ALTITUDE: Aliskiren Trial in Type 2 Diabetes Using Cardiovascular and Renal Disease Endpoints (Core and Extension Phases)
Sponsor
Novartis Pharmaceuticals (Industry)
Overall Status
Terminated
CT.gov ID
NCT00549757
Collaborator
(none)
8,606
778
2
64.1
11.1
0.2
Study Details
Study Description
Brief Summary
The purpose of this study was to determine whether, in patients with type 2 diabetes and pre-existing disease of the heart and the circulatory system and/or the kidney, aliskiren at a target dose of 300 mg once daily (compared to placebo), on top of conventional treatment, reduces death and disease caused by the heart, the circulatory system and the kidney.
AMENDMENT 4 RATIONALE (MARCH 2012) :
Protocol amendment 4 served to address the data monitoring committee recommendation dated 14 Dec 2011 to discontinue study treatment in all participating patients. It also addressed the subsequent Health Authorities request to implement a 12 month safety follow-up period (actual duration was 9 months in average) post study drug discontinuation.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
8606 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Determine Whether, in Patients With Type 2 Diabetes at High Risk for Cardiovascular and Renal Events, Aliskiren, on Top of Conventional Treatment, Reduces Cardiovascular and Renal Morbidity and Mortality
Study Start Date
:
Oct 1, 2007
Actual Primary Completion Date
:
Feb 1, 2013
Actual Study Completion Date
:
Feb 1, 2013
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Aliskiren In Core (Double Blind) phase, Aliskiren 150 mg once daily (o.d.) for 4 weeks; then patient was uptitrated to 300 mg o.d. at Visit 5/Week 4 (or 150 mg o.d. if patient could not tolerate target dose of study drug). Visits took place at 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase. With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment |
Drug: Aliskiren
Aliskiren 150 mg film-coated tablets
|
| Placebo Comparator: Placebo In Core (Double Blind) phase, placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase. With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment. |
Drug: Placebo
Placebo to match aliskiren 150 mg film-coated tablets
|
Outcome Measures
Primary Outcome Measures
- Percentage of Participants With Occurrence of Primary Composite Endpoint (Core : Active Treatment Phase) [Time from randomization to the first event (Maximum 50 months)]
Occurrence was defined as the first event of the following composite primary endpoint: Cardiovascular (CV) death Resuscitated sudden death Non-fatal myocardial infarction (MI) Non-fatal stroke Unplanned hospitalization for heart failure (HF) Onset of end-stage renal disease (ESRD) or death due to renal failure. Onset of ESRD was defined as initiation of dialysis, renal transplantation, or a serum creatinine concentration above 6.0 mg/dL (530 μmol/L), sustained for at least a month. Doubling of baseline serum creatinine concentration, sustained for at least one month. To fulfill the endpoint, the serum creatinine concentration had to be above the upper limit of normal for men and women according to the central laboratory. The upper limit of normal for men is 1.20 mg/dL and for women is 0.91 mg/dL.
- Percentage of Participants With Cardiovascular (CV) Death (Core: Active Treatment Phase) [Time from randomization to the first event (Maximum 50 months)]
- Percentage of Participants With Resuscitated Sudden Death (Core: Active Treatment Phase) [Time from randomization to the first event (Maximum 50 Months)]
Resuscitated sudden death was adjudicated when a subject experiences sudden death or cardiac arrest and is successfully resuscitated by cardioversion, defibrillation or cardiopulmonary resuscitation with a meaningful recovery of consciousness. This definition excludes known transient losses of consciousness such as seizure or vasovagal episodes that do not reflect significant cardiac dysfunction.
- Percentage of Participants With Fatal/Non-fatal Myocardial Infarction (MI) (Core: Active Treatment Phase) [Time from randomization to the first event (Maximum 50 Months)]
- Percentage of Participants With Fatal/Non-fatal Stroke (Core: Active Treatment Phase) [Time from randomization to the first event (Maximum 50 Months)]
- Percentage of Participants With Onset of End-stage Renal Disease (ESRD) (Core: Active Treatment Phase) [Time from randomization to the first event (Maximum 50 Months)]
ESRD is defined as initiation of dialysis, renal transplantation, or a serum creatinine concentration above 6.0 mg/dL (530 µmol per liter) or renal death
- Percentage of Participants With Doubling of Baseline Serum Creatinine Concentration, Sustained for at Least One Month (Core: Active Treatment Phase) [Time from randomization to the first event (Maximum 50 Months)]
To fulfill the endpoint, the serum creatinine concentration had to be above the upper limit of normal for men and women according to the central laboratory. The upper limit of normal for men is 1.20 mg/dL and for women is 0.91 mg/dL.
- Percentage of Participants With Unplanned Hospitalization for Heart Failure (Core: Active Treatment Phase) [Time from randomization to the first event (Maximum 50 Months)]
- Percentage of Participants With All Cause Mortality (Core: Active Treatment Phase) [Time from randomization to the first event (Maximum 50 months)]
- Percentage of Participants With Occurrence of Primary Composite Endpoint (Extension Phase) [From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)]
Occurrence was defined as the first event of the following composite primary endpoint: Cardiovascular (CV) death Resuscitated sudden death Non-fatal myocardial infarction (MI) Non-fatal stroke Unplanned hospitalization for heart failure (HF) Onset of end-stage renal disease (ESRD) or death due to renal failure. Onset of ESRD was defined as initiation of dialysis, renal transplantation, or a serum creatinine concentration above 6.0 mg/dL (530 μmol/L), sustained for at least a month. Doubling of baseline serum creatinine concentration, sustained for at least one month. To fulfill the endpoint, the serum creatinine concentration had to be above the upper limit of normal for men and women according to the central laboratory. The upper limit of normal for men is 1.20 mg/dL and for women is 0.91 mg/dL.
- Percentage of Participants With Cardiovascular (CV) Death (Extension Phase) [from cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)]
- Percentage of Participants With Resuscitated Sudden Death (Extension Phase) [From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)]
- Percentage of Participants Fatal/Non-fatal Myocardial Infarction (MI) (Extension Phase) [From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 month in average)]
- Percentage of Participants With Fatal/Non-fatal Stroke (Extension Phase) [From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)]
- Percentage of Participants With Onset of End-stage Renal Disease (ESRD) (Extension Phase) [From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)]
ESRD is defined as initiation of dialysis, renal transplantation, or a serum creatinine concentration above 6.0 mg/dL (530 µmol per liter) or renal death
- Percentage of Participants Doubling of Baseline Serum Creatinine Concentration, Sustained for at Least One Month (Extension Phase) [From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)]
To fulfill the endpoint, the serum creatinine concentration had to be above the upper limit of normal for men and women according to the central laboratory. The upper limit of normal for men is 1.20 mg/dL and for women is 0.91 mg/dL.
- Percentage of Participants With Unplanned Hospitalization for Heart Failure (Extension Phase) [From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)]
- Percentage of Participants With All Cause Mortality (Extension Phase) [from cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)]
Secondary Outcome Measures
- Percentage of Participants With Occurrence of Secondary Cardiovascular Composite Endpoint (Core: Active Treatment Phase) [Time from randomization to the first event (Maximum 50 months)]
Occurrence was defined as the first event of the following secondary cardiovascular composite endpoint: Cardiovascular (CV) death Resuscitated sudden death Non-fatal myocardial infarction (MI) Non-fatal stroke Unplanned hospitalization for heart failure (HF)
- Percentage of Participants With Occurrence of Secondary Renal Composite Endpoint (Core: Active Treatment Phase) [Time from randomization to the first event (Maximum 50 months)]
Occurrence was defined as the first event of the following secondary renal composite endpoint: Onset of end-stage renal disease (ESRD) or death due to renal failure. Onset of ESRD was defined as initiation of dialysis, renal transplantation, or a serum creatinine concentration above 6.0 mg/dL (530 μmol/L), sustained for at least a month. Doubling of baseline serum creatinine concentration, sustained for at least one month. To fulfill the endpoint, the serum creatinine concentration had to be above the upper limit of normal for men and women according to the central laboratory.The upper limit of normal for men is 1.20 mg/dL and for women is 0.91 mg/dL.
- Percentage of Participants With Occurrence of Secondary Cardiovascular Composite Endpoint (Extension Phase) [From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)]
Occurrence was defined as the first event of the following secondary cardiovascular composite endpoint: Cardiovascular (CV) death Resuscitated sudden death Non-fatal myocardial infarction (MI) Non-fatal stroke Unplanned hospitalization for heart failure (HF)
- Percentage of Participants With Occurrence of Secondary Renal Composite Endpoint (Extension Phase) [From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)]
Occurrence was defined as the first event of the following secondary renal composite endpoint: Onset of end-stage renal disease (ESRD) or death due to renal failure. Onset of ESRD was defined as initiation of dialysis, renal transplantation, or a serum creatinine concentration above 6.0 mg/dL (530 μmol/L), sustained for at least a month. Doubling of baseline serum creatinine concentration, sustained for at least one month. To fulfill the endpoint, the serum creatinine concentration had to be above the upper limit of normal for men and women according to the central laboratory. The upper limit of normal for men is 1.20 mg/dL and for women is 0.91 mg/dL.
Other Outcome Measures
- Percentage of Participants With Angioedema/Angioedema-like or Colorectal Events (Core : Active Treatment Phase) [Time from randomization to the first event (Maximum 50 months)]
AEs of special interest were reported according to a post-marketing commitment to Health Authorities and included angioedema/angioedema-like events and colorectal events/ procedures
- Change From Baseline in Urinary Albumin to Creatinine Ratio (UACR) to Month 6 and to Last Measurement (Core : Active Treatment Phase) [Baseline, Month 6 , last measurement (maximum at 50 months)]
Baseline is the geometric mean of last 3 measurements before visit 3, Post-baseline value is the geometric mean of last 3 measurements during each visit. Change from Baseline = Post - Baseline.
- Mean Changes in Estimated Glomerular Filtration Rate (eGFR) From Baseline to Month 3 and Month 6 (Core : Active Treatment Phase) [Baseline to Month 3 and Month 6]
The eGFR calculation was based on the Abbreviated Modification of Diet in Renal Disease (MDRD) Study Equation. Using this method, the applicable MDRD formula to calculate eGFR was as follows: Estimated GFR (mL/min/1.73 m^2) = 175 x (serum creatinine in mg/dL) -1.154 x (Age in years) -0.203 x (0.742 if female) x (1.210 if Black) Mean changes in eGFR from baseline to month 3 and month 6 were included for analysis. The LS Mean and Standard Error were based on an ANCOVA repeated-measure model with treatment, visit, treatment-by-visit and baseline eGFR as effect terms.
- Percentage of Participants With Angioedema/Angioedema-like Events or Colorectal Events (Extension Phase) [From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)]
AEs of special interest were reported according to a post-marketing commitment to Health Authorities and included angioedema/angioedema-like events and colorectal events/ procedures.
Eligibility Criteria
Criteria
Ages Eligible for Study:
35 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Type 2 diabetes and at least one of the following:
-
Macroalbuminuria and an eGFR ≥30 mL/min/1.73 m2
-
Microalbuminuria and a reduced kidney function (eGFR eGFR ≥30 and <60 mL/min/1.73 m2)
-
A history of CV disease (previous MI, previous stroke, heart failure, coronary artery disease, history of percutaneous coronary intervention, angiography proven stenosis ≥50% in at least one coronary artery and a reduced kidney function (eGFR ≥30 and <60 mL/min/1.73 m2)
-
Concomitant treatment should follow national guidelines and must include either an Angiotensin-converting-enzyme-inhibitor (ACEi) or an Angiotensin-receptor-blocker (ARB) but not both.
Exclusion Criteria:
-
Type 1 diabetes mellitus
-
Cardiovascular event or procedure ≤ 3 months prior to Visit 1
-
Unstable serum creatinine
-
Hypertension: Mean sitting systolic blood pressure (msSBP) ≥ 135 and < 170 mmHg or Mean sitting diastolic blood pressure (msDBP) ≥ 85 and < 110 mmHg unless treated with at least 3 anti-hypertensive medications
-
Hypertension msSBP ≥ 170 or msDBP ≥ 110 mmHg
-
Baseline Serum Potassium > 5.0 mmol/L
-
Patients who are treated with two renin-angiotensin-aldosterone-system-blockers
-
Patients with NYHA class III or IV heart failure
-
Known renal artery stenosis
-
Previous randomization into the AVOID trial (CSPP100C2201)
EXCLUSION SPECIFIC TO THE SAFETY FOLLOW-UP PERIOD:
- Aliskiren or aliskiren containing fixed combination products must not be used
Other protocol-defined inclusion/exclusion criteria applied
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Novartis Investigative Site | Birmingham | Alabama | United States | 35209 |
| 2 | Novartis Investigative Site | Birmingham | Alabama | United States | 35235 |
| 3 | Novartis Investigative Site | Huntsville | Alabama | United States | 35801 |
| 4 | Novartis Investigative Site | Mobile | Alabama | United States | 36608 |
| 5 | Novartis Investigative Site | Mobile | Alabama | United States | 36617 |
| 6 | Novartis Investigative Site | Montgomery | Alabama | United States | 36106 |
| 7 | Novartis Investigative Site | Muscle Shoals | Alabama | United States | 35662 |
| 8 | Novartis Investigative Site | Peoria | Arizona | United States | 85381 |
| 9 | Novartis Investigative Site | Phoenix | Arizona | United States | 85032 |
| 10 | Novartis Investigative Site | Tucson | Arizona | United States | 85712 |
| 11 | Novartis Investigative Site | Tucson | Arizona | United States | 85741 |
| 12 | Novartis Investigative Site | Fayetteville | Arkansas | United States | 72703 |
| 13 | Novartis Investigative Site | Burlingame | California | United States | 94010 |
| 14 | Novartis Investigative Site | Fullerton | California | United States | 92835 |
| 15 | Novartis Investigative Site | Huntington Beach | California | United States | 92648 |
| 16 | Novartis Investigative Site | Oakland | California | United States | 94609 |
| 17 | Novartis Investigative Site | Pasadena | California | United States | 91101 |
| 18 | Novartis Investigative Site | Riverside | California | United States | 92501 |
| 19 | Novartis Investigative Site | Spring Valley | California | United States | 91978-1522 |
| 20 | Novartis Investigative Site | Torrance | California | United States | 90502 |
| 21 | Novartis Investigative Site | Walnut Creek | California | United States | 94598 |
| 22 | Novartis Investigative Site | Denver | Colorado | United States | 80209 |
| 23 | Novartis Investigative Site | Bridgeport | Connecticut | United States | 06610 |
| 24 | Novartis Investigative Site | Aventura | Florida | United States | 33180 |
| 25 | Novartis Investigative Site | Boca Raton | Florida | United States | 33433 |
| 26 | Novartis Investigative Site | Ft. Lauderdale | Florida | United States | 33311 |
| 27 | Novartis Investigative Site | Hollywood | Florida | United States | 33021 |
| 28 | Novartis Investigative Site | Jacksonville | Florida | United States | 32204 |
| 29 | Novartis Investigative Site | Jacksonville | Florida | United States | 32205 |
| 30 | Novartis Investigative Site | Jacksonville | Florida | United States | 32209 |
| 31 | Novartis Investigative Site | Jacksonville | Florida | United States | 32216 |
| 32 | Novartis Investigative Site | Lauderdale Lakes | Florida | United States | 33313 |
| 33 | Novartis Investigative Site | Pensacola | Florida | United States | 32504 |
| 34 | Novartis Investigative Site | Plantation | Florida | United States | 33324 |
| 35 | Novartis Investigative Site | West Palm Beach | Florida | United States | 33401 |
| 36 | Novartis Investigative Site | Atlanta | Georgia | United States | 30309 |
| 37 | Novartis Investigative Site | Augusta | Georgia | United States | 30904 |
| 38 | Novartis Investigative Site | Augusta | Georgia | United States | 30909 |
| 39 | Novartis Investigative Site | Cumming | Georgia | United States | 30041 |
| 40 | Novartis Investigative Site | Honolulu | Hawaii | United States | 96813 |
| 41 | Novartis Investigative Site | Honolulu | Hawaii | United States | 96814 |
| 42 | Novartis Investigative Site | Champaign | Illinois | United States | 61820 |
| 43 | Novartis Investigative Site | Lake Zurich | Illinois | United States | 60047 |
| 44 | Novartis Investigative Site | Peoria | Illinois | United States | 61615 |
| 45 | Novartis Investigative Site | Topeka | Kansas | United States | 66606 |
| 46 | Novartis Investigative Site | Louisville | Kentucky | United States | 40202 |
| 47 | Novartis Investigative Site | Metairie | Louisiana | United States | 70006 |
| 48 | Novartis Investigative Site | Slidell | Louisiana | United States | 70458 |
| 49 | Novartis Investigative Site | Baltimore | Maryland | United States | 21204 |
| 50 | Novartis Investigative Site | Burlington | Massachusetts | United States | 01803 |
| 51 | Novartis Investigative Site | Haverhill | Massachusetts | United States | 01830 |
| 52 | Novartis Investigative Site | Jamaica Plain | Massachusetts | United States | 02130 |
| 53 | Novartis Investigative Site | Natick | Massachusetts | United States | 01760 |
| 54 | Novartis Investigative Site | North Dartmouth | Massachusetts | United States | 02747 |
| 55 | Novartis Investigative Site | Waltham | Massachusetts | United States | 02154 |
| 56 | Novartis Investigative Site | Worcester | Massachusetts | United States | 01609 |
| 57 | Novartis Investigative Site | Ann Arbor | Michigan | United States | 48109 |
| 58 | Novartis Investigative Site | Detroit | Michigan | United States | 48202 |
| 59 | Novartis Investigative Site | Detroit | Michigan | United States | 48236 |
| 60 | Novartis Investigative Site | Kalamazoo | Michigan | United States | 49048 |
| 61 | Novartis Investigative Site | Livonia | Michigan | United States | 48154 |
| 62 | Novartis Investigative Site | Minneapolis | Minnesota | United States | 55404 |
| 63 | Novartis Investigative Site | Minneapolis | Minnesota | United States | 55455 |
| 64 | Novartis Investigative Site | St. Louis Park | Minnesota | United States | 55416 |
| 65 | Novartis Investigative Site | Belzoni | Mississippi | United States | 39038 |
| 66 | Novartis Investigative Site | Gulfport | Mississippi | United States | 39501 |
| 67 | Novartis Investigative Site | Jackson | Mississippi | United States | 39209 |
| 68 | Novartis Investigative Site | Springfield | Missouri | United States | 65807 |
| 69 | Novartis Investigative Site | St. Louis | Missouri | United States | 63110-1093 |
| 70 | Novartis Investigative Site | St. Louis | Missouri | United States | 63141 |
| 71 | Novartis Investigative Site | Fremont | Nebraska | United States | 68025 |
| 72 | Novartis Investigative Site | Omaha | Nebraska | United States | 68131 |
| 73 | Novartis Investigative Site | Dover | New Hampshire | United States | 03820-2403 |
| 74 | Novartis Investigative Site | Princeton Junction | New Jersey | United States | 08550 |
| 75 | Novartis Investigative Site | Albuquerque | New Mexico | United States | 87106 |
| 76 | Novartis Investigative Site | Albany | New York | United States | 12206 |
| 77 | Novartis Investigative Site | Rochester | New York | United States | 14607 |
| 78 | Novartis Investigative Site | Cincinnati | Ohio | United States | 45236 |
| 79 | Novartis Investigative Site | Cleveland | Ohio | United States | 44115 |
| 80 | Novartis Investigative Site | Lyndhurst | Ohio | United States | 44124 |
| 81 | Novartis Investigative Site | Norman | Oklahoma | United States | 73069 |
| 82 | Novartis Investigative Site | Oklahoma City | Oklahoma | United States | 73112 |
| 83 | Novartis Investigative Site | Tulsa | Oklahoma | United States | 74133 |
| 84 | Novartis Investigative Site | Allentown | Pennsylvania | United States | 18103 |
| 85 | Novartis Investigative Site | Lancaster | Pennsylvania | United States | 17604 |
| 86 | Novartis Investigative Site | Lansdale | Pennsylvania | United States | 19446 |
| 87 | Novartis Investigative Site | Melrose Park | Pennsylvania | United States | 19027 |
| 88 | Novartis Investigative Site | Philadelphia | Pennsylvania | United States | 19138 |
| 89 | Novartis Investigative Site | Wyomissing | Pennsylvania | United States | 19610 |
| 90 | Novartis Investigative Site | Warwick | Rhode Island | United States | 02886 |
| 91 | Novartis Investigative Site | Aiken | South Carolina | United States | 29801 |
| 92 | Novartis Investigative Site | Charleston | South Carolina | United States | 29425 |
| 93 | Novartis Investigative Site | Columbia | South Carolina | United States | 29201 |
| 94 | Novartis Investigative Site | Greenville | South Carolina | United States | 29605 |
| 95 | Novartis Investigative Site | Orangeburg | South Carolina | United States | 29115 |
| 96 | Novartis Investigative Site | Collierville | Tennessee | United States | 38017 |
| 97 | Novartis Investigative Site | Amarillo | Texas | United States | 79106 |
| 98 | Novartis Investigative Site | Austin | Texas | United States | 78731 |
| 99 | Novartis Investigative Site | Dallas | Texas | United States | 75226 |
| 100 | Novartis Investigative Site | Dallas | Texas | United States | 75231 |
| 101 | Novartis Investigative Site | Dallas | Texas | United States | 75235 |
| 102 | Novartis Investigative Site | Dallas | Texas | United States | 75390 |
| 103 | Novartis Investigative Site | Houston | Texas | United States | 77030 |
| 104 | Novartis Investigative Site | Irving | Texas | United States | 75039 |
| 105 | Novartis Investigative Site | McAllen | Texas | United States | 78501 |
| 106 | Novartis Investigative Site | North Richland Hills | Texas | United States | 76180 |
| 107 | Novartis Investigative Site | Plano | Texas | United States | 75024 |
| 108 | Novartis Investigative Site | San Antonio | Texas | United States | 78207 |
| 109 | Novartis Investigative Site | San Antonio | Texas | United States | 78218 |
| 110 | Novartis Investigative Site | San Antonio | Texas | United States | 78229-4801 |
| 111 | Novartis Investigative Site | Temple | Texas | United States | 76508-0002 |
| 112 | Novartis Investigative Site | Bennington | Vermont | United States | 05201 |
| 113 | Novartis Investigative Site | Burlington | Vermont | United States | 05401 |
| 114 | Novartis Investigative Site | Alexandria | Virginia | United States | 22304-2315 |
| 115 | Novartis Investigative Site | Burke | Virginia | United States | 22015 |
| 116 | Novartis Investigative Site | Renton | Washington | United States | 98055 |
| 117 | Novartis Investigative Site | Charleston | West Virginia | United States | 25301 |
| 118 | Novartis Investigative Site | Appleton | Wisconsin | United States | 54911 |
| 119 | Novartis Investigative Site | Caba | Buenos Aires | Argentina | 1428 |
| 120 | Novartis Investigative Site | Caba | Buenos Aires | Argentina | C1181ACH |
| 121 | Novartis Investigative Site | Caba | Buenos Aires | Argentina | C1280AEB |
| 122 | Novartis Investigative Site | Caba | Buenos Aires | Argentina | C1408INH |
| 123 | Novartis Investigative Site | Caba | Buenos Aires | Argentina | C1416DRJ |
| 124 | Novartis Investigative Site | Caba | Buenos Aires | Argentina | C1425AST |
| 125 | Novartis Investigative Site | Florida | Buenos Aires | Argentina | B1602BPD |
| 126 | Novartis Investigative Site | Lanus | Buenos Aires | Argentina | B8000XAV |
| 127 | Novartis Investigative Site | Ramos Mejia | Buenos Aires | Argentina | B1704ETD |
| 128 | Novartis Investigative Site | Zarate | Buenos Aires | Argentina | 2800 |
| 129 | Novartis Investigative Site | Rosario | Santa Fe | Argentina | S2000AII |
| 130 | Novartis Investigative Site | Rosario | Santa Fe | Argentina | S2000CXH |
| 131 | Novartis Investigative Site | Rosario | Santa Fe | Argentina | S2000DFD |
| 132 | Novartis Investigative Site | Rosario | Santa Fe | Argentina | S2001ODA |
| 133 | Novartis Investigative Site | Rosario | Santa Fe | Argentina | S200CVD |
| 134 | Novartis Investigative Site | Buenos aires | Argentina | C1120AAC | |
| 135 | Novartis Investigative Site | Buenos Aires | Argentina | C1405BCH | |
| 136 | Novartis Investigative Site | Cordoba | Argentina | 5000 | |
| 137 | Novartis Investigative Site | Cordoba | Argentina | X5000AAW | |
| 138 | Novartis Investigative Site | Cordoba | Argentina | X5000EVQ | |
| 139 | Novartis Investigative Site | Cordoba | Argentina | X5000FGG | |
| 140 | Novartis Investigative Site | Cordoba | Argentina | X5000IUG | |
| 141 | Novartis Investigative Site | Cordoba | Argentina | X5000JHQ | |
| 142 | Novartis Investigative Site | Cordoba | Argentina | X5009BSN | |
| 143 | Novartis Investigative Site | Cordoba | Argentina | X5016KEH | |
| 144 | Novartis Investigative Site | Corrientes | Argentina | W3400 | |
| 145 | Novartis Investigative Site | Santa Fe | Argentina | S3000FNF | |
| 146 | Novartis Investigative Site | Santa Fe | Argentina | S3000FSO | |
| 147 | Novartis Investigative Site | Santa Fe | Argentina | S3000FVA | |
| 148 | Novartis Investigative Site | Bregenz | Austria | A-6900 | |
| 149 | Novartis Investigative Site | Feldkirch | Austria | 6807 | |
| 150 | Novartis Investigative Site | Graz | Austria | 8036 | |
| 151 | Novartis Investigative Site | Innsbruck | Austria | INNSBRUCK | |
| 152 | Novartis Investigative Site | Salzburg | Austria | A-5020 | |
| 153 | Novartis Investigative Site | Vienna | Austria | 1030 | |
| 154 | Novartis Investigative Site | Wien | Austria | 1090 | |
| 155 | Novartis Investigative Site | Wien | Austria | A-1130 | |
| 156 | Novartis Investigative Site | Wien | Austria | A-1220 | |
| 157 | Novartis Investigative Site | Bonheiden | Belgium | 2820 | |
| 158 | Novartis Investigative Site | Brugge | Belgium | 8000 | |
| 159 | Novartis Investigative Site | Brussel | Belgium | 9100 | |
| 160 | Novartis Investigative Site | Bruxelles | Belgium | 1070 | |
| 161 | Novartis Investigative Site | Bruxelles | Belgium | 1200 | |
| 162 | Novartis Investigative Site | Charleroi | Belgium | 6000 | |
| 163 | Novartis Investigative Site | De Pinte | Belgium | 9840 | |
| 164 | Novartis Investigative Site | Edegem | Belgium | 2650 | |
| 165 | Novartis Investigative Site | Genk | Belgium | 3600 | |
| 166 | Novartis Investigative Site | Gent | Belgium | 9000 | |
| 167 | Novartis Investigative Site | Hasselt | Belgium | 3500 | |
| 168 | Novartis Investigative Site | Kortrijk | Belgium | 8500 | |
| 169 | Novartis Investigative Site | La Louvière | Belgium | 7100 | |
| 170 | Novartis Investigative Site | Leuven | Belgium | 3000 | |
| 171 | Novartis Investigative Site | Liege | Belgium | 4000 | |
| 172 | Novartis Investigative Site | Roeselare | Belgium | 8800 | |
| 173 | Novartis Investigative Site | Ronse | Belgium | 9600 | |
| 174 | Novartis Investigative Site | Seraing | Belgium | 4100 | |
| 175 | Novartis Investigative Site | Sint-Gillis-Waas | Belgium | 9170 | |
| 176 | Novartis Investigative Site | Turnhout | Belgium | 2300 | |
| 177 | Novartis Investigative Site | Vilvoorde | Belgium | 1800 | |
| 178 | Novartis Investigative Site | Willebroek | Belgium | 2830 | |
| 179 | Novartis Investigative Site | Salvador | BA | Brazil | 40050-410 |
| 180 | Novartis Investigative Site | Fortaleza | CE | Brazil | 60120-021 |
| 181 | Novartis Investigative Site | Fortaleza | CE | Brazil | 60430-370 |
| 182 | Novartis Investigative Site | Vitoria | ES | Brazil | 29040-091 |
