Norway | 3513 | |
417 | GSK Investigational Site | Kolbjørnsvik | Norway | 4816 | |
418 | GSK Investigational Site | Oslo | Norway | 0319 | |
419 | GSK Investigational Site | Oslo | Norway | 0586 | |
420 | GSK Investigational Site | Stavanger | Norway | 4011 | |
421 | GSK Investigational Site | Trujillo | La Libertad | Peru | 13001 |
422 | GSK Investigational Site | Callao | Lima | Peru | Callao 2 |
423 | GSK Investigational Site | San Martin de Porres | Lima | Peru | Lima 33 |
424 | GSK Investigational Site | Arequipa | Peru | ||
425 | GSK Investigational Site | Lima | Peru | 01 | |
426 | GSK Investigational Site | Lima | Peru | 17 | |
427 | GSK Investigational Site | Lima | Peru | Lima 14 | |
428 | GSK Investigational Site | Lima | Peru | Lima 29 | |
429 | GSK Investigational Site | Lima | Peru | Lima 32 | |
430 | GSK Investigational Site | Piura | Peru | 20001 | |
431 | GSK Investigational Site | Cebu City | Philippines | 6000 | |
432 | GSK Investigational Site | Iloilo City | Philippines | 5000 | |
433 | GSK Investigational Site | Laoag City | Philippines | 2900 | |
434 | GSK Investigational Site | Bialystok | Poland | 15-435 | |
435 | GSK Investigational Site | Bydgoszcz | Poland | 85-231 | |
436 | GSK Investigational Site | Bydgoszcz | Poland | 85-863 | |
437 | GSK Investigational Site | Gdansk | Poland | 80-858 | |
438 | GSK Investigational Site | Gniewkowo | Poland | 88-140 | |
439 | GSK Investigational Site | Katowice | Poland | 40-081 | |
440 | GSK Investigational Site | Katowice | Poland | 40-772 | |
441 | GSK Investigational Site | Krakow | Poland | 30-539 | |
442 | GSK Investigational Site | Krakow | Poland | 31-261 | |
443 | GSK Investigational Site | Krakow | Poland | 31-530 | |
444 | GSK Investigational Site | Lublin | Poland | 20-538 | |
445 | GSK Investigational Site | Poznan | Poland | 60-111 | |
446 | GSK Investigational Site | Poznan | Poland | 61-655 | |
447 | GSK Investigational Site | Sopot | Poland | 81- 71 | |
448 | GSK Investigational Site | Warszawa | Poland | 00-465 | |
449 | GSK Investigational Site | Wierzchoslawice | Poland | 33-122 | |
450 | GSK Investigational Site | Wroclaw | Poland | 50-127 | |
451 | GSK Investigational Site | Wroclaw | Poland | 50-981 | |
452 | GSK Investigational Site | Wroclaw | Poland | 54-239 | |
453 | GSK Investigational Site | Arkhangelsk | Russian Federation | 163045 | |
454 | GSK Investigational Site | Barnaul | Russian Federation | 656 045 | |
455 | GSK Investigational Site | Chelyabinsk | Russian Federation | 454021 | |
456 | GSK Investigational Site | Chelyabinsk | Russian Federation | 454047 | |
457 | GSK Investigational Site | Ekaterinburg | Russian Federation | 620039 | |
458 | GSK Investigational Site | Ekaterinburg | Russian Federation | 620149 | |
459 | GSK Investigational Site | Ivanovo | Russian Federation | 153005 | |
460 | GSK Investigational Site | Kemerovo | Russian Federation | 650000 | |
461 | GSK Investigational Site | Kemerovo | Russian Federation | 650002 | |
462 | GSK Investigational Site | Krasnodar | Russian Federation | 350086 | |
463 | GSK Investigational Site | Moscow | Russian Federation | 117 036 | |
464 | GSK Investigational Site | Moscow | Russian Federation | 117 03 | |
465 | GSK Investigational Site | Moscow | Russian Federation | 117292 | |
466 | GSK Investigational Site | Moscow | Russian Federation | 119435 | |
467 | GSK Investigational Site | Moscow | Russian Federation | 119992 | |
468 | GSK Investigational Site | Moscow | Russian Federation | 127411 | |
469 | GSK Investigational Site | Moscow | Russian Federation | 129110 | |
470 | GSK Investigational Site | Nizhniy Novgorod | Russian Federation | 603126 | |
471 | GSK Investigational Site | Nizhny Novgorod | Russian Federation | 603003 | |
472 | GSK Investigational Site | Novosibirsk | Russian Federation | 630047 | |
473 | GSK Investigational Site | Novosibirsk | Russian Federation | 630091 | |
474 | GSK Investigational Site | Perm | Russian Federation | 614097 | |
475 | GSK Investigational Site | Rostov-on-Don | Russian Federation | 344022 | |
476 | GSK Investigational Site | Ryazan | Russian Federation | 390039 | |
477 | GSK Investigational Site | Saint Petersburg | Russian Federation | 195257 | |
478 | GSK Investigational Site | Samara | Russian Federation | 443067 | |
479 | GSK Investigational Site | Saratov | Russian Federation | 410053 | |
480 | GSK Investigational Site | Tomsk | Russian Federation | 634012 | |
481 | GSK Investigational Site | Tomsk | Russian Federation | 634041 | |
482 | GSK Investigational Site | Tomsk | Russian Federation | 634050 | |
483 | GSK Investigational Site | Voronezh | Russian Federation | 394018 | |
484 | GSK Investigational Site | Yaroslavl | Russian Federation | 150000 | |
485 | GSK Investigational Site | Yaroslavl | Russian Federation | 150003 | |
486 | GSK Investigational Site | Yaroslavl | Russian Federation | 150010 | |
487 | GSK Investigational Site | Yaroslavl | Russian Federation | 150030 | |
488 | GSK Investigational Site | Bloemfontein | Free State | South Africa | 9301 |
489 | GSK Investigational Site | Tongaat | KwaZulu- Natal | South Africa | 4400 |
490 | GSK Investigational Site | Bloemfontein | South Africa | 9301 | |
491 | GSK Investigational Site | Cape Town | South Africa | 7500 | |
492 | GSK Investigational Site | Houghton | South Africa | 2198 | |
493 | GSK Investigational Site | Kuilsrivier | South Africa | 7580 | |
494 | GSK Investigational Site | Paarl | South Africa | 7646 | |
495 | GSK Investigational Site | Pinelands | South Africa | 7405 | |
496 | GSK Investigational Site | Umhlanga | South Africa | 4319 | |
497 | GSK Investigational Site | Alicante | Spain | 03004 | |
498 | GSK Investigational Site | Almeria | Spain | 4001 | |
499 | GSK Investigational Site | Alzira/Valencia | Spain | 46600 | |
500 | GSK Investigational Site | Badalona / Barcelona | Spain | 08917 | |
501 | GSK Investigational Site | Badalona | Spain | 08916 | |
502 | GSK Investigational Site | Barcelona | Spain | 08003 | |
503 | GSK Investigational Site | Barcelona | Spain | 08006 | |
504 | GSK Investigational Site | Barcelona | Spain | 08026 | |
505 | GSK Investigational Site | Barcelona | Spain | 08907 | |
506 | GSK Investigational Site | Boadilla Del Monte (Madrid) | Spain | 28660 | |
507 | GSK Investigational Site | Canet De Mar - Barcelona | Spain | 08360 | |
508 | GSK Investigational Site | Cangas Del Narcea/Asturias | Spain | 33800 | |
509 | GSK Investigational Site | Centelles (Barcelona) | Spain | 08540 | |
510 | GSK Investigational Site | Córdoba | Spain | 14004 | |
511 | GSK Investigational Site | Elche | Spain | 03293 | |
512 | GSK Investigational Site | Granada | Spain | 18012 | |
513 | GSK Investigational Site | La Coruña | Spain | 15006 | |
514 | GSK Investigational Site | León | Spain | 24071 | |
515 | GSK Investigational Site | Madrid | Spain | 28006 | |
516 | GSK Investigational Site | Madrid | Spain | 28034 | |
517 | GSK Investigational Site | Madrid | Spain | 28040 | |
518 | GSK Investigational Site | Madrid | Spain | 28046 | |
519 | GSK Investigational Site | Madrid | Spain | 28050 | |
520 | GSK Investigational Site | Malaga | Spain | 29010 | |
521 | GSK Investigational Site | Málaga | Spain | 29010 | |
522 | GSK Investigational Site | Palma de Mallorca | Spain | 07010 | |
523 | GSK Investigational Site | Palma de Mallorca | Spain | 07198 | |
524 | GSK Investigational Site | Pontevedra | Spain | 36071 | |
525 | GSK Investigational Site | Pozuelo De Alarcón/Madrid | Spain | 28223 | |
526 | GSK Investigational Site | Sagunto/Valencia | Spain | 46520 | |
527 | GSK Investigational Site | San Juan (Alicante) | Spain | 03550 | |
528 | GSK Investigational Site | Sanlucar De Barrameda - Cádiz | Spain | 11540 | |
529 | GSK Investigational Site | Santa Coloma De Gramanet (Barcelona) | Spain | 08923 | |
530 | GSK Investigational Site | Santiago De Compostela | Spain | 15706 | |
531 | GSK Investigational Site | Sevilla | Spain | 41014 | |
532 | GSK Investigational Site | Tarrasa, Barcelona | Spain | 08221 | |
533 | GSK Investigational Site | Valencia | Spain | 46010 | |
534 | GSK Investigational Site | Valencia | Spain | 46017 | |
535 | GSK Investigational Site | Valencia | Spain | 46026 | |
536 | GSK Investigational Site | Vigo-Pontevedra | Spain | 36312 | |
537 | GSK Investigational Site | Borås | Sweden | SE-506 | |
538 | GSK Investigational Site | Eksjö | Sweden | SE-575 35 | |
539 | GSK Investigational Site | Göteborg | Sweden | SE-413 45 | |
540 | GSK Investigational Site | Helsingborg | Sweden | SE-252 | |
541 | GSK Investigational Site | Härnösand | Sweden | SE-871 | |
542 | GSK Investigational Site | Karlskrona | Sweden | SE-371 41 | |
543 | GSK Investigational Site | Kristianstad | Sweden | SE-291 85 | |
544 | GSK Investigational Site | Linköping | Sweden | SE-587 58 | |
545 | GSK Investigational Site | Ljungby | Sweden | SE-341 | |
546 | GSK Investigational Site | Malmö | Sweden | SE-205 02 | |
547 | GSK Investigational Site | Rättvik | Sweden | SE-795 30 | |
548 | GSK Investigational Site | Stockholm | Sweden | SE-111 | |
549 | GSK Investigational Site | Stockholm | Sweden | SE-113 61 | |
550 | GSK Investigational Site | Stockholm | Sweden | SE-182 88 | |
551 | GSK Investigational Site | Umeå | Sweden | SE-901 85 | |
552 | GSK Investigational Site | Uppsala | Sweden | SE-752 | |
553 | GSK Investigational Site | Örebro | Sweden | SE-703 62 | |
554 | GSK Investigational Site | Changhua | Taiwan | 500 | |
555 | GSK Investigational Site | Hualien | Taiwan | 970 | |
556 | GSK Investigational Site | Kaohsiung | Taiwan | 833 | |
557 | GSK Investigational Site | Taichung | Taiwan | 433 | |
558 | GSK Investigational Site | Tainan | Taiwan | 71004 | |
559 | GSK Investigational Site | Taipei | Taiwan | 10002 | |
560 | GSK Investigational Site | Taipei | Taiwan | 112 | |
561 | GSK Investigational Site | Bangkok | Thailand | 10330 | |
562 | GSK Investigational Site | Bangkok | Thailand | 10400 | |
563 | GSK Investigational Site | Chiangmai | Thailand | 50200 | |
564 | GSK Investigational Site | Pathumthani | Thailand | 12120 | |
565 | GSK Investigational Site | Songkla | Thailand | 90110 | |
566 | GSK Investigational Site | Chernivtsi | Ukraine | 58022 | |
567 | GSK Investigational Site | Dnipropetrovsk | Ukraine | 49038 | |
568 | GSK Investigational Site | Kharkiv | Ukraine | 61058 | |
569 | GSK Investigational Site | Kharkiv | Ukraine | 61070 | |
570 | GSK Investigational Site | Kherson | Ukraine | 73000 | |
571 | GSK Investigational Site | Kyiv | Ukraine | 01004 | |
572 | GSK Investigational Site | Kyiv | Ukraine | 01021 | |
573 | GSK Investigational Site | Kyiv | Ukraine | 02091 | |
574 | GSK Investigational Site | Kyiv | Ukraine | 03049 | |
575 | GSK Investigational Site | Kyiv | Ukraine | 04050 | |
576 | GSK Investigational Site | Kyiv | Ukraine | 04114 | |
577 | GSK Investigational Site | Mykolaiv | Ukraine | 54003 | |
578 | GSK Investigational Site | Odesa | Ukraine | 65025 | |
579 | GSK Investigational Site | Poltava | Ukraine | 36011 | |
580 | GSK Investigational Site | Uzhgorod | Ukraine | 88000 | |
581 | GSK Investigational Site | Vinnytsia | Ukraine | 21010 | |
582 | GSK Investigational Site | Zaporizhzhya | Ukraine | 69001 | |
583 | GSK Investigational Site | Soham | Cambridgeshire | United Kingdom | CB7 5J |
584 | GSK Investigational Site | Chesterfield | Derbyshire | United Kingdom | S40 4AAA |
585 | GSK Investigational Site | Romford | Essex | United Kingdom | RM1 3P |
586 | GSK Investigational Site | Northwood | Middlesex | United Kingdom | HA6 2R |
587 | GSK Investigational Site | Edinburgh | Midlothian | United Kingdom | EH4 2XU |
588 | GSK Investigational Site | Trowbridge | Wiltshire | United Kingdom | BA14 8 |
589 | GSK Investigational Site | Aberdeen | United Kingdom | AB25 2 | |
590 | GSK Investigational Site | Axbridge, Somerset | United Kingdom | BS26 2 | |
591 | GSK Investigational Site | Ayr | United Kingdom | KA6 6D | |
592 | GSK Investigational Site | Blackpool | United Kingdom | FY3 8NR | |
593 | GSK Investigational Site | Bristol | United Kingdom | BS10 5 | |
594 | GSK Investigational Site | Dumfries | United Kingdom | DG1 4AP | |
595 | GSK Investigational Site | Dundee | United Kingdom | DD1 9S | |
596 | GSK Investigational Site | Dundee | United Kingdom | DD4 6Q | |
597 | GSK Investigational Site | Dundee | United Kingdom | DD5 4LX | |
598 | GSK Investigational Site | Fife | United Kingdom | KY14 7AW | |
599 | GSK Investigational Site | Fife | United Kingdom | KY2 5A | |
600 | GSK Investigational Site | Gloucester | United Kingdom | GL1 3N | |
601 | GSK Investigational Site | Lancaster | United Kingdom | LA1 4R | |
602 | GSK Investigational Site | Manchester | United Kingdom | M23 9LT | |
603 | GSK Investigational Site | Newport | United Kingdom | PO30 5 | |
604 | GSK Investigational Site | Oxford | United Kingdom | OX3 7L | |
605 | GSK Investigational Site | Rotherham | United Kingdom | S60 2UD | |
606 | GSK Investigational Site | Sidcup, Kent | United Kingdom | DA14 6 | |
607 | GSK Investigational Site | Trowbridge | United Kingdom | BA14 9 | |
608 | GSK Investigational Site | Wigan | United Kingdom | WN1 2NN |
Sponsors and Collaborators
- GlaxoSmithKline
- Duke Clinical Research Institute
Investigators
- Study Director: GSK Clinical Trials, GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)
Study Documents (Full-Text)
More Information
Publications
- 116174
- 2014-001824-32
Study Results
Participant Flow
Recruitment Details | This was a randomized, double-blind, parallel group, placebo-controlled study in participants with Type 2 diabetes having a previous history of cardiovascular disease and not having optimal glycemic control. |
---|---|
Pre-assignment Detail | A total of 10793 participants were screened of which 1330 failed screening and 9463 participants were randomized in a 1:1 ratio to receive either once weekly albiglutide or matching placebo subcutaneous injections. The study was conducted in 28 countries |
Arm/Group Title | Placebo | Albiglutide |
---|---|---|
Arm/Group Description | Albiglutide matching placebo was administered once weekly as subcutaneous injection in the abdomen, thigh or upper arm region in addition to the standard of care therapy for diabetes and cardiovascular health. | Albiglutide was administered once weekly as subcutaneous injection in the abdomen, thigh or upper arm region. Participants were administered albiglutide at a dose of 30 milligrams (mg) or 50 mg once weekly in addition to the standard of care therapy for diabetes and cardiovascular health. |
Period Title: Overall Study | ||
STARTED | 4732 | 4731 |
COMPLETED | 4578 | 4620 |
NOT COMPLETED | 154 | 111 |
Baseline Characteristics
Arm/Group Title | Placebo | Albiglutide | Total |
---|---|---|---|
Arm/Group Description | Albiglutide matching placebo was administered once weekly as subcutaneous injection in the abdomen, thigh or upper arm region in addition to the standard of care therapy for diabetes and cardiovascular health. | Albiglutide was administered once weekly as subcutaneous injection in the abdomen, thigh or upper arm region. Participants were administered albiglutide at a dose of 30 milligrams (mg) or 50 mg once weekly in addition to the standard of care therapy for diabetes and cardiovascular health.. | Total of all reporting groups |
Overall Participants | 4732 | 4731 | 9463 |
Age (Years) [Mean (Standard Deviation) ] | |||
Mean (Standard Deviation) [Years] |
64.2
(8.65)
|
64.1
(8.71)
|
64.1
(8.68)
|
Sex: Female, Male (Count of Participants) | |||
Female |
1467
31%
|
1427
30.2%
|
2894
30.6%
|
Male |
3265
69%
|
3304
69.8%
|
6569
69.4%
|
Race/Ethnicity, Customized (Count of Participants) | |||
American Indian (Amer. Ind.) or Alaska Native |
238
5%
|
280
5.9%
|
518
5.5%
|
Central/South Asian Heritage (Her.) |
27
0.6%
|
25
0.5%
|
52
0.5%
|
Japanese Her./East Asian Her/South East Asian Her. |
215
4.5%
|
204
4.3%
|
419
4.4%
|
Black or African American (Amer.) |
118
2.5%
|
121
2.6%
|
239
2.5%