| 183 | Novartis Investigative Site | Juiz de Fora | MG | Brazil | 36036-110 |
| 184 | Novartis Investigative Site | Belem | PA | Brazil | 66073-000 |
| 185 | Novartis Investigative Site | Rio de Janeiro | RJ | Brazil | 20020-020 |
| 186 | Novartis Investigative Site | Rio de Janeiro | RJ | Brazil | 20551-030 |
| 187 | Novartis Investigative Site | Porto Alegre | RS | Brazil | 90020-090 |
| 188 | Novartis Investigative Site | Campinas | SP | Brazil | 13060-904 |
| 189 | Novartis Investigative Site | Campinas | SP | Brazil | 13083-190 |
| 190 | Novartis Investigative Site | Marilia | SP | Brazil | 17519-030 |
| 191 | Novartis Investigative Site | Santos | SP | Brazil | 11045-904 |
| 192 | Novartis Investigative Site | Sao Jose do Rio Preto | SP | Brazil | 15090-000 |
| 193 | Novartis Investigative Site | Sorocaba | SP | Brazil | 18030-210 |
| 194 | Novartis Investigative Site | São Paulo | SP | Brazil | 04023-900 |
| 195 | Novartis Investigative Site | São Paulo | SP | Brazil | 05403-000 |
| 196 | Novartis Investigative Site | Edmonton | Alberta | Canada | T5J 3N4 |
| 197 | Novartis Investigative Site | Edmonton | Alberta | Canada | T5N 3Y6 |
| 198 | Novartis Investigative Site | Vancouver | British Columbia | Canada | V6E 1M7 |
| 199 | Novartis Investigative Site | Winnipeg | Manitoba | Canada | R2V 4W3 |
| 200 | Novartis Investigative Site | Winnipeg | Manitoba | Canada | R3E 3P4 |
| 201 | Novartis Investigative Site | Bay Roberts | Newfoundland and Labrador | Canada | A0A 1G0 |
| 202 | Novartis Investigative Site | St. John's | Newfoundland and Labrador | Canada | A1E 4J8 |
| 203 | Novartis Investigative Site | Brampton | Ontario | Canada | L6Z 4N5 |
| 204 | Novartis Investigative Site | Burlington | Ontario | Canada | L7M 4Y1 |
| 205 | Novartis Investigative Site | Cambridge | Ontario | Canada | N1R 6V6 |
| 206 | Novartis Investigative Site | Courtice | Ontario | Canada | L1E 3C3 |
| 207 | Novartis Investigative Site | Etobicoke | Ontario | Canada | M9R 4E1 |
| 208 | Novartis Investigative Site | London | Ontario | Canada | N6A 4G5 |
| 209 | Novartis Investigative Site | North Bay | Ontario | Canada | P1B 2H3 |
| 210 | Novartis Investigative Site | Oakville | Ontario | Canada | L6H 3P1 |
| 211 | Novartis Investigative Site | Oshawa | Ontario | Canada | L1J 2K1 |
| 212 | Novartis Investigative Site | Ottawa | Ontario | Canada | K1H 7W9 |
| 213 | Novartis Investigative Site | Scarborough | Ontario | Canada | M1H 3G4 |
| 214 | Novartis Investigative Site | Thornhill | Ontario | Canada | L4J 8L7 |
| 215 | Novartis Investigative Site | Toronto | Ontario | Canada | M4G 3E8 |
| 216 | Novartis Investigative Site | Toronto | Ontario | Canada | M4N 3M5 |
| 217 | Novartis Investigative Site | Toronto | Ontario | Canada | M5C 2T2 |
| 218 | Novartis Investigative Site | Toronto | Ontario | Canada | N6G 4X8 |
| 219 | Novartis Investigative Site | Greenfield Park | Quebec | Canada | J4V 2H1 |
| 220 | Novartis Investigative Site | Mirabel | Quebec | Canada | J7J 2K8 |
| 221 | Novartis Investigative Site | Montreal | Quebec | Canada | H1T 2M4 |
| 222 | Novartis Investigative Site | Pointe-Claire | Quebec | Canada | H9R 4S3 |
| 223 | Novartis Investigative Site | Québec | Quebec | Canada | G1G 3Y8 |
| 224 | Novartis Investigative Site | Sainte-Foy | Quebec | Canada | G1V 4G5 |
| 225 | Novartis Investigative Site | Sainte-Foy | Quebec | Canada | G1W 4R4 |
| 226 | Novartis Investigative Site | Sherbrooke | Quebec | Canada | J1G 5K2 |
| 227 | Novartis Investigative Site | Ste-Foy | Quebec | Canada | G1V 4G2 |
| 228 | Novartis Investigative Site | Trois-Rivières | Quebec | Canada | G8Z 3R9 |
| 229 | Novartis Investigative Site | Saskatoon | Saskatchewan | Canada | S7H 5M3 |
| 230 | Novartis Investigative Site | Ouest-Montreal | Canada | H2W1R7 | |
| 231 | Novartis Investigative Site | Beijing | Beijing | China | 100044 |
| 232 | Novartis Investigative Site | Beijing | Beijing | China | 100083 |
| 233 | Novartis Investigative Site | Beijing | Beijing | China | 100730 |
| 234 | Novartis Investigative Site | Chongqing | Chongqing | China | 400016 |
| 235 | Novartis Investigative Site | Chongqing | Chongqing | China | |
| 236 | Novartis Investigative Site | Fuzhou | Fujian | China | 350025 |
| 237 | Novartis Investigative Site | Guangzhou | Guangdong | China | 510180 |
| 238 | Novartis Investigative Site | Shijiazhuang | Hebei | China | 050051 |
| 239 | Novartis Investigative Site | Harbin | Heilongjiang | China | 150001 |
| 240 | Novartis Investigative Site | Harbin | Heilongjiang | China | 150086 |
| 241 | Novartis Investigative Site | Wuhan | Hubei | China | 430030 |
| 242 | Novartis Investigative Site | Changsha City | Hunan | China | 410011 |
| 243 | Novartis Investigative Site | Changsha | Hunan | China | 410008 |
| 244 | Novartis Investigative Site | Nanjing | Jiangsu | China | 210006 |
| 245 | Novartis Investigative Site | Nanjing | Jiangsu | China | 210008 |
| 246 | Novartis Investigative Site | Nanjing | Jiangsu | China | 210009 |
| 247 | Novartis Investigative Site | Nanjing | Jiangsu | China | 210029 |
| 248 | Novartis Investigative Site | Suzhou | Jiangsu | China | 215004 |
| 249 | Novartis Investigative Site | Dalian | Liaoning | China | 116011 |
| 250 | Novartis Investigative Site | Shenyang | Liaoning | China | 110003 |
| 251 | Novartis Investigative Site | Qingdao | Shandong | China | 266011 |
| 252 | Novartis Investigative Site | Xi'an | Shanxi | China | 710032 |
| 253 | Novartis Investigative Site | Xi'an | Shanxi | China | 710061 |
| 254 | Novartis Investigative Site | Chengdu | Sichuan | China | 610041 |
| 255 | Novartis Investigative Site | Kunming | Yunnan | China | 650101 |
| 256 | Novartis Investigative Site | Hangzhou | Zhejiang | China | 310003 |
| 257 | Novartis Investigative Site | Hangzhou | Zhejiang | China | 310009 |
| 258 | Novartis Investigative Site | Hangzhou | Zhejiang | China | 310013 |
| 259 | Novartis Investigative Site | Hangzhou | Zhejiang | China | 310016 |
| 260 | Novartis Investigative Site | Beijing | China | 100028 | |
| 261 | Novartis Investigative Site | Beijing | China | 100029 | |
| 262 | Novartis Investigative Site | Beijing | China | 100034 | |
| 263 | Novartis Investigative Site | Beijing | China | 100088 | |
| 264 | Novartis Investigative Site | Beijing | China | 100176 | |
| 265 | Novartis Investigative Site | Beijing | China | ||
| 266 | Novartis Investigative Site | Chengdu | China | 610072 | |
| 267 | Novartis Investigative Site | Chongqing | China | 400038 | |
| 268 | Novartis Investigative Site | Dalian | China | ||
| 269 | Novartis Investigative Site | Guangzhou | China | 510000 | |
| 270 | Novartis Investigative Site | Shanghai | China | 200003 | |
| 271 | Novartis Investigative Site | Shanghai | China | 200025 | |
| 272 | Novartis Investigative Site | Shanghai | China | 200031 | |
| 273 | Novartis Investigative Site | Shanghai | China | 200233 | |
| 274 | Novartis Investigative Site | Tianjin | China | 300052 | |
| 275 | Novartis Investigative Site | Tianjin | China | 300142 | |
| 276 | Novartis Investigative Site | Bogotá | Colombia | ||
| 277 | Novartis Investigative Site | Cali | Colombia | ||
| 278 | Novartis Investigative Site | Florida Blanca | Colombia | ||
| 279 | Novartis Investigative Site | Medellín | Colombia | ||
| 280 | Novartis Investigative Site | Brno-Bohunice | Czech Republic | 639 01 | |
| 281 | Novartis Investigative Site | Brno | Czech Republic | 61300 | |
| 282 | Novartis Investigative Site | Ceske Budejovice | Czech Republic | 370 87 | |
| 283 | Novartis Investigative Site | Ostrava | Czech Republic | 702 00 | |
| 284 | Novartis Investigative Site | Pardubice | Czech Republic | 53002 | |
| 285 | Novartis Investigative Site | Pisek | Czech Republic | 397 01 | |
| 286 | Novartis Investigative Site | Prague 2 | Czech Republic | 128 02 | |
| 287 | Novartis Investigative Site | Prague 2 | Czech Republic | 128 08 | |
| 288 | Novartis Investigative Site | Prague 4 - Krc | Czech Republic | 14059 | |
| 289 | Novartis Investigative Site | Prague 5 - Motol | Czech Republic | 15112 | |
| 290 | Novartis Investigative Site | Aalborg | Denmark | DK-9100 | |
| 291 | Novartis Investigative Site | Copenhagen NV | Denmark | DK-2400 | |
| 292 | Novartis Investigative Site | Frederiksberg | Denmark | DK-2000 | |
| 293 | Novartis Investigative Site | Gentofte | Denmark | DK-2820 | |
| 294 | Novartis Investigative Site | Hillerød | Denmark | DK-3400 | |
| 295 | Novartis Investigative Site | Hvidovre | Denmark | 2650 | |
| 296 | Novartis Investigative Site | Roskilde | Denmark | DK-4000 | |
| 297 | Novartis Investigative Site | Slagelse | Denmark | DK-4200 | |
| 298 | Novartis Investigative Site | Svendborg | Denmark | DK-5700 | |
| 299 | Novartis Investigative Site | Århus | Denmark | DK-8000 | |
| 300 | Novartis Investigative Site | Helsinki | Finland | 00250 | |
| 301 | Novartis Investigative Site | Hyvinkää | Finland | FIN-05850 | |
| 302 | Novartis Investigative Site | Kajaani | Finland | FIN-87140 | |
| 303 | Novartis Investigative Site | Kuopio | Finland | FIN-70211 | |
| 304 | Novartis Investigative Site | Lohja | Finland | FIN-08200 | |
| 305 | Novartis Investigative Site | Oulu | Finland | 90100 | |
| 306 | Novartis Investigative Site | OYS | Finland | FIN-90029 | |
| 307 | Novartis Investigative Site | Pori | Finland | 28120 | |
| 308 | Novartis Investigative Site | Tammisaari | Finland | 10600 | |
| 309 | Novartis Investigative Site | Tampere | Finland | 33520 | |
| 310 | Novartis Investigative Site | Valkeakoski | Finland | 37600 | |
| 311 | Novartis Investigative Site | Besancon Cedex | France | 25030 | |
| 312 | Novartis Investigative Site | Bondy | France | 93143 | |
| 313 | Novartis Investigative Site | Corbeil Essonnes | France | 91100 | |
| 314 | Novartis Investigative Site | Grenoble | France | 38043 | |
| 315 | Novartis Investigative Site | La Rochelle | France | 17019 | |
| 316 | Novartis Investigative Site | Lagny sur Marne | France | 77405 | |
| 317 | Novartis Investigative Site | Limoges Cedex | France | 87042 | |
| 318 | Novartis Investigative Site | Lyon Cedex 03 | France | 69394 | |
| 319 | Novartis Investigative Site | Lyon | France | 69437 | |
| 320 | Novartis Investigative Site | Paris cedex 18 | France | 75877 | |
| 321 | Novartis Investigative Site | Paris Cedex 4 | France | 75181 | |
| 322 | Novartis Investigative Site | Poitiers Cedex | France | 86021 | |
| 323 | Novartis Investigative Site | Aschaffenburg | Germany | 63739 | |
| 324 | Novartis Investigative Site | Aschaffenburg | Germany | 63741 | |
| 325 | Novartis Investigative Site | Asslar | Germany | 35614 | |
| 326 | Novartis Investigative Site | Bad Oeynhausen | Germany | 32545 | |
| 327 | Novartis Investigative Site | Barsinghausen | Germany | 30890 | |
| 328 | Novartis Investigative Site | Bensheim | Germany | 64625 | |
| 329 | Novartis Investigative Site | Berlin | Germany | 13055 | |
| 330 | Novartis Investigative Site | Berlin | Germany | 13597 | |
| 331 | Novartis Investigative Site | Berlin | Germany | 14193 | |
| 332 | Novartis Investigative Site | Bonn | Germany | 53105 | |
| 333 | Novartis Investigative Site | Bottrop | Germany | 46242 | |
| 334 | Novartis Investigative Site | Bremen | Germany | 28277 | |
| 335 | Novartis Investigative Site | Bretten | Germany | 75015 | |
| 336 | Novartis Investigative Site | Cloppenburg | Germany | 49661 | |
| 337 | Novartis Investigative Site | Dippoldiswalde | Germany | 01744 | |
| 338 | Novartis Investigative Site | Dresden | Germany | 01127 | |
| 339 | Novartis Investigative Site | Dresden | Germany | 01307 | |
| 340 | Novartis Investigative Site | Duesseldorf | Germany | 40210 | |
| 341 | Novartis Investigative Site | Essen | Germany | 45127 | |
| 342 | Novartis Investigative Site | Essen | Germany | 45134 | |
| 343 | Novartis Investigative Site | Essen | Germany | 45138 | |
| 344 | Novartis Investigative Site | Fuldatal | Germany | 34233 | |
| 345 | Novartis Investigative Site | Göttingen | Germany | 37075 | |
| 346 | Novartis Investigative Site | Hagen | Germany | 58095 | |
| 347 | Novartis Investigative Site | Hamburg | Germany | 22335 | |
| 348 | Novartis Investigative Site | Hamburg | Germany | 22393 | |
| 349 | Novartis Investigative Site | Hannover | Germany | 30625 | |
| 350 | Novartis Investigative Site | Heidelberg | Germany | 69120 | |
| 351 | Novartis Investigative Site | Heilbronn | Germany | 74072 | |
| 352 | Novartis Investigative Site | Heilbronn | Germany | 74076 | |
| 353 | Novartis Investigative Site | Ingelheim | Germany | 55218 | |
| 354 | Novartis Investigative Site | Jena | Germany | 07743 | |
| 355 | Novartis Investigative Site | Kassel | Germany | 34117 | |
| 356 | Novartis Investigative Site | Krefeld | Germany | 47798 | |
| 357 | Novartis Investigative Site | Magdeburg | Germany | 39120 | |
| 358 | Novartis Investigative Site | Mainz | Germany | 55131 | |
| 359 | Novartis Investigative Site | Messkirch | Germany | 88605 | |
| 360 | Novartis Investigative Site | Muehldorf am Inn | Germany | 84453 | |
| 361 | Novartis Investigative Site | Neuwied | Germany | 56564 | |
| 362 | Novartis Investigative Site | Offenbach | Germany | 63065 | |
| 363 | Novartis Investigative Site | Rehburg-Loccum | Germany | 31547 | |
| 364 | Novartis Investigative Site | Riesa | Germany | 01587 | |
| 365 | Novartis Investigative Site | Schauenburg-Elgershausen | Germany | 34270 | |
| 366 | Novartis Investigative Site | Schwabenheim | Germany | 55270 | |
| 367 | Novartis Investigative Site | St. Ingbert - Oberwuerzbach | Germany | 66386 | |
| 368 | Novartis Investigative Site | Ursensollen | Germany | 92289 | |
| 369 | Novartis Investigative Site | Wetter | Germany | 58300 | |
| 370 | Novartis Investigative Site | Wiehl | Germany | 51674 | |
| 371 | Novartis Investigative Site | Wiesbaden | Germany | 65183 | |
| 372 | Novartis Investigative Site | Wuerzburg | Germany | 97072 | |
| 373 | Novartis Investigative Site | Alexandroupolis | Greece | GR 68 100 | |
| 374 | Novartis Investigative Site | Athens - GR | Greece | 10676 | |
| 375 | Novartis Investigative Site | Athens | Greece | GR 115 21 | |
| 376 | Novartis Investigative Site | Athens | Greece | GR 115 22 | |
| 377 | Novartis Investigative Site | Athens | Greece | GR 115 27 | |
| 378 | Novartis Investigative Site | Athens | Greece | GR 11527 | |
| 379 | Novartis Investigative Site | Athens | Greece | ||
| 380 | Novartis Investigative Site | Ioannina | Greece | GR 45500 | |
| 381 | Novartis Investigative Site | Patras | Greece | 26500 | |
| 382 | Novartis Investigative Site | Piraeurs | Greece | GR 184 54 | |
| 383 | Novartis Investigative Site | Thessaloniki | Greece | 57001 | |
| 384 | Novartis Investigative Site | Thessaloniki | Greece | GR 546 39 | |
| 385 | Novartis Investigative Site | Guatemala City | Guatemala | 01001 | |
| 386 | Novartis Investigative Site | Guatemala City | Guatemala | 01010 | |
| 387 | Novartis Investigative Site | Guatemala City | Guatemala | 01011 | |
| 388 | Novartis Investigative Site | Guatemala City | Guatemala | 01015 | |
| 389 | Novartis Investigative Site | Baja | Hungary | 6500 | |
| 390 | Novartis Investigative Site | Balatonfured | Hungary | 8230 | |
| 391 | Novartis Investigative Site | Budapest | Hungary | 1062 | |
| 392 | Novartis Investigative Site | Budapest | Hungary | 1083 | |
| 393 | Novartis Investigative Site | Budapest | Hungary | 1085 | |
| 394 | Novartis Investigative Site | Budapest | Hungary | 1096 | |
| 395 | Novartis Investigative Site | Budapest | Hungary | 1115 | |
| 396 | Novartis Investigative Site | Budapest | Hungary | H-1032 | |
| 397 | Novartis Investigative Site | Debrecen | Hungary | 4004 | |
| 398 | Novartis Investigative Site | Debrecen | Hungary | 4032 | |
| 399 | Novartis Investigative Site | Gyula | Hungary | 5703 | |
| 400 | Novartis Investigative Site | Kaposvar | Hungary | 7400 | |
| 401 | Novartis Investigative Site | Miskolc | Hungary | 3526 | |
| 402 | Novartis Investigative Site | Pecs | Hungary | 7324 | |
| 403 | Novartis Investigative Site | Szeged | Hungary | 6720 | |
| 404 | Novartis Investigative Site | Zalaegerszeg | Hungary | 8900 | |
| 405 | Novartis Investigative Site | Hyderabad | Andhra Pradesh, INDIA | India | 500034 |
| 406 | Novartis Investigative Site | Hyderabad | Andhra Pradesh | India | 500001 |
| 407 | Novartis Investigative Site | Hyderabad | Andhra Pradesh | India | 500012 |
| 408 | Novartis Investigative Site | Hyderabad | Andhra Pradesh | India | 500018 |
| 409 | Novartis Investigative Site | Ahmedabad | Gujarat | India | 380014 |
| 410 | Novartis Investigative Site | Bangalore | Karnataka | India | 560054 |
| 411 | Novartis Investigative Site | Banglaore | Karnataka | India | 560038 |
| 412 | Novartis Investigative Site | Mangalore | Karnataka | India | 575001 |
| 413 | Novartis Investigative Site | Kochi | Kerala | India | 682 026 |
| 414 | Novartis Investigative Site | Mumbai | Maharashtra | India | 400008 |
| 415 | Novartis Investigative Site | Pune | Maharashtra | India | 411011 |
| 416 | Novartis Investigative Site | Pune | Maharashtra | India | 411030 |
| 417 | Novartis Investigative Site | Chennai | Tamil Nadu | India | 600013 |
| 418 | Novartis Investigative Site | Vellore | Tamil Nadu | India | 632004 |
| 419 | Novartis Investigative Site | Bangalore | India | 560 034 | |
| 420 | Novartis Investigative Site | Chennai | India | 600010 | |
| 421 | Novartis Investigative Site | Chennai | India | 600086 | |
| 422 | Novartis Investigative Site | Hyderabad | India | 500 063 | |
| 423 | Novartis Investigative Site | Kolkota | India | 700020 | |
| 424 | Novartis Investigative Site | New Delhi | India | 110 029 | |
| 425 | Novartis Investigative Site | L'Aquila | AQ | Italy | 67100 |
| 426 | Novartis Investigative Site | Bergamo | BG | Italy | 24128 |
| 427 | Novartis Investigative Site | Belluno | BL | Italy | 32100 |
| 428 | Novartis Investigative Site | Bologna | BO | Italy | 40138 |
| 429 | Novartis Investigative Site | Campobasso | CB | Italy | 86100 |
| 430 | Novartis Investigative Site | Caserta | CE | Italy | 81100 |
| 431 | Novartis Investigative Site | Chieti | CH | Italy | 66100 |
| 432 | Novartis Investigative Site | Cuneo | CN | Italy | 12100 |
| 433 | Novartis Investigative Site | Cosenza | CS | Italy | 87100 |
| 434 | Novartis Investigative Site | Catanzaro | CZ | Italy | 88100 |
| 435 | Novartis Investigative Site | Cona | FE | Italy | 44100 |
| 436 | Novartis Investigative Site | Foggia | FG | Italy | 71100 |
| 437 | Novartis Investigative Site | Firenze | FI | Italy | 50134 |
| 438 | Novartis Investigative Site | Arenzano | GE | Italy | 16011 |
| 439 | Novartis Investigative Site | Genova | GE | Italy | 16132 |
| 440 | Novartis Investigative Site | Pozzilli | IS | Italy | 86077 |
| 441 | Novartis Investigative Site | Lecco | LC | Italy | 23900 |
| 442 | Novartis Investigative Site | Monza | MB | Italy | 20900 |
| 443 | Novartis Investigative Site | Milano | MI | Italy | 20123 |
| 444 | Novartis Investigative Site | Milano | MI | Italy | 20132 |
| 445 | Novartis Investigative Site | Milano | MI | Italy | 20146 |
| 446 | Novartis Investigative Site | Milano | MI | Italy | 20157 |
| 447 | Novartis Investigative Site | Passirana di Rho | MI | Italy | 20017 |
| 448 | Novartis Investigative Site | Palermo | PA | Italy | 90127 |
| 449 | Novartis Investigative Site | Perugia | PG | Italy | 06100 |
| 450 | Novartis Investigative Site | Pisa | PI | Italy | 56124 |
| 451 | Novartis Investigative Site | Pisa | PI | Italy | 56126 |
| 452 | Novartis Investigative Site | Pordenone | PN | Italy | 33170 |
| 453 | Novartis Investigative Site | Parma | PR | Italy | 43100 |
| 454 | Novartis Investigative Site | Casorate Primo | PV | Italy | 27022 |
| 455 | Novartis Investigative Site | Pavia | PV | Italy | 27100 |
| 456 | Novartis Investigative Site | Stradella | PV | Italy | 27049 |
| 457 | Novartis Investigative Site | Ravenna | RA | Italy | 48100 |
| 458 | Novartis Investigative Site | Roma | RM | Italy | 00122 |
| 459 | Novartis Investigative Site | Roma | RM | Italy | 00133 |
| 460 | Novartis Investigative Site | Roma | RM | Italy | 00157 |
| 461 | Novartis Investigative Site | Roma | RM | Italy | 00161 |
| 462 | Novartis Investigative Site | Roma | RM | Italy | 00163 |
| 463 | Novartis Investigative Site | Roma | RM | Italy | 00186 |
| 464 | Novartis Investigative Site | Roma | RM | Italy | 00189 |
| 465 | Novartis Investigative Site | Cava De' Tirreni | SA | Italy | 84013 |
| 466 | Novartis Investigative Site | Mercato San Severino | SA | Italy | 84085 |
| 467 | Novartis Investigative Site | Salerno | SA | Italy | 84125 |
| 468 | Novartis Investigative Site | Siena | SI | Italy | 53100 |
| 469 | Novartis Investigative Site | Olbia | SS | Italy | 07026 |
| 470 | Novartis Investigative Site | Sassari | SS | Italy | 07100 |
| 471 | Novartis Investigative Site | Torino | TO | Italy | 10126 |
| 472 | Novartis Investigative Site | Torino | TO | Italy | 10128 |
| 473 | Novartis Investigative Site | Torino | TO | Italy | 10154 |
| 474 | Novartis Investigative Site | Vittorio Veneto | TV | Italy | 31029 |
| 475 | Novartis Investigative Site | San Daniele Del Friuli | UD | Italy | 33038 |
| 476 | Novartis Investigative Site | Udine | UD | Italy | 33100 |
| 477 | Novartis Investigative Site | Venezia | VE | Italy | 30174 |
| 478 | Novartis Investigative Site | Verona | VR | Italy | 37126 |
| 479 | Novartis Investigative Site | Isernia | Italy | 86170 | |
| 480 | Novartis Investigative Site | Napoli | Italy | 80131 | |
| 481 | Novartis Investigative Site | Nagoya | Aichi | Japan | 451-8511 |
| 482 | Novartis Investigative Site | Nagoya | Aichi | Japan | 455-8530 |
| 483 | Novartis Investigative Site | Nagoya | Aichi | Japan | 460-0001 |
| 484 | Novartis Investigative Site | Nagoya | Aichi | Japan | 462-0802 |
| 485 | Novartis Investigative Site | Nagoya | Aichi | Japan | 462-0825 |
| 486 | Novartis Investigative Site | Asahi | Chiba | Japan | 289-2511 |
| 487 | Novartis Investigative Site | Kasuga | Fukuoka | Japan | 816-0864 |
| 488 | Novartis Investigative Site | Kitakyushu | Fukuoka | Japan | 800-0296 |
| 489 | Novartis Investigative Site | Koriyama-city | Fukushima | Japan | 963-8851 |
| 490 | Novartis Investigative Site | Asahikawa | Hokkaido | Japan | 078-8211 |
| 491 | Novartis Investigative Site | Sapporo-city | Hokkaido | Japan | 060-8648 |
| 492 | Novartis Investigative Site | Sapporo | Hokkaido | Japan | 003-0023 |
| 493 | Novartis Investigative Site | Sapporo | Hokkaido | Japan | 060-0033 |
| 494 | Novartis Investigative Site | Toride-city | Ibaraki | Japan | 302-0022 |
| 495 | Novartis Investigative Site | Takamatsu | Kagawa | Japan | 7600076 |
| 496 | Novartis Investigative Site | Aira-city | Kagoshima | Japan | 899-5431 |
| 497 | Novartis Investigative Site | Isehara-city | Kanagawa | Japan | 259-1131 |
| 498 | Novartis Investigative Site | Kawasaki | Kanagawa | Japan | 210-0852 |
| 499 | Novartis Investigative Site | Yatsushiro | Kumamoto | Japan | 866-8660 |
| 500 | Novartis Investigative Site | Kyoto-city | Kyoto | Japan | 612-8555 |
| 501 | Novartis Investigative Site | Kyoto-city | Kyoto | Japan | 615-0035 |
| 502 | Novartis Investigative Site | Sendai-city | Miyagi | Japan | 980-8574 |
| 503 | Novartis Investigative Site | Suwa | Nagano | Japan | 392-8510 |
| 504 | Novartis Investigative Site | Okayama-city | Okayama | Japan | 700-8558 |
| 505 | Novartis Investigative Site | Takatsuki-city | Osaka | Japan | 569-1096 |
| 506 | Novartis Investigative Site | Toyonaka | Osaka | Japan | 561-0871 |
| 507 | Novartis Investigative Site | Yao-city | Osaka | Japan | 581-0011 |
| 508 | Novartis Investigative Site | Tokorozawa | Saitama | Japan | 351-1151 |
| 509 | Novartis Investigative Site | Ohtsu-city | Shiga | Japan | 520-2192 |
| 510 | Novartis Investigative Site | Shimizu | Shizuoka | Japan | 411-8611 |
| 511 | Novartis Investigative Site | Bunkyo-ku | Tokyo | Japan | 113-8655 |
| 512 | Novartis Investigative Site | Chuo-ku | Tokyo | Japan | 103-0002 |
| 513 | Novartis Investigative Site | Takaoka | Toyama | Japan | 933-0955 |
| 514 | Novartis Investigative Site | Oita | Japan | 870-0039 | |
| 515 | Novartis Investigative Site | Oita | Japan | 870-0192 | |
| 516 | Novartis Investigative Site | Okayama | Japan | 701-1192 | |
| 517 | Novartis Investigative Site | Ansan | Gyeonggi-do | Korea, Republic of | 425-801 |
| 518 | Novartis Investigative Site | Anyang | Gyeonggi-do | Korea, Republic of | 431-070 |
| 519 | Novartis Investigative Site | Seoul | Korea | Korea, Republic of | 110 744 |
| 520 | Novartis Investigative Site | Seoul | Korea | Korea, Republic of | 120-752 |
| 521 | Novartis Investigative Site | Seoul | Korea | Korea, Republic of | 135-710 |
| 522 | Novartis Investigative Site | Bundang | Seongnam | Korea, Republic of | 463-707 |
| 523 | Novartis Investigative Site | Busan | Korea, Republic of | 602-739 | |
| 524 | Novartis Investigative Site | Daejeon | Korea, Republic of | 301-747 | |
| 525 | Novartis Investigative Site | Incheon | Korea, Republic of | 400-712 | |
| 526 | Novartis Investigative Site | Pusan | Korea, Republic of | 614-735 | |
| 527 | Novartis Investigative Site | Seoul | Korea, Republic of | 135-720 | |
| 528 | Novartis Investigative Site | Seoul | Korea, Republic of | 136 705 | |
| 529 | Novartis Investigative Site | Seoul | Korea, Republic of | 137-701 | |
| 530 | Novartis Investigative Site | Seoul | Korea, Republic of | 152-703 | |
| 531 | Novartis Investigative Site | Seoul | Korea, Republic of | 156-707 | |
| 532 | Novartis Investigative Site | Taegu | Korea, Republic of | 700 - 721 | |
| 533 | Novartis Investigative Site | Kaunas | Lithuania | 50009 | |
| 534 | Novartis Investigative Site | Klaipeda | Lithuania | 92304 | |
| 535 | Novartis Investigative Site | Vilnius | Lithuania | LT-08661 | |
| 536 | Novartis Investigative Site | Vilnius | Lithuania | ||
| 537 | Novartis Investigative Site | Alkmaar | Netherlands | 1851 JD | |
| 538 | Novartis Investigative Site | Almelo | Netherlands | 7609 PP | |
| 539 | Novartis Investigative Site | Amersfoort | Netherlands | 3800 BM | |
| 540 | Novartis Investigative Site | Amsterdam | Netherlands | 1061 AE | |
| 541 | Novartis Investigative Site | Apeldoorn | Netherlands | 7334 DZ | |
| 542 | Novartis Investigative Site | Arnhem | Netherlands | 6815 AD | |
| 543 | Novartis Investigative Site | Breda | Netherlands | 4818 CK | |
| 544 | Novartis Investigative Site | Delft | Netherlands | 2625 AD | |
| 545 | Novartis Investigative Site | Den Helder | Netherlands | 1782 GZ | |
| 546 | Novartis Investigative Site | Deventer | Netherlands | 7416 SE | |
| 547 | Novartis Investigative Site | Doetinchem | Netherlands | 7009 BL | |
| 548 | Novartis Investigative Site | Dordrecht | Netherlands | 3318AT | |
| 549 | Novartis Investigative Site | Eindhoven | Netherlands | 5623 EJ | |
| 550 | Novartis Investigative Site | Eindhoven | Netherlands | 5631 BM | |
| 551 | Novartis Investigative Site | Goes | Netherlands | 4462 RA | |
| 552 | Novartis Investigative Site | Groningen | Netherlands | 9713 GZ | |
| 553 | Novartis Investigative Site | Heerlen | Netherlands | 6419 PC | |
| 554 | Novartis Investigative Site | Hoogeveen | Netherlands | 7909 AA | |
| 555 | Novartis Investigative Site | Hoogwoud | Netherlands | 1718 BG | |
| 556 | Novartis Investigative Site | Losser | Netherlands | 7581 BV | |
| 557 | Novartis Investigative Site | Meppel | Netherlands | 7943 KA | |
| 558 | Novartis Investigative Site | Nieuwegein | Netherlands | 3435 CM | |
| 559 | Novartis Investigative Site | Oude Pekela | Netherlands | 9665 AR | |
| 560 | Novartis Investigative Site | Rotterdam | Netherlands | 3015 CE | |
| 561 | Novartis Investigative Site | Rotterdam | Netherlands | 3045 PM | |
| 562 | Novartis Investigative Site | Rotterdam | Netherlands | 3083 AN | |
| 563 | Novartis Investigative Site | Tiel | Netherlands | 4002 WP | |
| 564 | Novartis Investigative Site | Utrecht | Netherlands | 3508 GA | |
| 565 | Novartis Investigative Site | Venlo | Netherlands | 5912 BL | |
| 566 | Novartis Investigative Site | Woerden | Netherlands | 3443 GG | |
| 567 | Novartis Investigative Site | Zwijndrecht | Netherlands | NL-3331 LZ | |
| 568 | Novartis Investigative Site | Zwolle | Netherlands | 8025 AB | |
| 569 | Novartis Investigative Site | Bergen | Norway | 5013 | |
| 570 | Novartis Investigative Site | Fredrikstad | Norway | 1607 | |
| 571 | Novartis Investigative Site | Horten | Norway | 3191 | |
| 572 | Novartis Investigative Site | Hønefoss | Norway | 3515 | |
| 573 | Novartis Investigative Site | Oslo | Norway | 0160 | |
| 574 | Novartis Investigative Site | Skedsmokorset | Norway | 2020 | |
| 575 | Novartis Investigative Site | Skien | Norway | 3722 | |
| 576 | Novartis Investigative Site | Spikkestad | Norway | 3430 | |
| 577 | Novartis Investigative Site | Stavanger | Norway | 4011 | |
| 578 | Novartis Investigative Site | Svelvik | Norway | 3060 | |
| 579 | Novartis Investigative Site | Tromsø | Norway | NO-9038 | |
| 580 | Novartis Investigative Site | Trondheim | Norway | NO-7011 | |
| 581 | Novartis Investigative Site | Tønsberg | Norway | 3103 | |
| 582 | Novartis Investigative Site | Bellavista | Lima | Peru | Callao 02 |
| 583 | Novartis Investigative Site | Cercado de Lima | Lima | Peru | 01 |
| 584 | Novartis Investigative Site | San Borja | Lima | Peru | 41 |
| 585 | Novartis Investigative Site | San Isidro | Lima | Peru | 27 |
| 586 | Novartis Investigative Site | San Martin de Porres | Lima | Peru | 31 |
| 587 | Novartis Investigative Site | Santiago de Surco | Lima | Peru | 33 |
| 588 | Novartis Investigative Site | Almada | Portugal | 2801-951 | |
| 589 | Novartis Investigative Site | Amadora | Portugal | 2720-276 | |
| 590 | Novartis Investigative Site | Coimbra | Portugal | 3000-075 | |
| 591 | Novartis Investigative Site | Linda-a-Velha | Portugal | 2799-523 | |
| 592 | Novartis Investigative Site | Lisboa | Portugal | 1169-024 | |
| 593 | Novartis Investigative Site | Lisboa | Portugal | 1250-203 | |
| 594 | Novartis Investigative Site | Lisboa | Portugal | 1495-005 | |
| 595 | Novartis Investigative Site | Lisboa | Portugal | 1649-035 | |
| 596 | Novartis Investigative Site | Matosinhos | Portugal | 4454-509 | |
| 597 | Novartis Investigative Site | Portimão | Portugal | 8500-388 | |
| 598 | Novartis Investigative Site | Porto | Portugal | 4200-319 | |
| 599 | Novartis Investigative Site | Santa Maria da Feira | Portugal | 4520-211 | |
| 600 | Novartis Investigative Site | Santarém | Portugal | 2000-153 | |
| 601 | Novartis Investigative Site | Ponce | Puerto Rico | 00716 | |
| 602 | Novartis Investigative Site | Ponce | Puerto Rico | 00733-1471 | |
| 603 | Novartis Investigative Site | Singapore | Singapore | 119074 | |
| 604 | Novartis Investigative Site | Singapore | Singapore | 159964 | |
| 605 | Novartis Investigative Site | Singapore | Singapore | 168752 | |
| 606 | Novartis Investigative Site | Singapore | Singapore | 169608 | |
| 607 | Novartis Investigative Site | Singapore | Singapore | 308433 | |
| 608 | Novartis Investigative Site | Bratislava | Slovak Republic | Slovakia | 826 06 |
| 609 | Novartis Investigative Site | Kosice | Slovak Republic | Slovakia | 040 22 |
| 610 | Novartis Investigative Site | Zilina | Slovak Republic | Slovakia | 010 01 |
| 611 | Novartis Investigative Site | Banksa Bystrica | Slovakia | SK 97 517 | |
| 612 | Novartis Investigative Site | Bratislava | Slovakia | 811 08 | |
| 613 | Novartis Investigative Site | Bratislava | Slovakia | 812 72 | |
| 614 | Novartis Investigative Site | Bratislava | Slovakia | 81369 | |
| 615 | Novartis Investigative Site | Bratislava | Slovakia | 833 48 | |
| 616 | Novartis Investigative Site | Bratislava | Slovakia | 851 07 | |
| 617 | Novartis Investigative Site | Kosice | Slovakia | 040 01 | |
| 618 | Novartis Investigative Site | Lubochna | Slovakia | SK 03491 | |
| 619 | Novartis Investigative Site | Lucenec | Slovakia | 98439 | |
| 620 | Novartis Investigative Site | Martin | Slovakia | 03601 | |
| 621 | Novartis Investigative Site | Nitra | Slovakia | 949 01 | |
| 622 | Novartis Investigative Site | Piestany | Slovakia | 921 01 | |
| 623 | Novartis Investigative Site | Prievidza | Slovakia | 971 01 | |
| 624 | Novartis Investigative Site | Trstena | Slovakia | 549 16 | |
| 625 | Novartis Investigative Site | Somerset West | Western Cape | South Africa | 7130 |
| 626 | Novartis Investigative Site | Cape Town | South Africa | 7925 | |
| 627 | Novartis Investigative Site | Durban | South Africa | 4001 | |
| 628 | Novartis Investigative Site | Durban | South Africa | 4030 | |
| 629 | Novartis Investigative Site | Durban | South Africa | 4052 | |
| 630 | Novartis Investigative Site | Durban | South Africa | 4110 | |
| 631 | Novartis Investigative Site | Gauteng | South Africa | ||
| 632 | Novartis Investigative Site | Johannesburg | South Africa | 2196 | |
| 633 | Novartis Investigative Site | Port Elizabeth | South Africa | 6001 | |
| 634 | Novartis Investigative Site | Pretoria | South Africa | 0002 | |
| 635 | Novartis Investigative Site | Cadiz | Andalucia | Spain | 11010 |
| 636 | Novartis Investigative Site | Granada | Andalucia | Spain | 18014 |
| 637 | Novartis Investigative Site | Jerez de La Frontera | Andalucia | Spain | 11407 |
| 638 | Novartis Investigative Site | Malaga | Andalucia | Spain | 29010 |
| 639 | Novartis Investigative Site | Malaga | Andalucia | Spain | 29018 |
| 640 | Novartis Investigative Site | Málaga | Andalucia | Spain | 29010 |
| 641 | Novartis Investigative Site | Puerto de Santa Maria | Andalucia | Spain | 11500 |
| 642 | Novartis Investigative Site | Sanlúcar de Barrameda | Andalucia | Spain | 11540 |
| 643 | Novartis Investigative Site | Sevilla | Andalucia | Spain | 41009 |
| 644 | Novartis Investigative Site | Oviedo | Asturias | Spain | 33006 |
| 645 | Novartis Investigative Site | Oviedo | Asturias | Spain | 33008 |
| 646 | Novartis Investigative Site | Oviedo | Asturias | Spain | 33010 |
| 647 | Novartis Investigative Site | Hospitalet de Llobregat | Barcelona | Spain | 08907 |
| 648 | Novartis Investigative Site | Sabadell | Barcelona | Spain | 08208 |
| 649 | Novartis Investigative Site | Alcazar de San Juan | Castilla la Mancha | Spain | 13600 |
| 650 | Novartis Investigative Site | Aranda de Duero | Castilla y Leon | Spain | 09400 |
| 651 | Novartis Investigative Site | Miranda de Ebro | Castilla y Leon | Spain | 09200 |
| 652 | Novartis Investigative Site | Barcelona | Catalunya | Spain | 08025 |
| 653 | Novartis Investigative Site | Barcelona | Cataluña | Spain | 08025 |
| 654 | Novartis Investigative Site | Barcelona | Cataluña | Spain | 08905 |
| 655 | Novartis Investigative Site | Girona | Cataluña | Spain | 17007 |
| 656 | Novartis Investigative Site | La Pobla Llarga | Cataluña | Spain | 46670 |
| 657 | Novartis Investigative Site | Llança | Cataluña | Spain | 17490 |
| 658 | Novartis Investigative Site | Manresa | Cataluña | Spain | 08240 |
| 659 | Novartis Investigative Site | Mollet del Vallés | Cataluña | Spain | 08100 |
| 660 | Novartis Investigative Site | Rubi | Cataluña | Spain | 08191 |
| 661 | Novartis Investigative Site | Santa Coloma de Gramanet | Cataluña | Spain | 08923 |
| 662 | Novartis Investigative Site | Tarrega | Cataluña | Spain | 25300 |
| 663 | Novartis Investigative Site | Vic | Cataluña | Spain | 08500 |
| 664 | Novartis Investigative Site | Alacuas | Comunidad Valenciana | Spain | 46970 |
| 665 | Novartis Investigative Site | Alicante | Comunidad Valenciana | Spain | 03004 |
| 666 | Novartis Investigative Site | Alzira | Comunidad Valenciana | Spain | 46600 |
| 667 | Novartis Investigative Site | Benidorm | Comunidad Valenciana | Spain | 03550 |
| 668 | Novartis Investigative Site | Puerto de Sagunto | Comunidad Valenciana | Spain | 46520 |
| 669 | Novartis Investigative Site | Quart de Poblet | Comunidad Valenciana | Spain | 46930 |
| 670 | Novartis Investigative Site | Valencia | Comunidad Valenciana | Spain | 46010 |
| 671 | Novartis Investigative Site | Valencia | Comunidad Valenciana | Spain | 46011 |
| 672 | Novartis Investigative Site | Valencia | Comunidad Valenciana | Spain | 46014 |
| 673 | Novartis Investigative Site | Valencia | Comunidad Valenciana | Spain | 46017 |
| 674 | Novartis Investigative Site | Valencia | Comunidad Valenciana | Spain | 46019 |
| 675 | Novartis Investigative Site | Xixona | Comunidad Valenciana | Spain | 03100 |
| 676 | Novartis Investigative Site | Mérida | Extremadura | Spain | 06800 |
| 677 | Novartis Investigative Site | Begonte | Galicia | Spain | 27373 |
| 678 | Novartis Investigative Site | Ferrol | Galicia | Spain | 15405 |
| 679 | Novartis Investigative Site | La Coruña | Galicia | Spain | 15010 |
| 680 | Novartis Investigative Site | Pontevedra | Galicia | Spain | 36071 |
| 681 | Novartis Investigative Site | Santiago de Compostela | Galicia | Spain | 15706 |
| 682 | Novartis Investigative Site | Vigo | Galicia | Spain | 36200 |
| 683 | Novartis Investigative Site | Palma De Mallorca | Islas Baleares | Spain | |
| 684 | Novartis Investigative Site | Alcorcón | Madrid | Spain | 28922 |
| 685 | Novartis Investigative Site | Arganda del Rey | Madrid | Spain | 28500 |
| 686 | Novartis Investigative Site | Civdad Real | Madrid | Spain | 13002 |
| 687 | Novartis Investigative Site | Murcia | Madrid | Spain | 30007 |
| 688 | Novartis Investigative Site | Plentzia | Pais Vasco | Spain | 48620 |
| 689 | Novartis Investigative Site | San Sebastian | Pais Vasco | Spain | 20014 |
| 690 | Novartis Investigative Site | Villabona | Pais Vasco | Spain | 20150 |
| 691 | Novartis Investigative Site | Zumarraga | Pais Vasco | Spain | 20700 |
| 692 | Novartis Investigative Site | Alfaro | Rioja | Spain | 26540 |
| 693 | Novartis Investigative Site | Logroño | Rioja | Spain | 26005 |
| 694 | Novartis Investigative Site | Hospitalet de Llbregat | Spain | 08902 | |
| 695 | Novartis Investigative Site | Hospitalet de Llobregat | Spain | ||
| 696 | Novartis Investigative Site | Madrid | Spain | 28034 | |
| 697 | Novartis Investigative Site | Madrid | Spain | 28035 | |
| 698 | Novartis Investigative Site | Madrid | Spain | 28040 | |
| 699 | Novartis Investigative Site | Madrid | Spain | 28041 | |
| 700 | Novartis Investigative Site | Madrid | Spain | 28046 | |
| 701 | Novartis Investigative Site | Madrid | Spain | 28770 | |
| 702 | Novartis Investigative Site | Göteborg | Sweden | SE-412 55 | |
| 703 | Novartis Investigative Site | Helsingborg | Sweden | 251 87 | |
| 704 | Novartis Investigative Site | Karlstad | Sweden | 651 85 | |
| 705 | Novartis Investigative Site | Malmö | Sweden | 21152 | |
| 706 | Novartis Investigative Site | Rättvik | Sweden | 79530 | |
| 707 | Novartis Investigative Site | Stenstorp | Sweden | SE-521 60 | |
| 708 | Novartis Investigative Site | Uppsala | Sweden | 751 85 | |
| 709 | Novartis Investigative Site | Varberg | Sweden | s-432 81 | |
| 710 | Novartis Investigative Site | Estavayer-le-Lac | CH | Switzerland | 1470 |
| 711 | Novartis Investigative Site | Ascona | Switzerland | ||
| 712 | Novartis Investigative Site | Bern | Switzerland | 3010 | |
| 713 | Novartis Investigative Site | Bolligen | Switzerland | 3065 | |
| 714 | Novartis Investigative Site | Bruderholz | Switzerland | 4101 | |
| 715 | Novartis Investigative Site | Fribourg | Switzerland | 1700 | |
| 716 | Novartis Investigative Site | La Chaux-de-Fonds | Switzerland | 2300 | |
| 717 | Novartis Investigative Site | Lausanne | Switzerland | 1011 | |
| 718 | Novartis Investigative Site | Lugano | Switzerland | 6900 | |
| 719 | Novartis Investigative Site | Lugano | Switzerland | 6903 | |
| 720 | Novartis Investigative Site | Renens | Switzerland | 1020 | |
| 721 | Novartis Investigative Site | Schaffhausen | Switzerland | 8200 | |
| 722 | Novartis Investigative Site | St. Gallen | Switzerland | 9007 | |
| 723 | Novartis Investigative Site | Winterthur | Switzerland | 8400 | |
| 724 | Novartis Investigative Site | Zuerich | Switzerland | 8091 | |
| 725 | Novartis Investigative Site | Yungkang | Tainan | Taiwan | 710 |
| 726 | Novartis Investigative Site | Changhua | Taiwan | 500 | |
| 727 | Novartis Investigative Site | Kaohsiung | Taiwan | 807 | |
| 728 | Novartis Investigative Site | Niaosong Township | Taiwan | 83301 | |
| 729 | Novartis Investigative Site | Taichung County | Taiwan | ||
| 730 | Novartis Investigative Site | Taichung | Taiwan | 40705 | |
| 731 | Novartis Investigative Site | Taichung | Taiwan | ||
| 732 | Novartis Investigative Site | Taipei | Taiwan | 10002 | |
| 733 | Novartis Investigative Site | Taipei | Taiwan | 114 | |
| 734 | Novartis Investigative Site | Taipei | Taiwan | ||
| 735 | Novartis Investigative Site | Bangkok | Thailand | 10330 | |
| 736 | Novartis Investigative Site | Bangkok | Thailand | 10400 | |
| 737 | Novartis Investigative Site | Bangkok | Thailand | 10700 | |
| 738 | Novartis Investigative Site | Chiang Mai | Thailand | 50200 | |
| 739 | Novartis Investigative Site | Altunizade | Turkey | 34662 | |
| 740 | Novartis Investigative Site | Ankara | Turkey | 06100 | |
| 741 | Novartis Investigative Site | Ankara | Turkey | 06590 | |
| 742 | Novartis Investigative Site | Gaziantep | Turkey | 27070 | |
| 743 | Novartis Investigative Site | Izmir | Turkey | 35040 | |
| 744 | Novartis Investigative Site | Izmir | Turkey | 35340 | |
| 745 | Novartis Investigative Site | Kocaeli | Turkey | 41380 | |
| 746 | Novartis Investigative Site | High Wycombe | Buckinghamshire | United Kingdom | HP11 2TT |
| 747 | Novartis Investigative Site | Truro | Cornwall | United Kingdom | TR1 3LJ |
| 748 | Novartis Investigative Site | Paignton | Devon | United Kingdom | TQ4 5LA |
| 749 | Novartis Investigative Site | Cornwall | England | United Kingdom | PL23 1DT |
| 750 | Novartis Investigative Site | Welwyn Garden City, | Hertfordshire | United Kingdom | AL7 4HQ |
| 751 | Novartis Investigative Site | Gravesend | Kent | United Kingdom | DA1 24JW |
| 752 | Novartis Investigative Site | Glasgow | Scotland | United Kingdom | G12 8TA |
| 753 | Novartis Investigative Site | East Horsley | Surrey | United Kingdom | KT24 6QT |
| 754 | Novartis Investigative Site | Crawley | West Sussex | United Kingdom | RH10 7DX |
| 755 | Novartis Investigative Site | Bath | United Kingdom | BA2 3HT | |
| 756 | Novartis Investigative Site | Cardiff | United Kingdom | CF14 4XN | |
| 757 | Novartis Investigative Site | Cardiff | United Kingdom | CF5 4AD | |
| 758 | Novartis Investigative Site | Glasgow | United Kingdom | G11 6NT | |
| 759 | Novartis Investigative Site | Glasgow | United Kingdom | G21 3UW | |
| 760 | Novartis Investigative Site | Irvine | United Kingdom | KA12 0AY | |
| 761 | Novartis Investigative Site | Lancashire | United Kingdom | FY3 7EN | |
| 762 | Novartis Investigative Site | Lancashire | United Kingdom | FY4 3AD | |
| 763 | Novartis Investigative Site | London | United Kingdom | NW10 7NS | |
| 764 | Novartis Investigative Site | London | United Kingdom | SE1 9RT | |
| 765 | Novartis Investigative Site | London | United Kingdom | SW17 0QT | |
| 766 | Novartis Investigative Site | Manchester | United Kingdom | M13 9NT | |
| 767 | Novartis Investigative Site | Merseyside | United Kingdom | L7 8PX | |
| 768 | Novartis Investigative Site | Rugby | United Kingdom | CV21 5 PX | |
| 769 | Novartis Investigative Site | Vale of Glanmorgan | United Kingdom | CF63 4AR | |
| 770 | Novartis Investigative Site | Wrexham | United Kingdom | LL13 7TD | |
| 771 | Novartis Investigative Site | Caracas | Distrito Capital | Venezuela | 1010 |
| 772 | Novartis Investigative Site | Caracas | Distrito Capital | Venezuela | 1020 |
| 773 | Novartis Investigative Site | Caracas | Distrito Capital | Venezuela | 1040 |
| 774 | Novartis Investigative Site | Caracas | Distrito Capital | Venezuela | 1080-A |
| 775 | Novartis Investigative Site | Caracas | Distrito Capital | Venezuela | 1100 |
| 776 | Novartis Investigative Site | Puerto Ordaz | Estado Bolívar | Venezuela | 8050 |
| 777 | Novartis Investigative Site | Valencia | Estado Carabobo | Venezuela | 2001 |
| 778 | Novartis Investigative Site | Caracas | Estado Miranda | Venezuela | 1060 |
Sponsors and Collaborators
- Novartis Pharmaceuticals
Investigators
- Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals
- Study Chair: Novartis, Novartis
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00549757
Other Study ID Numbers:
- CSPP100E2337
- 2007-000860-25
First Posted:
Oct 26, 2007
Last Update Posted:
Apr 21, 2014
Last Verified:
Apr 1, 2014
Keywords provided by Novartis Pharmaceuticals
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | Per data monitoring committee (DMC) recommendation all patients were required to permanently stop study medication by 06Jan2012. A follow-up period (actual duration, 9 months in average) post study drug discontinuation on 7590 patients was implemented upon request of Health Authority following the recommendation of DMC to cease study treatment. |
| Arm/Group Title | Aliskiren | Placebo |
|---|---|---|
| Arm/Group Description | In Core (Double Blind) phase, Aliskiren 150 mg once daily (o.d.) for 4 weeks; then patient was uptitrated to 300 mg o.d. at Visit 5/Week 4 (or 150 mg o.d. if patient could not tolerate target dose of study drug). Visits took place at 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase. With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment. | In Core (Double Blind) phase, placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase. With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment. |
| Period Title: Active Treatment Phase: Max. 50 Months | ||
| STARTED | 4296 | 4310 |
| Full Analysis Set | 4274 | 4287 |
| Safety Set | 4272 | 4285 |
| COMPLETED | 0 | 0 |
| NOT COMPLETED | 4296 | 4310 |
| Period Title: Active Treatment Phase: Max. 50 Months | ||
| STARTED | 3773 | 3817 |
| COMPLETED | 3148 | 3182 |
| NOT COMPLETED | 625 | 635 |
Baseline Characteristics
| Arm/Group Title | Aliskiren | Placebo | Total |
|---|---|---|---|
| Arm/Group Description | In Core (Double Blind) phase, Aliskiren 150 mg once daily (o.d.) for 4 weeks; then patient was uptitrated to 300 mg o.d. at Visit 5/Week 4 (or 150 mg o.d. if patient could not tolerate target dose of study drug). Visits took place at 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase. With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment. | In Core (Double Blind) phase, placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase. With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment. | Total of all reporting groups |
| Overall Participants | 4274 | 4287 | 8561 |
| Age (Years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [Years] |
64.6
(9.62)
|
64.4
(9.87)
|
64.5
(9.75)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
1393
32.6%
|
1342
31.3%
|
2735
31.9%
|
| Male |
2881
67.4%
|
2945
68.7%
|
5826
68.1%
|
Outcome Measures
| Title | Percentage of Participants With Occurrence of Primary Composite Endpoint (Core : Active Treatment Phase) |
|---|---|
| Description | Occurrence was defined as the first event of the following composite primary endpoint: Cardiovascular (CV) death Resuscitated sudden death Non-fatal myocardial infarction (MI) Non-fatal stroke Unplanned hospitalization for heart failure (HF) Onset of end-stage renal disease (ESRD) or death due to renal failure. Onset of ESRD was defined as initiation of dialysis, renal transplantation, or a serum creatinine concentration above 6.0 mg/dL (530 μmol/L), sustained for at least a month. Doubling of baseline serum creatinine concentration, sustained for at least one month. To fulfill the endpoint, the serum creatinine concentration had to be above the upper limit of normal for men and women according to the central laboratory. The upper limit of normal for men is 1.20 mg/dL and for women is 0.91 mg/dL. |
| Time Frame | Time from randomization to the first event (Maximum 50 months) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set (FAS) - All patients randomized except mis-randomized patients who did not receive study drug. Mis-randomized patients were defined as not qualified for randomization and were inadvertently randomized into the study. |
| Arm/Group Title | Aliskiren | Placebo |
|---|---|---|
| Arm/Group Description | In Core (Double Blind) phase, Aliskiren 150 mg once daily (o.d.) for 4 weeks; then patient was uptitrated to 300 mg o.d. at Visit 5/Week 4 (or 150 mg o.d. if patient could not tolerate target dose of study drug). Visits took place at 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase. | In Core (Double Blind) phase, placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase. |
| Measure Participants | 4274 | 4287 |
| Number [percentage of participants] |
17.6
0.4%
|
16.3
0.4%
|
| Title | Percentage of Participants With Cardiovascular (CV) Death (Core: Active Treatment Phase) |
|---|---|
| Description | |
| Time Frame | Time from randomization to the first event (Maximum 50 months) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set (FAS) - All patients randomized except mis-randomized patients who did not receive study drug. Mis-randomized patients were defined as not qualified for randomization and were inadvertently randomized into the study. |
| Arm/Group Title | Aliskiren | Placebo |
|---|---|---|
| Arm/Group Description | In Core (Double Blind) phase, Aliskiren 150 mg once daily (o.d.) for 4 weeks; then patient was uptitrated to 300 mg o.d. at Visit 5/Week 4 (or 150 mg o.d. if patient could not tolerate target dose of study drug). Visits took place at 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase. | In Core (Double Blind) phase, placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase. |
| Measure Participants | 4274 | 4287 |
| Number [percentage of participants] |
5.5
0.1%
|
4.8
0.1%
|
| Title | Percentage of Participants With Resuscitated Sudden Death (Core: Active Treatment Phase) |
|---|---|
| Description | Resuscitated sudden death was adjudicated when a subject experiences sudden death or cardiac arrest and is successfully resuscitated by cardioversion, defibrillation or cardiopulmonary resuscitation with a meaningful recovery of consciousness. This definition excludes known transient losses of consciousness such as seizure or vasovagal episodes that do not reflect significant cardiac dysfunction. |
| Time Frame | Time from randomization to the first event (Maximum 50 Months) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set (FAS) - All patients randomized except mis-randomized patients who did not receive study drug. Mis-randomized patients were defined as not qualified for randomization and were inadvertently randomized into the study. |
| Arm/Group Title | Aliskiren | Placebo |
|---|---|---|
| Arm/Group Description | In Core (Double Blind) phase, Aliskiren 150 mg once daily (o.d.) for 4 weeks; then patient was uptitrated to 300 mg o.d. at Visit 5/Week 4 (or 150 mg o.d. if patient could not tolerate target dose of study drug). Visits took place at 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase. | In Core (Double Blind) phase, placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase. |
| Measure Participants | 4274 | 4287 |
| Number [percentage of participants] |
0.4
0%
|
0.2
0%
|
| Title | Percentage of Participants With Fatal/Non-fatal Myocardial Infarction (MI) (Core: Active Treatment Phase) |
|---|---|
| Description | |
| Time Frame | Time from randomization to the first event (Maximum 50 Months) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set (FAS) - All patients randomized except mis-randomized patients who did not receive study drug. Mis-randomized patients were defined as not qualified for randomization and were inadvertently randomized into the study. |
| Arm/Group Title | Aliskiren | Placebo |
|---|---|---|
| Arm/Group Description | In Core (Double Blind) phase, Aliskiren 150 mg once daily (o.d.) for 4 weeks; then patient was uptitrated to 300 mg o.d. at Visit 5/Week 4 (or 150 mg o.d. if patient could not tolerate target dose of study drug). Visits took place at 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase. | In Core (Double Blind) phase, placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase. |
| Measure Participants | 4274 | 4287 |
| Number [percentage of participants] |
3.3
0.1%
|
3.2
0.1%
|
| Title | Percentage of Participants With Fatal/Non-fatal Stroke (Core: Active Treatment Phase) |
|---|---|
| Description | |
| Time Frame | Time from randomization to the first event (Maximum 50 Months) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set (FAS) - All patients randomized except mis-randomized patients who did not receive study drug. Mis-randomized patients were defined as not qualified for randomization and were inadvertently randomized into the study. |
| Arm/Group Title | Aliskiren | Placebo |
|---|---|---|
| Arm/Group Description | In Core (Double Blind) phase, Aliskiren 150 mg once daily (o.d.) for 4 weeks; then patient was uptitrated to 300 mg o.d. at Visit 5/Week 4 (or 150 mg o.d. if patient could not tolerate target dose of study drug). Visits took place at 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase. | In Core (Double Blind) phase, placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase. |
| Measure Participants | 4274 | 4287 |
| Number [percentage of participants] |
3.4
0.1%
|
2.7
0.1%
|
| Title | Percentage of Participants With Onset of End-stage Renal Disease (ESRD) (Core: Active Treatment Phase) |
|---|---|
| Description | ESRD is defined as initiation of dialysis, renal transplantation, or a serum creatinine concentration above 6.0 mg/dL (530 µmol per liter) or renal death |
| Time Frame | Time from randomization to the first event (Maximum 50 Months) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set (FAS) - All patients randomized except mis-randomized patients who did not receive study drug. Mis-randomized patients were defined as not qualified for randomization and were inadvertently randomized into the study. |
| Arm/Group Title | Aliskiren | Placebo |
|---|---|---|
| Arm/Group Description | In Core (Double Blind) phase, Aliskiren 150 mg once daily (o.d.) for 4 weeks; then patient was uptitrated to 300 mg o.d. at Visit 5/Week 4 (or 150 mg o.d. if patient could not tolerate target dose of study drug). Visits took place at 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase. | In Core (Double Blind) phase, placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase. |
| Measure Participants | 4274 | 4287 |
| Number [percentage of participants] |
2.7
0.1%
|
2.5
0.1%
|
| Title | Percentage of Participants With Occurrence of Secondary Cardiovascular Composite Endpoint (Core: Active Treatment Phase) |
|---|---|
| Description | Occurrence was defined as the first event of the following secondary cardiovascular composite endpoint: Cardiovascular (CV) death Resuscitated sudden death Non-fatal myocardial infarction (MI) Non-fatal stroke Unplanned hospitalization for heart failure (HF) |
| Time Frame | Time from randomization to the first event (Maximum 50 months) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set (FAS) - All patients randomized except mis-randomized patients who did not receive study drug. Mis-randomized patients were defined as not qualified for randomization and were inadvertently randomized into the study. |
| Arm/Group Title | Aliskiren | Placebo |
|---|---|---|
| Arm/Group Description | In Core (Double Blind) phase, Aliskiren 150 mg once daily (o.d.) for 4 weeks; then patient was uptitrated to 300 mg o.d. at Visit 5/Week 4 (or 150 mg o.d. if patient could not tolerate target dose of study drug). Visits took place at 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase. | In Core (Double Blind) phase, Placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase. |
| Measure Participants | 4274 | 4287 |
| Number [percentage of participants] |
13.4
0.3%
|
12.1
0.3%
|
| Title | Percentage of Participants With Occurrence of Secondary Renal Composite Endpoint (Core: Active Treatment Phase) |
|---|---|
| Description | Occurrence was defined as the first event of the following secondary renal composite endpoint: Onset of end-stage renal disease (ESRD) or death due to renal failure. Onset of ESRD was defined as initiation of dialysis, renal transplantation, or a serum creatinine concentration above 6.0 mg/dL (530 μmol/L), sustained for at least a month. Doubling of baseline serum creatinine concentration, sustained for at least one month. To fulfill the endpoint, the serum creatinine concentration had to be above the upper limit of normal for men and women according to the central laboratory.The upper limit of normal for men is 1.20 mg/dL and for women is 0.91 mg/dL. |
| Time Frame | Time from randomization to the first event (Maximum 50 months) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set (FAS) - All patients randomized except mis-randomized patients who did not receive study drug. Mis-randomized patients were defined as not qualified for randomization and were inadvertently randomized into the study. |
| Arm/Group Title | Aliskiren | Placebo |
|---|---|---|