|
Native Hawaiian or Other Pacific Islander |
2
0%
|
3
0.1%
|
5
0.1%
|
White |
4024
85%
|
4006
84.7%
|
8030
84.9%
|
Amer Ind. or Alaska Native & Black or African Amer |
1
0%
|
3
0.1%
|
4
0%
|
Asian & Black or African Amer. |
1
0%
|
0
0%
|
1
0%
|
Asian & White |
0
0%
|
1
0%
|
1
0%
|
Black or African Amer. & White |
81
1.7%
|
67
1.4%
|
148
1.6%
|
Unknown |
1
0%
|
1
0%
|
2
0%
|
Amer. Ind. or Alaska Native & White |
24
0.5%
|
20
0.4%
|
44
0.5%
|
Outcome Measures
Title | Time to First Occurrence of Major Adverse Cardiovascular Events (MACE) During Cardiovascular (CV) Follow-up Time Period |
---|---|
Description | Time to MACE defined as the time to first occurrence of Cardiovascular Endpoint Committee (CEC)-adjudicated MACE (CV death, myocardial infarction [MI] or stroke) was analyzed using a Cox Proportional Hazards regression model with treatment group as the only covariate. The incidence rate per 100 person years (100*number of participants with at least 1 event)/first event person-years) is presented along with 95% confidence interval. First event person-years=(cumulative total time to first event for participants who have the event+cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period. The analysis was performed on the Intent to Treat (ITT) Population which comprised of all randomized participants excluding participants who did not provide consent. |
Time Frame | Median of 1.65 person years for CV follow-up time period |
Outcome Measure Data
Analysis Population Description |
---|
ITT Population |
Arm/Group Title | Placebo | Albiglutide |
---|---|---|
Arm/Group Description | Albiglutide matching placebo was administered once weekly as subcutaneous injection in the abdomen, thigh or upper arm region in addition to the standard of care therapy for diabetes and cardiovascular health. | Albiglutide was administered once weekly as subcutaneous injection in the abdomen, thigh or upper arm region. Participants were administered albiglutide at a dose of 30 milligrams (mg) or 50 mg once weekly in addition to the standard of care therapy for diabetes and cardiovascular health. |
Measure Participants | 4732 | 4731 |
Number (95% Confidence Interval) [Events per 100 person years] |
5.87
|
4.57
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Placebo, Albiglutide |
---|---|---|
Comments | ||
Type of Statistical Test | Non-Inferiority | |
Comments | Non-inferiority was determined by testing the hypothesis that the observed hazard ratio is significantly different from the null margin of 1.3 (a one-sided p <0.025 for such a test with result in appropriate direction being equivalent to the upper 95% confidence limit for the hazard ratio being less than 1.3) | |
Statistical Test of Hypothesis | p-Value | <0.0001 |
Comments | One-sided p-value based on Wald test of hazard ratio (HR) >=1.3 versus HR <1.3. | |
Method | Wald test | |
Comments | ||
Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
Estimated Value | 0.78 | |
Confidence Interval |
(2-Sided) 95% 0.68 to 0.90 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Hazard ratio is estimated using a Cox proportional hazard regression model with treatment as the only covariate |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | Placebo, Albiglutide |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | <0.001 |
Comments | Two-sided p-value based on Wald test of HR=1 versus HR not equal to 1 | |
Method | Wald test | |
Comments |
Title | Time to First Occurrence of MACE or Urgent Revascularization for Unstable Angina |
---|---|
Description | Time to first occurrence of CEC-adjudicated MACE (CV death, MI or stroke) or urgent revascularization for unstable angina was analyzed using a Cox Proportional Hazards regression model with treatment group as the only covariate. The incidence rate per 100 person years (100*number of participants with at least 1 event)/first event person-years) is presented along with 95% confidence interval. First event person-years=(cumulative total time to first event for participants who have the event+cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period. |
Time Frame | Median of 1.65 person years for CV follow-up time period |
Outcome Measure Data
Analysis Population Description |
---|
ITT Population |
Arm/Group Title | Placebo | Albiglutide |
---|---|---|
Arm/Group Description | Albiglutide matching placebo was administered once weekly as subcutaneous injection in the abdomen, thigh or upper arm region in addition to the standard of care therapy for diabetes and cardiovascular health. | Albiglutide was administered once weekly as subcutaneous injection in the abdomen, thigh or upper arm region. Participants were administered albiglutide at a dose of 30 milligrams (mg) or 50 mg once weekly in addition to the standard of care therapy for diabetes and cardiovascular health. |
Measure Participants | 4732 | 4731 |
Number (95% Confidence Interval) [Events per 100 person years] |
6.45
|
5.06
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Placebo, Albiglutide |
---|---|---|
Comments | ||
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | <0.001 |
Comments | Two-sided p-value based on the Wald statistic. | |
Method | Wald statistic | |
Comments | ||
Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
Estimated Value | 0.78 | |
Confidence Interval |
(2-Sided) 95% 0.69 to 0.90 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Hazard ratio is estimated using a Cox proportional hazard regression model with treatment as the only covariate. |
Title | Time to Adjudicated CV Death |
---|---|
Description | Time to adjudicated CV death was analyzed using a Cox Proportional Hazards regression model with treatment group as the only covariate. The incidence rate per 100 person years (100*number of participants with at least 1 event)/first event person-years) is presented along with 95% confidence interval. First event person-years=(cumulative total time to first event for participants who have the event+cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period. |
Time Frame | Median of 1.65 person years for the CV follow-up time period |
Outcome Measure Data
Analysis Population Description |
---|
ITT Population |
Arm/Group Title | Placebo | Albiglutide |
---|---|---|
Arm/Group Description | Albiglutide matching placebo was administered once weekly as subcutaneous injection in the abdomen, thigh or upper arm region in addition to the standard of care therapy for diabetes and cardiovascular health. | Albiglutide was administered once weekly as subcutaneous injection in the abdomen, thigh or upper arm region. Participants were administered albiglutide at a dose of 30 milligrams (mg) or 50 mg once weekly in addition to the standard of care therapy for diabetes and cardiovascular health. |
Measure Participants | 4732 | 4731 |
Number (95% Confidence Interval) [Events per 100 person years] |
1.72
|
1.61
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Placebo, Albiglutide |
---|---|---|
Comments | ||
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.578 |
Comments | Two-sided p-value based on the Wald statistic | |
Method | Wald statistic | |
Comments | ||
Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
Estimated Value | 0.93 | |
Confidence Interval |
(2-Sided) 95% 0.73 to 1.19 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Hazard ratio is estimated using a Cox proportional hazard regression model with treatment as the only covariate |
Title | Time to First Occurrence of Adjudicated MI |
---|---|
Description | Time to first occurrence of adjudicated MI was analyzed using a Cox Proportional Hazards regression model with treatment group as the only covariate. The incidence rate per 100 person years (100*number of participants with at least 1 event)/first event person-years) is presented along with 95% confidence interval. First event person-years=(cumulative total time to first event for participants who have the event+cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period. |
Time Frame | Median of 1.65 person years for CV follow-up time period |
Outcome Measure Data
Analysis Population Description |
---|
ITT Population |
Arm/Group Title | Placebo | Albiglutide |
---|---|---|
Arm/Group Description | Albiglutide matching placebo was administered once weekly as subcutaneous injection in the abdomen, thigh or upper arm region in addition to the standard of care therapy for diabetes and cardiovascular health. | Albiglutide was administered once weekly as subcutaneous injection in the abdomen, thigh or upper arm region. Participants were administered albiglutide at a dose of 30 milligrams (mg) or 50 mg once weekly in addition to the standard of care therapy for diabetes and cardiovascular health. |
Measure Participants | 4732 | 4731 |
Number (95% Confidence Interval) [Events per 100 person years] |
3.26
|
2.43
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Placebo, Albiglutide |
---|---|---|
Comments | ||
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.003 |
Comments | Two-sided p-value based on the Wald statistic. | |
Method | Wald statistic | |
Comments | ||
Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
Estimated Value | 0.75 | |
Confidence Interval |
(2-Sided) 95% 0.61 to 0.90 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Hazard ratio is estimated using a Cox proportional hazard regression model with treatment as the only covariate. |
Title | Time to First Occurrence of Adjudicated Stroke |
---|---|
Description | Time to first occurrence of adjudicated stroke was analyzed using a Cox Proportional Hazards regression model with treatment group as the only covariate. The incidence rate per 100 person years (100*number of participants with at least 1 event)/first event person-years) is presented along with 95% confidence interval. First event person-years=(cumulative total time to first event for participants who have the event+cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period. |
Time Frame | Median of 1.65 person years for CV follow-up time period |
Outcome Measure Data
Analysis Population Description |
---|
ITT Population |
Arm/Group Title | Placebo | Albiglutide |
---|---|---|
Arm/Group Description | Albiglutide matching placebo was administered once weekly as subcutaneous injection in the abdomen, thigh or upper arm region in addition to the standard of care therapy for diabetes and cardiovascular health. | Albiglutide was administered once weekly as subcutaneous injection in the abdomen, thigh or upper arm region. Participants were administered albiglutide at a dose of 30 milligrams (mg) or 50 mg once weekly in addition to the standard of care therapy for diabetes and cardiovascular health. |
Measure Participants | 4732 | 4731 |
Number (95% Confidence Interval) [Events per 100 person years] |
1.45
|
1.25
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Placebo, Albiglutide |
---|---|---|
Comments | ||
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.300 |
Comments | Two-sided p-value based on the Wald statistic. | |
Method | Wald statistic | |
Comments | ||
Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
Estimated Value | 0.86 | |
Confidence Interval |
(2-Sided) 95% 0.66 to 1.14 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Hazard ratio is estimated using a Cox proportional hazard regression model with treatment as the only covariate. |
Title | Time to First Occurrence of Adjudicated CV Death or Hospitalization for Heart Failure (HF) |
---|---|
Description | Time to first occurrence of adjudicated CV death or hospitalization for HF was analyzed using a Cox Proportional Hazards regression model with treatment group as the only covariate. The incidence rate per 100 person years (100*number of participants with at least 1 event)/first event person-years) is presented along with 95% confidence interval. First event person-years=(cumulative total time to first event for participants who have the event+cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period. |
Time Frame | Median of 1.65 person years for CV follow-up time period |
Outcome Measure Data
Analysis Population Description |
---|
ITT Population |
Arm/Group Title | Placebo | Albiglutide |
---|---|---|
Arm/Group Description | Albiglutide matching placebo was administered once weekly as subcutaneous injection in the abdomen, thigh or upper arm region in addition to the standard of care therapy for diabetes and cardiovascular health. | Albiglutide was administered once weekly as subcutaneous injection in the abdomen, thigh or upper arm region. Participants were administered albiglutide at a dose of 30 milligrams (mg) or 50 mg once weekly in addition to the standard of care therapy for diabetes and cardiovascular health. |
Measure Participants | 4732 | 4731 |
Number (95% Confidence Interval) [Events per 100 person years] |
2.92
|
2.49
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Placebo, Albiglutide |
---|---|---|
Comments | ||
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.113 |
Comments | Two-sided p-value based on the Wald statistic. | |
Method | Wald statistic | |
Comments | ||
Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
Estimated Value | 0.85 | |
Confidence Interval |
(2-Sided) 95% 0.70 to 1.04 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Hazard ratio is estimated using a Cox proportional hazard regression model with treatment as the only covariate. |
Title | Time to Initiation of Insulin of More Than 3 Months Duration for Those Participants Not Treated With Insulin at Study Start |
---|---|
Description | Time to initiation of insulin of more than 3 months duration in participants not treated with insulin at study start was analyzed using a Cox Proportional Hazards regression model with treatment group as the only covariate. The incidence rate per 100 person years (100*number of participants with at least 1 event)/first event person-years) is presented along with 95% confidence interval. First event person-years=(cumulative total time to first event for participants who have the event+cumulative total of censored time for participants without the event)/365.25, based on the on-therapy and post-therapy AE time period. The analysis was performed on Non-Insulin Population which comprised of participants in the ITT Population who were not on insulin at Baseline. |
Time Frame | Up to 2.7 years |
Outcome Measure Data
Analysis Population Description |
---|
Non-Insulin Population |
Arm/Group Title | Placebo | Albiglutide |
---|---|---|
Arm/Group Description | Albiglutide matching placebo was administered once weekly as subcutaneous injection in the abdomen, thigh or upper arm region in addition to the standard of care therapy for diabetes and cardiovascular health. | Albiglutide was administered once weekly as subcutaneous injection in the abdomen, thigh or upper arm region. Participants were administered albiglutide at a dose of 30 milligrams (mg) or 50 mg once weekly in addition to the standard of care therapy for diabetes and cardiovascular health. |
Measure Participants | 1995 | 1871 |
Number (95% Confidence Interval) [Events per 100 person years] |
8.58
|
3.56
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Placebo, Albiglutide |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | <0.001 |
Comments | Two-sided p-value based on Wald test of HR=1 versus HR not equal to 1. | |
Method | Wald test | |
Comments | ||
Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
Estimated Value | 0.42 | |
Confidence Interval |
(2-Sided) 95% 0.33 to 0.53 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Hazard ratio is estimated using a Cox proportional hazard regression model with treatment as the only covariate. |
Title | Time to Initiation of Prandial Insulin in Those Participants on Basal Insulin at Study Start |
---|---|