| Arm/Group Description | In Core (Double Blind) phase, Aliskiren 150 mg once daily (o.d.) for 4 weeks; then patient was uptitrated to 300 mg o.d. at Visit 5/Week 4 (or 150 mg o.d. if patient could not tolerate target dose of study drug). Visits took place at 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase. | In Core (Double Blind) Phase, Placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase. |
| Measure Participants | 4274 | 4287 |
| Number [percentage of participants] |
5.6
0.1%
|
5.5
0.1%
|
| Title | Percentage of Participants With Occurrence of Secondary Cardiovascular Composite Endpoint (Extension Phase) |
|---|---|
| Description | Occurrence was defined as the first event of the following secondary cardiovascular composite endpoint: Cardiovascular (CV) death Resuscitated sudden death Non-fatal myocardial infarction (MI) Non-fatal stroke Unplanned hospitalization for heart failure (HF) |
| Time Frame | From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Extension-phase Analysis Set (EAS) - All patients who had at least one scheduled or unscheduled visit or who died post cut-off date 20-Dec-2011/end of treatment (EOT). |
| Arm/Group Title | Aliskiren | Placebo |
|---|---|---|
| Arm/Group Description | With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment. | With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment. |
| Measure Participants | 3773 | 3817 |
| Number [percentage of participants] |
5.0
0.1%
|
4.8
0.1%
|
| Title | Percentage of Participants With Occurrence of Secondary Renal Composite Endpoint (Extension Phase) |
|---|---|
| Description | Occurrence was defined as the first event of the following secondary renal composite endpoint: Onset of end-stage renal disease (ESRD) or death due to renal failure. Onset of ESRD was defined as initiation of dialysis, renal transplantation, or a serum creatinine concentration above 6.0 mg/dL (530 μmol/L), sustained for at least a month. Doubling of baseline serum creatinine concentration, sustained for at least one month. To fulfill the endpoint, the serum creatinine concentration had to be above the upper limit of normal for men and women according to the central laboratory. The upper limit of normal for men is 1.20 mg/dL and for women is 0.91 mg/dL. |
| Time Frame | From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Extension-phase Analysis Set (EAS) - All patients who had at least one scheduled or unscheduled visit or who died post cut-off date 20-Dec-2011/end of treatment (EOT). |
| Arm/Group Title | Aliskiren | Placebo |
|---|---|---|
| Arm/Group Description | With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment. | With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment. |
| Measure Participants | 3773 | 3817 |
| Number [percentage of participants] |
3.3
0.1%
|
3.6
0.1%
|
| Title | Percentage of Participants With Doubling of Baseline Serum Creatinine Concentration, Sustained for at Least One Month (Core: Active Treatment Phase) |
|---|---|
| Description | To fulfill the endpoint, the serum creatinine concentration had to be above the upper limit of normal for men and women according to the central laboratory. The upper limit of normal for men is 1.20 mg/dL and for women is 0.91 mg/dL. |
| Time Frame | Time from randomization to the first event (Maximum 50 Months) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set (FAS) - All patients randomized except mis-randomized patients who did not receive study drug. Mis-randomized patients were defined as not qualified for randomization and were inadvertently randomized into the study. |
| Arm/Group Title | Aliskiren | Placebo |
|---|---|---|
| Arm/Group Description | In Core (Double Blind) phase, Aliskiren 150 mg once daily (o.d.) for 4 weeks; then patient was uptitrated to 300 mg o.d. at Visit 5/Week 4 (or 150 mg o.d. if patient could not tolerate target dose of study drug). Visits took place at 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase. | In Core (Double Blind) phase, placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase. |
| Measure Participants | 4274 | 4287 |
| Number [percentage of participants] |
4.6
0.1%
|
4.7
0.1%
|
| Title | Percentage of Participants With Unplanned Hospitalization for Heart Failure (Core: Active Treatment Phase) |
|---|---|
| Description | |
| Time Frame | Time from randomization to the first event (Maximum 50 Months) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set (FAS) - All patients randomized except mis-randomized patients who did not receive study drug. Mis-randomized patients were defined as not qualified for randomization and were inadvertently randomized into the study. |
| Arm/Group Title | Aliskiren | Placebo |
|---|---|---|
| Arm/Group Description | In Core (Double Blind) phase, Aliskiren 150 mg once daily (o.d.) for 4 weeks; then patient was uptitrated to 300 mg o.d. at Visit 5/Week 4 (or 150 mg o.d. if patient could not tolerate target dose of study drug). Visits took place at 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase. | In Core (Double Blind) phase, placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase. |
| Measure Participants | 4274 | 4287 |
| Number [percentage of participants] |
4.7
0.1%
|
5.0
0.1%
|
| Title | Percentage of Participants With All Cause Mortality (Core: Active Treatment Phase) |
|---|---|
| Description | |
| Time Frame | Time from randomization to the first event (Maximum 50 months) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set (FAS) - All patients randomized except mis-randomized patients who did not receive study drug. Mis-randomized patients were defined as not qualified for randomization and were inadvertently randomized into the study. |
| Arm/Group Title | Aliskiren | Placebo |
|---|---|---|
| Arm/Group Description | In Core (Double Blind) phase, Aliskiren 150 mg once daily (o.d.) for 4 weeks; then patient was uptitrated to 300 mg o.d. at Visit 5/Week 4 (or 150 mg o.d. if patient could not tolerate target dose of study drug). Visits took place at 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase. | In Core (Double Blind) Phase, Placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase. |
| Measure Participants | 4274 | 4287 |
| Number [percentage of participants] |
8.4
0.2%
|
8.0
0.2%
|
| Title | Percentage of Participants With Occurrence of Primary Composite Endpoint (Extension Phase) |
|---|---|
| Description | Occurrence was defined as the first event of the following composite primary endpoint: Cardiovascular (CV) death Resuscitated sudden death Non-fatal myocardial infarction (MI) Non-fatal stroke Unplanned hospitalization for heart failure (HF) Onset of end-stage renal disease (ESRD) or death due to renal failure. Onset of ESRD was defined as initiation of dialysis, renal transplantation, or a serum creatinine concentration above 6.0 mg/dL (530 μmol/L), sustained for at least a month. Doubling of baseline serum creatinine concentration, sustained for at least one month. To fulfill the endpoint, the serum creatinine concentration had to be above the upper limit of normal for men and women according to the central laboratory. The upper limit of normal for men is 1.20 mg/dL and for women is 0.91 mg/dL. |
| Time Frame | From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Extension-phase Analysis Set (EAS) - All patients who had at least one scheduled or unscheduled visit or who died post cut-off date 20-Dec-2011/EOT. |
| Arm/Group Title | Aliskiren | Placebo |
|---|---|---|
| Arm/Group Description | With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment. | With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment. |
| Measure Participants | 3773 | 3817 |
| Number [percentage of participants] |
8.0
0.2%
|
8.0
0.2%
|
| Title | Percentage of Participants With Cardiovascular (CV) Death (Extension Phase) |
|---|---|
| Description | |
| Time Frame | from cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Extension-phase Analysis Set (EAS) - All patients who had at least one scheduled or unscheduled visit or who died post cut-off date 20-Dec-2011/EOT. |
| Arm/Group Title | Aliskiren | Placebo |
|---|---|---|
| Arm/Group Description | With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment. | With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment. |
| Measure Participants | 3773 | 3817 |
| Number [percentage of participants] |
2.1
0%
|
1.9
0%
|
| Title | Percentage of Participants With Resuscitated Sudden Death (Extension Phase) |
|---|---|
| Description | |
| Time Frame | From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Extension-phase Analysis Set (EAS) - All patients who had at least one scheduled or unscheduled visit or who died post cut-off date 20-Dec-2011/EOT. |
| Arm/Group Title | Aliskiren | Placebo |
|---|---|---|
| Arm/Group Description | With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment. | With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment. |
| Measure Participants | 3773 | 3817 |
| Number [percentage of participants] |
0.1
0%
|
0.1
0%
|
| Title | Percentage of Participants Fatal/Non-fatal Myocardial Infarction (MI) (Extension Phase) |
|---|---|
| Description | |
| Time Frame | From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 month in average) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Extension-phase Analysis Set (EAS) - All patients who had at least one scheduled or unscheduled visit or who died post cut-off date 20-Dec-2011/EOT. |
| Arm/Group Title | Aliskiren | Placebo |
|---|---|---|
| Arm/Group Description | With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment. | With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment. |
| Measure Participants | 3773 | 3817 |
| Number [percentage of participants] |
1.4
0%
|
1.1
0%
|
| Title | Percentage of Participants With Fatal/Non-fatal Stroke (Extension Phase) |
|---|---|
| Description | |
| Time Frame | From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Extension-phase Analysis Set (EAS) - All patients who had at least one scheduled or unscheduled visit or who died post cut-off date 20-Dec-2011/EOT. |
| Arm/Group Title | Aliskiren | Placebo |
|---|---|---|
| Arm/Group Description | With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment. | With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment. |
| Measure Participants | 3773 | 3817 |
| Number [percentage of participants] |
0.9
0%
|
1.0
0%
|
| Title | Percentage of Participants With Onset of End-stage Renal Disease (ESRD) (Extension Phase) |
|---|---|
| Description | ESRD is defined as initiation of dialysis, renal transplantation, or a serum creatinine concentration above 6.0 mg/dL (530 µmol per liter) or renal death |
| Time Frame | From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Aliskiren | Placebo |
|---|---|---|
| Arm/Group Description | With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment. | With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment. |
| Measure Participants | 3773 | 3817 |
| Number [percentage of participants] |
1.4
0%
|
1.5
0%
|
| Title | Percentage of Participants Doubling of Baseline Serum Creatinine Concentration, Sustained for at Least One Month (Extension Phase) |
|---|---|
| Description | To fulfill the endpoint, the serum creatinine concentration had to be above the upper limit of normal for men and women according to the central laboratory. The upper limit of normal for men is 1.20 mg/dL and for women is 0.91 mg/dL. |
| Time Frame | From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Extension-phase Analysis Set (EAS) - All patients who had at least one scheduled or unscheduled visit or who died post cut-off date 20-Dec-2011/EOT. |
| Arm/Group Title | Aliskiren | Placebo |
|---|---|---|
| Arm/Group Description | With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment. | With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment. |
| Measure Participants | 3773 | 3817 |
| Number [percentage of participants] |
2.4
0.1%
|
2.5
0.1%
|
| Title | Percentage of Participants With Unplanned Hospitalization for Heart Failure (Extension Phase) |
|---|---|
| Description | |
| Time Frame | From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Extension-phase Analysis Set (EAS) - All patients who had at least one scheduled or unscheduled visit or who died post cut-off date 20-Dec-2011/EOT. |
| Arm/Group Title | Aliskiren | Placebo |
|---|---|---|
| Arm/Group Description | With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment. | With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment. |
| Measure Participants | 3773 | 3817 |
| Number [percentage of participants] |
1.7
0%
|
1.5
0%
|
| Title | Percentage of Participants With All Cause Mortality (Extension Phase) |
|---|---|
| Description | |
| Time Frame | from cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Extension-phase Analysis Set (EAS) - All patients who had at least one scheduled or unscheduled visit or who died post cut-off date 20-Dec-2011/EOT. |
| Arm/Group Title | Aliskiren | Placebo |
|---|---|---|
| Arm/Group Description | With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment. | With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment. |
| Measure Participants | 3773 | 3817 |
| Number [percentage of participants] |
3.8
0.1%
|
3.6
0.1%
|
| Title | Percentage of Participants With Angioedema/Angioedema-like or Colorectal Events (Core : Active Treatment Phase) |
|---|---|
| Description | AEs of special interest were reported according to a post-marketing commitment to Health Authorities and included angioedema/angioedema-like events and colorectal events/ procedures |
| Time Frame | Time from randomization to the first event (Maximum 50 months) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Set (SAF) - All patients who received at least one dose of trial medication. Patients were analyzed according to the treatment they received. |
| Arm/Group Title | Aliskiren | Placebo |
|---|---|---|
| Arm/Group Description | In Core (Double Blind) phase, Aliskiren 150 mg once daily (o.d.) for 4 weeks; then patient was uptitrated to 300 mg o.d. at Visit 5/Week 4 (or 150 mg o.d. if patient could not tolerate target dose of study drug). Visits took place at 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase. | In Core (Double Blind) Phase, Placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase. |
| Measure Participants | 4272 | 4285 |
| Angioedema / angioedema-like events |
4.4
0.1%
|
4.8
0.1%
|
| Colorectal events |
2.4
0.1%
|
2.4
0.1%
|
| Title | Change From Baseline in Urinary Albumin to Creatinine Ratio (UACR) to Month 6 and to Last Measurement (Core : Active Treatment Phase) |
|---|---|
| Description | Baseline is the geometric mean of last 3 measurements before visit 3, Post-baseline value is the geometric mean of last 3 measurements during each visit. Change from Baseline = Post - Baseline. |
| Time Frame | Baseline, Month 6 , last measurement (maximum at 50 months) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set (FAS) - All patients randomized except mis-randomized patients who did not receive study drug. Last observation carried forward (LOCF) computation technique was used for month 6 data. At each visit, only patients with values at both baseline and this time point are included. |
| Arm/Group Title | Aliskiren | Placebo |
|---|---|---|
| Arm/Group Description | In Core (Double Blind) phase, Aliskiren 150 mg once daily (o.d.) for 4 weeks; then patient was uptitrated to 300 mg o.d. at Visit 5/Week 4 (or 150 mg o.d. if patient could not tolerate target dose of study drug). Visits took place at 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase. | In Core (Double Blind) Phase, Placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase. |
| Measure Participants | 4274 | 4287 |
| Baseline to Month 6 (n= 4021, 4040) |
0.841
|
0.945
|
| Baseline to Last Measurement (n= 4045, 4080) |
0.872
|
1.043
|
| Title | Mean Changes in Estimated Glomerular Filtration Rate (eGFR) From Baseline to Month 3 and Month 6 (Core : Active Treatment Phase) |
|---|---|
| Description | The eGFR calculation was based on the Abbreviated Modification of Diet in Renal Disease (MDRD) Study Equation. Using this method, the applicable MDRD formula to calculate eGFR was as follows: Estimated GFR (mL/min/1.73 m^2) = 175 x (serum creatinine in mg/dL) -1.154 x (Age in years) -0.203 x (0.742 if female) x (1.210 if Black) Mean changes in eGFR from baseline to month 3 and month 6 were included for analysis. The LS Mean and Standard Error were based on an ANCOVA repeated-measure model with treatment, visit, treatment-by-visit and baseline eGFR as effect terms. |
| Time Frame | Baseline to Month 3 and Month 6 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set (FAS) - All patients randomized except mis-randomized patients who did not receive study drug. At each visit (baseline, Month 3 and Month 6) , only patients with values at both baseline and post-baseline time point are included. |
| Arm/Group Title | Aliskiren | Placebo |
|---|---|---|
| Arm/Group Description | In Core (Double Blind) phase, Aliskiren 150 mg once daily (o.d.) for 4 weeks; then patient was uptitrated to 300 mg o.d. at Visit 5/Week 4 (or 150 mg o.d. if patient could not tolerate target dose of study drug). Visits took place at 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase. | In Core (Double Blind) Phase, Placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase. |
| Measure Participants | 4113 | 4130 |
| Least Squares Mean (Standard Error) [mL/min/1.73 m^2] |
-2.048
(0.15)
|
-0.825
(0.15)
|
| Title | Percentage of Participants With Angioedema/Angioedema-like Events or Colorectal Events (Extension Phase) |
|---|---|
| Description | AEs of special interest were reported according to a post-marketing commitment to Health Authorities and included angioedema/angioedema-like events and colorectal events/ procedures. |
| Time Frame | From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Extension-phase Analysis Set (EAS) - All patients who had at least one scheduled or unscheduled visit or who died post cut-off date 20-Dec-2011/end of treatment (EOT). |
| Arm/Group Title | Aliskiren | Placebo |
|---|---|---|
| Arm/Group Description | With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment. | With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment. |
| Measure Participants | 3773 | 3817 |
| Angioedema/ Angioedema-like event |
0.8
0%
|
1.2
0%
|
| Colorectal events |
0.7
0%
|
0.8
0%
|
Adverse Events
| Time Frame | ||||||||
|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||
| Arm/Group Title | Core-phase: Aliskiren | Core-phase: Placebo | Extension-phase: Aliskiren | Extension-phase: Placebo | ||||
| Arm/Group Description | In Core (Double Blind) phase, Aliskiren 150 mg once daily (o.d.) for 4 weeks; then patient was uptitrated to 300 mg o.d. at Visit 5/Week 4 (or 150 mg o.d. if patient could not tolerate target dose of study drug). Visits took place at 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase. | In Core (Double Blind) Phase, Placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until final closure of the study. | With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment. | With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment. | ||||
All Cause Mortality |
||||||||
| Core-phase: Aliskiren | Core-phase: Placebo | Extension-phase: Aliskiren | Extension-phase: Placebo | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | ||||
Serious Adverse Events |
||||||||
| Core-phase: Aliskiren | Core-phase: Placebo | Extension-phase: Aliskiren | Extension-phase: Placebo | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1988/4272 (46.5%) | 1893/4285 (44.2%) | 704/3773 (18.7%) | 682/3817 (17.9%) | ||||
| Blood and lymphatic system disorders | ||||||||
| Anaemia | 55/4272 (1.3%) | 36/4285 (0.8%) | 13/3773 (0.3%) | 16/3817 (0.4%) | ||||
| Anaemia haemolytic autoimmune | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Anaemia macrocytic | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Anaemia of chronic disease | 2/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Anaemia vitamin B12 deficiency | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Aplastic anaemia | 0/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Coagulopathy | 0/4272 (0%) | 1/4285 (0%) | 2/3773 (0.1%) | 0/3817 (0%) | ||||
| Disseminated intravascular coagulation | 2/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Haemolytic anaemia | 0/4272 (0%) | 2/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Haemorrhagic anaemia | 2/4272 (0%) | 3/4285 (0.1%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Iron deficiency anaemia | 3/4272 (0.1%) | 7/4285 (0.2%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Leukocytosis | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Lymphadenopathy | 1/4272 (0%) | 1/4285 (0%) | 2/3773 (0.1%) | 0/3817 (0%) | ||||
| Lymphadenopathy mediastinal | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Microcytic anaemia | 0/4272 (0%) | 2/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Nephrogenic anaemia | 2/4272 (0%) | 2/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Neutropenia | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Normochromic normocytic anaemia | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Pancytopenia | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Spontaneous haematoma | 0/4272 (0%) | 0/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Thrombocytopenia | 2/4272 (0%) | 2/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Cardiac disorders | ||||||||
| Acute coronary syndrome | 27/4272 (0.6%) | 34/4285 (0.8%) | 5/3773 (0.1%) | 7/3817 (0.2%) | ||||
| Acute left ventricular failure | 4/4272 (0.1%) | 3/4285 (0.1%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Acute myocardial infarction | 48/4272 (1.1%) | 64/4285 (1.5%) | 21/3773 (0.6%) | 19/3817 (0.5%) | ||||
| Angina pectoris | 93/4272 (2.2%) | 85/4285 (2%) | 22/3773 (0.6%) | 22/3817 (0.6%) | ||||
| Angina unstable | 52/4272 (1.2%) | 43/4285 (1%) | 10/3773 (0.3%) | 11/3817 (0.3%) | ||||
| Aortic valve disease | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Aortic valve stenosis | 5/4272 (0.1%) | 5/4285 (0.1%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Arrhythmia | 10/4272 (0.2%) | 13/4285 (0.3%) | 1/3773 (0%) | 3/3817 (0.1%) | ||||
| Arrhythmia supraventricular | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Arteriosclerosis coronary artery | 10/4272 (0.2%) | 9/4285 (0.2%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Atrial fibrillation | 59/4272 (1.4%) | 64/4285 (1.5%) | 6/3773 (0.2%) | 17/3817 (0.4%) | ||||
| Atrial flutter | 12/4272 (0.3%) | 6/4285 (0.1%) | 6/3773 (0.2%) | 1/3817 (0%) | ||||
| Atrial tachycardia | 2/4272 (0%) | 1/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Atrioventricular block | 5/4272 (0.1%) | 5/4285 (0.1%) | 2/3773 (0.1%) | 0/3817 (0%) | ||||
| Atrioventricular block complete | 15/4272 (0.4%) | 10/4285 (0.2%) | 4/3773 (0.1%) | 2/3817 (0.1%) | ||||
| Atrioventricular block first degree | 1/4272 (0%) | 0/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Atrioventricular block second degree | 6/4272 (0.1%) | 6/4285 (0.1%) | 2/3773 (0.1%) | 1/3817 (0%) | ||||
| Bradyarrhythmia | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Bradycardia | 16/4272 (0.4%) | 15/4285 (0.4%) | 2/3773 (0.1%) | 4/3817 (0.1%) | ||||
| Bundle branch block left | 1/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Cardiac amyloidosis | 0/4272 (0%) | 0/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Cardiac arrest | 30/4272 (0.7%) | 23/4285 (0.5%) | 7/3773 (0.2%) | 5/3817 (0.1%) | ||||
| Cardiac asthma | 2/4272 (0%) | 2/4285 (0%) | 2/3773 (0.1%) | 1/3817 (0%) | ||||
| Cardiac disorder | 2/4272 (0%) | 1/4285 (0%) | 2/3773 (0.1%) | 0/3817 (0%) | ||||
| Cardiac failure | 173/4272 (4%) | 173/4285 (4%) | 67/3773 (1.8%) | 50/3817 (1.3%) | ||||
| Cardiac failure acute | 14/4272 (0.3%) | 16/4285 (0.4%) | 4/3773 (0.1%) | 3/3817 (0.1%) | ||||
| Cardiac failure chronic | 14/4272 (0.3%) | 15/4285 (0.4%) | 2/3773 (0.1%) | 6/3817 (0.2%) | ||||
| Cardiac failure congestive | 90/4272 (2.1%) | 71/4285 (1.7%) | 18/3773 (0.5%) | 21/3817 (0.6%) | ||||
| Cardiac fibrillation | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Cardiac tamponade | 1/4272 (0%) | 1/4285 (0%) | 2/3773 (0.1%) | 0/3817 (0%) | ||||
| Cardiac valve disease | 1/4272 (0%) | 0/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Cardio-respiratory arrest | 12/4272 (0.3%) | 13/4285 (0.3%) | 2/3773 (0.1%) | 3/3817 (0.1%) | ||||
| Cardiogenic shock | 6/4272 (0.1%) | 8/4285 (0.2%) | 1/3773 (0%) | 4/3817 (0.1%) | ||||
| Cardiomegaly | 1/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Cardiomyopathy | 2/4272 (0%) | 2/4285 (0%) | 0/3773 (0%) | 2/3817 (0.1%) | ||||
| Cardiopulmonary failure | 2/4272 (0%) | 4/4285 (0.1%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Cardiovascular disorder | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Cardiovascular insufficiency | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Congestive cardiomyopathy | 2/4272 (0%) | 1/4285 (0%) | 2/3773 (0.1%) | 1/3817 (0%) | ||||
| Coronary artery disease | 67/4272 (1.6%) | 71/4285 (1.7%) | 25/3773 (0.7%) | 20/3817 (0.5%) | ||||
| Coronary artery insufficiency | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Coronary artery occlusion | 7/4272 (0.2%) | 4/4285 (0.1%) | 0/3773 (0%) | 3/3817 (0.1%) | ||||
| Coronary artery stenosis | 13/4272 (0.3%) | 13/4285 (0.3%) | 3/3773 (0.1%) | 2/3817 (0.1%) | ||||
| Diastolic dysfunction | 3/4272 (0.1%) | 2/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Dilatation ventricular | 0/4272 (0%) | 0/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Hypertensive cardiomyopathy | 1/4272 (0%) | 2/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Hypertensive heart disease | 5/4272 (0.1%) | 1/4285 (0%) | 2/3773 (0.1%) | 2/3817 (0.1%) | ||||
| Ischaemic cardiomyopathy | 7/4272 (0.2%) | 4/4285 (0.1%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Left ventricular dysfunction | 5/4272 (0.1%) | 3/4285 (0.1%) | 3/3773 (0.1%) | 0/3817 (0%) | ||||
| Left ventricular failure | 8/4272 (0.2%) | 10/4285 (0.2%) | 3/3773 (0.1%) | 2/3817 (0.1%) | ||||
| Left ventricular hypertrophy | 2/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Mitral valve incompetence | 4/4272 (0.1%) | 1/4285 (0%) | 1/3773 (0%) | 2/3817 (0.1%) | ||||
| Mitral valve stenosis | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Myocardial infarction | 87/4272 (2%) | 65/4285 (1.5%) | 23/3773 (0.6%) | 30/3817 (0.8%) | ||||
| Myocardial ischaemia | 37/4272 (0.9%) | 35/4285 (0.8%) | 8/3773 (0.2%) | 8/3817 (0.2%) | ||||
| Nodal arrhythmia | 1/4272 (0%) | 2/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Nodal rhythm | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Palpitations | 4/4272 (0.1%) | 5/4285 (0.1%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Pericardial effusion | 5/4272 (0.1%) | 6/4285 (0.1%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Pericarditis | 0/4272 (0%) | 0/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Pericarditis constrictive | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Postinfarction angina | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Pulseless electrical activity | 0/4272 (0%) | 0/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Right ventricular failure | 2/4272 (0%) | 2/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Sick sinus syndrome | 8/4272 (0.2%) | 5/4285 (0.1%) | 4/3773 (0.1%) | 4/3817 (0.1%) | ||||
| Silent myocardial infarction | 1/4272 (0%) | 3/4285 (0.1%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Sinus arrhythmia | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Sinus bradycardia | 4/4272 (0.1%) | 3/4285 (0.1%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Supraventricular tachyarrhythmia | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Supraventricular tachycardia | 3/4272 (0.1%) | 1/4285 (0%) | 2/3773 (0.1%) | 0/3817 (0%) | ||||
| Tachyarrhythmia | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Tachycardia | 5/4272 (0.1%) | 6/4285 (0.1%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Tachycardia paroxysmal | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Tricuspid valve incompetence | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Trifascicular block | 1/4272 (0%) | 1/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Ventricular arrhythmia | 3/4272 (0.1%) | 3/4285 (0.1%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Ventricular dysfunction | 0/4272 (0%) | 0/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Ventricular extrasystoles | 3/4272 (0.1%) | 1/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Ventricular fibrillation | 10/4272 (0.2%) | 5/4285 (0.1%) | 1/3773 (0%) | 3/3817 (0.1%) | ||||
| Ventricular tachyarrhythmia | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Ventricular tachycardia | 7/4272 (0.2%) | 3/4285 (0.1%) | 0/3773 (0%) | 4/3817 (0.1%) | ||||
| Congenital, familial and genetic disorders | ||||||||
| Arnold-Chiari malformation | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Atrial septal defect | 1/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Congenital arterial malformation | 0/4272 (0%) | 0/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Familial hypocalciuric hypercalcaemia | 0/4272 (0%) | 0/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Haemoglobinopathy | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Hydrocele | 2/4272 (0%) | 2/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Hypertrophic cardiomyopathy | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Phimosis | 1/4272 (0%) | 2/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Rathke's cleft cyst | 0/4272 (0%) | 0/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Sickle cell anaemia with crisis | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Ear and labyrinth disorders | ||||||||
| Deafness | 0/4272 (0%) | 0/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Deafness neurosensory | 2/4272 (0%) | 2/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Deafness unilateral | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Hearing impaired | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Sudden hearing loss | 0/4272 (0%) | 3/4285 (0.1%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Tinnitus | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Vertigo | 17/4272 (0.4%) | 9/4285 (0.2%) | 1/3773 (0%) | 4/3817 (0.1%) | ||||
| Vertigo positional | 2/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Vestibular disorder | 0/4272 (0%) | 2/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Endocrine disorders | ||||||||
| Basedow's disease | 0/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Cushing's syndrome | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Goitre | 4/4272 (0.1%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Hyperparathyroidism | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Hyperthyroidism | 0/4272 (0%) | 4/4285 (0.1%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Hypoparathyroidism | 0/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Hypothyroidism | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Inappropriate antidiuretic hormone secretion | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Primary hyperaldosteronism | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Eye disorders | ||||||||
| Amaurosis | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Angle closure glaucoma | 0/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Blindness | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Blindness unilateral | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Cataract | 33/4272 (0.8%) | 32/4285 (0.7%) | 12/3773 (0.3%) | 6/3817 (0.2%) | ||||
| Cataract diabetic | 1/4272 (0%) | 0/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Cataract nuclear | 0/4272 (0%) | 0/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Cataract subcapsular | 0/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Corneal degeneration | 0/4272 (0%) | 2/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Cystoid macular oedema | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Detachment of macular retinal pigment epithelium | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Diabetic eye disease | 1/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Diabetic retinopathy | 23/4272 (0.5%) | 18/4285 (0.4%) | 2/3773 (0.1%) | 4/3817 (0.1%) | ||||
| Diplopia | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Ectropion | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Eye haemorrhage | 3/4272 (0.1%) | 1/4285 (0%) | 2/3773 (0.1%) | 0/3817 (0%) | ||||
| Eyelid oedema | 2/4272 (0%) | 2/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Eyelid ptosis | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Glaucoma | 4/4272 (0.1%) | 2/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Iridocyclitis | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Iris adhesions | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Lenticular opacities | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Macular degeneration | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Macular fibrosis | 4/4272 (0.1%) | 3/4285 (0.1%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Macular hole | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Macular oedema | 0/4272 (0%) | 2/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Ocular hypertension | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Optic neuropathy | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Periorbital oedema | 2/4272 (0%) | 2/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Pterygium | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Retinal artery occlusion | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Retinal detachment | 6/4272 (0.1%) | 6/4285 (0.1%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Retinal haemorrhage | 4/4272 (0.1%) | 5/4285 (0.1%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Retinal tear | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Retinal vein occlusion | 0/4272 (0%) | 2/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Retinopathy | 3/4272 (0.1%) | 4/4285 (0.1%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Retinopathy proliferative | 1/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Ulcerative keratitis | 0/4272 (0%) | 0/4285 (0%) | 1/3773 (0%) | 1/3817 (0%) | ||||
| Vision blurred | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Visual impairment | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Vitreous adhesions | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Vitreous haemorrhage | 17/4272 (0.4%) | 11/4285 (0.3%) | 0/3773 (0%) | 2/3817 (0.1%) | ||||
| Gastrointestinal disorders | ||||||||
| Abdominal adhesions | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Abdominal discomfort | 1/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Abdominal distension | 3/4272 (0.1%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Abdominal hernia | 1/4272 (0%) | 2/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Abdominal mass | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Abdominal pain | 13/4272 (0.3%) | 13/4285 (0.3%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Abdominal pain lower | 0/4272 (0%) | 0/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Abdominal pain upper | 5/4272 (0.1%) | 3/4285 (0.1%) | 2/3773 (0.1%) | 1/3817 (0%) | ||||
| Abdominal strangulated hernia | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Abdominal wall haematoma | 0/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Anal fistula | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Ascites | 2/4272 (0%) | 4/4285 (0.1%) | 2/3773 (0.1%) | 0/3817 (0%) | ||||
| Colitis | 4/4272 (0.1%) | 5/4285 (0.1%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Colitis ischaemic | 1/4272 (0%) | 2/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Colitis microscopic | 0/4272 (0%) | 0/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Colitis ulcerative | 1/4272 (0%) | 0/4285 (0%) | 2/3773 (0.1%) | 2/3817 (0.1%) | ||||
| Constipation | 4/4272 (0.1%) | 7/4285 (0.2%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Crohn's disease | 1/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Dental caries | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Diabetic enteropathy | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Diabetic gastroenteropathy | 0/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Diabetic gastroparesis | 2/4272 (0%) | 2/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Diarrhoea | 12/4272 (0.3%) | 15/4285 (0.4%) | 4/3773 (0.1%) | 4/3817 (0.1%) | ||||
| Diverticular perforation | 2/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Diverticulitis intestinal haemorrhagic | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Diverticulum | 2/4272 (0%) | 2/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Diverticulum intestinal | 2/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Diverticulum intestinal haemorrhagic | 2/4272 (0%) | 1/4285 (0%) | 1/3773 (0%) | 1/3817 (0%) | ||||
| Duodenal polyp | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Duodenal ulcer | 5/4272 (0.1%) | 5/4285 (0.1%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Duodenal ulcer haemorrhage | 4/4272 (0.1%) | 5/4285 (0.1%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Duodenitis | 0/4272 (0%) | 3/4285 (0.1%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Dyspepsia | 2/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Dysphagia | 4/4272 (0.1%) | 1/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Enteritis | 4/4272 (0.1%) | 3/4285 (0.1%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Enterocolitis | 2/4272 (0%) | 0/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Enterocolitis haemorrhagic | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Epigastric discomfort | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Faecal incontinence | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Faecaloma | 3/4272 (0.1%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Food poisoning | 2/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Functional gastrointestinal disorder | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Gastric haemorrhage | 1/4272 (0%) | 4/4285 (0.1%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Gastric mucosa erythema | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Gastric perforation | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Gastric polyps | 3/4272 (0.1%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Gastric ulcer | 7/4272 (0.2%) | 12/4285 (0.3%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Gastric ulcer haemorrhage | 1/4272 (0%) | 2/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Gastric ulcer perforation | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Gastritis | 10/4272 (0.2%) | 16/4285 (0.4%) | 2/3773 (0.1%) | 3/3817 (0.1%) | ||||
| Gastritis atrophic | 1/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Gastritis erosive | 2/4272 (0%) | 3/4285 (0.1%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Gastritis haemorrhagic | 2/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Gastroduodenitis | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Gastroduodenitis haemorrhagic | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Gastrointestinal dysplasia | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Gastrointestinal haemorrhage | 17/4272 (0.4%) | 14/4285 (0.3%) | 5/3773 (0.1%) | 3/3817 (0.1%) | ||||
| Gastrointestinal hypomotility | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Gastrointestinal inflammation | 2/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Gastrointestinal ischaemia | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Gastrointestinal necrosis | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Gastrointestinal ulcer haemorrhage | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Gastrooesophageal reflux disease | 3/4272 (0.1%) | 4/4285 (0.1%) | 0/3773 (0%) | 2/3817 (0.1%) | ||||
| Gingival bleeding | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Haematemesis | 4/4272 (0.1%) | 3/4285 (0.1%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Haematochezia | 3/4272 (0.1%) | 2/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Haemorrhoidal haemorrhage | 0/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Haemorrhoids | 2/4272 (0%) | 5/4285 (0.1%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Hernial eventration | 2/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Hiatus hernia | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Ileus | 3/4272 (0.1%) | 3/4285 (0.1%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Ileus paralytic | 2/4272 (0%) | 2/4285 (0%) | 2/3773 (0.1%) | 0/3817 (0%) | ||||
| Impaired gastric emptying | 2/4272 (0%) | 2/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Inguinal hernia | 8/4272 (0.2%) | 9/4285 (0.2%) | 2/3773 (0.1%) | 2/3817 (0.1%) | ||||
| Inguinal hernia, obstructive | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Intestinal angina | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Intestinal haemorrhage | 0/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Intestinal infarction | 2/4272 (0%) | 0/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Intestinal ischaemia | 0/4272 (0%) | 3/4285 (0.1%) | 0/3773 (0%) | 2/3817 (0.1%) | ||||
| Intestinal mass | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Intestinal obstruction | 4/4272 (0.1%) | 4/4285 (0.1%) | 2/3773 (0.1%) | 1/3817 (0%) | ||||
| Intestinal perforation | 2/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Intestinal polyp | 4/4272 (0.1%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Intestinal stenosis | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Intussusception | 0/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Irritable bowel syndrome | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Ischaemic pancreatitis | 0/4272 (0%) | 0/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Large intestinal ulcer | 1/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Large intestine perforation | 2/4272 (0%) | 1/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Large intestine polyp | 17/4272 (0.4%) | 17/4285 (0.4%) | 2/3773 (0.1%) | 6/3817 (0.2%) | ||||
| Lip oedema | 0/4272 (0%) | 2/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Lip swelling | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Lower gastrointestinal haemorrhage | 1/4272 (0%) | 2/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Mechanical ileus | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Melaena | 5/4272 (0.1%) | 5/4285 (0.1%) | 3/3773 (0.1%) | 0/3817 (0%) | ||||
| Mesenteric occlusion | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Mouth haemorrhage | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Nausea | 11/4272 (0.3%) | 8/4285 (0.2%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Oesophageal haemorrhage | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Oesophageal stenosis | 0/4272 (0%) | 0/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Oesophageal ulcer | 0/4272 (0%) | 2/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Oesophageal varices haemorrhage | 2/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Oesophagitis | 2/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Palatal disorder | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Pancreatic mass | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Pancreatitis | 5/4272 (0.1%) | 4/4285 (0.1%) | 4/3773 (0.1%) | 1/3817 (0%) | ||||
| Pancreatitis acute | 8/4272 (0.2%) | 5/4285 (0.1%) | 1/3773 (0%) | 1/3817 (0%) | ||||
| Pancreatitis chronic | 0/4272 (0%) | 0/4285 (0%) | 1/3773 (0%) | 1/3817 (0%) | ||||
| Pancreatolithiasis | 0/4272 (0%) | 0/4285 (0%) | 1/3773 (0%) | 1/3817 (0%) | ||||
| Peptic ulcer haemorrhage | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Peptic ulcer perforation | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Peritoneal haematoma | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Pneumatosis intestinalis | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Portal hypertensive gastropathy | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Proctitis | 0/4272 (0%) | 0/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Rectal haemorrhage | 8/4272 (0.2%) | 1/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Rectal polyp | 3/4272 (0.1%) | 1/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Retroperitoneal haematoma | 0/4272 (0%) | 0/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Retroperitoneal haemorrhage | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Retroperitoneal mass | 0/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Salivary gland calculus | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Sciatic hernia | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Small intestinal haemorrhage | 0/4272 (0%) | 0/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Small intestinal obstruction | 2/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 2/3817 (0.1%) | ||||
| Stress ulcer | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Subileus | 1/4272 (0%) | 2/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Swollen tongue | 1/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Thrombosis mesenteric vessel | 1/4272 (0%) | 0/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Umbilical hernia | 1/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Upper gastrointestinal haemorrhage | 8/4272 (0.2%) | 11/4285 (0.3%) | 0/3773 (0%) | 2/3817 (0.1%) | ||||
| Varices oesophageal | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Volvulus | 2/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Vomiting | 22/4272 (0.5%) | 18/4285 (0.4%) | 0/3773 (0%) | 2/3817 (0.1%) | ||||
| General disorders | ||||||||
| Adverse drug reaction | 0/4272 (0%) | 1/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Asthenia | 15/4272 (0.4%) | 4/4285 (0.1%) | 6/3773 (0.2%) | 5/3817 (0.1%) | ||||
| Cardiac death | 8/4272 (0.2%) | 7/4285 (0.2%) | 3/3773 (0.1%) | 2/3817 (0.1%) | ||||
| Catheter site haemorrhage | 0/4272 (0%) | 0/4285 (0%) | 2/3773 (0.1%) | 0/3817 (0%) | ||||
| Chest discomfort | 2/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Chest pain | 4/4272 (0.1%) | 7/4285 (0.2%) | 4/3773 (0.1%) | 1/3817 (0%) | ||||
| Chills | 2/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Death | 21/4272 (0.5%) | 15/4285 (0.4%) | 13/3773 (0.3%) | 17/3817 (0.4%) | ||||
| Device battery issue | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Device dislocation | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Device electrical finding | 1/4272 (0%) | 0/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Device failure | 1/4272 (0%) | 0/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Device lead issue | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Device malfunction | 3/4272 (0.1%) | 1/4285 (0%) | 1/3773 (0%) | 1/3817 (0%) | ||||
| Discomfort | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Disease progression | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Drug intolerance | 1/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Face oedema | 11/4272 (0.3%) | 10/4285 (0.2%) | 2/3773 (0.1%) | 0/3817 (0%) | ||||
| Facial pain | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Fat tissue increased | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Fatigue | 3/4272 (0.1%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Gait disturbance | 1/4272 (0%) | 3/4285 (0.1%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| General physical health deterioration | 2/4272 (0%) | 4/4285 (0.1%) | 2/3773 (0.1%) | 2/3817 (0.1%) | ||||
| General symptom | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Generalised oedema | 10/4272 (0.2%) | 11/4285 (0.3%) | 5/3773 (0.1%) | 3/3817 (0.1%) | ||||
| Granuloma | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Hyperplasia | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Hyperthermia | 1/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Impaired healing | 1/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Inflammation | 0/4272 (0%) | 2/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Influenza like illness | 2/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Localised oedema | 2/4272 (0%) | 3/4285 (0.1%) | 2/3773 (0.1%) | 0/3817 (0%) | ||||
| Malaise | 2/4272 (0%) | 4/4285 (0.1%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Medical device complication | 1/4272 (0%) | 1/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Multi-organ failure | 0/4272 (0%) | 5/4285 (0.1%) | 4/3773 (0.1%) | 3/3817 (0.1%) | ||||
| Non-cardiac chest pain | 37/4272 (0.9%) | 39/4285 (0.9%) | 8/3773 (0.2%) | 2/3817 (0.1%) | ||||
| Oedema | 2/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Oedema due to cardiac disease | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Oedema peripheral | 45/4272 (1.1%) | 41/4285 (1%) | 7/3773 (0.2%) | 9/3817 (0.2%) | ||||
| Pain | 0/4272 (0%) | 1/4285 (0%) | 1/3773 (0%) | 2/3817 (0.1%) | ||||
| Pelvic mass | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Perforated ulcer | 1/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Pyrexia | 25/4272 (0.6%) | 13/4285 (0.3%) | 4/3773 (0.1%) | 3/3817 (0.1%) | ||||
| Spinal pain | 1/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Sudden cardiac death | 19/4272 (0.4%) | 13/4285 (0.3%) | 4/3773 (0.1%) | 3/3817 (0.1%) | ||||
| Sudden death | 20/4272 (0.5%) | 16/4285 (0.4%) | 9/3773 (0.2%) | 4/3817 (0.1%) | ||||
| Swelling | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Systemic inflammatory response syndrome | 2/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Ulcer | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Ulcer haemorrhage | 1/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Hepatobiliary disorders | ||||||||
| Acute hepatic failure | 0/4272 (0%) | 1/4285 (0%) | 2/3773 (0.1%) | 0/3817 (0%) | ||||
| Autoimmune hepatitis | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Bile duct obstruction | 0/4272 (0%) | 1/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Bile duct stenosis | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Bile duct stone | 7/4272 (0.2%) | 3/4285 (0.1%) | 0/3773 (0%) | 2/3817 (0.1%) | ||||
| Biliary cirrhosis primary | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Biliary colic | 3/4272 (0.1%) | 0/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Biliary cyst | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Cholangitis | 6/4272 (0.1%) | 2/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Cholangitis acute | 2/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Cholecystitis | 13/4272 (0.3%) | 12/4285 (0.3%) | 3/3773 (0.1%) | 6/3817 (0.2%) | ||||
| Cholecystitis acute | 8/4272 (0.2%) | 11/4285 (0.3%) | 1/3773 (0%) | 2/3817 (0.1%) | ||||
| Cholecystitis chronic | 1/4272 (0%) | 3/4285 (0.1%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Cholelithiasis | 13/4272 (0.3%) | 20/4285 (0.5%) | 4/3773 (0.1%) | 2/3817 (0.1%) | ||||
| Cholestasis | 0/4272 (0%) | 0/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Dilatation intrahepatic duct acquired | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Hepatic artery aneurysm | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Hepatic cirrhosis | 7/4272 (0.2%) | 4/4285 (0.1%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Hepatic congestion | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Hepatic cyst | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Hepatic failure | 1/4272 (0%) | 1/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Hepatic function abnormal | 1/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Hepatitis | 2/4272 (0%) | 3/4285 (0.1%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Hepatitis acute | 0/4272 (0%) | 2/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Hepatitis cholestatic | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Hepatorenal syndrome | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Jaundice | 3/4272 (0.1%) | 1/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Jaundice cholestatic | 0/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Liver disorder | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Portal vein thrombosis | 0/4272 (0%) | 0/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Immune system disorders | ||||||||
| Anaphylactic shock | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Contrast media allergy | 2/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Drug hypersensitivity | 2/4272 (0%) | 1/4285 (0%) | 2/3773 (0.1%) | 0/3817 (0%) | ||||
| Hypersensitivity | 0/4272 (0%) | 3/4285 (0.1%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Iodine allergy | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Sarcoidosis | 0/4272 (0%) | 0/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Secondary immunodeficiency | 0/4272 (0%) | 0/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Infections and infestations | ||||||||
| Abdominal abscess | 1/4272 (0%) | 2/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Abdominal infection | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Abdominal sepsis | 2/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Abscess limb | 2/4272 (0%) | 6/4285 (0.1%) | 2/3773 (0.1%) | 0/3817 (0%) | ||||
| American trypanosomiasis | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Anal abscess | 2/4272 (0%) | 3/4285 (0.1%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Appendiceal abscess | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Appendicitis | 5/4272 (0.1%) | 2/4285 (0%) | 3/3773 (0.1%) | 1/3817 (0%) | ||||
| Appendicitis perforated | 0/4272 (0%) | 1/4285 (0%) | 1/3773 (0%) | 1/3817 (0%) | ||||
| Arthritis infective | 1/4272 (0%) | 0/4285 (0%) | 2/3773 (0.1%) | 0/3817 (0%) | ||||
| Atypical pneumonia | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Bacteraemia | 3/4272 (0.1%) | 2/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Bacterial infection | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Biliary abscess | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Biliary tract infection | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Bone abscess | 1/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Breast abscess | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Bronchiolitis | 0/4272 (0%) | 1/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Bronchitis | 22/4272 (0.5%) | 22/4285 (0.5%) | 4/3773 (0.1%) | 11/3817 (0.3%) | ||||
| Bronchitis bacterial | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Bronchopneumonia | 21/4272 (0.5%) | 22/4285 (0.5%) | 6/3773 (0.2%) | 0/3817 (0%) | ||||
| Campylobacter gastroenteritis | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Candidiasis | 0/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Carbuncle | 2/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Catheter site infection | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Cellulitis | 41/4272 (1%) | 41/4285 (1%) | 16/3773 (0.4%) | 10/3817 (0.3%) | ||||
| Cellulitis of male external genital organ | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Chronic hepatitis B | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Chronic sinusitis | 3/4272 (0.1%) | 2/4285 (0%) | 2/3773 (0.1%) | 0/3817 (0%) | ||||
| Clostridial infection | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Clostridium difficile colitis | 3/4272 (0.1%) | 2/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Clostridium difficile infection | 0/4272 (0%) | 2/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Cystitis | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Cystitis bacterial | 0/4272 (0%) | 0/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Cystitis klebsiella | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Cytomegalovirus hepatitis | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Dengue fever | 0/4272 (0%) | 0/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Device related infection | 10/4272 (0.2%) | 5/4285 (0.1%) | 2/3773 (0.1%) | 1/3817 (0%) | ||||
| Device related sepsis | 2/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Diabetic foot infection | 5/4272 (0.1%) | 2/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Diabetic gangrene | 4/4272 (0.1%) | 4/4285 (0.1%) | 0/3773 (0%) | 3/3817 (0.1%) | ||||
| Diarrhoea infectious | 2/4272 (0%) | 0/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Diverticulitis | 4/4272 (0.1%) | 8/4285 (0.2%) | 2/3773 (0.1%) | 0/3817 (0%) | ||||
| Eczema infected | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Emphysematous pyelonephritis | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Endocarditis | 5/4272 (0.1%) | 2/4285 (0%) | 0/3773 (0%) | 4/3817 (0.1%) | ||||
| Endocarditis bacterial | 2/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Endocarditis staphylococcal | 0/4272 (0%) | 0/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Endometritis | 0/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Endophthalmitis | 0/4272 (0%) | 0/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Endotoxic shock | 0/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Enteritis infectious | 1/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Enteritis necroticans | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Enterobacter infection | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Enterococcal bacteraemia | 0/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 2/3817 (0.1%) | ||||