Description | Time to initiation of prandial insulin in those participants on basal insulin at study start was analyzed using a Cox Proportional Hazards regression model with treatment group as the only covariate. The incidence rate per 100 person years (100*number of participants with at least 1 event)/first event person-years) is presented along with 95% confidence interval. First event person-years=(cumulative total time to first event for participants who have the event+cumulative total of censored time for participants without the event)/365.25, based on the on-therapy and post-therapy AE time period. The analysis was performed on Basal Insulin Population which comprised of participants in the ITT Population who were on basal insulin but not on other insulin at Baseline (i.e., will not include a participant on a mixed insulin or on a prandial-only insulin). |
Time Frame | Up to 2.7 years |
Outcome Measure Data
Analysis Population Description |
---|
Basal Insulin Population |
Arm/Group Title | Placebo | Albiglutide |
---|---|---|
Arm/Group Description | Albiglutide matching placebo was administered once weekly as subcutaneous injection in the abdomen, thigh or upper arm region in addition to the standard of care therapy for diabetes and cardiovascular health. | Albiglutide was administered once weekly as subcutaneous injection in the abdomen, thigh or upper arm region. Participants were administered albiglutide at a dose of 30 milligrams (mg) or 50 mg once weekly in addition to the standard of care therapy for diabetes and cardiovascular health. |
Measure Participants | 1040 | 1028 |
Number (95% Confidence Interval) [Events per 100 person years] |
5.09
|
3.59
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Placebo, Albiglutide |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.043 |
Comments | Two-sided p-value based on Wald test of HR=1 versus HR not equal to 1. | |
Method | Wald test | |
Comments | ||
Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
Estimated Value | 0.71 | |
Confidence Interval |
(2-Sided) 95% 0.51 to 0.99 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Hazard ratio is estimated using a Cox proportional hazard regression model with treatment as the only covariate. |
Title | Percentage of Participants Achieving Composite Metabolic Endpoint |
---|---|
Description | Percentage of participants achieving composite metabolic endpoint defined as the percentage of participants achieving glycemic control (glycated hemoglobin [HbA1c] <=7% ) with no severe hypoglycemic incidents and weight gain < 5%. Final Assessment is the latest post-Baseline assessment of both HbA1c and weight. |
Time Frame | Months 8, 16, 24 and final assessment (up to 2.7 years) |
Outcome Measure Data
Analysis Population Description |
---|
ITT Population. Only those participants with HbA1c and weight values at Baseline and at the specified visits were analyzed (represented by n=X in category titles) |
Arm/Group Title | Placebo | Albiglutide |
---|---|---|
Arm/Group Description | Albiglutide matching placebo was administered once weekly as subcutaneous injection in the abdomen, thigh or upper arm region in addition to the standard of care therapy for diabetes and cardiovascular health. | Albiglutide was administered once weekly as subcutaneous injection in the abdomen, thigh or upper arm region. Participants were administered albiglutide at a dose of 30 milligrams (mg) or 50 mg once weekly in addition to the standard of care therapy for diabetes and cardiovascular health. |
Measure Participants | 4732 | 4731 |
Month 8, n=4127, 4195 |
15.4
0.3%
|
32.2
0.7%
|
Month 16, n=3026, 3118 |
16.5
0.3%
|
28.7
0.6%
|
Month 24, n=1119, 1173 |
17.8
0.4%
|
28.6
0.6%
|
Final assessment, n=4401, 4455 |
15.1
0.3%
|
26.0
0.5%
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Placebo, Albiglutide |
---|---|---|
Comments | ||
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | <0.001 |
Comments | P-value based on the covariate-adjusted extended Mantel-Haenszel test. Covariates include Baseline HbA1c (<8.0% versus >= 8.0%) and Baseline diabetes therapy (diet and exercise alone versus all other therapies). | |
Method | Mantel Haenszel | |
Comments | Month 8 |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | Placebo, Albiglutide |
---|---|---|
Comments | ||
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | <0.001 |
Comments | P-value based on the covariate-adjusted extended Mantel-Haenszel test. Covariates include Baseline HbA1c (<8.0% versus >= 8.0%) and Baseline diabetes therapy (diet and exercise alone versus all other therapies). | |
Method | Mantel Haenszel | |
Comments | Month 16 |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | Placebo, Albiglutide |
---|---|---|
Comments | ||
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | <0.001 |
Comments | P-value based on the covariate-adjusted extended Mantel-Haenszel test. Covariates include Baseline HbA1c (<8.0% versus >= 8.0%) and Baseline diabetes therapy (diet and exercise alone versus all other therapies). | |
Method | Mantel Haenszel | |
Comments | Month 24 |
Statistical Analysis 4
Statistical Analysis Overview | Comparison Group Selection | Placebo, Albiglutide |
---|---|---|
Comments | ||
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | <0.001 |
Comments | P-value based on the covariate-adjusted extended Mantel-Haenszel test. Covariates include Baseline HbA1c (<8.0% versus >= 8.0%) and Baseline diabetes therapy (diet and exercise alone versus all other therapies). | |
Method | Mantel Haenszel | |
Comments | Final assessment |
Title | Time to First Occurrence of a Clinically Important Microvascular Event |
---|---|
Description | Clinically important microvascular events were defined as the following: need for renal transplant or dialysis, new diabetes-related blindness, and procedures (laser photocoagulation or anti-vascular endothelial growth factor treatment or vitrectomy for diabetic retinopathy/eye disease). Time to first occurrence of a clinically important microvascular event was analyzed using a Cox Proportional Hazards regression model with treatment group as the only covariate. The incidence rate per 100 person years (100*number of participants with at least 1 event)/first event person-years) is presented along with 95% confidence interval. First event person-years=(cumulative total time to first event for participants who have the event+cumulative total of censored time for participants without the event)/365.25, based on the on-therapy and post-therapy AE time period. |
Time Frame | Up to 2.7 years |
Outcome Measure Data
Analysis Population Description |
---|
ITT Population |
Arm/Group Title | Placebo | Albiglutide |
---|---|---|
Arm/Group Description | Albiglutide matching placebo was administered once weekly as subcutaneous injection in the abdomen, thigh or upper arm region in addition to the standard of care therapy for diabetes and cardiovascular health. | Albiglutide was administered once weekly as subcutaneous injection in the abdomen, thigh or upper arm region. Participants were administered albiglutide at a dose of 30 milligrams (mg) or 50 mg once weekly in addition to the standard of care therapy for diabetes and cardiovascular health. |
Measure Participants | 4732 | 4731 |
Number (95% Confidence Interval) [Events per 100 person years] |
0.69
|
0.46
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Placebo, Albiglutide |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.055 |
Comments | Two-sided p-value based on Wald test of HR=1 versus HR not equal to 1 | |
Method | Wald test | |
Comments | ||
Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
Estimated Value | 0.66 | |
Confidence Interval |
(2-Sided) 95% 0.43 to 1.01 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Hazard ratio is estimated using a Cox proportional hazard regression model with treatment as the only covariate. |
Title | Change From Baseline in HbA1c |
---|---|
Description | Change from Baseline in HbA1c was analyzed using mixed model repeated measures (MMRM) including observed case data (does not impute any missing data). Baseline is the last non-missing value assessed on or before treatment start date. Change from Baseline is the value at specified time point minus the Baseline value. Change from Baseline in HbA1c using Baseline data from Local or Central Laboratory, and post-Baseline Central Laboratory data is presented. |
Time Frame | Baseline and Months 8 and 16 |
Outcome Measure Data
Analysis Population Description |
---|
ITT Population. Only those participants with value at Baseline and at the specified visit is presented (represented by n=X in category titles) |
Arm/Group Title | Placebo | Albiglutide |
---|---|---|
Arm/Group Description | Albiglutide matching placebo was administered once weekly as subcutaneous injection in the abdomen, thigh or upper arm region in addition to the standard of care therapy for diabetes and cardiovascular health. | Albiglutide was administered once weekly as subcutaneous injection in the abdomen, thigh or upper arm region. Participants were administered albiglutide at a dose of 30 milligrams (mg) or 50 mg once weekly in addition to the standard of care therapy for diabetes and cardiovascular health. |
Measure Participants | 4732 | 4731 |
Month 8, n=4211, 4289 |
-0.28
(0.020)
|
-0.92
(0.019)
|
Month 16, n=3066, 3163 |
-0.31
(0.023)
|
-0.83
(0.022)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Placebo, Albiglutide |
---|---|---|
Comments | ||
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | <0.001 |
Comments | P-value from a two-sided t-test to test whether the difference of least square means (Albiglutide - Placebo) is equal to zero | |
Method | t-test, 2 sided | |
Comments | ||
Method of Estimation | Estimation Parameter | Mean Difference (Net) |
Estimated Value | -0.63 | |
Confidence Interval |
(2-Sided) 95% -0.69 to -0.58 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Based on MMRM model: Change=Baseline HbA1c+Treatment+Visit+Treatment-by-Visit Interaction+Baseline HbA1c-by-Visit Interaction. Difference of least squares means (Albiglutide-Placebo) is from MMRM model for Month 8 |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | Placebo, Albiglutide |
---|---|---|
Comments | ||
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | <0.001 |
Comments | P-value from a two-sided t-test to test whether the difference of least square means (Albiglutide - Placebo) is equal to zero | |
Method | t-test, 2 sided | |
Comments | ||
Method of Estimation | Estimation Parameter | Mean Difference (Net) |
Estimated Value | -0.52 | |
Confidence Interval |
(2-Sided) 95% -0.58 to -0.45 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Based on MMRM model: Change=Baseline HbA1c+Treatment+Visit+Treatment-by-Visit Interaction+Baseline HbA1c-by-Visit Interaction. Difference of least squares means (Albiglutide-Placebo) is from MMRM model for Month 16 |
Title | Change From Baseline in Body Weight |
---|---|
Description | Change from Baseline in body weight was analyzed using mixed model repeated measures including observed case data (does not impute any missing data). Baseline is the last non-missing value assessed on or before treatment start date. Change from Baseline is the value at specified time point minus the Baseline value. |
Time Frame | Baseline and Months 8 and 16 |
Outcome Measure Data
Analysis Population Description |
---|
ITT Population. Only those participants with value at Baseline and at the specified visit is presented (represented by n=X in category titles) |
Arm/Group Title | Placebo | Albiglutide |
---|---|---|
Arm/Group Description | Albiglutide matching placebo was administered once weekly as subcutaneous injection in the abdomen, thigh or upper arm region in addition to the standard of care therapy for diabetes and cardiovascular health. | Albiglutide was administered once weekly as subcutaneous injection in the abdomen, thigh or upper arm region. Participants were administered albiglutide at a dose of 30 milligrams (mg) or 50 mg once weekly in addition to the standard of care therapy for diabetes and cardiovascular health. |
Measure Participants | 4732 | 4731 |
Month 8, n=4217, 4286 |
-0.36
(0.062)
|
-1.02
(0.061)
|
Month 16, n=3068, 3173 |
-0.53
(0.084)
|
-1.36
(0.083)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Placebo, Albiglutide |
---|---|---|
Comments | ||
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | <0.001 |
Comments | P-value from a two-sided t-test to test whether the difference of least square means (Albiglutide-Placebo) is equal to zero | |
Method | t-test, 2 sided | |
Comments | ||
Method of Estimation | Estimation Parameter | Mean Difference (Net) |
Estimated Value | -0.66 | |
Confidence Interval |
(2-Sided) 95% -0.83 to -0.49 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Based on MMRM model: Change=Baseline Body Weight+Treatment+Visit+Treatment-by-Visit Interaction+Baseline Body Weight-by-Visit Interaction. Difference of least squares means (Albiglutide-Placebo) is from MMRM model for Month 8 |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | Placebo, Albiglutide |
---|---|---|
Comments | ||
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | <0.001 |
Comments | P-value from a two-sided t-test to test whether the difference of least square means (Albiglutide - Placebo) is equal to zero | |
Method | t-test, 2 sided | |
Comments | ||
Method of Estimation | Estimation Parameter | Mean Difference (Net) |
Estimated Value | -0.83 | |
Confidence Interval |
(2-Sided) 95% -1.06 to -0.60 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Based on MMRM model: Change=Baseline Body Weight+Treatment+Visit+Treatment-by-Visit Interaction+Baseline Body weight-by-Visit Interaction. Difference of least squares means (Albiglutide-Placebo) is from MMRM model for Month 16 |
Title | Change From Baseline in Treatment Related Impact Measures-Diabetes (TRIM-D) Total Score |
---|---|
Description | The TRIM-D is a 28 item treatment satisfaction measure with 5 domains assessing Treatment Burden, Daily Life, Diabetes Management, Compliance and Psychological Health. The raw score ranges for each subscale were: treatment burden (6 to 30), daily life (5 to 25), diabetes management (5 to 25), compliance (4 to 20) and psychological health (8 to 40), higher scores indicating better health state. Total raw score was determined by summing the raw scores for each of the subscales and the total score (transformed) was determined as [(raw score minus lowest possible raw score)/possible raw score range] x100. The possible total (transformed) score range is 0-100, where higher scores indicated better health state. Baseline is the last non-missing value assessed on or before treatment start date. Change from Baseline is the value at specified time point minus the Baseline value. |
Time Frame | Baseline and Months 8 and 16 |
Outcome Measure Data
Analysis Population Description |
---|
ITT Population. Only those participants with value at Baseline and at the specified visit is presented (represented by n=X in category titles) |
Arm/Group Title | Placebo | Albiglutide |
---|---|---|
Arm/Group Description | Albiglutide matching placebo was administered once weekly as subcutaneous injection in the abdomen, thigh or upper arm region in addition to the standard of care therapy for diabetes and cardiovascular health. | Albiglutide was administered once weekly as subcutaneous injection in the abdomen, thigh or upper arm region. Participants were administered albiglutide at a dose of 30 milligrams (mg) or 50 mg once weekly in addition to the standard of care therapy for diabetes and cardiovascular health. |
Measure Participants | 4732 | 4731 |
Month 8, n=3013, 3041 |
4.53
(0.194)
|
6.92
(0.193)
|
Month 16, n=1738, 1840 |
4.80
(0.247)
|
7.13
(0.241)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Placebo, Albiglutide |
---|---|---|
Comments | ||
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | <0.001 |
Comments | P-value from a two-sided t-test to test whether the difference of least square means (Albiglutide - Placebo) is equal to zero. | |