| Enterococcal sepsis | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Enterocolitis infectious | 2/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Epiglottitis | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Erysipelas | 18/4272 (0.4%) | 15/4285 (0.4%) | 6/3773 (0.2%) | 6/3817 (0.2%) | ||||
| Escherichia bacteraemia | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Escherichia sepsis | 2/4272 (0%) | 2/4285 (0%) | 1/3773 (0%) | 1/3817 (0%) | ||||
| Escherichia urinary tract infection | 2/4272 (0%) | 1/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Febrile infection | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Furuncle | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Gallbladder abscess | 2/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Gangrene | 14/4272 (0.3%) | 23/4285 (0.5%) | 0/3773 (0%) | 2/3817 (0.1%) | ||||
| Gas gangrene | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Gastritis viral | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Gastroenteritis | 32/4272 (0.7%) | 23/4285 (0.5%) | 7/3773 (0.2%) | 8/3817 (0.2%) | ||||
| Gastroenteritis bacterial | 0/4272 (0%) | 0/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Gastroenteritis norovirus | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Gastroenteritis viral | 0/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 2/3817 (0.1%) | ||||
| Gastrointestinal infection | 0/4272 (0%) | 2/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Gastrointestinal viral infection | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| H1N1 influenza | 0/4272 (0%) | 2/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| HIV infection | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Haematoma infection | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Herpes zoster | 6/4272 (0.1%) | 6/4285 (0.1%) | 4/3773 (0.1%) | 0/3817 (0%) | ||||
| Incision site infection | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Infected bites | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Infected bunion | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Infected fistula | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Infected skin ulcer | 6/4272 (0.1%) | 8/4285 (0.2%) | 3/3773 (0.1%) | 0/3817 (0%) | ||||
| Infection | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Infective exacerbation of bronchiectasis | 1/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Infective exacerbation of chronic obstructive airways disease | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Infective spondylitis | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Influenza | 4/4272 (0.1%) | 3/4285 (0.1%) | 1/3773 (0%) | 1/3817 (0%) | ||||
| Intervertebral discitis | 0/4272 (0%) | 1/4285 (0%) | 1/3773 (0%) | 1/3817 (0%) | ||||
| Keratitis bacterial | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Kidney infection | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Laryngitis | 0/4272 (0%) | 0/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Listeria sepsis | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Liver abscess | 4/4272 (0.1%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Lobar pneumonia | 7/4272 (0.2%) | 8/4285 (0.2%) | 3/3773 (0.1%) | 4/3817 (0.1%) | ||||
| Localised infection | 14/4272 (0.3%) | 10/4285 (0.2%) | 1/3773 (0%) | 3/3817 (0.1%) | ||||
| Lower respiratory tract infection | 10/4272 (0.2%) | 6/4285 (0.1%) | 5/3773 (0.1%) | 3/3817 (0.1%) | ||||
| Lower respiratory tract infection viral | 1/4272 (0%) | 0/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Lung abscess | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Lung infection | 21/4272 (0.5%) | 22/4285 (0.5%) | 6/3773 (0.2%) | 2/3817 (0.1%) | ||||
| Lymph node tuberculosis | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Lymphangitis | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Malaria | 1/4272 (0%) | 3/4285 (0.1%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Mastoid abscess | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Mediastinitis | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Meningitis | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Meningitis aseptic | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Meningitis bacterial | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Myelitis | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Myiasis | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Nasopharyngitis | 1/4272 (0%) | 3/4285 (0.1%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Necrotising fasciitis | 0/4272 (0%) | 1/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Nosocomial infection | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Oesophageal candidiasis | 2/4272 (0%) | 3/4285 (0.1%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Oral candidiasis | 0/4272 (0%) | 0/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Orchitis | 2/4272 (0%) | 2/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Oropharyngeal candidiasis | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Osteomyelitis | 20/4272 (0.5%) | 17/4285 (0.4%) | 3/3773 (0.1%) | 8/3817 (0.2%) | ||||
| Osteomyelitis chronic | 1/4272 (0%) | 3/4285 (0.1%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Otitis externa | 1/4272 (0%) | 2/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Otitis media chronic | 1/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Paronychia | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Parotitis | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Parvovirus infection | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Pericoronitis | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Perihepatic abscess | 2/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Periodontitis | 0/4272 (0%) | 0/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Periorbital cellulitis | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Perirectal abscess | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Peritoneal abscess | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Peritonitis | 6/4272 (0.1%) | 4/4285 (0.1%) | 1/3773 (0%) | 3/3817 (0.1%) | ||||
| Peritonsillar abscess | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Pharyngitis | 1/4272 (0%) | 2/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Pneumococcal sepsis | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Pneumonia | 121/4272 (2.8%) | 100/4285 (2.3%) | 42/3773 (1.1%) | 39/3817 (1%) | ||||
| Pneumonia bacterial | 2/4272 (0%) | 3/4285 (0.1%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Pneumonia legionella | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Pneumonia necrotising | 0/4272 (0%) | 0/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Pneumonia pneumococcal | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Pneumonia pseudomonas aeruginosa | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Pneumonia staphylococcal | 0/4272 (0%) | 0/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Pneumonia streptococcal | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Pneumonia viral | 0/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Post procedural cellulitis | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Post procedural infection | 4/4272 (0.1%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Post procedural sepsis | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Postoperative wound infection | 3/4272 (0.1%) | 7/4285 (0.2%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Prostate infection | 1/4272 (0%) | 0/4285 (0%) | 1/3773 (0%) | 1/3817 (0%) | ||||
| Proteus infection | 0/4272 (0%) | 0/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Pseudomembranous colitis | 0/4272 (0%) | 0/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Pulmonary sepsis | 2/4272 (0%) | 1/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Pulmonary tuberculosis | 4/4272 (0.1%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Purulent discharge | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Pyelonephritis | 10/4272 (0.2%) | 3/4285 (0.1%) | 4/3773 (0.1%) | 3/3817 (0.1%) | ||||
| Pyelonephritis acute | 5/4272 (0.1%) | 8/4285 (0.2%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Pyelonephritis chronic | 0/4272 (0%) | 2/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Pyonephrosis | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Q fever | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Renal abscess | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Respiratory moniliasis | 0/4272 (0%) | 0/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Respiratory tract infection | 11/4272 (0.3%) | 13/4285 (0.3%) | 2/3773 (0.1%) | 6/3817 (0.2%) | ||||
| Rhinitis | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Salmonellosis | 0/4272 (0%) | 1/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Schistosomiasis liver | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Scrotal infection | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Sepsis | 28/4272 (0.7%) | 27/4285 (0.6%) | 9/3773 (0.2%) | 18/3817 (0.5%) | ||||
| Septic encephalopathy | 0/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Septic shock | 15/4272 (0.4%) | 14/4285 (0.3%) | 5/3773 (0.1%) | 7/3817 (0.2%) | ||||
| Sinusitis | 0/4272 (0%) | 2/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Sinusitis fungal | 0/4272 (0%) | 0/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Skin infection | 1/4272 (0%) | 4/4285 (0.1%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Soft tissue infection | 3/4272 (0.1%) | 3/4285 (0.1%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Splenic abscess | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Staphylococcal abscess | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Staphylococcal bacteraemia | 0/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Staphylococcal infection | 5/4272 (0.1%) | 2/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Staphylococcal sepsis | 0/4272 (0%) | 2/4285 (0%) | 4/3773 (0.1%) | 0/3817 (0%) | ||||
| Staphylococcal skin infection | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Streptococcal bacteraemia | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Streptococcal sepsis | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Subcutaneous abscess | 4/4272 (0.1%) | 2/4285 (0%) | 2/3773 (0.1%) | 2/3817 (0.1%) | ||||
| Syphilis | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Tongue abscess | 0/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Tonsillitis | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Tooth abscess | 2/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Tooth infection | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Tracheitis | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Tracheobronchitis | 1/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Tuberculosis | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Tuberculous pleurisy | 0/4272 (0%) | 1/4285 (0%) | 2/3773 (0.1%) | 0/3817 (0%) | ||||
| Upper respiratory tract infection | 4/4272 (0.1%) | 4/4285 (0.1%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Upper respiratory tract infection bacterial | 0/4272 (0%) | 0/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Ureteritis | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Urethritis | 0/4272 (0%) | 0/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Urinary tract infection | 56/4272 (1.3%) | 44/4285 (1%) | 10/3773 (0.3%) | 15/3817 (0.4%) | ||||
| Urinary tract infection pseudomonal | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Urosepsis | 5/4272 (0.1%) | 14/4285 (0.3%) | 4/3773 (0.1%) | 2/3817 (0.1%) | ||||
| Vestibular neuronitis | 0/4272 (0%) | 2/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Viral diarrhoea | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Viral infection | 2/4272 (0%) | 6/4285 (0.1%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Viral pericarditis | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Wound infection | 3/4272 (0.1%) | 4/4285 (0.1%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Wound infection staphylococcal | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Injury, poisoning and procedural complications | ||||||||
| Abdominal injury | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Abdominal wound dehiscence | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Accidental exposure to product | 0/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Acetabulum fracture | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Ankle fracture | 5/4272 (0.1%) | 3/4285 (0.1%) | 2/3773 (0.1%) | 2/3817 (0.1%) | ||||
| Arterial injury | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Arterial restenosis | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Arteriovenous fistula site complication | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Bone contusion | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Brain contusion | 1/4272 (0%) | 1/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Burns second degree | 2/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Burns third degree | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Carbon monoxide poisoning | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Cervical vertebral fracture | 0/4272 (0%) | 3/4285 (0.1%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Clavicle fracture | 2/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Comminuted fracture | 0/4272 (0%) | 0/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Compression fracture | 0/4272 (0%) | 0/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Concussion | 1/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Contusion | 3/4272 (0.1%) | 3/4285 (0.1%) | 1/3773 (0%) | 3/3817 (0.1%) | ||||
| Coronary artery restenosis | 1/4272 (0%) | 2/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Craniocerebral injury | 0/4272 (0%) | 2/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Excoriation | 3/4272 (0.1%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Eye injury | 1/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Face injury | 1/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Facial bones fracture | 0/4272 (0%) | 0/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Fall | 23/4272 (0.5%) | 10/4285 (0.2%) | 2/3773 (0.1%) | 5/3817 (0.1%) | ||||
| Fat embolism | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Femoral neck fracture | 8/4272 (0.2%) | 9/4285 (0.2%) | 1/3773 (0%) | 2/3817 (0.1%) | ||||
| Femur fracture | 7/4272 (0.2%) | 13/4285 (0.3%) | 4/3773 (0.1%) | 3/3817 (0.1%) | ||||
| Fibula fracture | 2/4272 (0%) | 3/4285 (0.1%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Foot fracture | 4/4272 (0.1%) | 2/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Foreign body aspiration | 1/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Foreign body in eye | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Gun shot wound | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Haemodialysis complication | 0/4272 (0%) | 0/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Hand fracture | 2/4272 (0%) | 2/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Head injury | 7/4272 (0.2%) | 6/4285 (0.1%) | 1/3773 (0%) | 5/3817 (0.1%) | ||||
| Heat stroke | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Hip fracture | 9/4272 (0.2%) | 14/4285 (0.3%) | 3/3773 (0.1%) | 0/3817 (0%) | ||||
| Humerus fracture | 10/4272 (0.2%) | 8/4285 (0.2%) | 0/3773 (0%) | 2/3817 (0.1%) | ||||
| Incision site complication | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Incision site haematoma | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Incision site haemorrhage | 2/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Incisional hernia | 1/4272 (0%) | 2/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Intentional overdose | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Joint dislocation | 2/4272 (0%) | 2/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Joint injury | 2/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Laceration | 3/4272 (0.1%) | 2/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Ligament injury | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Ligament sprain | 0/4272 (0%) | 2/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Limb injury | 5/4272 (0.1%) | 2/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Limb traumatic amputation | 1/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Lower limb fracture | 3/4272 (0.1%) | 4/4285 (0.1%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Lumbar vertebral fracture | 2/4272 (0%) | 2/4285 (0%) | 1/3773 (0%) | 2/3817 (0.1%) | ||||
| Meniscus injury | 2/4272 (0%) | 2/4285 (0%) | 2/3773 (0.1%) | 0/3817 (0%) | ||||
| Multiple injuries | 1/4272 (0%) | 0/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Muscle rupture | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Muscle strain | 0/4272 (0%) | 0/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Overdose | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Patella fracture | 2/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 2/3817 (0.1%) | ||||
| Pelvic fracture | 1/4272 (0%) | 3/4285 (0.1%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Peritoneal dialysis complication | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Pneumothorax traumatic | 2/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Post laminectomy syndrome | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Post procedural complication | 2/4272 (0%) | 4/4285 (0.1%) | 1/3773 (0%) | 1/3817 (0%) | ||||
| Post procedural diarrhoea | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Post procedural haematoma | 1/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Post procedural haemorrhage | 2/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Post procedural myocardial infarction | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Post-traumatic neck syndrome | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Postoperative fever | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Postoperative hernia | 2/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Postoperative respiratory distress | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Postoperative wound complication | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Postpericardiotomy syndrome | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Procedural complication | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Procedural pain | 1/4272 (0%) | 1/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Radius fracture | 1/4272 (0%) | 1/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Rib fracture | 9/4272 (0.2%) | 4/4285 (0.1%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Road traffic accident | 9/4272 (0.2%) | 6/4285 (0.1%) | 1/3773 (0%) | 1/3817 (0%) | ||||
| Scratch | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Shunt occlusion | 0/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Shunt stenosis | 0/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Skeletal injury | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Skin injury | 0/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Skull fracture | 2/4272 (0%) | 0/4285 (0%) | 1/3773 (0%) | 1/3817 (0%) | ||||
| Soft tissue injury | 2/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Spinal column injury | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Spinal compression fracture | 4/4272 (0.1%) | 2/4285 (0%) | 1/3773 (0%) | 1/3817 (0%) | ||||
| Spinal cord injury | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Spinal cord injury cervical | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Spinal fracture | 1/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Subdural haematoma | 2/4272 (0%) | 6/4285 (0.1%) | 3/3773 (0.1%) | 1/3817 (0%) | ||||
| Subdural haemorrhage | 2/4272 (0%) | 3/4285 (0.1%) | 1/3773 (0%) | 1/3817 (0%) | ||||
| Sunburn | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Suture rupture | 0/4272 (0%) | 2/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Synovial rupture | 0/4272 (0%) | 0/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Tendon rupture | 4/4272 (0.1%) | 3/4285 (0.1%) | 1/3773 (0%) | 1/3817 (0%) | ||||
| Thermal burn | 3/4272 (0.1%) | 3/4285 (0.1%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Thoracic vertebral fracture | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Tibia fracture | 1/4272 (0%) | 4/4285 (0.1%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Toxicity to various agents | 2/4272 (0%) | 0/4285 (0%) | 3/3773 (0.1%) | 1/3817 (0%) | ||||
| Traumatic fracture | 10/4272 (0.2%) | 3/4285 (0.1%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Traumatic haemorrhage | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Traumatic intracranial haemorrhage | 0/4272 (0%) | 2/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Traumatic lung injury | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Traumatic shock | 0/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Traumatic ulcer | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Ulna fracture | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Upper limb fracture | 2/4272 (0%) | 1/4285 (0%) | 3/3773 (0.1%) | 0/3817 (0%) | ||||
| Vascular graft occlusion | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Vascular pseudoaneurysm | 0/4272 (0%) | 0/4285 (0%) | 1/3773 (0%) | 1/3817 (0%) | ||||
| Wound | 5/4272 (0.1%) | 5/4285 (0.1%) | 0/3773 (0%) | 3/3817 (0.1%) | ||||
| Wound dehiscence | 0/4272 (0%) | 2/4285 (0%) | 0/3773 (0%) | 2/3817 (0.1%) | ||||
| Wound haematoma | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Wrist fracture | 0/4272 (0%) | 1/4285 (0%) | 2/3773 (0.1%) | 0/3817 (0%) | ||||
| Investigations | ||||||||
| Anticoagulation drug level above therapeutic | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Blood creatine increased | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Blood creatine phosphokinase increased | 2/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Blood creatinine increased | 20/4272 (0.5%) | 15/4285 (0.4%) | 5/3773 (0.1%) | 0/3817 (0%) | ||||
| Blood glucose abnormal | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Blood glucose increased | 3/4272 (0.1%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Blood pressure decreased | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Blood pressure increased | 1/4272 (0%) | 3/4285 (0.1%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Brain natriuretic peptide increased | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| C-reactive protein increased | 0/4272 (0%) | 0/4285 (0%) | 1/3773 (0%) | 1/3817 (0%) | ||||
| Electrocardiogram abnormal | 0/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Electrocardiogram ambulatory abnormal | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Glomerular filtration rate abnormal | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| HIV test positive | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Haemoglobin decreased | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| International normalised ratio increased | 1/4272 (0%) | 0/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Occult blood | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Occult blood positive | 0/4272 (0%) | 1/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Oxygen saturation decreased | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Prostatic specific antigen increased | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Prothrombin time prolonged | 0/4272 (0%) | 0/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Red blood cell sedimentation rate increased | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Respiratory rate increased | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Troponin increased | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 3/3817 (0.1%) | ||||
| Urinary sediment present | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Urine output decreased | 2/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Weight decreased | 3/4272 (0.1%) | 1/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Weight increased | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Metabolism and nutrition disorders | ||||||||
| Acidosis | 2/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Cachexia | 0/4272 (0%) | 2/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Decreased appetite | 2/4272 (0%) | 2/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Dehydration | 26/4272 (0.6%) | 16/4285 (0.4%) | 5/3773 (0.1%) | 8/3817 (0.2%) | ||||
| Diabetes mellitus | 44/4272 (1%) | 49/4285 (1.1%) | 11/3773 (0.3%) | 8/3817 (0.2%) | ||||
| Diabetes mellitus inadequate control | 39/4272 (0.9%) | 36/4285 (0.8%) | 9/3773 (0.2%) | 10/3817 (0.3%) | ||||
| Diabetes with hyperosmolarity | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Diabetic complication | 1/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Diabetic ketoacidosis | 6/4272 (0.1%) | 5/4285 (0.1%) | 5/3773 (0.1%) | 1/3817 (0%) | ||||
| Dyslipidaemia | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Electrolyte imbalance | 2/4272 (0%) | 2/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Fluid overload | 6/4272 (0.1%) | 5/4285 (0.1%) | 4/3773 (0.1%) | 3/3817 (0.1%) | ||||
| Fluid retention | 1/4272 (0%) | 1/4285 (0%) | 2/3773 (0.1%) | 2/3817 (0.1%) | ||||
| Gout | 10/4272 (0.2%) | 12/4285 (0.3%) | 3/3773 (0.1%) | 3/3817 (0.1%) | ||||
| Hypercalcaemia | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 2/3817 (0.1%) | ||||
| Hyperglycaemia | 43/4272 (1%) | 45/4285 (1.1%) | 8/3773 (0.2%) | 11/3817 (0.3%) | ||||
| Hyperglycaemic hyperosmolar nonketotic syndrome | 2/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 2/3817 (0.1%) | ||||
| Hyperkalaemia | 44/4272 (1%) | 22/4285 (0.5%) | 8/3773 (0.2%) | 7/3817 (0.2%) | ||||
| Hyperlipidaemia | 2/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Hypernatraemia | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Hyperosmolar state | 0/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Hyperphosphataemia | 0/4272 (0%) | 0/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Hyperproteinaemia | 0/4272 (0%) | 0/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Hyperuricaemia | 4/4272 (0.1%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Hypervolaemia | 0/4272 (0%) | 1/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Hypocalcaemia | 1/4272 (0%) | 2/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Hypoglycaemia | 66/4272 (1.5%) | 57/4285 (1.3%) | 18/3773 (0.5%) | 15/3817 (0.4%) | ||||
| Hypoglycaemia unawareness | 0/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Hypokalaemia | 4/4272 (0.1%) | 7/4285 (0.2%) | 1/3773 (0%) | 2/3817 (0.1%) | ||||
| Hypomagnesaemia | 0/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Hyponatraemia | 8/4272 (0.2%) | 11/4285 (0.3%) | 2/3773 (0.1%) | 5/3817 (0.1%) | ||||
| Hypophagia | 0/4272 (0%) | 0/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Hypoproteinaemia | 1/4272 (0%) | 3/4285 (0.1%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Hypovitaminosis | 0/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Hypovolaemia | 1/4272 (0%) | 4/4285 (0.1%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Insulin resistance | 0/4272 (0%) | 1/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Iron deficiency | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Ketoacidosis | 0/4272 (0%) | 2/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Lactic acidosis | 0/4272 (0%) | 2/4285 (0%) | 0/3773 (0%) | 2/3817 (0.1%) | ||||
| Malnutrition | 0/4272 (0%) | 1/4285 (0%) | 1/3773 (0%) | 2/3817 (0.1%) | ||||
| Metabolic acidosis | 6/4272 (0.1%) | 5/4285 (0.1%) | 0/3773 (0%) | 3/3817 (0.1%) | ||||
| Metabolic disorder | 1/4272 (0%) | 5/4285 (0.1%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Metabolic syndrome | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Obesity | 4/4272 (0.1%) | 2/4285 (0%) | 4/3773 (0.1%) | 1/3817 (0%) | ||||
| Shock hypoglycaemic | 2/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Sodium retention | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Type 2 diabetes mellitus | 8/4272 (0.2%) | 7/4285 (0.2%) | 0/3773 (0%) | 2/3817 (0.1%) | ||||
| Musculoskeletal and connective tissue disorders | ||||||||
| Arthralgia | 3/4272 (0.1%) | 10/4285 (0.2%) | 1/3773 (0%) | 1/3817 (0%) | ||||
| Arthritis | 1/4272 (0%) | 3/4285 (0.1%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Arthritis reactive | 1/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Arthropathy | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Back pain | 10/4272 (0.2%) | 11/4285 (0.3%) | 1/3773 (0%) | 1/3817 (0%) | ||||
| Bone cyst | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Bone formation increased | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Bursitis | 0/4272 (0%) | 2/4285 (0%) | 1/3773 (0%) | 1/3817 (0%) | ||||
| Cervical spinal stenosis | 0/4272 (0%) | 1/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Costochondritis | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Dupuytren's contracture | 1/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Exostosis | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Fasciitis | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Fistula | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Flank pain | 3/4272 (0.1%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Foot deformity | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Fracture malunion | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Fracture nonunion | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Gouty arthritis | 4/4272 (0.1%) | 4/4285 (0.1%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Gouty tophus | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Inguinal mass | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Intervertebral disc degeneration | 0/4272 (0%) | 0/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Intervertebral disc disorder | 1/4272 (0%) | 5/4285 (0.1%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Intervertebral disc protrusion | 9/4272 (0.2%) | 11/4285 (0.3%) | 1/3773 (0%) | 5/3817 (0.1%) | ||||
| Joint effusion | 0/4272 (0%) | 0/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Joint range of motion decreased | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Knee deformity | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Limb discomfort | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Lumbar spinal stenosis | 7/4272 (0.2%) | 11/4285 (0.3%) | 0/3773 (0%) | 2/3817 (0.1%) | ||||
| Mobility decreased | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Muscle atrophy | 2/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Muscle necrosis | 2/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Muscle rigidity | 0/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Muscle spasms | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Muscle twitching | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Muscular weakness | 7/4272 (0.2%) | 1/4285 (0%) | 1/3773 (0%) | 1/3817 (0%) | ||||
| Musculoskeletal chest pain | 4/4272 (0.1%) | 2/4285 (0%) | 0/3773 (0%) | 2/3817 (0.1%) | ||||
| Musculoskeletal pain | 3/4272 (0.1%) | 5/4285 (0.1%) | 0/3773 (0%) | 2/3817 (0.1%) | ||||
| Myalgia | 1/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Myalgia intercostal | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Myofascial pain syndrome | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Myopathy toxic | 0/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Myositis | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Neck mass | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Neck pain | 1/4272 (0%) | 3/4285 (0.1%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Neuropathic arthropathy | 3/4272 (0.1%) | 0/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Osteitis | 1/4272 (0%) | 2/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Osteoarthritis | 24/4272 (0.6%) | 35/4285 (0.8%) | 2/3773 (0.1%) | 2/3817 (0.1%) | ||||
| Osteolysis | 1/4272 (0%) | 1/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Osteonecrosis | 4/4272 (0.1%) | 2/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Osteoporosis | 3/4272 (0.1%) | 1/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Pain in extremity | 7/4272 (0.2%) | 3/4285 (0.1%) | 1/3773 (0%) | 1/3817 (0%) | ||||
| Pain in jaw | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Pathological fracture | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Periarthritis | 2/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Polyarthritis | 3/4272 (0.1%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Polymyalgia rheumatica | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Rhabdomyolysis | 2/4272 (0%) | 5/4285 (0.1%) | 1/3773 (0%) | 1/3817 (0%) | ||||
| Rheumatoid arthritis | 0/4272 (0%) | 0/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Rotator cuff syndrome | 4/4272 (0.1%) | 2/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Sjogren's syndrome | 0/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Spinal column stenosis | 4/4272 (0.1%) | 5/4285 (0.1%) | 0/3773 (0%) | 2/3817 (0.1%) | ||||
| Spinal osteoarthritis | 8/4272 (0.2%) | 6/4285 (0.1%) | 1/3773 (0%) | 1/3817 (0%) | ||||
| Spondylolisthesis | 4/4272 (0.1%) | 4/4285 (0.1%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Synovial cyst | 0/4272 (0%) | 0/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Synovitis | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Systemic lupus erythematosus | 0/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Tendon pain | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Tendonitis | 1/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Tenosynovitis | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Trigger finger | 1/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||
| Abdominal neoplasm | 0/4272 (0%) | 0/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Acute myeloid leukaemia | 0/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Adenocarcinoma | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Adenocarcinoma gastric | 3/4272 (0.1%) | 1/4285 (0%) | 2/3773 (0.1%) | 1/3817 (0%) | ||||
| Adenocarcinoma of colon | 2/4272 (0%) | 4/4285 (0.1%) | 3/3773 (0.1%) | 2/3817 (0.1%) | ||||
| Adenocarcinoma pancreas | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Adrenal adenoma | 0/4272 (0%) | 2/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Adrenal gland cancer | 0/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Adrenal gland cancer metastatic | 0/4272 (0%) | 0/4285 (0%) | 1/3773 (0%) | 1/3817 (0%) | ||||
| Adrenal neoplasm | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Anal squamous cell carcinoma | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Angiomyolipoma | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Anogenital warts | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Astrocytoma malignant | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Basal cell carcinoma | 7/4272 (0.2%) | 8/4285 (0.2%) | 1/3773 (0%) | 2/3817 (0.1%) | ||||
| Benign breast neoplasm | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Benign laryngeal neoplasm | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Benign neoplasm | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Benign neoplasm of bladder | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Benign neoplasm of skin | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Benign pancreatic neoplasm | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Bladder cancer | 9/4272 (0.2%) | 8/4285 (0.2%) | 5/3773 (0.1%) | 1/3817 (0%) | ||||
| Bladder cancer recurrent | 0/4272 (0%) | 0/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Bladder neoplasm | 3/4272 (0.1%) | 3/4285 (0.1%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Bladder papilloma | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Bladder transitional cell carcinoma | 3/4272 (0.1%) | 2/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Bone neoplasm | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Brain cancer metastatic | 2/4272 (0%) | 0/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Brain neoplasm | 2/4272 (0%) | 3/4285 (0.1%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Breast adenoma | 0/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Breast cancer | 2/4272 (0%) | 5/4285 (0.1%) | 2/3773 (0.1%) | 2/3817 (0.1%) | ||||
| Breast cancer metastatic | 0/4272 (0%) | 2/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Breast neoplasm | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Bronchial carcinoma | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Carcinoid tumour of the duodenum | 0/4272 (0%) | 0/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Cerebellar tumour | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Cervix carcinoma | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Cholangiocarcinoma | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Chronic lymphocytic leukaemia | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Colon adenoma | 6/4272 (0.1%) | 7/4285 (0.2%) | 2/3773 (0.1%) | 2/3817 (0.1%) | ||||
| Colon cancer | 8/4272 (0.2%) | 9/4285 (0.2%) | 2/3773 (0.1%) | 2/3817 (0.1%) | ||||
| Colon cancer metastatic | 1/4272 (0%) | 2/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Colon neoplasm | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Colorectal cancer | 1/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Craniopharyngioma | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Ear neoplasm | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Endocrine neoplasm malignant | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Endometrial adenocarcinoma | 1/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Endometrial cancer | 0/4272 (0%) | 2/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Epithelioid mesothelioma | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Fibrosarcoma | 0/4272 (0%) | 1/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Gallbladder adenocarcinoma | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Gallbladder cancer | 0/4272 (0%) | 1/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Gastric cancer | 1/4272 (0%) | 8/4285 (0.2%) | 2/3773 (0.1%) | 3/3817 (0.1%) | ||||
| Gastric cancer stage IV | 0/4272 (0%) | 2/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Gastric neoplasm | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Gastrointestinal carcinoma | 0/4272 (0%) | 3/4285 (0.1%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Gastrointestinal stromal tumour | 1/4272 (0%) | 1/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Gastrointestinal tract adenoma | 2/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Glioblastoma multiforme | 0/4272 (0%) | 0/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Glottis carcinoma | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Hepatic cancer | 0/4272 (0%) | 1/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Hepatic cancer metastatic | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Hepatic neoplasm | 0/4272 (0%) | 4/4285 (0.1%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Hepatocellular carcinoma | 4/4272 (0.1%) | 5/4285 (0.1%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Intestinal adenocarcinoma | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Invasive ductal breast carcinoma | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Invasive lobular breast carcinoma | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Kaposi's sarcoma | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Keratoacanthoma | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Large intestine benign neoplasm | 2/4272 (0%) | 2/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Laryngeal cancer | 1/4272 (0%) | 2/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Laryngeal papilloma | 2/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Leiomyoma | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Leukaemia | 0/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Lip neoplasm | 0/4272 (0%) | 0/4285 (0%) | 1/3773 (0%) | 1/3817 (0%) | ||||
| Lipoma | 2/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Lung adenocarcinoma | 2/4272 (0%) | 6/4285 (0.1%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Lung adenocarcinoma stage IV | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Lung cancer metastatic | 2/4272 (0%) | 1/4285 (0%) | 1/3773 (0%) | 1/3817 (0%) | ||||
| Lung carcinoma cell type unspecified stage I | 0/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Lung neoplasm | 1/4272 (0%) | 3/4285 (0.1%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Lung neoplasm malignant | 12/4272 (0.3%) | 11/4285 (0.3%) | 2/3773 (0.1%) | 3/3817 (0.1%) | ||||
| Lymphoma | 1/4272 (0%) | 1/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Malignant ascites | 0/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Malignant melanoma | 4/4272 (0.1%) | 1/4285 (0%) | 0/3773 (0%) | 2/3817 (0.1%) | ||||
| Malignant melanoma in situ | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Malignant neoplasm of renal pelvis | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Malignant peritoneal neoplasm | 0/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Melanoma recurrent | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Meningioma | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Metastases to abdominal cavity | 0/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Metastases to bone | 2/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 3/3817 (0.1%) | ||||
| Metastases to central nervous system | 4/4272 (0.1%) | 2/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Metastases to liver | 3/4272 (0.1%) | 4/4285 (0.1%) | 1/3773 (0%) | 2/3817 (0.1%) | ||||
| Metastases to lung | 0/4272 (0%) | 0/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Metastases to peritoneum | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Metastases to spine | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Metastatic carcinoid tumour | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Metastatic gastric cancer | 0/4272 (0%) | 2/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Metastatic neoplasm | 1/4272 (0%) | 1/4285 (0%) | 2/3773 (0.1%) | 1/3817 (0%) | ||||
| Myelodysplastic syndrome | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 2/3817 (0.1%) | ||||
| Myxofibrosarcoma | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Neoplasm malignant | 1/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Neoplasm prostate | 0/4272 (0%) | 4/4285 (0.1%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Neoplasm skin | 2/4272 (0%) | 0/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Neuroendocrine carcinoma | 1/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Neuroendocrine tumour | 0/4272 (0%) | 0/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Neurofibroma | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Neuroma | 0/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Non-Hodgkin's lymphoma | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Non-small cell lung cancer | 2/4272 (0%) | 0/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Non-small cell lung cancer stage IV | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Oesophageal adenocarcinoma | 1/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Oesophageal cancer metastatic | 0/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Oesophageal carcinoma | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Osteochondroma | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Ovarian adenoma | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Ovarian cancer | 1/4272 (0%) | 0/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Ovarian neoplasm | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Pancreatic carcinoma | 3/4272 (0.1%) | 3/4285 (0.1%) | 1/3773 (0%) | 1/3817 (0%) | ||||
| Pancreatic carcinoma metastatic | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Pancreatic neoplasm | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Paraneoplastic syndrome | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Parathyroid tumour benign | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Pelvic neoplasm | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Peritoneal carcinoma metastatic | 0/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Plasma cell myeloma | 1/4272 (0%) | 1/4285 (0%) | 1/3773 (0%) | 1/3817 (0%) | ||||
| Plasmacytoma | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Pleural mesothelioma | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Prostate cancer | 26/4272 (0.6%) | 19/4285 (0.4%) | 2/3773 (0.1%) | 8/3817 (0.2%) | ||||
| Prostate cancer metastatic | 2/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Prostatic adenoma | 0/4272 (0%) | 2/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Rectal adenocarcinoma | 1/4272 (0%) | 2/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Rectal cancer | 2/4272 (0%) | 2/4285 (0%) | 3/3773 (0.1%) | 2/3817 (0.1%) | ||||
| Rectal cancer stage IV | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Rectal neoplasm | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Renal cancer | 3/4272 (0.1%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Renal cancer metastatic | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Renal cell carcinoma | 5/4272 (0.1%) | 1/4285 (0%) | 3/3773 (0.1%) | 0/3817 (0%) | ||||
| Renal neoplasm | 6/4272 (0.1%) | 3/4285 (0.1%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Salivary gland adenoma | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Sarcoma | 0/4272 (0%) | 0/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Skin cancer | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Skin papilloma | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Small cell lung cancer | 2/4272 (0%) | 2/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Small intestine adenocarcinoma | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Soft tissue cancer | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Splenic neoplasm malignancy unspecified | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Squamous cell carcinoma | 3/4272 (0.1%) | 4/4285 (0.1%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Squamous cell carcinoma of lung | 2/4272 (0%) | 0/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Squamous cell carcinoma of skin | 2/4272 (0%) | 4/4285 (0.1%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Squamous cell carcinoma of the cervix | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Squamous cell carcinoma of the tongue | 0/4272 (0%) | 2/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Testis cancer | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Thyroid adenoma | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Thyroid cancer | 0/4272 (0%) | 2/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Thyroid neoplasm | 2/4272 (0%) | 2/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Tongue neoplasm | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Tongue neoplasm malignant stage unspecified | 1/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Transitional cell carcinoma | 5/4272 (0.1%) | 2/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Transitional cell carcinoma metastatic | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Tumour haemorrhage | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Tumour ulceration | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Ureteric cancer | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Uterine cancer | 1/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Uterine leiomyoma | 1/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Uterine neoplasm | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Vocal cord neoplasm | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Nervous system disorders | ||||||||
| Altered state of consciousness | 0/4272 (0%) | 2/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Amnesia | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Apallic syndrome | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Aphasia | 2/4272 (0%) | 1/4285 (0%) | 1/3773 (0%) | 1/3817 (0%) | ||||
| Ataxia | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Autonomic nervous system imbalance | 1/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Autonomic neuropathy | 1/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Basal ganglia infarction | 2/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Basilar artery occlusion | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Brain hypoxia | 0/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Brain injury | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Brain oedema | 2/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Brain stem haemorrhage | 2/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Brain stem infarction | 2/4272 (0%) | 1/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Brain stem stroke | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Carotid artery disease | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Carotid artery occlusion | 1/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Carotid artery stenosis | 10/4272 (0.2%) | 18/4285 (0.4%) | 3/3773 (0.1%) | 4/3817 (0.1%) | ||||
| Carotid sinus syndrome | 0/4272 (0%) | 0/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Carpal tunnel syndrome | 2/4272 (0%) | 2/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Central nervous system lesion | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Cerebellar haemorrhage | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Cerebellar infarction | 1/4272 (0%) | 3/4285 (0.1%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Cerebral artery occlusion | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Cerebral haematoma | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Cerebral haemorrhage | 11/4272 (0.3%) | 11/4285 (0.3%) | 4/3773 (0.1%) | 2/3817 (0.1%) | ||||
| Cerebral infarction | 30/4272 (0.7%) | 27/4285 (0.6%) | 4/3773 (0.1%) | 10/3817 (0.3%) | ||||
| Cerebral ischaemia | 7/4272 (0.2%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Cerebral thrombosis | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Cerebrovascular accident | 93/4272 (2.2%) | 66/4285 (1.5%) | 23/3773 (0.6%) | 22/3817 (0.6%) | ||||
| Cerebrovascular disorder | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Cerebrovascular insufficiency | 1/4272 (0%) | 1/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Cervical myelopathy | 0/4272 (0%) | 2/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Cervicobrachial syndrome | 3/4272 (0.1%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Cognitive disorder | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Coma | 4/4272 (0.1%) | 4/4285 (0.1%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Complex partial seizures | 0/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Complicated migraine | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Convulsion | 5/4272 (0.1%) | 3/4285 (0.1%) | 1/3773 (0%) | 2/3817 (0.1%) | ||||
| Dementia | 2/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 2/3817 (0.1%) | ||||
| Dementia Alzheimer's type | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Demyelination | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Depressed level of consciousness | 2/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Diabetic autonomic neuropathy | 0/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Diabetic coma | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Diabetic hyperosmolar coma | 0/4272 (0%) | 2/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Diabetic neuropathy | 11/4272 (0.3%) | 12/4285 (0.3%) | 2/3773 (0.1%) | 6/3817 (0.2%) | ||||
| Dizziness | 19/4272 (0.4%) | 12/4285 (0.3%) | 2/3773 (0.1%) | 1/3817 (0%) | ||||
| Dysarthria | 1/4272 (0%) | 3/4285 (0.1%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Embolic stroke | 1/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Encephalitis | 2/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Encephalopathy | 0/4272 (0%) | 2/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Epidural lipomatosis | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Epilepsy | 7/4272 (0.2%) | 4/4285 (0.1%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Facial paresis | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Grand mal convulsion | 2/4272 (0%) | 2/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Haemorrhage intracranial | 0/4272 (0%) | 2/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Haemorrhagic cerebral infarction | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Haemorrhagic stroke | 3/4272 (0.1%) | 5/4285 (0.1%) | 1/3773 (0%) | 1/3817 (0%) | ||||
| Headache | 9/4272 (0.2%) | 5/4285 (0.1%) | 1/3773 (0%) | 3/3817 (0.1%) | ||||
| Hemianopia homonymous | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Hemiparesis | 8/4272 (0.2%) | 5/4285 (0.1%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Hemiplegia | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Hepatic encephalopathy | 0/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Hydrocephalus | 2/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Hypertensive encephalopathy | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 2/3817 (0.1%) | ||||
| Hypoaesthesia | 3/4272 (0.1%) | 2/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Hypoglycaemic coma | 2/4272 (0%) | 4/4285 (0.1%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Hypoglycaemic encephalopathy | 0/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Hypoglycaemic seizure | 0/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Hypoxic-ischaemic encephalopathy | 3/4272 (0.1%) | 2/4285 (0%) | 2/3773 (0.1%) | 1/3817 (0%) | ||||
| Intracranial aneurysm | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Intracranial pressure increased | 0/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Ischaemic cerebral infarction | 2/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Ischaemic stroke | 17/4272 (0.4%) | 15/4285 (0.4%) | 3/3773 (0.1%) | 6/3817 (0.2%) | ||||
| Lacunar infarction | 8/4272 (0.2%) | 6/4285 (0.1%) | 2/3773 (0.1%) | 1/3817 (0%) | ||||
| Lateral medullary syndrome | 0/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Lethargy | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Loss of consciousness | 7/4272 (0.2%) | 3/4285 (0.1%) | 0/3773 (0%) | 3/3817 (0.1%) | ||||
| Lumbar radiculopathy | 2/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Memory impairment | 0/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Metabolic encephalopathy | 2/4272 (0%) | 2/4285 (0%) | 2/3773 (0.1%) | 0/3817 (0%) | ||||
| Monoparesis | 0/4272 (0%) | 2/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Motor dysfunction | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Motor neurone disease | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Movement disorder | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Myasthenia gravis | 0/4272 (0%) | 0/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Myelitis transverse | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Myelopathy | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Myoclonus | 0/4272 (0%) | 2/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Nerve compression | 1/4272 (0%) | 3/4285 (0.1%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Neuralgia | 1/4272 (0%) | 3/4285 (0.1%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Neuroglycopenia | 2/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Neuropathy peripheral | 1/4272 (0%) | 2/4285 (0%) | 1/3773 (0%) | 1/3817 (0%) | ||||
| Normal pressure hydrocephalus | 1/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Occipital neuralgia | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Optic neuritis | 0/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Paraesthesia | 2/4272 (0%) | 3/4285 (0.1%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Paraparesis | 0/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Parkinson's disease | 0/4272 (0%) | 2/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Parkinsonism | 2/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Partial seizures | 0/4272 (0%) | 0/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Peripheral sensorimotor neuropathy | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Peroneal nerve palsy | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Phantom pain | 0/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Polyneuropathy | 2/4272 (0%) | 1/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Posterior reversible encephalopathy syndrome | 0/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Presyncope | 5/4272 (0.1%) | 3/4285 (0.1%) | 1/3773 (0%) | 1/3817 (0%) | ||||