Method | t-test, 2 sided | |
Comments | ||
Method of Estimation | Estimation Parameter | Mean Difference (Net) |
Estimated Value | 2.39 | |
Confidence Interval |
(2-Sided) 95% 1.85 to 2.93 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Based on MMRM model: Change=Baseline Total Score+Treatment+Visit+Treatment-by-Visit Interaction+Baseline Total Score-by-Visit Interaction. Difference of least squares means (Albiglutide-Placebo) is from MMRM model for Month 8 |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | Placebo, Albiglutide |
---|---|---|
Comments | ||
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | <0.001 |
Comments | P-value from a two-sided t-test to test whether the difference of least square means (Albiglutide-Placebo) is equal to zero | |
Method | t-test, 2 sided | |
Comments | ||
Method of Estimation | Estimation Parameter | Mean Difference (Net) |
Estimated Value | 2.33 | |
Confidence Interval |
(2-Sided) 95% 1.66 to 3.01 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Based on MMRM model: Change=Baseline Total Score+Treatment+Visit+Treatment-by-Visit Interaction+Baseline Total Score-by-Visit Interaction. Difference of least squares means (Albiglutide-Placebo) is from MMRM model for Month 16 |
Title | Change From Baseline in EuroQol- 5 Dimension (EQ-5D) Visual Analogue Scale (VAS) Score |
---|---|
Description | The EQ-5D is a standardized instrument used to evaluate generic health-related quality of life, comprising 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. It provides a simple descriptive profile and a single index value for health status. The EQ-5D self-reported questionnaire includes a visual analog scale (VAS), which records the respondent's self-rated health status on a graduated (0-100) scale, where 0 represents the worst imaginable health state and 100 represents the best imaginable health state. Baseline is the last non-missing value assessed on or before treatment start date. Change from Baseline is the value at specified time point minus the Baseline value. |
Time Frame | Baseline and Months 8 and 16 |
Outcome Measure Data
Analysis Population Description |
---|
ITT Population. Only those participants with value at Baseline and at the specified visit is presented (represented by n=X in category titles) |
Arm/Group Title | Placebo | Albiglutide |
---|---|---|
Arm/Group Description | Albiglutide matching placebo was administered once weekly as subcutaneous injection in the abdomen, thigh or upper arm region in addition to the standard of care therapy for diabetes and cardiovascular health. | Albiglutide was administered once weekly as subcutaneous injection in the abdomen, thigh or upper arm region. Participants were administered albiglutide at a dose of 30 milligrams (mg) or 50 mg once weekly in addition to the standard of care therapy for diabetes and cardiovascular health. |
Measure Participants | 4732 | 4731 |
Month 8, n=3982, 4014 |
1.36
(0.217)
|
2.83
(0.216)
|
Month 16, n=2347, 2481 |
1.87
(0.287)
|
2.39
(0.279)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Placebo, Albiglutide |
---|---|---|
Comments | ||
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | <0.001 |
Comments | P-value from a two-sided t-test to test whether the difference of least square means (Albiglutide-Placebo) is equal to zero. | |
Method | t-test, 2 sided | |
Comments | ||
Method of Estimation | Estimation Parameter | Mean Difference (Net) |
Estimated Value | 1.47 | |
Confidence Interval |
(2-Sided) 95% 0.87 to 2.07 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Based on MMRM model: Change=Baseline Score+Treatment+Visit+Treatment-by-Visit Interaction+Baseline Score-by-Visit Interaction. Difference of least squares means (Albiglutide-Placebo) is from MMRM model for Month 8. |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | Placebo, Albiglutide |
---|---|---|
Comments | ||
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.192 |
Comments | P-value from a two-sided t-test to test whether the difference of least square means (Albiglutide - Placebo) is equal to zero | |
Method | t-test, 2 sided | |
Comments | ||
Method of Estimation | Estimation Parameter | Mean Difference (Net) |
Estimated Value | 0.52 | |
Confidence Interval |
(2-Sided) 95% -0.26 to 1.31 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Based on MMRM model: Change=Baseline Score+Treatment+Visit+Treatment-by-Visit Interaction+Baseline Score-by-Visit Interaction. Difference of least squares means (Albiglutide - Placebo) is from MMRM model for Month 16 |
Title | Time to Death |
---|---|
Description | Time to death was analyzed using a Cox Proportional Hazards regression model with treatment group as the only covariate. The incidence rate per 100 person years (100*number of participants who died/endpoint person-years) is presented along with 95% confidence interval. Endpoint person-years=(cumulative total time to event for participants who have the event+cumulative total of censored time for participants without the event)/365.25, based on the Vital Status follow-up time period. |
Time Frame | Median of 1.73 years for the Vital Status follow-up time period |
Outcome Measure Data
Analysis Population Description |
---|
ITT Population |
Arm/Group Title | Placebo | Albiglutide |
---|---|---|
Arm/Group Description | Albiglutide matching placebo was administered once weekly as subcutaneous injection in the abdomen, thigh or upper arm region in addition to the standard of care therapy for diabetes and cardiovascular health. | Albiglutide was administered once weekly as subcutaneous injection in the abdomen, thigh or upper arm region. Participants were administered albiglutide at a dose of 30 milligrams (mg) or 50 mg once weekly in addition to the standard of care therapy for diabetes and cardiovascular health. |
Measure Participants | 4732 | 4731 |
Number (95% Confidence Interval) [Events per 100 person years] |
2.56
|
2.44
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Placebo, Albiglutide |
---|---|---|
Comments | ||
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.644 |
Comments | Two-sided p-value based on Wald test of HR=1 versus HR not equal to 1. | |
Method | Wald test | |
Comments | ||
Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
Estimated Value | 0.95 | |
Confidence Interval |
(2-Sided) 95% 0.79 to 1.16 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Hazard ratio is estimated using a Cox proportional hazard regression model with treatment as the only covariate. |
Title | Number of Participants With Non-fatal Serious Adverse Events (SAEs) |
---|---|
Description | SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; is a congenital anomaly/birth defect; other important medical events that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed before; is associated with liver injury and impaired liver function. Number of participants with on-therapy non-fatal SAEs are presented. Safety Population comprised of all randomized participants who received at least one dose of study treatment. |
Time Frame | Up to 2.7 years |
Outcome Measure Data
Analysis Population Description |
---|
Safety Population |
Arm/Group Title | Placebo | Albiglutide |
---|---|---|
Arm/Group Description | Albiglutide matching placebo was administered once weekly as subcutaneous injection in the abdomen, thigh or upper arm region in addition to the standard of care therapy for diabetes and cardiovascular health. | Albiglutide was administered once weekly as subcutaneous injection in the abdomen, thigh or upper arm region. Participants were administered albiglutide at a dose of 30 milligrams (mg) or 50 mg once weekly in addition to the standard of care therapy for diabetes and cardiovascular health. |
Measure Participants | 4715 | 4717 |
Count of Participants [Participants] |
974
20.6%
|
891
18.8%
|
Title | Number of Participants With Adverse Events (AEs) Leading to Discontinuation of Investigational Product (AELD) |
---|---|
Description | The number of participants with on-therapy AEs leading to discontinuation of investigational product is reported. |
Time Frame | Up to 2.7 years |
Outcome Measure Data
Analysis Population Description |
---|
Safety Population |
Arm/Group Title | Placebo | Albiglutide |
---|---|---|
Arm/Group Description | Albiglutide matching placebo was administered once weekly as subcutaneous injection in the abdomen, thigh or upper arm region in addition to the standard of care therapy for diabetes and cardiovascular health. | Albiglutide was administered once weekly as subcutaneous injection in the abdomen, thigh or upper arm region. Participants were administered albiglutide at a dose of 30 milligrams (mg) or 50 mg once weekly in addition to the standard of care therapy for diabetes and cardiovascular health. |
Measure Participants | 4715 | 4717 |
Count of Participants [Participants] |
334
7.1%
|
427
9%
|
Title | Number of Participants With AEs of Special Interest |
---|---|
Description | The protocol defined AEs of special interest included: development of thyroid cancer; hematologic malignancy; pancreatic cancer; pancreatitis (investigator reported and pancreatitis positively adjudicated by the Pancreatic Adjudication Committee [PAC]); investigational product injection site reactions; immunological reactions; severe hypoglycemic events; hepatic events; hepatic enzyme elevations (including gamma glutamyl transferase [GGT]); serious gastrointestinal (GI) events; appendicitis; atrial fibrillation/flutter; pneumonia; worsening renal function and diabetic retinopathy. The number of participants with on-therapy AEs of special interest is reported. |
Time Frame | Up to 2.7 years |
Outcome Measure Data
Analysis Population Description |
---|
Safety Population |
Arm/Group Title | Placebo | Albiglutide |
---|---|---|
Arm/Group Description | Albiglutide matching placebo was administered once weekly as subcutaneous injection in the abdomen, thigh or upper arm region in addition to the standard of care therapy for diabetes and cardiovascular health. | Albiglutide was administered once weekly as subcutaneous injection in the abdomen, thigh or upper arm region. Participants were administered albiglutide at a dose of 30 milligrams (mg) or 50 mg once weekly in addition to the standard of care therapy for diabetes and cardiovascular health. |
Measure Participants | 4715 | 4717 |
Thyroid cancer diagnosis |
0
0%
|
0
0%
|
Hematologic malignancy |
5
0.1%
|
9
0.2%
|
Pancreatic cancer |
5
0.1%
|
6
0.1%
|
Investigational product injection site reaction |
29
0.6%
|
86
1.8%
|
Hypersensitivity |
48
1%
|
45
1%
|
Severe hypoglycemic events |
55
1.2%
|
31
0.7%
|
Hepatic events |
74
1.6%
|
98
2.1%
|
Hepatic enzyme elevations (including GGT) |
34
0.7%
|
51
1.1%
|
Serious GI Events |
87
1.8%
|
92
1.9%
|
Appendicitis |
8
0.2%
|
3
0.1%
|
Atrial fibrillation/atrial flutter |
131
2.8%
|
108
2.3%
|
Pneumonia |
138
2.9%
|
131
2.8%
|
Renal impairment |
319
6.7%
|
279
5.9%
|
Diabetic retinopathy |
89
1.9%
|
78
1.6%
|
Investigator-reported pancreatitis |
13
0.3%
|
14
0.3%
|
Pancreatitis positively adjudicated by PAC |
7
0.1%
|
10
0.2%
|
Title | Change in Estimated Glomerular Filtration Rate (eGFR) Calculated Using Modification of Diet in Renal Disease (MDRD) Formula |
---|---|
Description | Blood samples were collected for the measurement of serum creatinine. Serum creatinine values were used to calculate eGFR using the MDRD formula, eGFR=175 x (serum creatinine)^-1.154 x (Age)^-0.203 x (0.742 if female) x (1.212 if African American). Baseline is the last non-missing value assessed on or before treatment start date. Change from Baseline is the value at specified time point minus the Baseline value. Change from Baseline in eGFR using Baseline data from Local or Central Laboratory, and post-Baseline Central Laboratory data for the on-treatment time period is presented. |
Time Frame | Baseline and Months 8 and 16 |
Outcome Measure Data
Analysis Population Description |
---|
Safety Population. Only those participants with a value at Baseline and specified visit were analyzed (represented by n=X in category titles) |
Arm/Group Title | Placebo | Albiglutide |
---|---|---|
Arm/Group Description | Albiglutide matching placebo was administered once weekly as subcutaneous injection in the abdomen, thigh or upper arm region in addition to the standard of care therapy for diabetes and cardiovascular health. | Albiglutide was administered once weekly as subcutaneous injection in the abdomen, thigh or upper arm region. Participants were administered albiglutide at a dose of 30 milligrams (mg) or 50 mg once weekly in addition to the standard of care therapy for diabetes and cardiovascular health. |
Measure Participants | 4715 | 4717 |
Month 8; n=3977,4008 |
1.22
(0.264)
|
0.10
(0.262)
|
Month 16; n=2354,2496 |
-0.90
(0.303)
|
-1.33
(0.296)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Placebo, Albiglutide |
---|---|---|
Comments | ||
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.003 |
Comments | P-value from a two-sided t-test to test whether the difference of least square means (Albiglutide-Placebo) is equal to zero. | |
Method | t-test, 2 sided | |
Comments | ||
Method of Estimation | Estimation Parameter | Mean Difference (Net) |
Estimated Value | -1.11 | |
Confidence Interval |
(2-Sided) 95% -1.84 to -0.39 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Based on MMRM model: Change=Baseline eGFR+Treatment+Visit+Treatment-by-Visit Interaction+Baseline eGFR-by-Visit Interaction. Difference of least squares means (Albiglutide-Placebo) is from MMRM model for Month 8. |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | Placebo, Albiglutide |
---|---|---|
Comments | ||
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.315 |
Comments | P-value from a two-sided t-test to test whether the difference of least square means (Albiglutide-Placebo) is equal to zero | |
Method | t-test, 2 sided | |
Comments | ||
Method of Estimation | Estimation Parameter | Mean Difference (Net) |
Estimated Value | -0.43 | |
Confidence Interval |
(2-Sided) 95% -1.26 to 0.41 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Based on MMRM model: Change=Baseline eGFR+Treatment+Visit+Treatment-by-Visit Interaction+Baseline eGFR-by-Visit Interaction. Difference of least squares means (Albiglutide-Placebo) is from MMRM model for Month 16. |
Title | Change From Baseline in Blood Pressure |
---|---|
Description | Systolic blood pressure (SBP) and diastolic blood pressure (DBP) were taken with the participant in a semi-recumbent or seated position after at least a 5-minute rest period. Baseline is the last non-missing value assessed on or before treatment start date. Change from Baseline is the value at specified time point minus the Baseline value. |
Time Frame | Baseline and Months 8,16,24 and end of study (up to 2.7 years) |
Outcome Measure Data
Analysis Population Description |
---|
Safety Population. Only those participants with a value at Baseline and specified visit were analyzed (represented n=X in category titles) |
Arm/Group Title | Placebo | Albiglutide |
---|---|---|
Arm/Group Description | Albiglutide matching placebo was administered once weekly as subcutaneous injection in the abdomen, thigh or upper arm region in addition to the standard of care therapy for diabetes and cardiovascular health. | Albiglutide was administered once weekly as subcutaneous injection in the abdomen, thigh or upper arm region. Participants were administered albiglutide at a dose of 30 milligrams (mg) or 50 mg once weekly in addition to the standard of care therapy for diabetes and cardiovascular health. |
Measure Participants | 4715 | 4717 |
SBP, Month 8; n=4241, 4319 |
-0.5
(17.33)
|
-1.0
(16.80)
|
SBP, Month 16; n=3082, 3187 |
-0.5
(17.45)
|
-0.9
(17.58)
|
SBP, Month 24; n=1133, 1198 |
-0.9
(18.62)
|
-1.2
(17.51)
|
SBP, End of study; n=3897, 4015 |
0.0
(17.68)
|
-0.4
(17.58)
|
DBP, Month 8; n=4241, 4319 |
-0.5
(10.26)
|
-0.4
(10.12)
|