| Radiculopathy | 0/4272 (0%) | 1/4285 (0%) | 1/3773 (0%) | 1/3817 (0%) | ||||
| Sciatica | 3/4272 (0.1%) | 7/4285 (0.2%) | 2/3773 (0.1%) | 0/3817 (0%) | ||||
| Sensory disturbance | 0/4272 (0%) | 0/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Simple partial seizures | 0/4272 (0%) | 0/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Somnolence | 1/4272 (0%) | 0/4285 (0%) | 1/3773 (0%) | 1/3817 (0%) | ||||
| Speech disorder | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Spinal claudication | 1/4272 (0%) | 2/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Spinal cord haemorrhage | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Spinal cord oedema | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Subarachnoid haemorrhage | 5/4272 (0.1%) | 4/4285 (0.1%) | 3/3773 (0.1%) | 0/3817 (0%) | ||||
| Subdural effusion | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Subdural hygroma | 0/4272 (0%) | 0/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Syncope | 40/4272 (0.9%) | 33/4285 (0.8%) | 7/3773 (0.2%) | 6/3817 (0.2%) | ||||
| Thalamic infarction | 3/4272 (0.1%) | 1/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Thalamus haemorrhage | 1/4272 (0%) | 0/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Thoracic outlet syndrome | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Thrombotic stroke | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Transient ischaemic attack | 24/4272 (0.6%) | 25/4285 (0.6%) | 4/3773 (0.1%) | 9/3817 (0.2%) | ||||
| Tremor | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Ulnar neuritis | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Uraemic encephalopathy | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| VIIth nerve paralysis | 4/4272 (0.1%) | 1/4285 (0%) | 1/3773 (0%) | 1/3817 (0%) | ||||
| Vascular encephalopathy | 1/4272 (0%) | 2/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Vertebrobasilar insufficiency | 6/4272 (0.1%) | 1/4285 (0%) | 1/3773 (0%) | 3/3817 (0.1%) | ||||
| Vocal cord paresis | 0/4272 (0%) | 0/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Psychiatric disorders | ||||||||
| Acute stress disorder | 0/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Aggression | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Agitation | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Anger | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Anxiety | 1/4272 (0%) | 2/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Anxiety disorder | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Bipolar disorder | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Completed suicide | 1/4272 (0%) | 0/4285 (0%) | 1/3773 (0%) | 1/3817 (0%) | ||||
| Confusional state | 9/4272 (0.2%) | 3/4285 (0.1%) | 2/3773 (0.1%) | 1/3817 (0%) | ||||
| Delirium | 3/4272 (0.1%) | 2/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Depression | 3/4272 (0.1%) | 2/4285 (0%) | 0/3773 (0%) | 3/3817 (0.1%) | ||||
| Disorientation | 1/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Echopraxia | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Hallucination | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Major depression | 1/4272 (0%) | 0/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Mental disorder | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Mental disorder due to a general medical condition | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Mental status changes | 0/4272 (0%) | 0/4285 (0%) | 1/3773 (0%) | 4/3817 (0.1%) | ||||
| Mood disorder due to a general medical condition | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Post-traumatic stress disorder | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Psychogenic pain disorder | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Psychotic disorder | 0/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Psychotic disorder due to a general medical condition | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Restlessness | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Schizophrenia | 0/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Sleep disorder | 0/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Social avoidant behaviour | 0/4272 (0%) | 0/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Stress | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Suicidal ideation | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Suicide attempt | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Transient psychosis | 0/4272 (0%) | 2/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Renal and urinary disorders | ||||||||
| Acute prerenal failure | 2/4272 (0%) | 2/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Albuminuria | 0/4272 (0%) | 0/4285 (0%) | 1/3773 (0%) | 1/3817 (0%) | ||||
| Anuria | 2/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Azotaemia | 4/4272 (0.1%) | 4/4285 (0.1%) | 2/3773 (0.1%) | 4/3817 (0.1%) | ||||
| Bladder cyst | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Bladder prolapse | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Bladder spasm | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Bladder stenosis | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Calculus bladder | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Calculus ureteric | 7/4272 (0.2%) | 3/4285 (0.1%) | 2/3773 (0.1%) | 1/3817 (0%) | ||||
| Calculus urinary | 1/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Chromaturia | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Diabetic end stage renal disease | 0/4272 (0%) | 0/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Diabetic nephropathy | 60/4272 (1.4%) | 57/4285 (1.3%) | 14/3773 (0.4%) | 14/3817 (0.4%) | ||||
| Dysuria | 1/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Glomerulonephritis membranous | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Glomerulonephritis rapidly progressive | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Glycosuria | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Haematuria | 7/4272 (0.2%) | 10/4285 (0.2%) | 2/3773 (0.1%) | 3/3817 (0.1%) | ||||
| Henoch-Schonlein purpura nephritis | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Hydronephrosis | 4/4272 (0.1%) | 3/4285 (0.1%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Hydroureter | 0/4272 (0%) | 1/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Intercapillary glomerulosclerosis | 0/4272 (0%) | 2/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Micturition disorder | 0/4272 (0%) | 2/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Nephrolithiasis | 6/4272 (0.1%) | 2/4285 (0%) | 1/3773 (0%) | 1/3817 (0%) | ||||
| Nephropathy | 3/4272 (0.1%) | 1/4285 (0%) | 1/3773 (0%) | 1/3817 (0%) | ||||
| Nephrotic syndrome | 6/4272 (0.1%) | 8/4285 (0.2%) | 2/3773 (0.1%) | 2/3817 (0.1%) | ||||
| Neurogenic bladder | 1/4272 (0%) | 0/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Nocturia | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Obstructive uropathy | 2/4272 (0%) | 4/4285 (0.1%) | 1/3773 (0%) | 1/3817 (0%) | ||||
| Oliguria | 3/4272 (0.1%) | 0/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Polyuria | 1/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Proteinuria | 2/4272 (0%) | 2/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Renal amyloidosis | 0/4272 (0%) | 0/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Renal artery stenosis | 0/4272 (0%) | 3/4285 (0.1%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Renal colic | 3/4272 (0.1%) | 4/4285 (0.1%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Renal cyst | 2/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Renal disorder | 0/4272 (0%) | 0/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Renal failure | 45/4272 (1.1%) | 24/4285 (0.6%) | 11/3773 (0.3%) | 15/3817 (0.4%) | ||||
| Renal failure acute | 73/4272 (1.7%) | 56/4285 (1.3%) | 27/3773 (0.7%) | 23/3817 (0.6%) | ||||
| Renal failure chronic | 74/4272 (1.7%) | 53/4285 (1.2%) | 26/3773 (0.7%) | 33/3817 (0.9%) | ||||
| Renal haemorrhage | 0/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Renal hypertension | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Renal impairment | 84/4272 (2%) | 64/4285 (1.5%) | 15/3773 (0.4%) | 13/3817 (0.3%) | ||||
| Renal mass | 0/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Renal tubular necrosis | 0/4272 (0%) | 0/4285 (0%) | 1/3773 (0%) | 1/3817 (0%) | ||||
| Tubulointerstitial nephritis | 0/4272 (0%) | 2/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Ureteral polyp | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Ureteric obstruction | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Urethral obstruction | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Urethral stenosis | 3/4272 (0.1%) | 5/4285 (0.1%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Urinary bladder haemorrhage | 0/4272 (0%) | 2/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Urinary bladder polyp | 0/4272 (0%) | 2/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Urinary incontinence | 6/4272 (0.1%) | 2/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Urinary retention | 5/4272 (0.1%) | 7/4285 (0.2%) | 2/3773 (0.1%) | 0/3817 (0%) | ||||
| Urinary tract obstruction | 3/4272 (0.1%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Urine abnormality | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Vesicoureteric reflux | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Reproductive system and breast disorders | ||||||||
| Acquired phimosis | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Benign prostatic hyperplasia | 13/4272 (0.3%) | 18/4285 (0.4%) | 4/3773 (0.1%) | 1/3817 (0%) | ||||
| Breast mass | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Dysfunctional uterine bleeding | 0/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Endometrial hyperplasia | 0/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Epididymitis | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Erectile dysfunction | 1/4272 (0%) | 0/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Menorrhagia | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Menstruation irregular | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Metrorrhagia | 1/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Ovarian cyst | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Penile haemorrhage | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Prostatic disorder | 0/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Prostatic obstruction | 0/4272 (0%) | 0/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Prostatitis | 5/4272 (0.1%) | 1/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Prostatomegaly | 0/4272 (0%) | 2/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Scrotal oedema | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Spermatocele | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Urogenital prolapse | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Uterine haemorrhage | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Uterine polyp | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Uterine prolapse | 1/4272 (0%) | 2/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Vaginal cyst | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Vaginal prolapse | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Vulval oedema | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Respiratory, thoracic and mediastinal disorders | ||||||||
| Acute pulmonary oedema | 19/4272 (0.4%) | 17/4285 (0.4%) | 7/3773 (0.2%) | 3/3817 (0.1%) | ||||
| Acute respiratory distress syndrome | 1/4272 (0%) | 0/4285 (0%) | 1/3773 (0%) | 1/3817 (0%) | ||||
| Acute respiratory failure | 12/4272 (0.3%) | 11/4285 (0.3%) | 4/3773 (0.1%) | 3/3817 (0.1%) | ||||
| Allergic bronchitis | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Alveolitis | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Asphyxia | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Aspiration | 1/4272 (0%) | 1/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Asthma | 10/4272 (0.2%) | 4/4285 (0.1%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Asthma late onset | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Asthmatic crisis | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Atelectasis | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Bronchiectasis | 2/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Bronchitis chronic | 3/4272 (0.1%) | 2/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Bronchopneumopathy | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Bronchospasm | 2/4272 (0%) | 2/4285 (0%) | 1/3773 (0%) | 1/3817 (0%) | ||||
| Choking | 1/4272 (0%) | 1/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Chronic obstructive pulmonary disease | 29/4272 (0.7%) | 23/4285 (0.5%) | 16/3773 (0.4%) | 9/3817 (0.2%) | ||||
| Cough | 6/4272 (0.1%) | 2/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Dyspnoea | 55/4272 (1.3%) | 52/4285 (1.2%) | 11/3773 (0.3%) | 10/3817 (0.3%) | ||||
| Dyspnoea at rest | 1/4272 (0%) | 2/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Dyspnoea exertional | 6/4272 (0.1%) | 5/4285 (0.1%) | 2/3773 (0.1%) | 2/3817 (0.1%) | ||||
| Dyspnoea paroxysmal nocturnal | 3/4272 (0.1%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Emphysema | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Eosinophilic pneumonia | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Epistaxis | 4/4272 (0.1%) | 3/4285 (0.1%) | 1/3773 (0%) | 1/3817 (0%) | ||||
| Haemoptysis | 3/4272 (0.1%) | 2/4285 (0%) | 1/3773 (0%) | 2/3817 (0.1%) | ||||
| Haemothorax | 3/4272 (0.1%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Hiccups | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Hydrothorax | 3/4272 (0.1%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Hypercapnia | 0/4272 (0%) | 1/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Hyperventilation | 0/4272 (0%) | 2/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Hypoxia | 5/4272 (0.1%) | 6/4285 (0.1%) | 3/3773 (0.1%) | 0/3817 (0%) | ||||
| Interstitial lung disease | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Laryngeal oedema | 0/4272 (0%) | 0/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Lower respiratory tract inflammation | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Lung disorder | 3/4272 (0.1%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Lung infiltration | 1/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Nasal polyps | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Nasal septum deviation | 2/4272 (0%) | 1/4285 (0%) | 1/3773 (0%) | 1/3817 (0%) | ||||
| Nasal turbinate hypertrophy | 0/4272 (0%) | 2/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Obstructive airways disorder | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Orthopnoea | 4/4272 (0.1%) | 2/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Pharyngeal cyst | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Pleural effusion | 12/4272 (0.3%) | 16/4285 (0.4%) | 5/3773 (0.1%) | 7/3817 (0.2%) | ||||
| Pleurisy | 2/4272 (0%) | 2/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Pneumonia aspiration | 2/4272 (0%) | 4/4285 (0.1%) | 0/3773 (0%) | 2/3817 (0.1%) | ||||
| Pneumonitis | 1/4272 (0%) | 2/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Pneumothorax | 0/4272 (0%) | 3/4285 (0.1%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Productive cough | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Pulmonary congestion | 1/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Pulmonary embolism | 10/4272 (0.2%) | 11/4285 (0.3%) | 5/3773 (0.1%) | 5/3817 (0.1%) | ||||
| Pulmonary fibrosis | 1/4272 (0%) | 3/4285 (0.1%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Pulmonary hypertension | 6/4272 (0.1%) | 6/4285 (0.1%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Pulmonary mass | 0/4272 (0%) | 4/4285 (0.1%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Pulmonary necrosis | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Pulmonary oedema | 22/4272 (0.5%) | 13/4285 (0.3%) | 4/3773 (0.1%) | 3/3817 (0.1%) | ||||
| Rales | 2/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Respiratory arrest | 2/4272 (0%) | 6/4285 (0.1%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Respiratory disorder | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Respiratory distress | 1/4272 (0%) | 8/4285 (0.2%) | 1/3773 (0%) | 1/3817 (0%) | ||||
| Respiratory failure | 29/4272 (0.7%) | 12/4285 (0.3%) | 10/3773 (0.3%) | 9/3817 (0.2%) | ||||
| Restrictive pulmonary disease | 0/4272 (0%) | 0/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Rhinitis hypertrophic | 1/4272 (0%) | 0/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Rhinorrhoea | 0/4272 (0%) | 0/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Sleep apnoea syndrome | 12/4272 (0.3%) | 10/4285 (0.2%) | 3/3773 (0.1%) | 4/3817 (0.1%) | ||||
| Stridor | 0/4272 (0%) | 0/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Tachypnoea | 0/4272 (0%) | 3/4285 (0.1%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Thoracic haemorrhage | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Upper airway resistance syndrome | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Vocal cord cyst | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Wheezing | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Skin and subcutaneous tissue disorders | ||||||||
| Actinic keratosis | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Angioedema | 8/4272 (0.2%) | 5/4285 (0.1%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Blister | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Decubitus ulcer | 3/4272 (0.1%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Dermatitis allergic | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Diabetic dermopathy | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Diabetic foot | 23/4272 (0.5%) | 22/4285 (0.5%) | 4/3773 (0.1%) | 7/3817 (0.2%) | ||||
| Diabetic ulcer | 3/4272 (0.1%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Drug eruption | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Dry gangrene | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Dry skin | 0/4272 (0%) | 1/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Eczema | 3/4272 (0.1%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Henoch-Schonlein purpura | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Hyperhidrosis | 3/4272 (0.1%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Hyperkeratosis | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Leukocytoclastic vasculitis | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Petechiae | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Pruritus | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Psoriasis | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Purpura | 0/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Pustular psoriasis | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Rash | 1/4272 (0%) | 2/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Rash erythematous | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Rash papular | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Rash vesicular | 0/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Skin necrosis | 1/4272 (0%) | 2/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Skin ulcer | 35/4272 (0.8%) | 21/4285 (0.5%) | 5/3773 (0.1%) | 3/3817 (0.1%) | ||||
| Stasis dermatitis | 2/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Stevens-Johnson syndrome | 1/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Swelling face | 2/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Social circumstances | ||||||||
| Activities of daily living impaired | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Drug abuser | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Vascular disorders | ||||||||
| Accelerated hypertension | 3/4272 (0.1%) | 2/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Aortic aneurysm | 8/4272 (0.2%) | 5/4285 (0.1%) | 1/3773 (0%) | 1/3817 (0%) | ||||
| Aortic aneurysm rupture | 2/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Aortic arteriosclerosis | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Aortic rupture | 0/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Aortic stenosis | 5/4272 (0.1%) | 4/4285 (0.1%) | 2/3773 (0.1%) | 2/3817 (0.1%) | ||||
| Arterial disorder | 4/4272 (0.1%) | 2/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Arterial insufficiency | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Arterial occlusive disease | 0/4272 (0%) | 2/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Arterial stenosis | 0/4272 (0%) | 2/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Arteriosclerosis | 4/4272 (0.1%) | 7/4285 (0.2%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Arteriosclerosis Moenckeberg-type | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Arteriovenous fistula | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Blood pressure inadequately controlled | 4/4272 (0.1%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Circulatory collapse | 6/4272 (0.1%) | 5/4285 (0.1%) | 1/3773 (0%) | 1/3817 (0%) | ||||
| Deep vein thrombosis | 8/4272 (0.2%) | 5/4285 (0.1%) | 5/3773 (0.1%) | 0/3817 (0%) | ||||
| Diabetic macroangiopathy | 0/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Diabetic vascular disorder | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Distributive shock | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Embolism arterial | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Essential hypertension | 0/4272 (0%) | 0/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Extremity necrosis | 0/4272 (0%) | 2/4285 (0%) | 0/3773 (0%) | 2/3817 (0.1%) | ||||
| Femoral artery aneurysm | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Femoral artery embolism | 0/4272 (0%) | 2/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Femoral artery occlusion | 3/4272 (0.1%) | 1/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Flushing | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Haematoma | 6/4272 (0.1%) | 2/4285 (0%) | 2/3773 (0.1%) | 1/3817 (0%) | ||||
| Haemodynamic instability | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Haemorrhage | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Hypertension | 38/4272 (0.9%) | 47/4285 (1.1%) | 7/3773 (0.2%) | 13/3817 (0.3%) | ||||
| Hypertensive crisis | 14/4272 (0.3%) | 18/4285 (0.4%) | 3/3773 (0.1%) | 3/3817 (0.1%) | ||||
| Hypertensive emergency | 1/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Hypotension | 31/4272 (0.7%) | 32/4285 (0.7%) | 3/3773 (0.1%) | 11/3817 (0.3%) | ||||
| Hypovolaemic shock | 3/4272 (0.1%) | 2/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Iliac artery occlusion | 1/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Infarction | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Intermittent claudication | 10/4272 (0.2%) | 8/4285 (0.2%) | 1/3773 (0%) | 2/3817 (0.1%) | ||||
| Jugular vein thrombosis | 0/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Labile hypertension | 0/4272 (0%) | 0/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Leriche syndrome | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Lymphocele | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Lymphoedema | 2/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Neovascularisation | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Orthostatic hypotension | 12/4272 (0.3%) | 8/4285 (0.2%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Peripheral arterial occlusive disease | 23/4272 (0.5%) | 31/4285 (0.7%) | 8/3773 (0.2%) | 10/3817 (0.3%) | ||||
| Peripheral artery aneurysm | 0/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Peripheral artery stenosis | 9/4272 (0.2%) | 13/4285 (0.3%) | 3/3773 (0.1%) | 4/3817 (0.1%) | ||||
| Peripheral circulatory failure | 0/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Peripheral embolism | 2/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Peripheral ischaemia | 13/4272 (0.3%) | 11/4285 (0.3%) | 2/3773 (0.1%) | 2/3817 (0.1%) | ||||
| Peripheral vascular disorder | 5/4272 (0.1%) | 10/4285 (0.2%) | 1/3773 (0%) | 3/3817 (0.1%) | ||||
| Phlebitis | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Poor peripheral circulation | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Shock | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 2/3817 (0.1%) | ||||
| Shock haemorrhagic | 0/4272 (0%) | 3/4285 (0.1%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Subclavian artery stenosis | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Subclavian steal syndrome | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Temporal arteritis | 1/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Thrombophlebitis | 1/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Thrombophlebitis superficial | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Thrombosis | 1/4272 (0%) | 0/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Varicophlebitis | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Varicose ulceration | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Varicose vein | 1/4272 (0%) | 2/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Vascular stenosis | 1/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Vasculitis | 1/4272 (0%) | 1/4285 (0%) | 1/3773 (0%) | 0/3817 (0%) | ||||
| Vena cava thrombosis | 1/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Venous insufficiency | 1/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
| Venous thrombosis | 0/4272 (0%) | 1/4285 (0%) | 0/3773 (0%) | 1/3817 (0%) | ||||
| Venous thrombosis limb | 2/4272 (0%) | 0/4285 (0%) | 0/3773 (0%) | 0/3817 (0%) | ||||
Other (Not Including Serious) Adverse Events |
||||||||
| Core-phase: Aliskiren | Core-phase: Placebo | Extension-phase: Aliskiren | Extension-phase: Placebo | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 3205/4272 (75%) | 3069/4285 (71.6%) | 995/3773 (26.4%) | 1023/3817 (26.8%) | ||||
| Blood and lymphatic system disorders | ||||||||
| Anaemia | 270/4272 (6.3%) | 270/4285 (6.3%) | 94/3773 (2.5%) | 76/3817 (2%) | ||||
| Gastrointestinal disorders | ||||||||
| Constipation | 202/4272 (4.7%) | 241/4285 (5.6%) | 48/3773 (1.3%) | 45/3817 (1.2%) | ||||
| Diarrhoea | 405/4272 (9.5%) | 305/4285 (7.1%) | 56/3773 (1.5%) | 41/3817 (1.1%) | ||||
| General disorders | ||||||||
| Oedema peripheral | 655/4272 (15.3%) | 670/4285 (15.6%) | 130/3773 (3.4%) | 112/3817 (2.9%) | ||||
| Infections and infestations | ||||||||
| Bronchitis | 217/4272 (5.1%) | 211/4285 (4.9%) | 36/3773 (1%) | 61/3817 (1.6%) | ||||
| Nasopharyngitis | 398/4272 (9.3%) | 369/4285 (8.6%) | 83/3773 (2.2%) | 89/3817 (2.3%) | ||||
| Upper respiratory tract infection | 214/4272 (5%) | 215/4285 (5%) | 48/3773 (1.3%) | 58/3817 (1.5%) | ||||
| Urinary tract infection | 286/4272 (6.7%) | 243/4285 (5.7%) | 72/3773 (1.9%) | 88/3817 (2.3%) | ||||
| Metabolism and nutrition disorders | ||||||||
| Hyperkalaemia | 1650/4272 (38.6%) | 1229/4285 (28.7%) | 270/3773 (7.2%) | 252/3817 (6.6%) | ||||
| Hypoglycaemia | 334/4272 (7.8%) | 297/4285 (6.9%) | 98/3773 (2.6%) | 87/3817 (2.3%) | ||||
| Musculoskeletal and connective tissue disorders | ||||||||
| Arthralgia | 295/4272 (6.9%) | 299/4285 (7%) | 52/3773 (1.4%) | 51/3817 (1.3%) | ||||
| Back pain | 360/4272 (8.4%) | 344/4285 (8%) | 54/3773 (1.4%) | 46/3817 (1.2%) | ||||
| Pain in extremity | 292/4272 (6.8%) | 311/4285 (7.3%) | 57/3773 (1.5%) | 42/3817 (1.1%) | ||||
| Nervous system disorders | ||||||||
| Dizziness | 314/4272 (7.4%) | 305/4285 (7.1%) | 45/3773 (1.2%) | 57/3817 (1.5%) | ||||
| Headache | 188/4272 (4.4%) | 219/4285 (5.1%) | 42/3773 (1.1%) | 28/3817 (0.7%) | ||||
| Renal and urinary disorders | ||||||||
| Renal impairment | 352/4272 (8.2%) | 321/4285 (7.5%) | 72/3773 (1.9%) | 87/3817 (2.3%) | ||||
| Respiratory, thoracic and mediastinal disorders | ||||||||
| Cough | 256/4272 (6%) | 280/4285 (6.5%) | 53/3773 (1.4%) | 47/3817 (1.2%) | ||||
| Vascular disorders | ||||||||
| Hypertension | 380/4272 (8.9%) | 410/4285 (9.6%) | 121/3773 (3.2%) | 105/3817 (2.8%) | ||||
| Hypotension | 496/4272 (11.6%) | 321/4285 (7.5%) | 34/3773 (0.9%) | 58/3817 (1.5%) | ||||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
Results Point of Contact
| Name/Title | Study Director |
|---|---|
| Organization | Novartis Pharmaceuticals |
| Phone | 862-778-8300 |
| trialandresults.registries@novartis.com |
Responsible Party:
Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00549757
Other Study ID Numbers:
- CSPP100E2337
- 2007-000860-25
First Posted:
Oct 26, 2007
Last Update Posted:
Apr 21, 2014
Last Verified:
Apr 1, 2014