DBP, Month 16; n=3082, 3187 |
-0.9
(10.74)
|
-0.5
(10.39)
|
DBP, Month 24; n=1133, 1198 |
-1.1
(10.87)
|
-1.0
(10.29)
|
DBP, End of study; n=3897, 4015 |
-0.7
(10.66)
|
-0.6
(10.57)
|
Title | Change From Baseline in Heart Rate |
---|---|
Description | Heart rate was measured with the participant in a semi-recumbent or seated position after at least a 5-minute rest period. Baseline is the last non-missing value assessed on or before treatment start date. Change from Baseline is the value at specified time point minus the Baseline value. |
Time Frame | Baseline and Months 8, 16, 24 and end of study (up to 2.7 years) |
Outcome Measure Data
Analysis Population Description |
---|
Safety Population. Only those participants with a value at Baseline and specified visit were analyzed (represented n=X in category titles) |
Arm/Group Title | Placebo | Albiglutide |
---|---|---|
Arm/Group Description | Albiglutide matching placebo was administered once weekly as subcutaneous injection in the abdomen, thigh or upper arm region in addition to the standard of care therapy for diabetes and cardiovascular health. | Albiglutide was administered once weekly as subcutaneous injection in the abdomen, thigh or upper arm region. Participants were administered albiglutide at a dose of 30 milligrams (mg) or 50 mg once weekly in addition to the standard of care therapy for diabetes and cardiovascular health. |
Measure Participants | 4715 | 4717 |
Month 8; n=4239, 4312 |
0.2
(9.99)
|
1.6
(10.07)
|
Month 16; n=3078, 3181 |
0.3
(10.19)
|
1.6
(10.16)
|
Month 24; n=1131, 1195 |
0.6
(10.84)
|
1.7
(10.32)
|
End of study; n=3892, 4005 |
0.8
(10.64)
|
1.8
(10.50)
|
Adverse Events
Time Frame | On-therapy non-SAEs and SAEs were reported on or after treatment start date and within 56 days after treatment stop date (Up to 2.7 years) | |||
---|---|---|---|---|
Adverse Event Reporting Description | SAEs, non-SAELDs and non-SAEs of pre-specified interest were reported systematically in the Safety Population. Some investigators collected other non-SAEs for some participants (i.e. non-systematically). CV events referred for adjudication as study endpoints were not duplicate reported as AEs. Deaths were reported for ITT Population. | |||
Arm/Group Title | Albiglutide | Placebo | ||
Arm/Group Description | Albiglutide was administered once weekly as subcutaneous injection in the abdomen, thigh or upper arm region. Participants were administered albiglutide at a dose of 30 milligrams (mg) or 50 mg once weekly in addition to the standard of care therapy for diabetes and cardiovascular health.. | Albiglutide matching placebo was administered once weekly as subcutaneous injection in the abdomen, thigh or upper arm region in addition to the standard of care therapy for diabetes and cardiovascular health. | ||
All Cause Mortality |
||||
Albiglutide | Placebo | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 196/4731 (4.1%) | 205/4732 (4.3%) | ||
Serious Adverse Events |
||||
Albiglutide | Placebo | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 932/4717 (19.8%) | 1022/4715 (21.7%) | ||
Blood and lymphatic system disorders | ||||
Anaemia | 7/4717 (0.1%) | 8 | 10/4715 (0.2%) | 10 |
Iron deficiency anaemia | 5/4717 (0.1%) | 5 | 3/4715 (0.1%) | 3 |
Haemorrhagic anaemia | 5/4717 (0.1%) | 5 | 1/4715 (0%) | 1 |
Lymphadenopathy mediastinal | 2/4717 (0%) | 2 | 0/4715 (0%) | 0 |
Microcytic anaemia | 0/4717 (0%) | 0 | 2/4715 (0%) | 2 |
Anaemia of chronic disease | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Coagulopathy | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Haemolysis | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Lymph node fibrosis | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Normochromic anaemia | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Normocytic anaemia | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Pancytopenia | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Thrombocytopenia | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Cardiac disorders | ||||
Atrial fibrillation | 45/4717 (1%) | 48 | 41/4715 (0.9%) | 47 |
Angina pectoris | 37/4717 (0.8%) | 38 | 36/4715 (0.8%) | 39 |
Coronary artery disease | 24/4717 (0.5%) | 24 | 31/4715 (0.7%) | 31 |
Atrial flutter | 6/4717 (0.1%) | 6 | 14/4715 (0.3%) | 15 |
Atrioventricular block complete | 11/4717 (0.2%) | 11 | 5/4715 (0.1%) | 5 |
Ventricular tachycardia | 6/4717 (0.1%) | 7 | 9/4715 (0.2%) | 10 |
Cardiac failure | 10/4717 (0.2%) | 10 | 4/4715 (0.1%) | 4 |
Cardiogenic shock | 9/4717 (0.2%) | 9 | 4/4715 (0.1%) | 4 |
Myocardial ischaemia | 6/4717 (0.1%) | 6 | 7/4715 (0.1%) | 7 |
Bradycardia | 8/4717 (0.2%) | 8 | 4/4715 (0.1%) | 4 |
Cardiac failure congestive | 3/4717 (0.1%) | 3 | 9/4715 (0.2%) | 10 |
Cardio-respiratory arrest | 5/4717 (0.1%) | 5 | 5/4715 (0.1%) | 6 |
Arteriosclerosis coronary artery | 4/4717 (0.1%) | 4 | 5/4715 (0.1%) | 5 |
Cardiac arrest | 4/4717 (0.1%) | 4 | 5/4715 (0.1%) | 5 |
Coronary artery stenosis | 3/4717 (0.1%) | 3 | 6/4715 (0.1%) | 6 |
Sinus node dysfunction | 2/4717 (0%) | 2 | 6/4715 (0.1%) | 6 |
Atrioventricular block second degree | 3/4717 (0.1%) | 3 | 4/4715 (0.1%) | 4 |
Ventricular fibrillation | 4/4717 (0.1%) | 4 | 3/4715 (0.1%) | 3 |
Aortic valve stenosis | 3/4717 (0.1%) | 3 | 3/4715 (0.1%) | 3 |
Acute coronary syndrome | 4/4717 (0.1%) | 4 | 1/4715 (0%) | 1 |
Pericarditis | 1/4717 (0%) | 1 | 4/4715 (0.1%) | 5 |
Supraventricular tachycardia | 3/4717 (0.1%) | 3 | 2/4715 (0%) | 2 |
Angina unstable | 2/4717 (0%) | 2 | 2/4715 (0%) | 2 |
Atrioventricular block | 1/4717 (0%) | 1 | 3/4715 (0.1%) | 3 |
Ventricular arrhythmia | 1/4717 (0%) | 1 | 3/4715 (0.1%) | 3 |
Arrhythmia | 1/4717 (0%) | 1 | 2/4715 (0%) | 2 |
Bundle branch block left | 1/4717 (0%) | 1 | 2/4715 (0%) | 2 |
Cardiopulmonary failure | 1/4717 (0%) | 1 | 2/4715 (0%) | 2 |
Ischaemic cardiomyopathy | 0/4717 (0%) | 0 | 3/4715 (0.1%) | 3 |
Aortic valve disease | 0/4717 (0%) | 0 | 2/4715 (0%) | 2 |
Aortic valve incompetence | 1/4717 (0%) | 1 | 1/4715 (0%) | 1 |
Arrhythmia supraventricular | 1/4717 (0%) | 1 | 1/4715 (0%) | 1 |
Cardiac asthma | 1/4717 (0%) | 1 | 1/4715 (0%) | 1 |
Cardiac failure chronic | 2/4717 (0%) | 2 | 0/4715 (0%) | 0 |
Cardiomegaly | 1/4717 (0%) | 1 | 1/4715 (0%) | 1 |
Cardiomyopathy | 1/4717 (0%) | 1 | 1/4715 (0%) | 1 |
Cardiovascular disorder | 0/4717 (0%) | 0 | 2/4715 (0%) | 2 |
Coronary artery occlusion | 1/4717 (0%) | 1 | 1/4715 (0%) | 1 |
Left ventricular failure | 2/4717 (0%) | 2 | 0/4715 (0%) | 0 |
Myocardial fibrosis | 0/4717 (0%) | 0 | 2/4715 (0%) | 2 |
Sinus tachycardia | 2/4717 (0%) | 2 | 0/4715 (0%) | 0 |
Acute left ventricular failure | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Acute myocardial infarction | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Atrial thrombosis | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Brugada syndrome | 1/4717 (0%) | 2 | 0/4715 (0%) | 0 |
Cardiorenal syndrome | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Coronary artery dissection | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Coronary no-reflow phenomenon | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Coronary ostial stenosis | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Hypertensive heart disease | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Intracardiac thrombus | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Mitral valve incompetence | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Myocarditis | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Palpitations | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Pericardial effusion | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Right ventricular failure | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Sinoatrial block | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Sinus arrest | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Sinus bradycardia | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Tachycardia | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Torsade de pointes | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Ventricular extrasystoles | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Congenital, familial and genetic disorders | ||||
Adenomatous polyposis coli | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Haemorrhagic arteriovenous malformation | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Hypertrophic cardiomyopathy | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Phimosis | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Ear and labyrinth disorders | ||||
Vertigo | 2/4717 (0%) | 2 | 5/4715 (0.1%) | 6 |
Deafness | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Deafness unilateral | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Vertigo positional | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Endocrine disorders | ||||
Adrenal mass | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Goitre | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Hyperparathyroidism | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Eye disorders | ||||
Cataract | 7/4717 (0.1%) | 7 | 5/4715 (0.1%) | 6 |
Glaucoma | 1/4717 (0%) | 1 | 6/4715 (0.1%) | 6 |
Vitreous haemorrhage | 5/4717 (0.1%) | 5 | 2/4715 (0%) | 2 |
Diabetic retinopathy | 1/4717 (0%) | 1 | 3/4715 (0.1%) | 3 |
Eyelid ptosis | 1/4717 (0%) | 1 | 1/4715 (0%) | 1 |
Macular degeneration | 1/4717 (0%) | 1 | 1/4715 (0%) | 1 |
Blindness | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Choroidal detachment | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Diplopia | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Eye pain | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Hypotony of eye | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Posterior capsule rupture | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Retinal artery occlusion | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Retinal detachment | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Retinopathy | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Retinopathy proliferative | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Gastrointestinal disorders | ||||
Gastrointestinal haemorrhage | 8/4717 (0.2%) | 12 | 10/4715 (0.2%) | 10 |
Gastritis | 5/4717 (0.1%) | 5 | 8/4715 (0.2%) | 8 |
Small intestinal obstruction | 5/4717 (0.1%) | 5 | 5/4715 (0.1%) | 6 |
Pancreatitis acute | 6/4717 (0.1%) | 7 | 3/4715 (0.1%) | 3 |
Inguinal hernia | 6/4717 (0.1%) | 6 | 2/4715 (0%) | 2 |
Colitis | 3/4717 (0.1%) | 3 | 4/4715 (0.1%) | 4 |
Upper gastrointestinal haemorrhage | 4/4717 (0.1%) | 4 | 3/4715 (0.1%) | 4 |
Abdominal pain | 2/4717 (0%) | 2 | 4/4715 (0.1%) | 4 |
Abdominal pain upper | 3/4717 (0.1%) | 3 | 3/4715 (0.1%) | 4 |
Diarrhoea | 4/4717 (0.1%) | 4 | 2/4715 (0%) | 2 |
Vomiting | 5/4717 (0.1%) | 5 | 1/4715 (0%) | 1 |
Duodenal ulcer | 1/4717 (0%) | 1 | 4/4715 (0.1%) | 4 |
Gastric ulcer | 3/4717 (0.1%) | 3 | 2/4715 (0%) | 2 |
Large intestine polyp | 2/4717 (0%) | 2 | 3/4715 (0.1%) | 3 |
Abdominal hernia | 3/4717 (0.1%) | 3 | 1/4715 (0%) | 1 |
Constipation | 3/4717 (0.1%) | 3 | 1/4715 (0%) | 1 |
Dyspepsia | 2/4717 (0%) | 2 | 2/4715 (0%) | 2 |
Impaired gastric emptying | 1/4717 (0%) | 1 | 3/4715 (0.1%) | 3 |
Gastric ulcer haemorrhage | 1/4717 (0%) | 1 | 2/4715 (0%) | 2 |
Gastritis erosive | 2/4717 (0%) | 2 | 1/4715 (0%) | 1 |
Gastrooesophageal reflux disease | 2/4717 (0%) | 2 | 1/4715 (0%) | 1 |
Lower gastrointestinal haemorrhage | 2/4717 (0%) | 5 | 1/4715 (0%) | 1 |
Oesophagitis | 1/4717 (0%) | 1 | 2/4715 (0%) | 2 |
Pancreatitis | 1/4717 (0%) | 1 | 2/4715 (0%) | 2 |
Chronic gastritis | 0/4717 (0%) | 0 | 2/4715 (0%) | 2 |
Diverticulum intestinal | 2/4717 (0%) | 2 | 0/4715 (0%) | 0 |
Duodenal ulcer haemorrhage | 0/4717 (0%) | 0 | 2/4715 (0%) | 2 |
Enteritis | 0/4717 (0%) | 0 | 2/4715 (0%) | 2 |
Haemorrhoidal haemorrhage | 1/4717 (0%) | 1 | 1/4715 (0%) | 1 |
Hiatus hernia | 1/4717 (0%) | 1 | 1/4715 (0%) | 1 |
Intestinal obstruction | 2/4717 (0%) | 2 | 0/4715 (0%) | 0 |
Melaena | 1/4717 (0%) | 1 | 1/4715 (0%) | 1 |
Nausea | 2/4717 (0%) | 2 | 0/4715 (0%) | 0 |
Oesophageal varices haemorrhage | 0/4717 (0%) | 0 | 2/4715 (0%) | 2 |
Pancreatitis chronic | 1/4717 (0%) | 1 | 1/4715 (0%) | 1 |
Peptic ulcer | 2/4717 (0%) | 2 | 0/4715 (0%) | 0 |
Rectal haemorrhage | 1/4717 (0%) | 1 | 1/4715 (0%) | 1 |
Strangulated umbilical hernia | 0/4717 (0%) | 0 | 2/4715 (0%) | 2 |
Abdominal discomfort | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Alcoholic pancreatitis | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Anal fistula | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Aortoenteric fistula | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Ascites | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Biliary ascites | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Colitis ischaemic | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Colitis ulcerative | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Crohn's disease | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Diabetic gastroparesis | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Duodenal ulcer perforation | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Duodenitis | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Dysphagia | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Epiploic appendagitis | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Erosive oesophagitis | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Faecaloma | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Gastric antral vascular ectasia | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Gastric haemorrhage | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Gastroenteritis eosinophilic | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Gastrointestinal disorder | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Gastrointestinal necrosis | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Haematemesis | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Haemorrhoids | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Hypoaesthesia oral | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Ileus | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Intestinal perforation | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Intestinal polyp | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Irritable bowel syndrome | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Lip oedema | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Oesophageal stenosis | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Oesophageal ulcer | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Palatal ulcer | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Pancreatic duct stenosis | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Peptic ulcer perforation | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Proctalgia | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Rectal polyp | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Retroperitoneal haematoma | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Umbilical hernia | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Uvulitis | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Varices oesophageal | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
General disorders | ||||
Non-cardiac chest pain | 15/4717 (0.3%) | 19 | 22/4715 (0.5%) | 23 |
Death | 10/4717 (0.2%) | 10 | 14/4715 (0.3%) | 14 |
Chest pain | 8/4717 (0.2%) | 8 | 10/4715 (0.2%) | 10 |
Multiple organ dysfunction syndrome | 6/4717 (0.1%) | 6 | 6/4715 (0.1%) | 6 |
Asthenia | 4/4717 (0.1%) | 4 | 4/4715 (0.1%) | 4 |
Sudden death | 2/4717 (0%) | 2 | 3/4715 (0.1%) | 3 |
Vascular stent stenosis | 3/4717 (0.1%) | 3 | 2/4715 (0%) | 2 |
Impaired healing | 1/4717 (0%) | 1 | 3/4715 (0.1%) | 4 |
Catheter site haemorrhage | 1/4717 (0%) | 1 | 1/4715 (0%) | 1 |
Generalised oedema | 0/4717 (0%) | 0 | 2/4715 (0%) | 2 |
Pyrexia | 2/4717 (0%) | 2 | 0/4715 (0%) | 0 |
Sudden cardiac death | 2/4717 (0%) | 2 | 0/4715 (0%) | 0 |
Systemic inflammatory response syndrome | 0/4717 (0%) | 0 | 2/4715 (0%) | 2 |
Accidental death | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Cardiac complication associated with device | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Complication associated with device | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Condition aggravated | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Discomfort | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Drug withdrawal syndrome | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Fatigue | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Incarcerated hernia | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Inflammation | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Mass | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Necrobiosis | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Necrosis | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Pain | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Soft tissue inflammation | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Treatment noncompliance | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Vascular stent occlusion | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Vascular stent thrombosis | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Hepatobiliary disorders | ||||
Cholelithiasis | 12/4717 (0.3%) | 12 | 7/4715 (0.1%) | 7 |
Cholecystitis | 7/4717 (0.1%) | 7 | 5/4715 (0.1%) | 5 |
Cholecystitis acute | 7/4717 (0.1%) | 7 | 4/4715 (0.1%) | 4 |
Bile duct stone | 2/4717 (0%) | 2 | 1/4715 (0%) | 1 |
Hepatic cirrhosis | 1/4717 (0%) | 1 | 2/4715 (0%) | 2 |
Hepatic failure | 0/4717 (0%) | 0 | 3/4715 (0.1%) | 3 |
Biliary colic | 2/4717 (0%) | 2 | 0/4715 (0%) | 0 |
Cholecystitis chronic | 0/4717 (0%) | 0 | 2/4715 (0%) | 2 |
Hepatitis acute | 0/4717 (0%) | 0 | 2/4715 (0%) | 2 |
Ischaemic hepatitis | 1/4717 (0%) | 1 | 1/4715 (0%) | 1 |
Acute hepatic failure | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Drug-induced liver injury | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Hepatic steatosis | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Hepatotoxicity | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Jaundice cholestatic | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Liver disorder | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Liver injury | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Non-alcoholic steatohepatitis | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Immune system disorders | ||||
Anaphylactic reaction | 2/4717 (0%) | 2 | 0/4715 (0%) | 0 |
Contrast media reaction | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Drug hypersensitivity | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Hypersensitivity | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Infections and infestations | ||||
Pneumonia | 74/4717 (1.6%) | 79 | 77/4715 (1.6%) | 81 |
Sepsis | 23/4717 (0.5%) | 23 | 28/4715 (0.6%) | 29 |
Urinary tract infection | 26/4717 (0.6%) | 27 | 23/4715 (0.5%) | 27 |
Cellulitis | 20/4717 (0.4%) | 22 | 20/4715 (0.4%) | 20 |
Bronchitis | 10/4717 (0.2%) | 10 | 11/4715 (0.2%) | 12 |
Erysipelas | 9/4717 (0.2%) | 9 | 12/4715 (0.3%) | 14 |
Osteomyelitis | 6/4717 (0.1%) | 6 | 14/4715 (0.3%) | 14 |
Gangrene | 6/4717 (0.1%) | 6 | 13/4715 (0.3%) | 14 |
Gastroenteritis | 8/4717 (0.2%) | 8 | 8/4715 (0.2%) | 8 |
Urosepsis | 6/4717 (0.1%) | 6 | 8/4715 (0.2%) | 8 |
Diabetic foot infection | 4/4717 (0.1%) | 6 | 9/4715 (0.2%) | 9 |
Septic shock | 4/4717 (0.1%) | 4 | 7/4715 (0.1%) | 7 |
Postoperative wound infection | 6/4717 (0.1%) | 6 | 4/4715 (0.1%) | 4 |
Respiratory tract infection | 5/4717 (0.1%) | 5 | 5/4715 (0.1%) | 5 |
Appendicitis | 2/4717 (0%) | 2 | 7/4715 (0.1%) | 7 |
Influenza | 3/4717 (0.1%) | 3 | 5/4715 (0.1%) | 5 |
Localised infection | 3/4717 (0.1%) | 3 | 4/4715 (0.1%) | 4 |
Endocarditis | 1/4717 (0%) | 1 | 5/4715 (0.1%) | 5 |
Infected skin ulcer | 5/4717 (0.1%) | 5 | 1/4715 (0%) | 1 |
Pyelonephritis | 2/4717 (0%) | 2 | 4/4715 (0.1%) | 4 |
Staphylococcal infection | 2/4717 (0%) | 2 | 4/4715 (0.1%) | 4 |
Subcutaneous abscess | 2/4717 (0%) | 2 | 4/4715 (0.1%) | 4 |
Upper respiratory tract infection | 2/4717 (0%) | 2 | 4/4715 (0.1%) | 4 |
Abscess limb | 2/4717 (0%) | 2 | 3/4715 (0.1%) | 3 |
Anal abscess | 0/4717 (0%) | 0 | 5/4715 (0.1%) | 5 |
Bacteraemia | 3/4717 (0.1%) | 4 | 2/4715 (0%) | 2 |
Cystitis | 3/4717 (0.1%) | 3 | 2/4715 (0%) | 2 |
Infective exacerbation of chronic obstructive airways disease | 2/4717 (0%) | 2 | 3/4715 (0.1%) | 3 |
Lower respiratory tract infection | 1/4717 (0%) | 1 | 4/4715 (0.1%) | 5 |
Escherichia urinary tract infection | 3/4717 (0.1%) | 3 | 1/4715 (0%) | 1 |
Gastroenteritis viral | 3/4717 (0.1%) | 3 | 1/4715 (0%) | 1 |
Osteomyelitis acute | 2/4717 (0%) | 2 | 2/4715 (0%) | 2 |
Wound infection | 1/4717 (0%) | 1 | 3/4715 (0.1%) | 3 |
Arthritis bacterial | 3/4717 (0.1%) | 3 | 0/4715 (0%) | 0 |
Diabetic gangrene | 1/4717 (0%) | 1 | 2/4715 (0%) | 2 |
Diverticulitis | 1/4717 (0%) | 2 | 2/4715 (0%) | 3 |
Epididymitis | 1/4717 (0%) | 1 | 2/4715 (0%) | 2 |
Groin abscess | 2/4717 (0%) | 2 | 1/4715 (0%) | 1 |
Staphylococcal sepsis | 0/4717 (0%) | 0 | 3/4715 (0.1%) | 3 |
Viral infection | 2/4717 (0%) | 2 | 1/4715 (0%) | 1 |
Abscess soft tissue | 2/4717 (0%) | 2 | 0/4715 (0%) | 0 |
Acute sinusitis | 1/4717 (0%) | 1 | 1/4715 (0%) | 1 |
Bronchitis bacterial | 0/4717 (0%) | 0 | 2/4715 (0%) | 2 |
Clostridium difficile infection | 1/4717 (0%) | 1 | 1/4715 (0%) | 1 |
Device related infection | 0/4717 (0%) | 0 | 2/4715 (0%) | 2 |
Graft infection | 0/4717 (0%) | 0 | 2/4715 (0%) | 2 |
Hepatitis C | 1/4717 (0%) | 1 | 1/4715 (0%) | 1 |
Infection | 1/4717 (0%) | 1 | 1/4715 (0%) | 1 |
Intervertebral discitis | 0/4717 (0%) | 0 | 2/4715 (0%) | 2 |
Liver abscess | 2/4717 (0%) | 2 | 0/4715 (0%) | 0 |
Perirectal abscess | 2/4717 (0%) | 3 | 0/4715 (0%) | 0 |
Pneumonia viral | 2/4717 (0%) | 2 | 0/4715 (0%) | 0 |
Post procedural sepsis | 1/4717 (0%) | 1 | 1/4715 (0%) | 1 |
Pulmonary sepsis | 2/4717 (0%) | 2 | 0/4715 (0%) | 0 |
Sinusitis | 2/4717 (0%) | 2 | 0/4715 (0%) | 0 |
Staphylococcal bacteraemia | 0/4717 (0%) | 0 | 2/4715 (0%) | 2 |
Wound sepsis | 0/4717 (0%) | 0 | 2/4715 (0%) | 2 |
Abdominal abscess | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Abdominal sepsis | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Abdominal wall abscess | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Abscess neck | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Abscess oral | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Arthritis infective | 0/4717 (0%) | 0 | 1/4715 (0%) | 2 |
Beta haemolytic streptococcal infection | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Brain abscess | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Campylobacter gastroenteritis | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Candiduria | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Cellulitis gangrenous | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Cellulitis of male external genital organ | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Cholecystitis infective | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Chronic sinusitis | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Citrobacter infection | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Citrobacter sepsis | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Clostridial infection | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Clostridium difficile colitis | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Cystitis klebsiella | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Dacryocystitis | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Dengue fever | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Dengue haemorrhagic fever | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Emphysematous pyelonephritis | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Empyema | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Enterobacter sepsis | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Enterococcal bacteraemia | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Enterocolitis infectious | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Extradural abscess | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Gas gangrene | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Gastroenteritis salmonella | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
H1N1 influenza | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Haematoma infection | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Helicobacter gastritis | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Helicobacter infection | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Hepatitis E | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Herpes zoster | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Herpes zoster infection neurological | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Infected bite | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Infectious pleural effusion | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Lower respiratory tract infection bacterial | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Medical device site infection | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Meningitis pneumococcal | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Meningitis viral | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Nasopharyngitis | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Oesophageal candidiasis | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Oral candidiasis | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Osteomyelitis chronic | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Otitis externa | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Otitis media | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Parotitis | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Pharyngeal abscess | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Pneumonia bacterial | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Pneumonia haemophilus | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Pneumonia influenzal | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Pneumonia moraxella | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Post procedural cellulitis | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Post procedural infection | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Prostatic abscess | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Psoas abscess | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Pyelonephritis acute | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Pyonephrosis | 1/4717 (0%) | 2 | 0/4715 (0%) | 0 |
Renal abscess | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Respiratory syncytial virus infection | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Retroperitoneal abscess | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Septic embolus | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Soft tissue infection | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Sternitis | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Streptococcal bacteraemia | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Streptococcal endocarditis | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Streptococcal sepsis | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Systemic candida | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Systemic infection | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Tongue abscess | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Tonsillitis | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Tuberculosis | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Viral diarrhoea | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Viral upper respiratory tract infection | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Vulval abscess | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Injury, poisoning and procedural complications | ||||
Fall | 7/4717 (0.1%) | 8 | 6/4715 (0.1%) | 7 |
Hip fracture | 6/4717 (0.1%) | 6 | 2/4715 (0%) | 2 |
Road traffic accident | 3/4717 (0.1%) | 3 | 4/4715 (0.1%) | 4 |
Upper limb fracture | 4/4717 (0.1%) | 4 | 3/4715 (0.1%) | 3 |
Rib fracture | 2/4717 (0%) | 2 | 4/4715 (0.1%) | 4 |
Ankle fracture | 2/4717 (0%) | 2 | 3/4715 (0.1%) | 3 |
Contusion | 2/4717 (0%) | 2 | 3/4715 (0.1%) | 4 |
Humerus fracture | 3/4717 (0.1%) | 3 | 2/4715 (0%) | 2 |
Joint dislocation | 2/4717 (0%) | 2 | 3/4715 (0.1%) | 3 |
Tibia fracture | 3/4717 (0.1%) | 3 | 2/4715 (0%) | 2 |
Craniocerebral injury | 4/4717 (0.1%) | 4 | 0/4715 (0%) | 0 |
Femur fracture | 1/4717 (0%) | 1 | 3/4715 (0.1%) | 3 |
Meniscus injury | 2/4717 (0%) | 2 | 2/4715 (0%) | 2 |
Peripheral artery restenosis | 0/4717 (0%) | 0 | 4/4715 (0.1%) | 4 |
Tendon rupture | 2/4717 (0%) | 2 | 2/4715 (0%) | 2 |
Coronary artery restenosis | 0/4717 (0%) | 0 | 3/4715 (0.1%) | 4 |
Fibula fracture | 1/4717 (0%) | 1 | 2/4715 (0%) | 2 |
Incisional hernia | 3/4717 (0.1%) | 3 | 0/4715 (0%) | 0 |
Limb injury | 1/4717 (0%) | 1 | 2/4715 (0%) | 2 |
Post procedural haematoma | 1/4717 (0%) | 1 | 2/4715 (0%) | 2 |
Post procedural haemorrhage | 1/4717 (0%) | 1 | 2/4715 (0%) | 3 |
Spinal fracture | 1/4717 (0%) | 1 | 2/4715 (0%) | 2 |
Wound dehiscence | 0/4717 (0%) | 0 | 3/4715 (0.1%) | 3 |
Cardiac procedure complication | 0/4717 (0%) | 0 | 2/4715 (0%) | 2 |
Concussion | 0/4717 (0%) | 0 | 2/4715 (0%) | 2 |
Femoral neck fracture | 1/4717 (0%) | 1 | 1/4715 (0%) | 1 |
Hand fracture | 0/4717 (0%) | 0 | 2/4715 (0%) | 2 |
Head injury | 1/4717 (0%) | 1 | 1/4715 (0%) | 1 |
Lower limb fracture | 1/4717 (0%) | 1 | 1/4715 (0%) | 1 |
Lumbar vertebral fracture | 0/4717 (0%) | 0 | 2/4715 (0%) | 2 |
Postoperative thoracic procedure complication | 2/4717 (0%) | 2 | 0/4715 (0%) | 0 |
Postoperative wound complication | 1/4717 (0%) | 2 | 1/4715 (0%) | 1 |
Spinal compression fracture | 2/4717 (0%) | 2 | 0/4715 (0%) | 0 |
Subdural haematoma | 2/4717 (0%) | 2 | 0/4715 (0%) | 0 |
Vascular pseudoaneurysm | 2/4717 (0%) | 2 | 0/4715 (0%) | 0 |
Accidental overdose | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Adjacent segment degeneration | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Anastomotic stenosis | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Animal bite | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Arterial restenosis | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Carbon monoxide poisoning | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Cartilage injury | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Chest injury | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Fractured coccyx | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Fractured sacrum | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Gastrointestinal disorder postoperative | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Graft thrombosis | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Gun shot wound | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Intentional overdose | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Joint injury | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Kidney contusion | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Ligament injury | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Ligament sprain | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Limb traumatic amputation | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Lip injury | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Multiple injuries | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Muscle rupture | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Open globe injury | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Overdose | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Patella fracture | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Perirenal haematoma | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Post procedural haematuria | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Post-traumatic pain | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Postoperative delirium | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Procedural pneumothorax | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Radius fracture | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Shunt stenosis | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Sternal fracture | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Subarachnoid haemorrhage | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Suture related complication | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Suture rupture | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Thoracic vertebral fracture | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Traumatic haematoma | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Traumatic intracranial haemorrhage | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Ulnar nerve injury | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Vascular graft occlusion | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Vascular graft thrombosis | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Wound evisceration | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Investigations | ||||
Electrocardiogram QT prolonged | 4/4717 (0.1%) | 4 | 0/4715 (0%) | 0 |
Blood creatinine increased | 1/4717 (0%) | 1 | 2/4715 (0%) | 2 |
Hepatic enzyme increased | 3/4717 (0.1%) | 3 | 0/4715 (0%) | 0 |
Liver function test increased | 2/4717 (0%) | 2 | 1/4715 (0%) | 1 |
Glomerular filtration rate decreased | 0/4717 (0%) | 0 | 2/4715 (0%) | 2 |
Troponin increased | 1/4717 (0%) | 1 | 1/4715 (0%) | 1 |
Alanine aminotransferase increased | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Anticoagulation drug level above therapeutic | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Aspiration bronchial | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Blood alkaline phosphatase increased | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Blood glucose abnormal | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Blood ketone body increased | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Gamma-glutamyltransferase increased | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Myocardial necrosis marker increased | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Thyroid function test normal | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Weight decreased | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Weight increased | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Metabolism and nutrition disorders | ||||
Hyperglycaemia | 16/4717 (0.3%) | 16 | 30/4715 (0.6%) | 42 |
Hypoglycaemia | 12/4717 (0.3%) | 12 | 30/4715 (0.6%) | 34 |
Diabetes mellitus inadequate control | 4/4717 (0.1%) | 4 | 13/4715 (0.3%) | 13 |
Dehydration | 3/4717 (0.1%) | 3 | 9/4715 (0.2%) | 9 |
Diabetic ketoacidosis | 5/4717 (0.1%) | 5 | 6/4715 (0.1%) | 6 |
Diabetic metabolic decompensation | 2/4717 (0%) | 2 | 8/4715 (0.2%) | 9 |
Hyperkalaemia | 5/4717 (0.1%) | 5 | 5/4715 (0.1%) | 5 |
Type 2 diabetes mellitus | 4/4717 (0.1%) | 4 | 6/4715 (0.1%) | 6 |
Diabetes mellitus | 2/4717 (0%) | 2 | 6/4715 (0.1%) | 6 |
Hypokalaemia | 1/4717 (0%) | 1 | 4/4715 (0.1%) | 4 |
Metabolic acidosis | 1/4717 (0%) | 1 | 4/4715 (0.1%) | 4 |
Obesity | 2/4717 (0%) | 2 | 3/4715 (0.1%) | 3 |
Hyperglycaemic hyperosmolar nonketotic syndrome | 2/4717 (0%) | 2 | 2/4715 (0%) | 3 |
Lactic acidosis | 0/4717 (0%) | 0 | 3/4715 (0.1%) | 3 |
Hypocalcaemia | 1/4717 (0%) | 1 | 1/4715 (0%) | 1 |
Hypomagnesaemia | 1/4717 (0%) | 1 | 1/4715 (0%) | 1 |
Decreased appetite | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Failure to thrive | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Fluid overload | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Food intolerance | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Gout | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Hypercalcaemia | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Hyperosmolar state | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Hypoalbuminaemia | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Hyponatraemia | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Hypovolaemia | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Insulin-requiring type 2 diabetes mellitus | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Iron deficiency | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Ketoacidosis | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Ketosis | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Musculoskeletal and connective tissue disorders | ||||
Osteoarthritis | 7/4717 (0.1%) | 9 | 16/4715 (0.3%) | 16 |
Musculoskeletal chest pain | 4/4717 (0.1%) | 6 | 6/4715 (0.1%) | 6 |
Lumbar spinal stenosis | 4/4717 (0.1%) | 4 | 4/4715 (0.1%) | 4 |
Rotator cuff syndrome | 6/4717 (0.1%) | 6 | 2/4715 (0%) | 2 |
Back pain | 4/4717 (0.1%) | 4 | 3/4715 (0.1%) | 4 |
Intervertebral disc protrusion | 4/4717 (0.1%) | 4 | 2/4715 (0%) | 2 |
Spinal column stenosis | 1/4717 (0%) | 1 | 3/4715 (0.1%) | 3 |
Muscle haemorrhage | 2/4717 (0%) | 2 | 1/4715 (0%) | 1 |
Muscular weakness | 0/4717 (0%) | 0 | 3/4715 (0.1%) | 4 |
Musculoskeletal pain | 2/4717 (0%) | 2 | 1/4715 (0%) | 1 |
Arthralgia | 2/4717 (0%) | 2 | 0/4715 (0%) | 0 |
Intervertebral disc degeneration | 0/4717 (0%) | 0 | 2/4715 (0%) | 2 |
Osteitis | 2/4717 (0%) | 2 | 0/4715 (0%) | 0 |
Osteonecrosis | 1/4717 (0%) | 1 | 1/4715 (0%) | 1 |
Pain in extremity | 1/4717 (0%) | 1 | 1/4715 (0%) | 1 |
Rheumatoid arthritis | 1/4717 (0%) | 1 | 1/4715 (0%) | 1 |
Spinal osteoarthritis | 1/4717 (0%) | 1 | 1/4715 (0%) | 1 |
Spinal pain | 0/4717 (0%) | 0 | 2/4715 (0%) | 2 |
Arthritis | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Arthropathy | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Articular calcification | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Bursitis | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Cervical spinal stenosis | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Costochondritis | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Fibromyalgia | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Fracture nonunion | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Intervertebral disc disorder | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Myalgia | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Neuropathic arthropathy | 1/4717 (0%) | 2 | 0/4715 (0%) | 0 |
Osteochondrosis | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Osteolysis | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Osteoporosis | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Osteoporotic fracture | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Rhabdomyolysis | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Sjogren's syndrome | 1/4717 (0%) | 2 | 0/4715 (0%) | 0 |
Spondylolisthesis | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Tendonitis | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
Prostate cancer | 5/4717 (0.1%) | 5 | 12/4715 (0.3%) | 12 |
Lung neoplasm malignant | 9/4717 (0.2%) | 9 | 2/4715 (0%) | 2 |
Breast cancer | 4/4717 (0.1%) | 4 | 5/4715 (0.1%) | 5 |
Bladder cancer | 1/4717 (0%) | 1 | 7/4715 (0.1%) | 7 |
Adenocarcinoma of colon | 2/4717 (0%) | 2 | 5/4715 (0.1%) | 5 |
Pancreatic carcinoma metastatic | 4/4717 (0.1%) | 4 | 2/4715 (0%) | 2 |
Lung cancer metastatic | 3/4717 (0.1%) | 3 | 2/4715 (0%) | 2 |
Metastases to liver | 2/4717 (0%) | 2 | 3/4715 (0.1%) | 3 |
Pancreatic carcinoma | 2/4717 (0%) | 2 | 3/4715 (0.1%) | 3 |
Breast cancer metastatic | 1/4717 (0%) | 1 | 3/4715 (0.1%) | 3 |
Colon cancer | 1/4717 (0%) | 1 | 3/4715 (0.1%) | 3 |
Metastases to central nervous system | 2/4717 (0%) | 2 | 2/4715 (0%) | 2 |
Adenocarcinoma | 0/4717 (0%) | 0 | 3/4715 (0.1%) | 3 |
Basal cell carcinoma | 2/4717 (0%) | 2 | 1/4715 (0%) | 1 |
Bronchial carcinoma | 2/4717 (0%) | 2 | 1/4715 (0%) | 1 |
Colon cancer metastatic | 0/4717 (0%) | 0 | 3/4715 (0.1%) | 3 |
Hepatocellular carcinoma | 1/4717 (0%) | 1 | 2/4715 (0%) | 2 |
Malignant melanoma | 2/4717 (0%) | 2 | 1/4715 (0%) | 1 |
Renal neoplasm | 2/4717 (0%) | 2 | 1/4715 (0%) | 1 |
Salivary gland neoplasm | 2/4717 (0%) | 2 | 1/4715 (0%) | 1 |
Squamous cell carcinoma | 2/4717 (0%) | 2 | 1/4715 (0%) | 1 |
Uterine cancer | 0/4717 (0%) | 0 | 3/4715 (0.1%) | 3 |
Uterine leiomyoma | 2/4717 (0%) | 2 | 1/4715 (0%) | 1 |
Acute myeloid leukaemia | 2/4717 (0%) | 2 | 0/4715 (0%) | 0 |
Adenocarcinoma gastric | 2/4717 (0%) | 2 | 0/4715 (0%) | 0 |
B-cell lymphoma | 1/4717 (0%) | 1 | 1/4715 (0%) | 1 |
Bladder neoplasm | 1/4717 (0%) | 1 | 1/4715 (0%) | 1 |
Cholangiocarcinoma | 1/4717 (0%) | 1 | 1/4715 (0%) | 1 |
Gastric cancer | 2/4717 (0%) | 2 | 0/4715 (0%) | 0 |
Hepatic cancer | 2/4717 (0%) | 2 | 0/4715 (0%) | 0 |
Intraductal proliferative breast lesion | 0/4717 (0%) | 0 | 2/4715 (0%) | 2 |
Laryngeal cancer | 1/4717 (0%) | 1 | 1/4715 (0%) | 1 |
Laryngeal papilloma | 1/4717 (0%) | 1 | 1/4715 (0%) | 1 |
Lung adenocarcinoma | 0/4717 (0%) | 0 | 2/4715 (0%) | 2 |
Lung neoplasm | 0/4717 (0%) | 0 | 2/4715 (0%) | 2 |
Lymphoproliferative disorder | 2/4717 (0%) | 2 | 0/4715 (0%) | 0 |
Malignant neoplasm of unknown primary site | 2/4717 (0%) | 2 | 0/4715 (0%) | 0 |
Meningioma | 0/4717 (0%) | 0 | 2/4715 (0%) | 2 |
Metastases to bone | 1/4717 (0%) | 1 | 1/4715 (0%) | 1 |
Metastatic gastric cancer | 0/4717 (0%) | 0 | 2/4715 (0%) | 2 |
Prostatic adenoma | 1/4717 (0%) | 1 | 1/4715 (0%) | 1 |
Rectal cancer | 2/4717 (0%) | 2 | 0/4715 (0%) | 0 |
Squamous cell carcinoma of lung | 0/4717 (0%) | 0 | 2/4715 (0%) | 2 |
Squamous cell carcinoma of skin | 1/4717 (0%) | 1 | 1/4715 (0%) | 1 |
Squamous cell carcinoma of the oral cavity | 0/4717 (0%) | 0 | 2/4715 (0%) | 2 |
Adrenal adenoma | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Benign gastric neoplasm | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Benign neoplasm of bladder | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Benign salivary gland neoplasm | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Bladder cancer recurrent | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Bladder cancer stage 0, with cancer in situ | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Bladder cancer stage III | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Bone cancer | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Brain neoplasm malignant | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Breast cancer stage II | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Breast fibroma | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Breast neoplasm | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Bronchial neoplasm | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Cardiac myxoma | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Chromophobe renal cell carcinoma | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Chronic lymphocytic leukaemia | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Chronic myeloid leukaemia | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Colon cancer stage 0 | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Colon cancer stage IV | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Colorectal adenocarcinoma | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Corneoconjunctival intraepithelial neoplasia | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Dermatofibrosarcoma protuberans | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Diffuse large B-cell lymphoma | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Endometrial adenocarcinoma | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Glioblastoma | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Hypopharyngeal cancer | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Intestinal adenocarcinoma | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Intestinal metastasis | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Invasive ductal breast carcinoma | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Laryngeal squamous cell carcinoma | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Lip squamous cell carcinoma | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Lymphocytic leukaemia | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Malignant melanoma in situ | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Metastases to adrenals | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Metastases to lung | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Metastases to peritoneum | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Metastatic bronchial carcinoma | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Metastatic neoplasm | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Nervous system neoplasm benign | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Neuroendocrine carcinoma | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Neuroendocrine carcinoma metastatic | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Non-small cell lung cancer metastatic | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Non-small cell lung cancer stage II | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Oesophageal cancer metastatic | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Oesophageal carcinoma | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Oesophageal squamous cell carcinoma | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Oral papilloma | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Osteoma | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Osteosarcoma metastatic | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Ovarian adenoma | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Ovarian cancer stage I | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Papillary cystadenoma lymphomatosum | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Plasma cell myeloma | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Polycythaemia vera | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Prostate cancer metastatic | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Prostate cancer recurrent | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Rectal adenocarcinoma | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Rectosigmoid cancer stage II | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Renal adenoma | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Renal cancer | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Renal cancer metastatic | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Renal cell carcinoma | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Retroperitoneal neoplasm | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Small cell lung cancer | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Small intestine carcinoma | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Squamous cell carcinoma of the tongue | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Squamous cell carcinoma of the vulva | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Testicular neoplasm | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Vulval cancer | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Nervous system disorders | ||||
Syncope | 14/4717 (0.3%) | 17 | 13/4715 (0.3%) | 15 |
Carotid artery stenosis | 9/4717 (0.2%) | 11 | 7/4715 (0.1%) | 7 |
Presyncope | 5/4717 (0.1%) | 5 | 3/4715 (0.1%) | 3 |
Metabolic encephalopathy | 5/4717 (0.1%) | 5 | 1/4715 (0%) | 1 |
Carotid artery occlusion | 3/4717 (0.1%) | 3 | 2/4715 (0%) | 2 |
Diabetic neuropathy | 2/4717 (0%) | 2 | 3/4715 (0.1%) | 3 |
Dizziness | 2/4717 (0%) | 2 | 3/4715 (0.1%) | 3 |
Seizure | 1/4717 (0%) | 1 | 4/4715 (0.1%) | 4 |
Headache | 2/4717 (0%) | 2 | 2/4715 (0%) | 2 |
Brain injury | 3/4717 (0.1%) | 3 | 0/4715 (0%) | 0 |
Dementia | 0/4717 (0%) | 0 | 3/4715 (0.1%) | 3 |
Encephalopathy | 1/4717 (0%) | 1 | 2/4715 (0%) | 2 |
Facial paralysis | 1/4717 (0%) | 1 | 2/4715 (0%) | 2 |
Migraine | 3/4717 (0.1%) | 3 | 0/4715 (0%) | 0 |
Vertebrobasilar insufficiency | 2/4717 (0%) | 2 | 1/4715 (0%) | 1 |
Carotid arteriosclerosis | 1/4717 (0%) | 1 | 1/4715 (0%) | 1 |
Carpal tunnel syndrome | 1/4717 (0%) | 1 | 1/4715 (0%) | 1 |
Cerebral arteriosclerosis | 0/4717 (0%) | 0 | 2/4715 (0%) | 2 |
Cerebral haemorrhage | 1/4717 (0%) | 1 | 1/4715 (0%) | 1 |
Cervicobrachial syndrome | 1/4717 (0%) | 1 | 1/4715 (0%) | 1 |
Dizziness postural | 0/4717 (0%) | 0 | 2/4715 (0%) | 2 |
Epilepsy | 0/4717 (0%) | 0 | 2/4715 (0%) | 2 |
Facial paresis | 1/4717 (0%) | 1 | 1/4715 (0%) | 1 |
IIIrd nerve paresis | 2/4717 (0%) | 2 | 0/4715 (0%) | 0 |
Loss of consciousness | 0/4717 (0%) | 0 | 2/4715 (0%) | 2 |
Myelopathy | 0/4717 (0%) | 0 | 2/4715 (0%) | 2 |
Neuropathy peripheral | 0/4717 (0%) | 0 | 2/4715 (0%) | 2 |
Peripheral sensory neuropathy | 1/4717 (0%) | 1 | 1/4715 (0%) | 1 |
Acoustic neuritis | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Aphasia | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Autonomic neuropathy | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Basilar artery aneurysm | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Carotid artery disease | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Cauda equina syndrome | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Cerebral infarction | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Cerebral ischaemia | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Cerebrovascular accident | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Cognitive disorder | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Dementia Alzheimer's type | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Depressed level of consciousness | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Diabetic mononeuropathy | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Dysarthria | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Facial nerve disorder | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Hemiparesis | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Hydrocephalus | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Hypoaesthesia | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Hypoglycaemic coma | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Hypoglycaemic unconsciousness | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
IIIrd nerve disorder | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Intensive care unit acquired weakness | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Intracranial aneurysm | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Lacunar infarction | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Lumbosacral radiculopathy | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Memory impairment | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Mixed dementia | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Mononeuritis | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Mononeuropathy multiplex | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Multiple system atrophy | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Myasthenia gravis | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Nerve degeneration | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Neuromyopathy | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Normal pressure hydrocephalus | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Orthostatic intolerance | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Partial seizures | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Post stroke seizure | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Radial nerve compression | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Sciatica | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Sinus headache | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Spinal cord compression | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Spinal cord herniation | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Spinal cord ischaemia | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Toxic encephalopathy | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Transient ischaemic attack | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Tremor | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Vertebral artery dissection | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Vertebral artery stenosis | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Vocal cord paralysis | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Product Issues | ||||
Device malfunction | 1/4717 (0%) | 1 | 3/4715 (0.1%) | 3 |
Device failure | 2/4717 (0%) | 2 | 1/4715 (0%) | 1 |
Device extrusion | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Device issue | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Psychiatric disorders | ||||
Depression | 2/4717 (0%) | 2 | 3/4715 (0.1%) | 3 |
Mental status changes | 0/4717 (0%) | 0 | 5/4715 (0.1%) | 5 |
Suicide attempt | 1/4717 (0%) | 1 | 2/4715 (0%) | 2 |
Delirium | 0/4717 (0%) | 0 | 2/4715 (0%) | 2 |
Suicidal ideation | 1/4717 (0%) | 4 | 1/4715 (0%) | 1 |
Adjustment disorder | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Affective disorder | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Alcoholism | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Anxiety disorder | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Bipolar disorder | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Breathing-related sleep disorder | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Completed suicide | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Hallucination | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Impulse-control disorder | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Psychotic disorder | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Renal and urinary disorders | ||||
Acute kidney injury | 42/4717 (0.9%) | 46 | 47/4715 (1%) | 52 |
Renal impairment | 17/4717 (0.4%) | 17 | 12/4715 (0.3%) | 13 |
Renal failure | 9/4717 (0.2%) | 10 | 7/4715 (0.1%) | 7 |
Chronic kidney disease | 5/4717 (0.1%) | 5 | 7/4715 (0.1%) | 7 |
Haematuria | 5/4717 (0.1%) | 5 | 3/4715 (0.1%) | 3 |
Nephrolithiasis | 2/4717 (0%) | 2 | 6/4715 (0.1%) | 6 |
Ureterolithiasis | 3/4717 (0.1%) | 3 | 4/4715 (0.1%) | 4 |
Hydronephrosis | 1/4717 (0%) | 1 | 2/4715 (0%) | 2 |
Renal artery stenosis | 2/4717 (0%) | 2 | 1/4715 (0%) | 1 |
Renal colic | 1/4717 (0%) | 1 | 2/4715 (0%) | 2 |
Renal tubular necrosis | 2/4717 (0%) | 2 | 1/4715 (0%) | 1 |
Urinary tract obstruction | 1/4717 (0%) | 1 | 1/4715 (0%) | 1 |
Bladder neck obstruction | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Calculus urinary | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Diabetic nephropathy | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Glomerulonephritis acute | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Hypertonic bladder | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Lower urinary tract symptoms | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Nephropathy | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Nephropathy toxic | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Nephrotic syndrome | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Renal cyst | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Renal disorder | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Renal haematoma | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Renal injury | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Renal mass | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Urethral obstruction | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Urethral stenosis | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Urinary incontinence | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Urinary retention | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Reproductive system and breast disorders | ||||
Benign prostatic hyperplasia | 3/4717 (0.1%) | 3 | 6/4715 (0.1%) | 6 |
Prostatitis | 3/4717 (0.1%) | 3 | 2/4715 (0%) | 2 |
Endometrial hyperplasia | 0/4717 (0%) | 0 | 3/4715 (0.1%) | 3 |
Breast haematoma | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Cervical dysplasia | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Cystocele | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Dysfunctional uterine bleeding | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Ovarian cyst | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Prostatic varices | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Uterine polyp | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Uterine prolapse | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Respiratory, thoracic and mediastinal disorders | ||||
Chronic obstructive pulmonary disease | 21/4717 (0.4%) | 30 | 21/4715 (0.4%) | 33 |
Acute respiratory failure | 7/4717 (0.1%) | 7 | 14/4715 (0.3%) | 16 |
Respiratory failure | 10/4717 (0.2%) | 10 | 6/4715 (0.1%) | 6 |
Pleural effusion | 4/4717 (0.1%) | 5 | 10/4715 (0.2%) | 11 |
Pulmonary oedema | 5/4717 (0.1%) | 5 | 7/4715 (0.1%) | 9 |
Pulmonary embolism | 6/4717 (0.1%) | 6 | 4/4715 (0.1%) | 4 |
Dyspnoea | 5/4717 (0.1%) | 5 | 4/4715 (0.1%) | 4 |
Acute pulmonary oedema | 3/4717 (0.1%) | 4 | 5/4715 (0.1%) | 5 |
Asthma | 2/4717 (0%) | 2 | 5/4715 (0.1%) | 6 |
Pneumonia aspiration | 4/4717 (0.1%) | 4 | 3/4715 (0.1%) | 3 |
Pulmonary hypertension | 5/4717 (0.1%) | 5 | 1/4715 (0%) | 1 |
Hypoxia | 1/4717 (0%) | 2 | 3/4715 (0.1%) | 4 |
Respiratory distress | 0/4717 (0%) | 0 | 4/4715 (0.1%) | 4 |
Sleep apnoea syndrome | 3/4717 (0.1%) | 4 | 1/4715 (0%) | 1 |
Atelectasis | 1/4717 (0%) | 1 | 2/4715 (0%) | 2 |
Dyspnoea exertional | 1/4717 (0%) | 1 | 2/4715 (0%) | 2 |
Cough | 0/4717 (0%) | 0 | 2/4715 (0%) | 2 |
Epistaxis | 0/4717 (0%) | 0 | 2/4715 (0%) | 2 |
Haemothorax | 2/4717 (0%) | 2 | 0/4715 (0%) | 0 |
Respiratory arrest | 2/4717 (0%) | 2 | 0/4715 (0%) | 0 |
Bronchiectasis | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Chronic respiratory failure | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Epiglottic cyst | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Hydrothorax | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Hypercapnia | 0/4717 (0%) | 0 | 1/4715 (0%) | 2 |
Hyperventilation | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Idiopathic pulmonary fibrosis | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Lower respiratory tract congestion | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Nasal septum deviation | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Nasal ulcer | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Obstructive airways disorder | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Pharyngeal cyst | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Pleuritic pain | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Pneumothorax | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Pulmonary arterial hypertension | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Pulmonary congestion | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Pulmonary fibrosis | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Pulmonary mass | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Respiratory depression | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Rhinitis hypertrophic | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Vocal cord leukoplakia | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Skin and subcutaneous tissue disorders | ||||
Diabetic foot | 14/4717 (0.3%) | 16 | 22/4715 (0.5%) | 26 |
Skin ulcer | 9/4717 (0.2%) | 9 | 7/4715 (0.1%) | 7 |
Urticaria | 1/4717 (0%) | 1 | 3/4715 (0.1%) | 3 |
Angioedema | 1/4717 (0%) | 1 | 1/4715 (0%) | 1 |
Actinic keratosis | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Dermatitis allergic | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Diabetic neuropathic ulcer | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Hidradenitis | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Hyperhidrosis | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Panniculitis | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Psoriasis | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Pustular psoriasis | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Rash papular | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Skin necrosis | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Umbilical discharge | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Surgical and medical procedures | ||||
Finger amputation | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Vascular disorders | ||||
Peripheral arterial occlusive disease | 33/4717 (0.7%) | 37 | 41/4715 (0.9%) | 48 |
Hypertension | 11/4717 (0.2%) | 12 | 12/4715 (0.3%) | 12 |
Peripheral ischaemia | 7/4717 (0.1%) | 11 | 13/4715 (0.3%) | 13 |
Hypertensive crisis | 8/4717 (0.2%) | 8 | 11/4715 (0.2%) | 11 |
Hypotension | 10/4717 (0.2%) | 10 | 7/4715 (0.1%) | 7 |
Peripheral vascular disorder | 3/4717 (0.1%) | 3 | 13/4715 (0.3%) | 19 |
Extremity necrosis | 7/4717 (0.1%) | 7 | 5/4715 (0.1%) | 6 |
Deep vein thrombosis | 9/4717 (0.2%) | 9 | 2/4715 (0%) | 2 |
Orthostatic hypotension | 4/4717 (0.1%) | 5 | 6/4715 (0.1%) | 6 |
Peripheral artery stenosis | 4/4717 (0.1%) | 6 | 5/4715 (0.1%) | 6 |
Aortic stenosis | 4/4717 (0.1%) | 4 | 4/4715 (0.1%) | 4 |
Peripheral artery occlusion | 2/4717 (0%) | 2 | 6/4715 (0.1%) | 6 |
Aortic aneurysm | 4/4717 (0.1%) | 4 | 3/4715 (0.1%) | 3 |
Embolism arterial | 5/4717 (0.1%) | 5 | 1/4715 (0%) | 1 |
Haematoma | 5/4717 (0.1%) | 5 | 1/4715 (0%) | 1 |
Arteriosclerosis | 0/4717 (0%) | 0 | 4/4715 (0.1%) | 4 |
Intermittent claudication | 2/4717 (0%) | 3 | 2/4715 (0%) | 2 |
Peripheral artery thrombosis | 3/4717 (0.1%) | 3 | 1/4715 (0%) | 1 |
Aortic dissection | 3/4717 (0.1%) | 3 | 0/4715 (0%) | 0 |
Arterial disorder | 0/4717 (0%) | 0 | 3/4715 (0.1%) | 3 |
Hypertensive emergency | 3/4717 (0.1%) | 3 | 0/4715 (0%) | 0 |
Hypovolaemic shock | 0/4717 (0%) | 0 | 3/4715 (0.1%) | 3 |
Subclavian artery stenosis | 1/4717 (0%) | 1 | 2/4715 (0%) | 2 |
Diabetic vascular disorder | 2/4717 (0%) | 2 | 0/4715 (0%) | 0 |
Essential hypertension | 1/4717 (0%) | 1 | 1/4715 (0%) | 1 |
Leriche syndrome | 0/4717 (0%) | 0 | 2/4715 (0%) | 2 |
Venous thrombosis | 2/4717 (0%) | 2 | 0/4715 (0%) | 0 |
Accelerated hypertension | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Arterial haemorrhage | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Bleeding varicose vein | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Blood pressure inadequately controlled | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Circulatory collapse | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Diabetic microangiopathy | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Dry gangrene | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Femoral artery embolism | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Granulomatosis with polyangiitis | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Haemorrhage | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Iliac artery occlusion | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Lymphorrhoea | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Lymphostasis | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Malignant hypertension | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Peripheral venous disease | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Subclavian artery occlusion | 1/4717 (0%) | 1 | 0/4715 (0%) | 0 |
Varicose vein | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Venous occlusion | 0/4717 (0%) | 0 | 1/4715 (0%) | 1 |
Other (Not Including Serious) Adverse Events |
||||
Albiglutide | Placebo | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/4717 (0%) | 0/4715 (0%) |
Limitations/Caveats
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.
Results Point of Contact
Name/Title | GSK Response Center |
---|---|
Organization | GlaxoSmithKline |
Phone | 866-435-7343 |
GSKClinicalSupportHD@gsk.com |
- 116174
- 2014-001824-32